Recommendations for the Use of Antiretroviral Drugs in ...2020/12/15 · Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions

Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States

Recommendations for the Use of Antiretroviral Drugs inPregnant Women with HIV Infection and Interventions to Reduce

Perinatal HIV Transmission in the United States


2

Table of Contents

Table 1 Outline of the Guidelines Development Process3Table 2 Rating Scheme for Recommendations5Table 3 Drug Interactions Between Antiretroviral Agents and Hormonal Contraceptives6Table 4 What to Start Initial Combination Regimens for the Antiretroviral-Naive Pregnant Women 16Table 5 Situation-Specific Recommendations for Use of Antiretroviral Drugs in Pregnant Womenand Nonpregnant Women Who Are Trying to Conceive20Table 6 HIV-Related Laboratory Monitoring Schedule for Pregnant Women with HIV24Table 7 Intrapartum Care and Recommended Interventions to Prevent Perinatal HIV Transmission for Women with HIV Based on Maternal HIV RNA Levels at the Time of Delivery26Table 8 Newborn Antiretroviral Management According to Risk of HIV Infection in theNewborn29Table 9 Newborn Antiretroviral Dosing Recommendations31Table 10 Antiretroviral Drug Use in Pregnant Women with HIV Infection Pharmacokinetic and Toxicity Data in Human Pregnancy and Recommendations for Use in Pregnancy34Supplemental Table 1 Results of Major Studies on Antiretroviral Prophylaxis to PreventPerinatal HIV Transmission 64


3

Guidelines Development ProcessTable 1 Outline of the Guidelines Development Process

Topic CommentGoal of the Guidelines Provide guidance to HIV care practitioners in the United States on the

optimal use of antiretroviral (ARV) agents to treat pregnant women with HIV and to prevent perinatal HIV transmission in HIV-exposed infants

Panel Members The Panel is composed of approximately 30 voting members who have expertise in managing the care of pregnant women with HIV (eg training in obstetricsgynecology infectious diseases or womenrsquos health) the pharmacology of ARV drugs during pregnancy and the interventions for prevention of perinatal transmission (eg specialized training in pediatric HIV infection) The Panel also includes community representatives with knowledge of HIV infection in pregnant women and interventions for prevention of perinatal transmission

The US government representatives appointed by their agencies include at least one representative from each of the following Department of Health and Human Services agencies the Centers for Disease Control and Prevention (CDC) the Food and Drug Administration (FDA) the Health Resources and Services Administration (HRSA) and the National Institutes of Health (NIH) Members who do not represent US government agencies are selected by Panel members after an open call for nominations Each member serves on the Panel for a 3-year period with an option for reappointment The Panel also may include liaison members from the National Perinatal HIV Hotline the American Academy of Pediatrics Committee on Pediatric AIDS the American College of Obstetricians and Gynecologists the Society of Obstetricians and Gynaecologists of Canada and the Canadian Pediatric and Perinatal Research Group A list of all Panel members can be found in the Guidelines Panel Members section

Financial Disclosures All members of the Panel submit an annual written financial disclosure that reports any association with manufacturers of ARV drugs or diagnostics used to manage HIV infection See Financial Disclosure for a list of the latest disclosures

Users of the Guidelines Providers of care to pregnant women with HIV and to infants who have been exposed to HIV

Developer The Panel on Treatment of Pregnant Women with HIV Infection and Prevention of Perinatal Transmissionmdasha working group of the Office of AIDS Research Advisory Council (OARAC)

Funding Source Office of AIDS Research NIHEvidence for Recommendations

The recommendations in these guidelines are generally based on studies published in peer-reviewed journals On some occasions particularly when new information may affect patient safety unpublished data that were presented at major conferences or prepared by the FDA andor manufacturers as warnings to the public may be used as evidence to revise the guidelines

Recommendation Grading See Table 2


4

Topic CommentMethod of Synthesizing Data Each section of the guidelines is assigned to a small group of Panel members

with expertise in the area of interest A structured literature search is conducted by a technical assistance consultant and provided to the Panel working group The members review and synthesize the available data and propose recommendations to the entire Panel The Panel discusses all proposals during monthly teleconferences Proposals are modified based on Panel discussions and then distributed with ballots to all Panel members If there are substantive comments or votes against approval the recommended changes and areas of disagreement are brought back to the full Panel (via email or teleconference) for review discussion and further modification to reach a final version that is acceptable to all Panel members The recommendations in these final versions represent the consensus of Panel members and are included in the guidelines as official Panel recommendations

Other Guidelines These guidelines focus on pregnant women with HIV and their infants Other guidelines (all of which are available on the ClinicalInfo website) outline the use of ARV agents in nonpregnant adults and adolescents with HIV use of ARV agents in infants and children with HIV treatment and prevention of opportunistic infections (OIs) in adults and adolescents with HIV including pregnant women treatment and prevention of OIs in children who have been exposed to HIV or who have HIV infection and treatment of people who experience occupational or nonoccupational exposure to HIV Preconception management for nonpregnant women of reproductive potential is briefly discussed in this document However for a more detailed discussion of the issues surrounding the treatment of nonpregnant adults please consult the Adult and Adolescent Antiretroviral Guidelines and the Adult and Adolescent Opportunistic Infection Guidelines

Update Plan The Panel meets monthly by teleconference to review data that may affect the content of the guidelines Updates may be prompted by new drug approvals (or new indications new dosing formulations andor changes in dosing frequency) significant new safety or efficacy data or other information that may have a significant impact on the clinical care of patients In the event of significant new data that may affect patient safety the Panel may issue a warning announcement and recommendations on the HIVinfo website until the guidelines can be updated with appropriate changes

Public Comments A 2-week public comment period follows the release of the updated guidelines on the ClinicalInfo website The Panel reviews comments to determine whether additional revisions to the guidelines are indicated The public also may submit comments to the Panel at any time at contactusHIVinfonihgov

Basis for RecommendationsThe recommendations in these guidelines are based on scientific evidence and expert opinion Each recommendation statement includes a letter (A B or C) that represents the strength of the recommendation and a Roman numeral (I II or III) that represents the quality of the evidence that supports the recommendation


5

Table 2 Rating Scheme for Recommendations


A-6

Strength of Recommendation Quality of Evidence for RecommendationA Strong recommendation for the statement

B Moderate recommendation for the statement

C Optional recommendation for the statement

I One or more randomized trials with clinical out-comes andor validated laboratory endpoints

II One or more well-designed nonrandomized trials or observational cohort studies with long-term clinical outcomes

III Expert opinion

References

1 US Preventive Services Task Force Owens DK Davidson KW et al Screening for HIV infection US preventive services task force recommendation statement JAMA 2019321(23)2326-2336 Available at httpswwwncbinlmnihgovpubmed31184701

2 Peters H Francis K Sconza R et al UK mother-to-child HIV transmission rates continue to decline 2012ndash2014 Clin Infect Dis 201764(4)527-528 Available at httpswwwncbinlmnihgovpubmed28174911

3 Centers for Disease Control and Prevention Monitoring selected national HIV prevention and care objectives by using HIV surveillance datamdashUnited States and 6 dependent areas 2017 HIV Surveillance Supplemental Report 2019 201924(3) Available at httpwwwcdcgovhivlibraryreports

4 Nesheim S Taylor A Lampe MA et al A framework for elimination of perinatal transmission of HIV in the United States Pediatrics 2012130(4)738-744 Available at httpwwwncbinlmnihgovpubmed22945404

5 Andrews MM Storm DS Burr CK et al Perinatal HIV service coordination closing gaps in the HIV care continuum for pregnant women and eliminating perinatal HIV transmission in the United States Public Health Rep 2018133(5)532-542 Available at httpswwwncbinlmnihgovpubmed30096026

6 Nesheim SR FitzHarris LF Mahle Gray K and Lampe MA Epidemiology of perinatal HIV transmission in the United States in the era of its elimination Pediatr Infect Dis J 201938(6)611-616 Available at httpswwwncbinlmnihgovpubmed30724833

7 FitzHarris LF Johnson CH Nesheim SR et al Prenatal HIV testing and the impact of state HIV testing laws 2004 to 2011 Sex Transm Dis 201845(9)583-587 Available at httpswwwncbinlmnihgovpubmed29485541

8 Salvant Valentine S and Poulin A Consistency of state statutes and regulations with Centers for Disease Control and Preventionrsquos 2006 perinatal HIV testing recommendations Public Health Rep 2018133(5)601-605 Available at httpswwwncbinlmnihgovpubmed30096022

9 Koumans EH Harrison A House LD et al Characteristics associated with lack of HIV testing during pregnancy and delivery in 36 US states 2004ndash2013 Int J STD AIDS 201829(12)1225-1233 Available at httpswwwncbinlmnihgovpubmed29969977

10 Aslam MV Owusu-Edusei K Nesheim SR Gray KM Lampe MA Dietz PM Trends in women with an HIV diagnosis at delivery hospitalization in the United States 2006mdash2014 Public Health Rep 2020135(4)524-533 Available at httpswwwncbinlmnihgovpubmed32649273


6

Table 3 Drug Interactions Between Antiretroviral Agents and Hormonal ContraceptivesNote All recommendations in this table are based on consensus expert opinion More details can be found in CDCrsquos US Medical Eligibility Criteria for Contraceptive Use 2016

ARV Drug

Effect on Contraceptive Drug Levels and Contraceptiversquos Effects

on ART and HIV

Clinical Studies

Dosing RecommendationClinical Comment

for COCPR


for POPs


for DMPAa

Dosing RecommendationClinical Comment for Etonogestrel

Implants

JustificationEvidence for

Recommendation

NNRTIsEFV COC

bull No effect on EE concentrations

bull darr active metabolites of norgestimate LNG AUC darr 83 and norelgestromin AUC darr 6429

bull Etonogestrel (in COC) C24h darr 6135

DMPAbull No effect on DMPA

levels2628

Etonogestrel Implantbull darr 49 in Etonorge-

strel concentration 45

bull Etonogestrel AUC darr 63 to 824953

bull uarr pregnancy incidence rate among women using LNG or ENG implants more among ENG users51

COCbull No difference

in pregnancy rates50

bull Pregnancy rate was 13 higher in women using COCs and EFV than in women using COCs alone4857

bull Progesterone gt3 ngmL (a surrogate for ovulation) in three of 16 women58

bull No ovulations29

DMPAbull No increase

in pregnancy rates 26485055

Consider an alternative method (or a reliable method of barrier contraception) in addition to this method


No additional contraceptive protection is needed

Consider an alternative method (or a reliable method of barrier con-traception) in addition to this method

For COCs some studies suggest higher pregnancy rate and ovulation rate and decreased progestin levels EFV may decrease but clinical significance unclear

For DMPA evidence does not show effects on pregnancy rate ovulation or DMPA levels Also no effect on HIV disease progression or EFV levels


7

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation

NNRTIs continuedLNG Implantbull darr61 LNG

concentration 45

bull LNG AUC darr 4740

bull LNG (emergency contraception) AUC darr 5824


Changes in ARV Levels andor Effects on HIVCOCbull No effect on EFV

concentrations29

bull EFV C12h darr 22 was under therapeutic threshold in three of 16 subjects35

DMPAbull No effect on

HIV disease progression265455

bull No effect on EFV concentrations26

bull Low progester-one262855

Etonogestrel Implantbull Pregnancy rate

higher with EFV compared with no ART but still lower with implants than with other hormonal methods of contraception48

bull Presumptive ovulation in 553

LN Implantbull 12 pregnancy

rate36

bull 15 pregnancy rate40

bull Pregnancy rate higher with EFV compared with no ART but still lower with implants than with other hormonal-

For implants some studies suggest higher pregnancy rate and decreased hormone levels

For vaginally administered etonogestrelEE PK evaluation showed that etonogestrel levels were 79 lower and EE levels were 59 lower in participants on EFV than in controls after 21 days56


8

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation

NNRTIs continuedLNG Implantbull No effect on HIV

disease progression40

Vaginally Administered EtonogestrelEEbull Etonogestrel darr 79

EE darr 5956

methods of contraception48

bull No increase in pregnancy rate50



ETR EE AUC uarr 2259

No significant effect on NE59

COCNo ovulations59





For COCs one study found no ovulations and no significant change in progestin levels

No data on POPs


9

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation

NNRTIs continuedNVP EE AUC darr 2960 no

change in EE AUC61

NE AUC darr 1860

Etonogestrel(in COC) C24h darr 2235

DMPA bull No significant

change26

LNG Implantbull LNG AUC uarr 3540 bull uarr pregnancy

incidence rate among women using LNG or ENG implants more among ENG users51

Changes in ARV Levels andor Effects on HIVCOCbull No significant effect

on NVP levels586062



LNG Implantbull No effect on


COCbull No increase

in pregnancy 4850576566



in pregnancy rate48505565


Etonogestrel Implantbull No increase

in pregnancy rate48

LNG ImplantNo increase in pregnancy3640485064





For COCs evidence does not show effects on pregnancy rate or ovulations Evidence demonstrated small decrease in progestin levels No effect on NVP levels

For DMPA evidence does not show effects on pregnancy rate ovulation or DMPA levels No effect on HIV disease progression

For implants evidence does not show effects on pregnancy rate or HIV disease progression


10

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation

NNRTIs continuedRPV EE AUC uarr 1434

No significant change on NE34

Changes in ARV Levels andor Effects on HIVCOCNo change in RPV levels compared to historical controls34

COCNo change in progesterone34





For COCs evidence does not show effects on ovulation or progestin levels No change in RPV levels

No data on POPs

DOR No clinically significant interaction with EE and LNG67

NA No additional contraceptive protection is needed




No clinical data

RTV-Boosted PIsATVr EE AUC darr 1968

Norgestimate AUC uarr 8568

POPbull NE AUC uarr 5069

Vaginally Administered EtonogestrelEEbull Etonogestrel uarr 71bull EE darr 3856





For COCs increase in progestin levels seen in only one studyFor POPs increase in progestin levels seen in only one study RTV inhibits CYP3A4 which may increase contraceptive hormone levels


11

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation

RTV-Boosted PIs continuedDRVr EE AUC darr 4470

NE AUC darr 1470

NA Can consider an alternative method (or a reliable method of barrier contraception) in addition to this method

Can consider an alternative method (or a reliable method of barrier contraception) in addition to this method



For COCs small decrease in progestin levels

No data on POPS

LPVr EE AUC darr 5525

NE AUC darr 17

Patchbull EE AUC darr 4525

bull Norelgestromin AUC uarr 8325

DMPAbull DMPA AUC uarr 4638

Etonogestrel Implantbull Etonogestrel AUC uarr

5253

COCbull Increased

pregnancy rate but CIs overlap48

Patchbull No ovulations25

DMPAbull No pregnancies

and no ovulations38

bull Increased pregnancy rate but CIs overlap48





For COCs nonsignificant increase in pregnancy rate Small decrease in progestin level

For patch no ovulations and progestin levels increased

For DMPA evidence shows no effect on pregnancy rate or ovulations Progestin levels increased


12

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation

RTV-Boosted PIs continuedChanges in ARV Levels andor Effects on HIVPatchbull LPVr darr 1925

DMPAbull No effect on HIV


bull No change in LPVr levels38


in pregnancy rate48

LN ImplantNo increase in pregnancy rate3648

For implants evidence shows no effect on pregnancy rate Progestin levels increased

COBI-Boosted PIsATVc Drospirenone AUC uarr

23-fold

No change in LNG concentration25 decrease in EE C24

42

NA Contraindi-cated with drospirenone- containing hormonal con-traceptives due to potential for hyperkalemia

Consider alternative or additional contraceptive method




No data on POPs

DRVc Drospirenone AUC uarr 16-fold

EE AUC darr 3043

NA Clinical monitoring is recommended when DRVc is used in combination with




No data on POPs


13

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation

COBI-Boosted PIs continueddrospirenone-containingCOCs as a result of the potential for hyperkalemia


PIs without RTVATV COC

bull EE AUC uarr 4871

bull NE AUC uarr 11071

NA Prescribe oral contraceptive that contains no more than 30 mcg of EE or recommend alternative contraceptive method




For COCs increased concentrations of estrogen and progestin but the only data available are from the product labelNo data on POPs

CCR5 AntagonistMVC COC

bull No significant effect on EE or LN72





For COCs no change in EE or progestin No clinical data

No data on POPs


14

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation

INSTIsBICFTCTAF

No significant drug interactions with EE or norgestimate





No clinical data

DTG COCbull No significant effect

on norgestimate or EE

bull No change in DTG AUC39






No data on POPs

EVGc COCbull Norgestimate AUC

uarr 126

bull EE AUC darr 257374





When administered as the four-drug regimen EVGcFTCTDF increases in progestin and a small decrease in EE were observed No clinical data

No data on POPs

RAL COCbull No change in EE bull Norgestimate AUC uarr

1475





For COCs no change in EE and a small increase in progestin No clinical data


15

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation

INSTIs continuedNo data on POPs

a Because the hormonal levels achieved with DMPA are substantially higher than the levels that are required for contraception any small reduction in hormonal level attributed to ARV drugs is unlikely to reduce contraceptive effectiveness

Key to Symbols uarr = increase darr = decrease

Key APV = amprenavir ART = antiretroviral therapy ARV = antiretroviral ATV = atazanavir ATVc = atazanavircobicistat ATVr = atazanavirritonavir AUC = area under the curve BIC = bictegravir C12h = concentration at 12 hours post-dose C24h = concentration at 24 hours post-dose CD4 = CD4 T lymphocyte CDC = Centers for Disease Control and Prevention CHC = combination hormonal contraceptives CI = confidence interval Cmin = minimum plasma concentration COBI = cobicistat COCPR = combined oral contraceptivespatchring CYP = cytochrome P450 DMPA = depot medroxyprogesterone acetate DOR= doravirine DRVc = darunavircobicistat DRVr = darunavirritonavir DTG = dolutegravir EE = ethinyl estradiol EFV = efavirenz ENG = etonogestrel ETR = etravirine EVGc = elvitegravircobicistat FPV = fosamprenavir FPVr = fosamprenavirritonavir FTC = emtricitabine IDV = indinavir INSTI = integrase strand transfer inhibitor LNG = levonorgestrelLPVr = lopinavirritonavir MVC = maraviroc NE = norethindrone NFV = nelfinavir NNRTI = non-nucleoside reverse transcriptase inhibitor NVP = nevirapine P = progestin PI = protease inhibitor PIr = protease inhibitorritonavir PK = pharmacokinetic POP = progesterone-only oral contraceptive pills RAL = raltegravir RPV = rilpivirine RTV = ritonavir SQVr = saquinavirritonavir TAF = tenofovir alafenamide TDF = tenofovir disoproxil fumarate TPV = tipranavir TPVr = tipranavirritonavir

Source Panel on Antiretroviral Guidelines for Adults and Adolescents Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV Department of Health and Human Services Tables 21a 21b and 21d


16

Table 4 What to Start Initial Combination Regimens for Antiretroviral-Naive Pregnant Women (Last updated February 10 2021 last reviewed February 10 2021)

Recommendations for initial therapy are intended for pregnant women who have never received ART or ARV drugs for prophylaxis (ie women who are ARV-naive) and who show no evidence of significant resistance to regimen components (also see Pregnant Women with HIV Who Have Never Received Antiretroviral Drugs and Table 5)

In general the Panel recommends that women who are already on fully suppressive ARV regimens when pregnancy occurs should continue to use those regimens unless they are receiving an ARV drug or ARV regimen that is not recommended for use in adults or there are concerns about safety and inferior efficacy during pregnancy (see Table 5 and Pregnant Women with HIV Who Are Currently Receiving Antiretroviral Therapy) Clinicians may need to consider additional factors when initiating ART in women who previously received ART or ARV drugs for prophylaxis (see Pregnant Women with HIV Who Have Previously Received Antiretroviral Treatment or Prophylaxis but Are Not Currently Receiving Any Antiretroviral Medications and Table 5)

Regimens are listed alphabetically within each drug class and recommendation category so the order does not indicate a ranking of preference In addition the Panel makes no recommendation of one agent or regimen over another within each category (Preferred or Alternative) The table also indicates antiretroviral drugs or regimens that are available in fixed-dose combination (FDC) tablets

Note For more information about the use of specific drugs and dosing in pregnancy see Table 5 the individual drug sections in Appendix B and Table 10

Drug or Drug Combination Comments

Preferred Initial Regimens in PregnancyDrugs or drug combinations are designated as Preferred for therapy in pregnant women when clinical trial data in adults have demonstrated efficacy and durability with acceptable toxicity and ease of use and pregnancy-specific PK data are available to guide dosing In addition the available data must suggest a favorable risk-benefit balance for the drug or drug combination compared with other ARV drug options the assessment of risks and benefits should incorporate outcomes for women fetuses and infants Some Preferred drugs or regimens may have minimal toxicity or teratogenicity risks that are offset by other advantages for women with HIV who are pregnant or who are trying to conceive Therefore it is important to read all the information on each drug in the Perinatal Guidelines before administering any of these medications to patients (also see Appendix B Supplement Safety and Toxicity of Individual Antiretroviral Agents in Pregnancy)

Preferred Dual-NRTI Backbones

ABC3TC

Available as an FDC Can be administered once daily ABC should not be used in patients who test positive for HLA-B5701 because of the risk of developing a hypersen-sitivity reaction ABC3TC administered with ATVr or EFV is not recommended if pre-treatment HIV RNA is gt100000 copiesmL

TDFFTCor

TDF3TC

TDFFTC is available as an FDC Either coformulated TDFFTC or separate doses of TDF and 3TC can be administered once daily TDF has potential renal toxicity thus TDF-based dual-NRTI combinations should be used with caution in patients with renal insufficiency

Preferred INSTI Regimens

DTGABC3TC (FDC)or

DTG plus a Preferred Dual-NRTI Backbonea

Administered once daily The use of DTGABC3TC requires HLA-B5701 testing because this FDC contains ABC INSTI-based regimens may be particularly useful when drug interactions or the potential for preterm delivery with a PI-based regimen are a concernIn nonpregnant adults DTG is associated with lower rates of INSTI resistance than RAL like RAL DTG has been shown to rapidly decrease viral load in ARV-naive pregnant women who present to care


17

Preferred INSTI Regimenslater in pregnancy DTG is Preferred for the treatment of pregnant women with acute HIV infection and for women who present to care late in pregnancy There are specific timing andor fasting recommendations if DTG is taken with calcium or iron (eg in prenatal vitamins see Table 10) The use of DTG at conception and in very early pregnancy has been associated with a small but statistically significant increase in the risk of NTDs this information should be discussed with patients to ensure informed decision-making For more information see Recommendations for Use of Antiretroviral Drugs During Pregnancy Table 5 Teratogenicity and Appendix C Antiretroviral Counseling Guide for Health Care Providers

RAL plus a Preferred Dual-NRTI Backbone

PK data are available for RAL in pregnancy when using the twice-daily formulation (400 mg twice daily) but data are not available for the once-daily 1200 mg (2 x 600 mg) extended-release formulation ldquoraltegravir HDrdquo Twice-daily dosing is required in pregnancy RAL has been shown to produce rapid viral load decline to undetectable levels in women who present for initial therapy late in pregnancy INSTI-based regimens may be particularly useful when drug interactions or the potential for preterm delivery with PI-based regimens are a concern There are specific timing andor fasting recommendations if RAL is taken with calcium or iron (eg in prenatal vitamins see Table 10)

Preferred PI Regimens

ATVr plus a Preferred Dual-NRTI Backbone

Once-daily administration Extensive experience with use in pregnancy Maternal hyperbilirubinemia no clinically significant neonatal hyperbilirubinemia or kernicterus reported but neonatal bilirubin monitoring is recommended Cannot be administered with PPIs Specific timing recommended for dosing with H2 blockers (see Table 10)

DRVr plus a Preferred Dual-NRTI Backbone

Better tolerated than LPVr Experience with use in pregnancy is increasing Must be used twice daily in pregnancy

Drug CommentsAlternative Initial Regimens in PregnancyDrugs or drug combinations are designated as Alternative options for therapy in pregnant women when clinical trial data in adults show efficacy and the data in pregnant individuals are generally favorable but limited Most Alternative drugs or regimens are associated with more PK dosing tolerability formulation administration or interaction concerns than those in the Preferred category but they are acceptable for use in pregnancy Some Alternative drugs or regimens may have known toxicity or teratogenicity risks that are offset by other advantages for women with HIV who are pregnant or who are trying to conceive Therefore it is important to read all the information on each drug in the Perinatal Guidelines before administering any of these medications to patients (also see Appendix B Supplement Safety and Toxicity of Individual Antiretroviral Agents in Pregnancy)

Alternative Dual-NRTI Backbones

TAFFTC

Available as an FDC Data about the use of TAF at conception and during pregnancy are limited For both boosted and non-boosted regimens plasma TAF exposures in pregnant adults are similar to those seen in nonpregnant adults a change in dosing is not required

ZDV3TC

Available as an FDC Although not recommended for initial therapy in nonpregnant adults ZDV3TC is the NRTI combination with most experience for use in pregnancy It has the disadvantages of requiring twice-daily administration which increases the potential for hematologic toxicities and other toxicities


18

Alternative NNRTI Regimens

EFVTDFFTC (FDC)or

EFVTDF3TC (FDC)or

EFV plus a Preferred Dual-NRTI Backbone

Birth defects have been reported in primate studies of EFV no evidence has been found of an increased risk of birth defects in human studies and extensive experience in pregnancy cautionary text remains in the package insert (see Teratogenicity Efavirenz and Table 10) These regimens are useful for women who require treatment with drugs that have significant interactions with Preferred agents or who need the convenience of a coformulated single-tablet once-daily regimen and are not eligible for DTG or RPV Screening for antenatal and postpartum depression is recommended Higher rate of adverse events than some Preferred drugs

RPVTDFFTC (FDC) or

RPVTAFFTC (FDC)RPV plus a Preferred Dual-NRTI Backbone

RPV is not recommended in patients with pretreatment HIV RNA gt100000 copiesmL or CD4 counts lt200 cellsmm3 Do not use with PPIs PK data are available for pregnant individuals but there is relatively little experience with use in pregnancy PK data suggest lower drug levels and risk of viral rebound in second and third trimesters if used consider monitoring viral load more frequently Should be taken with food Available in a coformulated single-tablet once-daily regimen

Drug CommentsInsufficient Data in Pregnancy to Recommend for Initial Regimens in ART-Naive Women These drugs are approved for use in adultsbut lack adequate pregnancy-specific PK or safety dataBICTAFFTC (FDC) Limited data on the use of BIC in pregnancyDOR No data on the use of DOR in pregnancyIBA No data on the use of IBA in pregnancy

Drug CommentsNot Recommended for Initial ART or Use in PregnancyThese drugs and drug combinations are recommended for use in adults but are not recommended for use during pregnancy because of limited data about use in pregnancy andor concerns about maternal or fetal safety or PK changes or inferior efficacy including viral breakthroughs in the second and third trimester (see Table 5 and Table 10)

Note When a pregnant woman presents to care while virally suppressed on one of these drugs or drug combinations providers should consider whether to continue her current regimen or switch to a recommended ARV regimen (see Pregnant Women with HIV Who Are Currently Receiving Antiretroviral Therapy and Table 5)

ATVcLimited data on the use of ATV with COBI in pregnancy Substantial reductions in trough levels of ATV in the second and third trimesters have been reported when taken with COBI

DRVc (FDC) or

DRVcFTCTAF (FDC)

Limited data on the use of DRV with COBI in pregnancy Inadequate levels of both DRV and COBI in second and third trimester as well as viral breakthroughs have been reported

EVGcFTCTAF (FDC)

Limited data on the use of EVG with COBI (see above) Inadequate levels of both EVG and COBI in second and third trimester as well as viral breakthroughs have been reported Specific timing andor fasting recommendations especially if taken with calcium or iron (eg in prenatal vitamins see Table 10)

EVGcFTCTDF (FDC) Limited data on the use of EVG with COBI in pregnancy Inadequate levels of both EVG and COBI in second and third trimester as well as viral breakthroughs have been reported Specific timing andor fasting recommendations especially if taken with calcium or iron (eg in prenatal vitamins see Table 10)


19

Drug CommentsNot Recommended for Initial ART in Pregnancy and Not Recommended Except in Special Circumstances for Treatment-Experienced Women in Pregnancy These drugs are not recommended for use in pregnant women who have never received ART With the exception of NVP and LPVr data about the PKs safety and efficacy of these drugs during pregnancy are limited

Some of these drugs are also categorized as not recommended except in special circumstances during pregnancy because the Panel recognizes that circumstances may exist in which pregnant women who are ART-experienced may need to initiate or continue these drugs to reach or maintain viral suppression (see Table 5)

ETR Not recommended for use in ART-naive populations Data about the use of ETR in pregnancy are limited

LPVr plus a Preferred Dual-NRTI Backbone

Abundant experience and established PKs in pregnancy Has been associated with an increased risk of preterm delivery see Antiretroviral Drug Regimens and Maternal and Neonatal Outcomes More nausea than with Preferred or Alternative agents Twice-daily administration A dose increase is recommended during the third trimester (see Table 10) Once-daily LPVr is not recommended for use in pregnant women

MVCNot recommended for use in ART-naive populations MVC requires tropism testing before use Available PK data suggest that using the standard adult dose is appropriate for pregnant patients although data about use in pregnancy are limited

NVP

Not recommended because of the potential for adverse events complex lead-in dosing and low barrier to resistance NVP should be used with caution when initiating ART in women with CD4 counts gt250 cellsmm3 Use NVP and ABC together with caution both can cause hypersensitivity reactions in the first few weeks after initiation

T-20 Not recommended for use in ART-naive populations

Note The following drugs and drug combinations (not listed above) should not be used during pregnancy women who become pregnant while taking these medications should switch to a recommended regimen d4T ddI FPV FPVr IDV IDVr NFV RTV (as the sole PI) SQV SQVr TPV TPVr two-drug ARV regimens or a three-NRTI ARV regimen (eg ABCZDV3TC) See Archived Drugs in the Perinatal Guidelines and What Not to Use in the Adult and Adolescent Antiretro-viral Guidelines for individual ARV drugs ARV combinations and ARV regimens that are not recommended or that should not be used in adults

Key 3TC = lamivudine ABC = abacavir ART = antiretroviral therapy ARV = antiretroviral ATV = atazanavir ATVc = atazanavircobicistat ATVr = atazanavirritonavir BIC = bictegravir CD4 = CD4 T lymphocyte cell COBI = cobicistat d4T = stavudine ddI = didanosine DOR = doravirine DRV = darunavir DRVc = darunavircobicistat DRVr = darunavirritonavir DTG = dolutegravir EFV = efavirenz ETR = etravirine EVG = elvitegravir EVGc = elvitegravircobicistat FDC = fixed-dose combination FPV = fosamprenavir FPVr = fosamprenavirritonavir FTC = emtricitabine IBA = ibalizumab IDV = indinavir IDVr = indinavirritonavir INSTI = integrase strand transfer inhibitor LPVr = lopinavirritonavir MVC = maraviroc NFV = nelfinavir NNRTI = non-nucleoside reverse transcriptase inhibitor NRTI = nucleoside reverse transcriptase inhibitor NTD = neural tube defect NVP = nevirapine the Panel = the Panel on Treatment of Pregnant Women with HIV Infection and Prevention of Perinatal Transmission PI = protease inhibitor PK = pharmacokinetic PPI = proton pump inhibitor RAL = raltegravir RPV = rilpivirine RTV = ritonavir SQV = saquinavir SQVr = saquinavirritonavir T-20 = enfuvirtide TAF = tenofovir alafenamide TDF = tenofovir disoproxil fumarate TPV = tipranavir TPVr = tipranavirritonavir ZDV = zidovudine


20

Table 5 Situation-Specific Recommendations for Use of Antiretroviral Drugs in Pregnant People and Nonpregnant People Who Are Trying to Conceive

(Last updated December 15 2020 last reviewed December 15 2020)

ART Regimen Component

ART for Pregnant People Who Have

Never Received ARV Drugs and Who Are Initiating ART for

the First Time

Continuing ART for People Who Become Pregnant on a Fully Suppressive Well-Tolerated Regimen


Received ARV Drugs in the Past and Who Are Restarting ARTa

New ART Regimen for Pregnant People

Whose Current Regimen Is Not

Well Tolerated andor Is Not Fully Suppressivea

ART for Nonpregnant People Who Are Trying to

Conceiveab

Integrase Strand Transfer Inhibitor (INSTI) DrugsUsed in combination with a dual-nucleoside reverse transcriptase inhibitor (NRTI) backbonec

DTG Preferred Continue Preferred Preferred PreferredRAL Preferred Continue Preferred Preferred PreferredBIC Insufficient data Insufficient data Insufficient data Insufficient data Insufficient data

EVGcd

Not recommended Continue with frequent viral load monitoring or consider switching

Not recommended Not recommended Not recommended

Protease Inhibitor (PI) DrugsUsed in combination with a dual-NRTI backbonec

ATVr Preferred Continue Preferred Preferred PreferredDRVr Preferred Continue Preferred Preferred Preferred

LPVrNot recommended except in special circumstances

Continue Not recommended except in special circumstances

Not recommended except in special circumstances


ATVcdNot recommended Continue with frequent

viral load monitoring or consider switching


DRVcdNot recommended Continue with frequent




C-1

People should be given information about the benefits and risks of initiating an antiretroviral (ARV) regimen or making changes to an existing regimen so they can make informed decisions about their care Patient autonomy and informed choice should be considered in all aspects of medical care including HIV and obstetric care This is the primary guiding principle in all the Panelrsquos recommendations


21

Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) DrugsUsed in combination with a dual-NRTI backbonec

EFV Alternative Continue Alternative Alternative AlternativeRPVe Alternative Continue Alternative Alternative AlternativeDOR Insufficient data Insufficient data Insufficient data Insufficient data Insufficient data

ETRfNot recommended Continue Not recommended

except in special circumstances



NVPfNot recommended Continue Not recommended




NRTI Drugscg

ABCh Preferred Continue Preferred Preferred PreferredFTC Preferred Continue Preferred Preferred Preferred3TC Preferred Continue Preferred Preferred PreferredTDF Preferred Continue Preferred Preferred PreferredZDV Alternative Continue Alternative Alternative AlternativeTAFi Alternative Continue Alternative Alternative Alternative

Entry Attachment and Fusion Inhibitor DrugsIBA Insufficient data Insufficient data Insufficient data Insufficient data Insufficient data

MVCfNot recommended Continue Not recommended




T-20fNot recommended Continue Not recommended




FTR Insufficient data Insufficient data Insufficient data Insufficient data Insufficient dataFixed-Dose Combination (FDC) Regimensdg

The individual drug component that is most responsible for the overall recommendation is indicated in parenthesesABCDTG3TCh Preferred Continue Preferred Preferred PreferredEFVFTCTDF Alternative (EFV) Continue Alternative (EFV) Alternative (EFV) Alternative (EFV)EFV3TCTDF Alternative (EFV) Continue Alternative (EFV) Alternative (EFV) Alternative (EFV)FTCRPVTDFe Alternative (RPV) Continue (RPV) Alternative (RPV) Alternative (RPV) Alternative (RPV)BICFTCTAF Insufficient data (BIC) Insufficient data (BIC) Insufficient data (BIC) Insufficient data (BIC) Insufficient data (BIC)


C-2


22

DOR3TCTDF Insufficient data (DOR)

Insufficient data (DOR)




FTCRPVTAF Alternative Continue Alternative Alternative Alternative

EVGcFTCTDFd

Not recommended (EVGc)

Continue with frequent viral load monitoring or consider switching

(EVGc)




EVGcFTCTAFd



(EVGc)




DRVcFTCTAFd

Not recommended (DRVc)


(DRVc)




DTG3TCAs a complete

regimenj

Not recommended Not recommended switch or add

additional agents


DTGRPV As a complete

regimenj


additional agentse


a Do not initiate ARV regimens with components that have documented resistance or suspected resistance based on prior ARV exposure

b This guidance is intended for people who are pregnant or trying to conceive These recommendations are not intended for all people with HIV who might become pregnant

c ABC plus 3TC TDF plus FTC and TDF plus 3TC are Preferred dual-NRTI backbones and ZDV plus 3TC and TAF plus FTC are Alternative dual-NRTI backbones for ARV regimens

d DRVc EVGc and ATVc are not recommended for use in pregnancy because of PK changes that pose a risk for low drug levels and viral rebound in the second and third trimesters However in cases where virologically suppressed pregnant people present to care on regimens that include these drugs these drug combinations can be continued with frequent viral load monitoring or can be switched to a recommended or alternative agent If there are concerns about switching see Pregnant People with HIV Who Are Currently Receiving Antiretroviral Therapy If the cobicistat pharmacologic booster is replaced with ritonavir for ATV and DRV attention to dosing in pregnancy is critical with higher doses of ATV required if coadministered with TDF or antacids and twice-daily dosing required for DRV in the second and third trimesters


23

e Although PK data indicate that RPV plasma concentration is reduced during the second and third trimesters the reduction is less than the reductions seen with use of EVGc or DRVc Higher-than-standard doses of RPV have not been studied so data are insufficient to recommend a dose change in pregnancy With standard dosing viral load should be monitored more frequently

f Although these drugs are not recommended for initial treatment in ART-naive pregnant people there may be special circumstances in which ART-experienced people may need to continue or initiate ETR NVP MVC and T-20 in order to maintain or achieve viral suppression Safety and efficacy data are limited about the use of ETR MVC and T 20 in pregnancy NVP is not recommended for ART-naive people because it has a greater potential for adverse events than other NNRTIs complex lead-in dosing and a low barrier to resistance however if a pregnant person presents to care on a well-tolerated NVP-containing regimen it is likely that NVP will be safe and effective during pregnancy See Table 4 and Nevirapine for more information

g When using FDC tablets refer to Table 8 and the drug sections in Appendix B for information about the dosing and safety of individual components of the FDC tablet during pregnancy

h Testing for HLA-B5701 identifies patients who are at risk of developing hypersensitivity reactions while taking ABC testing should be performed and a patient should be documented as negative before initiating ABC

i Available data about the use of TAF in pregnancy support continuing it in pregnant people who are virally suppressed although data are insufficient to recommend it when initiating ART in pregnancy

j Two-drug ARV regimens are not recommended for use in pregnancy

The following drugs and drug combinations (that are not listed above) should not be used during pregnancy if a person becomes pregnant while taking any of these medications she should switch to a recommended regimen d4T ddI FPV FPVr IDV IDVr NFV RTV (as the sole PI) SQV SQVr TPV TPVr or a three-NRTI ARV regimen (eg ABCZDV3TC) See Archived Drugs in the Perinatal Guidelines and What Not to Use in the Adult and Adolescent Antiretroviral Guidelines for individual ARV drugs ARV combinations and ARV regimens that are not recommended or that should not be used in adults Refer to the table above and Table 4 for ARV regimens that are recommended for use in pregnancy

Key 3TC = lamivudine ABC = abacavir ART = antiretroviral therapy ARV = antiretroviral ATV = atazanavir ATVc = atazanavircobicistat ATVr = atazanavirritonavir BIC = bictegravir d4T = stavudine ddI = didanosine DOR = doravirine DRV = darunavir DRVc = darunavircobicistat DRVr = darunavirritonavir DTG = dolutegravir EFV = efavirenz ETR = etravirine EVG = elvitegravir EVGc = elvitegravircobicistat FDC = fixed-dose combination FPV = fosamprenavir FPVr = fosamprenavirritonavir FTC = emtricitabine FTR = fostemsavir IBA = ibalizumab IDV = indinavir IDVr = indinavirritonavir INSTI = integrase strand transfer inhibitor LPV = lopinavir LPVr = lopinavirritonavir MVC = maraviroc NFV = nelfinavir NNRTI = non-nucleoside reverse transcriptase inhibitor NRTI = nucleoside reverse transcriptase inhibitor NVP = nevirapine PI = protease inhibitor PK = pharmacokinetic RAL = raltegravir RPV = rilpivirine RTV = ritonavir SQV = saquinavir SQVr = saquinavirritonavir T 20 = enfuvirtide TAF = tenofovir alafenamide TDF = tenofovir disoproxil fumarate TPV = tipranavir TPVr = tipranavirritonavir ZDV = zidovudine


24

Table 6 HIV-Related Laboratory Monitoring Schedule for Pregnant Women with HIV

Timepoint or Frequency of Testing

Laboratory Test

Entry Into Antenatal Care

ART Initiation or Modification

2 to 4 Weeks After ART

Initiation or Modification

MonthlyEvery 3

Months During Pregnancy

At 24 to 28 Weeks Gestation

At 34 to 36 Weeks

Gestation to Inform Mode

of Delivery and Infant ARV

Regimen

HIV RNA Levelsb

If a result is not available within 2 weeks of ART

initiation or modification

Until HIV

RNA levels are undetectable

At least every 3

monthsc

CD4 Countd

For women

who have been on ART for lt2 years women

with CD4 counts lt300 cellsmm3 and women with

inconsistent adherence andor detectable viral loads

Resistance Testinge

Standard Glucose

Screeningf

For women on

ARTf


C-5


25

LFTs for Women on ART

Or as needed

Monitoring for ARV-Specific

Toxicitiesg

Refer to the recommendations in the package inserts for the individual ARV drugs

aFor additional information see Laboratory Monitoring in the Adult and Adolescent Antiretroviral Guidelinesb The plasma HIV RNA levels of pregnant women with HIV should be monitored at the initial antenatal visit (AI) 2 to 4 weeks after initiating (or changing) antiretroviral therapy (ART) (BI) monthly until RNA levels are undetectable (BIII) and then at least every 3 months during pregnancy (BIII) Obtain an HIV RNA level at the time of ART initiation or modification if a recent result within 2 weeks prior is not available c More frequent viral load monitoring (every 1-2 months) may be indicated for women who are taking ARVs that have been shown to have reduced drug levels in the 2nd and 3rd trimesters and are at risk for loss of viral suppression eg cobicistat elvitegravir or rilpivirine (see Table 4 and Table 5 and Pregnant Women Living with HIV Who Are Currently Receiving Antiretroviral Therapy)d CD4 T lymphocyte (CD4) cell count should be measured at the initial antenatal visit (AI) Patients who have been on ART for ge2 years and who have had consistent viral suppression and CD4 counts that are consistently gt300 cellsmm3 do not need to have their CD4 counts monitored after the initial antenatal visit during this pregnancy per the Adult and Adolescent Antiretroviral Guidelines (CIII) Women who have been on ART for lt2 years women with CD4 counts lt300 cellsmm3 and women with inconsistent adherence andor detectable viral loads should have CD4 counts monitored every 3 months during pregnancy (CIII)e ARV drug-resistance testing (genotypic testing and if indicated phenotypic testing) should be performed in women whose HIV RNA levels are above the threshold for standard resistance testing (ie gt500 copiesmL to 1000 copiesmL) beforemdash

bull Initiating ART in ARV-naive pregnant women who have not been previously tested for ARV drug resistance (AII) bull Initiating ART in ARV-experienced pregnant women (AIII) orbull Modifying ARV regimens for women who become pregnant while receiving ARV drugs or women who have suboptimal virologic response to ARV drugs that were started during pregnancy (AII)

ART should be initiated in pregnant women prior to receiving the results of ARV-resistance tests ART should be modified if necessary based on the results of resistance testing (BIII)f Women who are taking ART during pregnancy should undergo standard glucose screening (AIII) Some experts suggest performing glucose screening early in pregnancy for women who are receiving protease inhibitor (PI)-based regimens that were initiated before pregnancy in accordance with recommendations for women who are at risk for glucose intolerance (BIII) For more information on PIs see Combination Antiretroviral Drug Regimens and Maternal and Neonatal Outcomesg Laboratory testing to monitor complications of ARV drugs during pregnancy should be based on what is known about the adverse effects of the drugs a woman is receiving (AIII)

Key ART = antiretroviral therapy ARV = antiretroviral CD4 = CD4 T lymphocyte LFT = liver function test PI = protease inhibitor


26Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States

C-10

Table 7 Intrapartum Care and Recommended Interventions to Prevent Perinatal HIV Transmission for Women with HIV Based on Maternal HIV RNA Levels at the Time of Delivery

All women with HIV should be receiving antiretroviral therapy (ART) or initiate ART in pregnancy as early as possible to suppress HIV RNA to undetectable levels (lt50 copiesmL)

Maternal HIV RNA at Time of DeliveryAssessed at ge34 to 36 Weeks Gestation (or 4ndash6 Weeks Before Delivery) with No Concerns Regarding

ART Adherencea

lt50 copiesmL and on ART with No Concerns About Adherence

ge50 to le1000 copiesmL

gt1000 copiesmL

bull Unknown HIV RNA

bull ART Adherence Concerns

bull Not Receiving ART

bull HIV Diagnosis in Labor

Intrapartum ART Women should take their prescribed ART on schedule as much as possible during labor and before scheduled cesarean delivery (CIII) In general ARV regimens are initiated postpartum for women diagnosed with HIV during labor

Intrapartum IV ZDV

Not required (BII) Not required but may be considered (CII) many experts recommend

Yes recommended (AI)b

IV ZDV 1-hour loading dose at 2 mgkg followed by a continuous ZDV infusion of 1 mgkg for 2 hours (at least 3 hours total) (AII)

Mode of delivery Normal vaginal deliveryc (AII)

Normal vaginal deliveryc (AII)

Scheduled cesarean delivery at 38 weeksd (AII)

Individualized care see footnoted

Artificial rupture of membranese

Per standard obstetric indications (BII)

Avoid if possible (BIII)

Not applicable cesarean delivery recommended

Avoid if possible in women with detectable or unknown viral load who are not receiving a cesarean delivery (BIII)

Induction of labor Per standard obstetric indications including use of pitocin Women with HIV RNA le1000 copiesmL should NOT be routinely induced at 38 weeks

Not applicable scheduled cesarean delivery recommended


IUPC Data not available for women with HIV use IUPC with caution and only if there are clear obstetric indications


27


ART Adherencea


ge50 to le1000 cop-iesmL

gt1000 copiesmL





Fetal scalp electrodes for fetal monitoring

Avoid particularly when maternal viral load is not suppressed (ge50 copiesmL) or is unknown because of the potential risk of HIV transmission (BIII) See Antiretroviral Management of Newborns with Perinatal HIV Exposure or Perinatal HIV

Operative delivery with forceps or a vacuum extractor

Per standard ob-stetric indications (BIII)

Avoid for women in the setting of viremia if possible (BIII)

Delayed cord clamping

Per standard obstetric indications and care

Use of methergine for postpartum hemorrhage

Because of potential drug interactions with some ARV drugs consider a womanrsquos ARV regimen when treating postpartum bleeding caused by uterine atony (BIII)f

Infant ARVs and infant feeding

See Antiretroviral Management of Newborns with Perinatal HIV Exposure or Perinatal HIV Table 8 Table 9 Postpartum Care and Guidelines for Counseling and Managing Women with HIV in the United States Who Desire to Breastfeed

Key ART = antiretroviral therapy CYP3A4 = cytochrome P450 3A4 HIV = human immunodeficiency virus IUPC = intrauterine pressure catheter IV = intravenous RNA = ribonucleic acid ZDV = zidovudine

a Assess ART adherence at every visit and upon presentation for delivery b Begin IV ZDV when women present in labor or at least 3 hours before a cesarean delivery using a 1-hour loading dose of ZDV at 2 mgkg followed by a continuous ZDV infusion of 1 mgkg for at least 2 hours (AII) c Scheduled cesarean delivery performed solely for prevention of perinatal HIV transmission in women receiving ART with HIV RNA le1000 copiesmL is not recommended given the low rate of perinatal transmission in this group (AII) In women with HIV RNA levels le1000 copiesmL if scheduled cesarean delivery or induction is indicated it should be performed at the standard time for obstetric indications (AII)d Provide individualized care If HIV RNA is gt1000 copiesmL or unknown evidence is insufficient to determine whether cesarean delivery reduces the risk of perinatal HIV transmission for women who present in spontaneous labor or with ruptured membranes Management of women originally scheduled for cesarean delivery because of HIV who present in labor must be individualized at the time of presentation (BII) In these circumstances consultation with an expert in perinatal HIV (eg telephone consultation with the National Perinatal HIVAIDS Clinical Consultation Center at 1-888-448-8765) may be helpful in rapidly developing an individualized plan e In women on ART with suppressed viral load (HIV RNA lt50 copiesmL) duration of ruptured membranes is not associated with an increased risk of perinatal transmission and is not an indication for cesarean delivery to prevent HIV transmission (BII)



C-12

f Consider drug interactions with ART when treating postpartum bleeding caused by uterine atony In women who are receiving a cytochrome P450 3A4 enzyme inhibitor (eg a protease inhibitor cobicistat) methergine should be used only if no alternative treatments for postpartum hemorrhage are available and the need for pharmacologic treatment outweighs the risks If methergine is used it should be administered at the lowest effective dose for the shortest possible duration (BIII) In women who are receiving a CYP3A4 enzyme inducer if such as nevirapine efavirenz or etravirine additional uterotonic agents may be needed because of the potential for decreased methergine levels and inadequate treatment effect (BIII)

Rating of Recommendations A = Strong B = Moderate C = Optional

Rating of Evidence I = One or more randomized trials with clinical outcomes andor validated laboratory endpoints II = One or more well-designed nonrandomized trials or observational cohort studies with long-term clinical outcomes III = Expert opinion


29

Table 8 Neonatal Antiretroviral Management According to Risk of HIV Infection in the Newborn

Drug selection and dosing considerations are related to the age and gestational age of the newborn Consultation is available through the National Perinatal HIV Hotline (1-888-448-8765)

Level of Perinatal HIV Transmission

RiskDescription Neonatal ARV Management

Low Risk of Perinatal HIV Transmission

Mothers who received ART during pregnancy with viral suppression (defined as a confirmed HIV RNA level lt50 copiesmL) near delivery and no concerns related to adherence

ZDV for 4 weeksa

High Risk of Perinatal HIV Transmissionab

Mothers who did not receive antepartum or intrapartum ARV drugs

Mothers who received only intrapartum ARV drugs

Mothers who received antepartum and intrapartum ARV drugs but did not have viral suppression (defined as a confirmed HIV RNA level lt50 copiesmL) near delivery

Mothers with acute or primary HIV infection during pregnancy or breastfeeding (in which case the mother should immediately discontinue breastfeeding)c

Presumptive HIV therapy using either ZDV 3TC and NVP (treatment dose) or ZDV 3TC and RAL administered from birth up to 6 weeksd

Presumed Newborn HIV Exposure

Mothers with unconfirmed HIV status who have at least one positive HIV test at delivery or postpartum orMothers whose newborns have a positive HIV antibody test

ARV management as described above for newborns with a high risk of perinatal HIV transmission

Infant ARV drugs should be discontinued immediately if supplemental testing confirms that the mother does not have HIV

Newborn with HIVe

Positive newborn HIV virologic testNAT

Three-drug ARV regimen using treatment doses

a A 4-week ZDV prophylaxis regimen is recommended for infants born to mothers with HIV-2 mono-infection see HIV-2 Infection and Pregnancy If the mother has HIV-1 and HIV-2 infection the infant ARV regimen should be based on the determination of low or high risk of HIV-1 transmission as described in the above table Because HIV-2 is not susceptible to NVP RAL should be considered


30

See text for evidence that supports the use of presumptive HIV therapy and a two-drug ARV prophylaxis regimenb See Intrapartum Care for guidance on indications for scheduled cesarean delivery and intrapartum IV ZDV to reduce the risk of perinatal HIV transmission for mothers with an elevated viral load at deliveryc Most Panel members would opt to administer presumptive HIV therapy to infants whose mothers had acute HIV during pregnancy because of the higher risk for in utero transmission If acute HIV is diagnosed during breastfeeding the mother should immediately discontinue nursingd The optimal duration of presumptive HIV therapy in newborns who are at a high risk for perinatal HIV transmission is unknown If possible newborns who are at a high risk for HIV acquisition should receive ZDV for 6 weeks Additional medications such as 3TC RAL or NVP may need to administered for 2 to 6 weeks the recommended duration for these drugs varies depending on HIV NAT results maternal viral load at the time of delivery and additional risk factors for HIV transmission Consultation with an expert in pediatric HIV is recommended when selecting a therapy duration because this decision should be based on case-specific risk factors and interim HIV NAT results The two-drug regimen used in the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)-HIV Prevention Trials Network (HPTN) 040Pediatric AIDS Clinical Trials Group (PACTG) 1043 for infants who were at a high risk for HIV acquisition is described in the text (see the Two-Drug Antiretroviral Prophylaxis section) e Most Panel members strongly recommend initiating ART without waiting for the results of confirmatory HIV NAT testing given the low likelihood of a false-positive HIV NAT

Note ARV drugs should be initiated as close to the time of birth as possible preferably within 6 hours of delivery See Table 9 for dosing specifics

Key 3TC = lamivudine ART = antiretroviral therapy ARV =antiretroviral IV = intravenous NAT = nucleic acid test NVP = nevirapine Panel = Panel on Treatment of Pregnant Women with HIV Infection and Prevention of Perinatal Transmission RAL = raltegravir ZDV = zidovudine



C-5

Table 9 Antiretroviral Drug Dosing Recommendations for Newborns

Newborns at Low Risk of Perinatal HIV Transmission

Recommended Regimen Recommended DurationZDV ZDV administered for 4 weeks at the doses listed below

Newborns at High Risk of Perinatal HIV TransmissionRecommended Regimen Recommended Duration

Three-drug HIV therapy ZDV plus 3TC plus (NVP or RAL)

ZDV administered for 6 weeks with no increase to the 12 mgkg dose unless the infant has confirmed HIV infection Dosing for 3TC NVP and RAL is described below Duration for these three drugs may vary see the guidance in footnotea

Newborns with HIV InfectionRecommended Regimen Lifelong Duration Recommendedb


Lifelong therapy in accordance with current treatment guidelines The ARV regimen should be individualized based on the infantrsquos age and clinical determinants RAL can be used in infants who were born at a postmenstrual age of ge37 weeks (defined as the time from the first day of the motherrsquos last menstrual period to birth plus the time elapsed after birth) and who weigh ge2 kg LPVr can be used when the infant reaches a postmenstrual age of ge42 weeks and a postnatal age ge14 days DTG tablets for oral suspension (dispersible tablets) can replace LPVr NVP or RAL in infants at least 4 weeks of age and weighing at least 3 kg

Drug Drug Doses by Gestational Age at BirthZDV

Note For newborns who are unable to toler-ate oral agents the IV dose is 75 of the oral dose while maintaining the same dosing inter-val

ge35 Weeksrsquo Gestation at BirthBirth to Age 4 Weeks bull ZDV 4 mgkg per dose orally twice daily

Age gt4 Weeks bull ZDV 12 mgkg per dose orally twice daily only make this dose increase

for infants with confirmed HIV infection

Simplified Weight-Band Dosing for Newborns Aged ge35 Weeksrsquo Gestation from Birth to 4 Weeks

Weight Band

Volume of ZDV 10 mgmL Oral Syrup Twice Daily

2 to lt3 kg 1 mL3 to lt4 kg 15 mL4 to lt5 kg 2 mL



C-6

ge30 to lt35 Weeksrsquo Gestation at Birth Birth to Age 2 Weeks bull ZDV 2 mgkg per dose orally twice daily

Age 2 Weeks to 6 to 8 Weeks bull ZDV 3 mgkg per dose orally twice daily

Age gt6 to 8 Weeks bull ZDV 12 mgkg per dose orally twice daily only make this dose increase for

infants with confirmed HIV infectionlt30 Weeksrsquo Gestation at Birth Birth to Age 4 Weeks bull ZDV 2 mgkg per dose orally twice dailyAge 4 to 8ndash10 Weeksbull ZDV 3 mgkg per dose orally twice dailyAge gt8 to 10 Weeksbull ZDV 12 mgkg per dose orally twice daily only make this dose increase for

infants with confirmed HIV infection3TC ge32 Weeksrsquo Gestation at Birth

Birth to Age 4 Weeksbull 3TC 2 mgkg per dose orally twice daily

Age gt4 Weeksbull 3TC 4 mgkg per dose orally twice daily

NVP ge37 Weeksrsquo Gestation at Birth Birth to Age 4 Weeks bull NVP 6 mgkg per dose orally twice dailyc

Age gt4 Weeksbull NVP 200 mgm2 BSA per dose orally twice daily only make this dose increase

for infants with confirmed HIV infection ge34 to lt37 Weeksrsquo Gestation at Birth Birth to Age 1 Week bull NVP 4 mgkg per dose orally twice dailyAge 1 to 4 Weeks bull NVP 6 mgkg per dose orally twice dailyAge gt4 Weeksbull NVP 200 mgm2 BSA per dose orally twice daily only make this dose increase

for infants with confirmed HIV infectionRAL

Note If the mother has taken RAL 2ndash24 hours prior to delivery the neonatersquos first dose of RAL should be delayed until 24ndash48 hours after

ge37 Weeksrsquo Gestation at Birth and Weighing ge2 kgd

Birth to Age 6 Weeks

Body Weight Volume (Dose) of RAL 10 mgmL Suspension

Birth to 1 Week Once-Daily Dosing Approximately 15 mgkg per dose2 to lt3 kg 04 mL (4 mg) once daily


33

birth additional ARV drugs should be started as soon as possible7

3 to lt4 kg 05 mL (5 mg) once daily4 to lt5 kg 07 mL (7 mg) once daily

1 to 4 Weeks Twice-Daily Dosing Approximately 3 mgkg per dose2 to lt3 kg 08 mL (8 mg) twice daily3 to lt4 kg 1 mL (10 mg) twice daily4 to lt5 kg 15 mL (15 mg) twice daily


DTG

Note Only tablets for oral suspension (dispersible tablets) are approved for use in infants gt 4 weeks of age and gt 3 kg

Age gt 4 weeks of age AND gt 3 kg

Pediatric

Body Weight

Recommended Dosee

Dolutegravir Dispersible Tablets

Number of tablets

3 to lt6 kg 5 mg once daily 16 to lt10 kg 15 mg once daily 310 to lt14 kg 20 mg once daily 414 to lt20 kg 25 mg once daily 5ge20 kg 30 mg once daily 6

a The optimal duration of presumptive HIV therapy in newborns who are at a high risk for perinatal HIV trans-mission is unknown If possible newborns who are at a high risk for HIV acquisition should receive ZDV for 6 weeks Additional medications such as 3TC RAL or NVP may need to administered for 2 to 6 weeks the rec-ommended duration for these drugs varies based on HIV NAT results maternal viral load at the time of delivery and additional risk factors for HIV transmission Consultation with an expert in pediatric HIV is recommended when selecting a therapy duration because this decision should be based on case-specific risk factors and interim HIV NAT results The two-drug regimen used in NICHD-HPTN 040PACTG 1043 for infants who were at a high risk for HIV acquisition is described in the text (see the Two-Drug Antiretroviral Prophylaxis section)b For ARV management after the newborn period see the Pediatric Antiretroviral Guidelinesc This dose is an investigational NVP treatment dose recommended by the Panel the FDA has not approved a dose of NVP for infants aged lt1 month See the Two-Drug Antiretroviral Prophylaxis section in the text for prophylactic NVP dosing if using the NICHD-HPTN 040PACTG 1043 prophylaxis regimend RAL dosing is increased at 1 and 4 weeks of age because metabolism by UGT1A1 is low at birth and increas-es rapidly during the next 4ndash6 weeks of life No dosing information is available for preterm infants or infants weighing lt2 kg at birthe If certain UGT1A or CYP3A inducers are coadministered then administer twice daily

Key 3TC = lamivudine ARV =antiretroviral BSA = body surface area DTG = dolutegravir FDA = Food and Drug Administration IV = intravenous LPVr = lopinavirritonavir NAT = nucleic acid test NVP = nevirap-ine the Panel = the Panel on Treatment of Pregnant Women with HIV Infection and Prevention of Perinatal Transmission RAL = raltegravir UGT = uridine diphosphate glucotransferase ZDV = zidovudine


34

Table 10 Antiretroviral Drug Use in Pregnant Women with HIV Pharmacokinetic and Toxicity Data in Human Pregnancy and Recommendations for Use in Pregnancy

Appendix B Safety and Toxicity of Individual Antiretroviral Agents in Pregnancy

Note When using FDCs refer to other sections in Appendix B and Table 10 for information about the dosing and safety of individual drug components of the FDC during pregnancy

Generic Name(Abbreviation)

Trade NameFormulation Dosing Recommendationsa Use in Pregnancy Last

Reviewed

NRTIsNRTIs interfere with HIV reverse transcriptase by competitive inhibition Nucleoside analogue drugs require three intracellular phosphorylation steps to form the triphosphate nucleoside which is the active drug moiety The nucleotide analogue tenofovir contains a monophosphate component attached to the adenine base and requires only two phosphorylation steps to form the active moietyAbacavir(ABC)Ziagen

(ABC3TC)Epzicom

(ABCDTG3TC)Triumeq

(ABC3TCZDV)Trizivir

Note Generic products are available for some formulations

ABC (Ziagen)d

Tabletbull 300 mg

Oral Solutionbull 20 mgmL

ABC3TC (Epzicom)d

bull ABC 600 mg3TC 300 mg tablet

ABCDTG3TC (Triumeq)bull ABC 600 mgDTG

50 mg3TC 300 mg tablet

ABC3TCZDV (Trizivir)d

bull ABC 300 mg3TC 150 mgZDV 300 mg tablet

Standard Adult DosesABC (Ziagen) bull ABC 300 mg twice daily or ABC 600 mg once

daily without regard to food

ABC3TC (Epzicom)bull One tablet once daily without regard to food

ABCDTG3TC (Triumeq)bull One tablet once daily without regard to food

ABC3TCZDV (Trizivir)bull One tablet twice daily without regard to food

PregnancyPKs in Pregnancybull PKs not significantly altered in pregnancy

Dosing in Pregnancybull No change in dose indicated

For guidance about use of combination products in pregnancy please see the specific sections on other components (ie 3TC ZDV DTG)

High placental transfer to fetusb

No evidence of human teratogenicity (can rule out 15-fold increase in overall birth defects)

HSRs occur in approximately 5 to 8 of nonpregnant individuals A small percentage of reactions are fatal and these fatal reactions are usually associated with re-challenge Rate of reactions during pregnancy is unknown Testing for HLA-B5701 identifies patients at risk of reactions and a patientrsquos status should be documented as negative before initiating ABC Patients should be educated regarding symptoms of HSR

December 29 2020


35




Reviewed

Emtricitabine(FTC)Emtriva

(FTCEFVTDF)Atripla

(FTCBICTAF)Biktarvy

(FTCRPVTDF)Complera

(FTCTAF)Descovy

(FTCEVGcTAF)Genvoya

(FTCRPVTAF)Odefsey

(FTCEVGcTDF)Stribild

(FTCDRVcTAF)Symtuza

(FTCTDF)Truvada

FTC (Emtriva)Capsuled

bull 200 mg


FTCEFVTDF (Atripla)d

bull FTC 200 mgEFV 600 mgTDF 300-mg tablet

FTCBICTAF (Biktarvy)bull FTC 200 mgBIC

50 mgTAF 25-mg tablet

FTCRPVTDF (Complera)bull FTC 200 mgRPV

25 mgTDF 300-mg tablet

FTCTAF (Descovy)bull FTC 200 mgTAF

25 mg tablet

Standard Adult DosesFTC (Emtriva) Capsule bull FTC 200 mg once daily without regard to foodOral Solutionbull FTC 240 mg (24 mL) once daily without regard

to food

FTCEFVTDF (Atripla) bull One tablet once daily at or before bedtimebull Take on an empty stomach to reduce or

mitigate side effects

FTCBICTAF (Biktarvy)bull One tablet once daily with or without food

FTCRPVTDF (Complera)bull One tablet once daily with food

FTCTAF (Descovy)bull One tablet once daily with or without food

FTCEVGcTAF (Genvoya)bull One tablet once daily with food

FTCRPVTAF (Odefsey)bull One tablet once daily with food

FTCEVGcTDF (Stribild)bull One tablet once daily with food



If patient has HBVHIV coinfection it is possible that a HBV flare may occur if the drug is stopped see Hepatitis B VirusHIV Coinfection

December 29 2020


36




Reviewed


FTCEVGcTAF (Genvoya)bull FTC 200 mgEVG

150 mgCOBI 150 mgTAF 10-mg tablet

FTCRPVTAF (Odefsey)bull FTC 200 mgRPV

25 mgTAF 25 mg tablet

FTCEVGcTDF (Stribild)bull FTC 200 mgEVG

150 mgCOBI 150 mgTDF 300-mg tablet

FTCDRVcTAF (Symtuza)bull FTC 200 mgDRV


FTCTDF (Truvada)d

bull FTC 200 mgTDF 300-mg tablet

FTCDRVcTAF (Symtuza)bull One tablet once daily with food

FTCTDF (Truvada)bull One tablet once daily without regard to foodPregnancyPKs in Pregnancybull PKs of FTC are not significantly altered in

pregnancy


For guidance about the use of combination prod-ucts in pregnancy please see the specific sections on other components (ie TDF TAF EFV RPV DRV EVG BIC COBI)


37




Reviewed

Lamivudine(3TC)Epivir

(3TCTDF)Cimduo

(3TCZDV)Combivir

(3TCDORTDF)Delstrigo

(3TCDTG)Dovato

(3TCABC)Epzicom

(3TCEFVTDF)Symfi

(3TCEFVTDF)Symfi Lo

(3TCTDF)Temixys

(3TCABCDTG)Triumeq

3TC (Epivir)d

Tabletsbull 150 mgbull 300 mg


3TCTDF (Cimduo)bull 3TC 300 mgTDF

300 mg tablet

3TCZDV (Combivir)d

bull 3TC 150 mgZDV 300 mg tablet

3TCDORTDF (Delstrigo)bull 3TC 300 mgDOR

100 mgTDF 300 mg tablet

3TCDTG (Dovato)bull 3TC 300 mgDTG

50 mg tablet

3TCABC (Epzicom)d

bull 3TC 300 mgABC 600 mg tablet

Standard Adult Doses3TC (Epivir)bull 3TC 150 mg twice daily or 300 mg once daily

without regard to food

3TCTDF (Cimduo)bull One tablet once daily without regard to food

3TCZDV (Combivir)bull One tablet twice daily without regard to food

3TCDORTDF (Delstrigo)bull One tablet once daily without regard to food

3TCDTG (Dovato)bull One tablet once daily without regard to food

3TCABC (Epzicom)bull One tablet once daily without regard to food

3TCEFVTDF (Symfi or Symfi Lo)bull One tablet once daily on an empty stomach and

preferably at bedtime

3TCTDF (Temixys)bull One tablet once daily without regard to food

3TCABCDTG (Triumeq)bull One tablet once daily without regard to food



If patient has HBVHIV coinfection it is possible that an HBV flare may occur if the drug is stopped see Hepatitis B VirusHIV Coinfection

3TC products that were developed specifically for treatment of HBV (eg Epivir-HBV) contain a lower dose of 3TC that is not appropriate for treatment of HIV

December 29 2020


38




Reviewed

(3TCABCZDV)Trizivir


3TCEFVTDF (Symfi)bull 3TC 300 mgEFV

600 mg plus TDF 300 mg tablet

3TCEFVTDF (Symfi Lo)bull 3TC 300 mg

EFV 400 mgTDF 300 mg tablet

3TCTDF (Temixys)bull 3TC 300 mgTDF

300 mg tablet

3TCABCDTG (Triumeq)bull 3TC 300 mgABC

600 mgDTG 50 mg tablet

3TCABCZDV (Trizivir)d

bull 3TC 150 mgABC 300 mgZDV 300 mg tablet

3TCABCZDV (Trizivir)bull One tablet twice daily without regard to food



For guidance about the use of combination products in pregnancy please see the specific sections on other components (ie ABC DOR DTG EFV TDF ZDV)


39




Reviewed

Tenofovir Alafenamide (TAF)Vemlidy

(TAFBICFTC)Biktarvy

(TAFFTC)Descovy

(TAFEVGcFTC)Genvoya

(TAFFTCRPV)Odefsey

(TAFDRVcFTC)Symtuza

TAF (Vemlidy)Tabletbull 25 mg

TAFBICFTC (Biktarvy)bull TAF 25 mgBIC 50

mgFTC 200 mg tablet

TAFFTC (Descovy)bull TAF 25 mgFTC

200 mg tablet

TAFEVGcFTC (Genvoya)bull TAF 10 mgEVG

150 mgCOBI 150 mgFTC 200 mg tablet

TAFFTCRPV (Odefsey)bull TAF 25 mgFTC

200 mgRPV 25 mg tablet

TAFDRVcFTC (Symtuza)bull TAF 10 mgDRV


Standard Adult DosesTAF (Vemlidy)bull One tablet once daily with food

TAFBICFTC(Biktarvy)bull One tablet once daily with or without food

TAFFTC (Descovy)bull One tablet once daily with or without foodbull Same dose (TAF 25 mg) can be used with or

without PK enhancers

TAFEVGcFTC (Genvoya)bull One tablet once daily with food

TAFFTCRPV (Odefsey)bull One tablet once daily with food

TAFDRVcFTC (Symtuza)bull One tablet once daily with food

PregnancyPKs in Pregnancybull Plasma PKs not significantly altered in

pregnancy


For guidance about the use of combination products in pregnancy please see the specific sections on other components (ie BIC COBI DRV EVG FTC RPV)

Low placental transfer to fetusb

Insufficient data to assess for teratogenicity in humans No evidence of teratogenicity in rats

Renal function should be monitored because of the potential for renal toxicity

December 29 2020


40




Reviewed

Tenofovir Disoproxil Fumarate(TDF)Viread

(TDFEFVFTC)Atripla

(TDF3TC)Cimduo

(TDFFTCRPV)Complera

(TDFDOR3TC)Delstrigo

(TDFEVGcFTC)Stribild

(TDFEFV3TC)Symfi

(TDFEFV3TC)Symfi Lo

(TDF3TC)Temixys

(TDFFTC)Truvada

TDF (Viread)Tabletd

bull 300 mg

Powderbull 40 mg1 g oral

powder

TDFEFVFTC (Atripla)bull TDF 300 mg

EFV 600 mgFTC 200 mg tablet

TDF3TC (Cimduo)bull TDF 300 mg

3TC 300 mg tablet

TDFFTCRPV (Complera)bull TDF 300 mg

FTC 200 mgRPV 25 mg tablet

TDFDOR3TC (Delstrigo)bull TDF 300 mg

DOR 100 mg3TC 300 mg tablet

Standard Adult DosesTDF (Viread) Tablet bull TDF 300 mg once daily without regard to foodPowderbull TDF 8 mgkg daily (up to a maximum of TDF

300 mg) Take with food

TDFEFVFTC (Atripla) bull One tablet once daily at or before bedtime

Take on an empty stomach to reduce side effects

TDF3TC (Cimduo)bull One tablet once daily without regard to food

TDFFTCRPV (Complera)bull One tablet once daily with food

TDFDOR3TC (Delstrigo)bull One tablet once daily without regard to food

TDFEVGcFTC (Stribild) bull One tablet once daily with food

TDFEFV3TC (Symfi or Symfi Lo)bull One tablet once daily on an empty stomach and


TDF3TC (Temixys)bull One tablet once daily without regard to food



Studies in monkeys (at doses approximately twofold higher than those for human therapeutic use) show decreased fetal growth and reduction in fetal bone porosity within 2 months of starting maternal therapy Human studies demonstrate no consistent link to low birth weight but data are conflicting about potential effects on growth outcomes later in infancy

If patient has HBVHIV coinfection it is possible that an HBV flare may occur if TDF is stopped see Hepatitis B VirusHIV Coinfection

Renal function should be monitored because of potential for renal toxicity

December 29 2020


41




Reviewed


TDFEVGcFTC (Stribild)bull TDF 300 mg

EVG 150 mgCOBI 150 mgFTC 200 mg tablet

TDFEFV3TC (Symfi)bull TDF 300 mg

EFV 600 mg3TC 300 mg tablet

TDFEFV3TC (Symfi Lo)bull TDF 300 mgEFV


TDF3TC (Temixys)bull TDF 300 mg3TC

300 mg tablet

TDFFTC (Truvada)bull TDF 300 mgFTC

200 mg tablet

TDFFTC (Truvada) bull One tablet once daily without regard to food

PregnancyPKs in Pregnancybull AUC is lower in third trimester than

postpartum but trough levels are adequate


For guidance about the use of combination prod-ucts in pregnancy please see the specific sections on other components (ie 3TC COBI DOR EFV EVG FTC RPV)


42




Reviewed

Zidovudine(ZDV)Retrovir

(ZDV3TC)Combivir

(ZDVABC3TC)Trizivir

Note Generic products are available for all formulations

ZDV (Retrovir)Capsulebull 100 mg

Tabletbull 300 mg


IV Solutionbull 10 mgmL

ZDV3TC (Combivir) bull ZDV 300 mg3TC

150 mg tablet

ZDVABC3TC (Trizivir)bull ZDV 300 mgABC


Standard Adult DosesZDV (Retrovir)bull ZDV 300 mg twice daily or ZDV 200 mg three

times a day without regard to food bull Patients in active labor should receive ZDV

2 mgkg IV as a loading dose followed by ZDV 1 mgkghour continuous infusion from beginning of active labor until delivery

ZDV3TC (Combivir)bull One tablet twice daily without regard to food

ZDVABC3TC (Trizivir)bull One tablet twice daily without regard to food



For guidance about the use of combination products in pregnancy please see the specific sections on other components (ie ABC 3TC)



December 29 2020


43




Reviewed

NNRTI NNRTIs interfere with HIV reverse transcriptase by binding directly to the enzymeDoravirine(DOR)Pifeltro

(DOR3TCTDF)Delstrigo

DOR (Pifeltro) bull 100 mg tablet

DOR3TCTDF (Delstrigo)bull DOR 100 mg3TC


Standard Adult DosesDOR (Pifeltro)bull DOR 100 mg once daily with or without food

DOR3TCTDF (Delstrigo)bull One tablet once daily with or without food

PregnancyPKs in Pregnancy bull No PK studies in human pregnancy

Dosing in Pregnancybull Insufficient data to make dosing

recommendations

For guidance about use of combination products in pregnancy please see the specific sections on other components (ie 3TC TDF)

No data are available on the placental transfer of DOR in humans but animal studies suggest that DOR crosses the placenta

Insufficient data to assess for teratogenicity in humans No evidence of teratogenicity in rats or rabbits

December 29 2020

Efavirenz(EFV)Sustiva

(EFVFTCTDF)Atripla

(EFV3TCTDF)Symfi

EFV (Sustiva)d

Capsulesbull 50 mgbull 200 mg

Tabletbull 600 mg

Standard Adult DosesEFV (Sustiva)bull EFV 600 mg once daily at or before bedtimebull Take on an empty stomach to reduce side

effects

EFVFTCTDF (Atripla)bull One tablet once daily at or before bedtimebull Take on an empty stomach to reduce side

effects

Moderate placental transfer to fetusb

The FDA advises women to avoid becoming pregnant while taking EFV and advises health care providers to avoid administration during the first trimester of pregnancy as fetal harm may occur However the data on more than 7900

December 29 2020


44




Reviewed

(EFV3TCTDF)Symfi Lo


EFVFTCTDF (Atripla)bull EFV 600 mgFTC


EFV3TCTDF (Symfi)bull EFV 600 mg3TC


EFV3TCTDF (Symfi Lo)bull EFV 400 mg3TC


EFV3TCTDF (Symfi or Symfi Lo)bull One tablet once daily on an empty stomach and


PregnancyPKs in Pregnancybull AUC is decreased during the third trimester

compared with postpartum but nearly all third trimester participants exceeded target exposure

Dosing in Pregnancybull No change in dose is indicated

For guidance about the use of combination products in pregnancy please see the specific sections on other components (ie 3TC FTC TDF)

periconception EFV exposures from Botswana rule out a threefold or greater increased risk of NTDs As a result the current Perinatal Guidelines do not restrict the use of EFV in pregnant women or in women who are planning to become pregnant This is consistent with both the British HIV Association and WHO guidelines for use of ARV drugs in pregnancy

EFV should be continued in pregnant women who are on a virally suppressive EFV-based regimen because ARV drug changes during pregnancy may be associated with loss of viral control and an increased risk of perinatal transmission (see Pregnant Women Living with HIV Who are Currently Receiving Antiretroviral Therapy)


45



G-12

Table 10 Antiretroviral Drug Use in Pregnant Women with HIV Pharmacokinetic and Toxicity Data in Human Pregnancy and Recommendations for Use in Pregnancy (page 12 of 29)



Reviewed

Etravirine(ETR)Intelence

Tabletsbull 25 mgbull 100 mgbull 200 mg

For patients who are unable to swallow tablets whole the tablets may be dispersed in a glass of water

Standard Adult Dosesbull 200 mg twice daily with food

PregnancyPK in Pregnancybull PK data in pregnancy suggest 12-fold to

16-fold increases in ETR exposure during pregnancy


Placental transfer varies it is usually in the moderate-to-high categories ranging 019ndash425b


December 29 2020

Nevirapine(NVP)Viramune Viramune XR


NVP (Viramune)Tabletbull 200 mgd

Oral Suspensionbull 50 mg5 mLd

Viramune XRTabletsbull 100 mgbull 400 mgd

Standard Adult Dosesbull NVP 200 mg once daily (using Viramune

immediate release) for a 14-day lead-in period thereafter NVP 200 mg twice daily or 400 mg (using Viramune XR tablet) once daily without regard to food

bull Repeat lead-in period if therapy is discontinued for gt7 days

bull In patients who develop mild-to-moderate rash without constitutional symptoms during the lead-in period continue lead-in dosing until rash resolves but administer for le28 days total

PregnancyPKs in Pregnancybull PKs of immediate-release tablets not

significantly altered in pregnancybull No data available on extended-release

formulations in pregnancy


No evidence of human teratogenicity (can rule out 15-fold increase in overall birth defects and twofold increase in cardiovascular and genitourinary defects)

There is an increased risk of symptomatic liver toxicity when first initiating therapy in women with CD4 counts ge250mm3 Liver toxicity is often associated with a rash and can be fatal Pregnancy does not appear to increase this risk

December 29 2020


46




Reviewed


NVP should be initiated in pregnant women with CD4 counts ge250 cellsmm3 only if benefit clearly outweighs risk There is a potential increased risk of life-threatening hepatotoxicity in women with high CD4 counts Elevated transaminase levels at baseline may increase the risk of NVP toxicity

Women who become pregnant while taking NVP-containing regimens and who are tolerating their regimens well can continue taking those regimens regardless of their CD4 counts

Rilpivirine(RPV)Edurant

(RPVFTCTDF)Complera

(RPVDTG)Juluca

(RPVFTCTAF)Odefsey

RPV (Edurant)Tabletsbull 25 mg

RPVFTCTDF (Complera) bull RPV 25 mgFTC


RPVDTG (Juluca)bull RPV 25 mg DTG

50 mg tablet

Standard Adult DosesRPV (Edurant)bull RPV 25 mg once daily with a meal

RPVFTCTDF (Complera) bull One tablet once daily with a meal

RPVDTG (Juluca) bull One tablet once daily with a meal

RPVFTCTAF (Odefsey) bull One tablet once daily with a meal

Moderate-to-high placental transfer to fetusb

No evidence of human teratogenicity (can rule out twofold increase in overall birth defects)

Two-drug regimens (eg the RPVDTG FDC) are not recommended for use in pregnancy

December 29 2020


47




Reviewed

RPVFTCTAF (Odefsey) bull RPV 25 mg FTC

200 mg TAF 25 mg tablet

PregnancyPKs in Pregnancybull RPV PKs are highly variable during pregnancy

RPV AUC and trough concentrations are 20 to 50 lower in pregnancy than postpartum Although most pregnant women exceeded tar-get exposure those with detectable viral loads had lower RPV troughs

Dosing in Pregnancybull Although RPV plasma concentration is reduced

during pregnancy higher-than-standard doses have not been studied and not enough data are available to recommend a dosing change during pregnancy Pregnant women receiving standard dosing should have their viral loads monitored more frequently than women who are not receiving RPV

For guidance about the use of combination products in pregnancy please see the specific sections on other components (ie DTG FTC TAF TDF)


48




Reviewed

PIsPIs block the activity of the protease enzyme which is required to assemble new HIV viral particles that are capable of infecting new cells Atazanavir (ATV)Reyataz


Note ATV must be combined with low-dose RTV boosting in pregnancy

(ATVc)Evotaz

ATV (Reyataz)Capsulesbull 100 mg (generic

product only)bull 150 mgd

bull 200 mgd

bull 300 mgd

Oral Powderbull 50 mg packet

ATVc (Evotaz)bull ATV 300 mgCOBI

150-mg tablet

Standard Adult DosesIn ARV-Naive Patients Without RTV Boosting bull ATV 400 mg once daily with food

ATV without RTV boosting is not recommended when used with TDF H2-receptor antagonists PPIs or during pregnancy

In ARV-Naive Patients With RTV Boosting bull ATVr 300 mg100 mg once daily with

food bull When combined with EFV in ARV-naive

patients ATVr 400 mg100 mg once daily with food

In ARV-Experienced Patientsbull ATV 300 mg plus RTV 100 mg once daily

with foodbull Do not use with PPIs or EFV

In ARV-Experienced Patients Who Are Receiving an H2-Receptor Antagonist bull ATVr 300100 mg once daily with food

In ARV-Experienced Patients Who Are Receiving an H2-Receptor Antagonist and TDF bull ATVr 400 mg100 mg once daily with

food



Must be given with RTV boosting in pregnancy

Effect of in utero ATV exposure on infant indirect bilirubin levels is unclear Nonpathologic elevations of neonatal bilirubin have been observed in some but not all clinical trials to date

Oral powder (but not capsules) contains phenylalanine which can be harmful to patients with phenylketonuria

Use of ATVc is not recommended during pregnancy See Recommendations for Use of Antiretroviral Drugs During Pregnancy Table 4 and Table 5 for discussions about avoiding-the use of ATVc during pregnancy

December 29 2020


49




Reviewed

Powder Formulation bull Oral powder is taken with RTV once daily

with food at the same recommended adult dose as the capsules

ATVc (Evotaz)bull One tablet once daily with foodPregnancyPKs in PregnancyATV (Reyataz)bull ATV concentrations are reduced during

pregnancy and they are further reduced when ATV is given concomitantly with TDF or an H2-receptor antagonist

ATVc (Evotaz) bull Use of ATVc is not recommended

during pregnancy because ATV trough concentrations are 80 to 85 lower than the ATV concentrations seen in nonpregnant adults

Dosing in PregnancyATV (Reyataz)bull Use of unboosted ATV is not

recommended during pregnancybull Use of ATV is not recommended for

ARV-experienced pregnant women who are taking TDF and an H2-receptor antagonist

bull Use of an increased dose (ATVr 400 mg100 mg once daily with food) during the second and -


50




Reviewed

third trimesters results in plasma ATV concentrations equivalent to those seen in nonpregnant adults receiving standard dosing Although some experts recommend increased ATV dosing in all women during the second and third trimesters the package insert recommends increased ATV dosing only for ARV-experienced pregnant women in the second and third trimesters who are also receiving either TDF or an H2-receptor antagonist

ATVc (Evotaz)bull Insufficient data to make dosing

recommendation in pregnancy (see COBI)

For guidance about the use of combination products in pregnancy please see the specific sections on other components (ie COBI)


51



G-18




Reviewed

Darunavir(DRV)Prezista

Note Must becombined with low-dose RTV or COBIboosting

(DRVc)Prezcobix

(DRVcFTCTAF)Symtuza

DRV (Prezista)Tabletbull 75 mgbull 150 mgbull 600 mgbull 800 mg

Oral Suspensionbull 100 mgmL

DRVc (Prezcobix)bull DRVc 800 mg

150 mg tablet

DRVcFTCTAF (Symtuza)bull DRV 800 mg

COBI 150 mg FTC 200 mg TAF 10 mg tablet

Standard Adult DosesARV-Naive Patientsbull DRVr 800 mg

100 mg once daily with foodbull DRVc 800 mg

150 mg once daily with food

ARV-Experienced PatientsIf Patient Has No DRV Resistance Mutationsbull DRVr 800 mg


150 mg once daily with foodIf Any DRV Resistance Mutations Are Present bull DRVr 600 mg

100 mg twice daily with food

DRVc (Prezcobix)bull One tablet once daily with food

DRVcFTCTAF (Symtuza)bull One tablet once daily with food

PregnancyPKs in Pregnancy bull Decreased exposure in pregnancy with use of

DRVr


No evidence of teratogenicity in mice rats or rabbits No evidence of human teratogenicity

Must be boosted with low-dose RTV

The Panel does not recommend once-daily dosing with DRVr during pregnancy or the use of DRVc during pregnancy If a DRVc regimen is continued during pregnancy viral load should be monitored frequently

December 29 2020


52




Reviewed

Dosing in Pregnancybull The Panel does not recommend once-daily

dosing with DRVr during pregnancy or the use of DRVc during pregnancy

bull Twice-daily DRVr dosing (DRVr 600 mg100 mg with food) is recommended for all pregnant women

bull Increased twice-daily DRV dose (DRVr 800 mg100 mg with food) during pregnancy does not result in an increase in DRV exposure and is not recommended

For guidance about the use of combination products in pregnancy please see the specific sections on other components (ie COBI FTC TAF)

LopinavirRitonavir(LPVr)Kaletra

LPVr (Kaletra)Tablets bull LPVr 200 mg50

mgbull LPVr 100 mg25

mg

Oral Solution bull Each 5 mL contains

LPVr 400 mg100 mg

Standard Adult Dosesbull LPVr 400 mg100 mg twice daily orbull LPVr 800 mg200 mg once daily

Tabletsbull Take without regard to food

Oral Solutionbull Take with food

With EFV or NVP in PI-Naive or PI-Experienced Patientsbull LPVr 500 mg125 mg tablets twice daily

without regard to meals (use a combination of two LPVr 200 mg50 mg tablets and one LPVr 100 mg25 mg tablet) or



Oral solution contains 42 alcohol and 15 propylene glycol and is not recommended for use in pregnancy

Once-daily LPVr dosing is not recommended during pregnancy

December 29 2020


53



G-20




Reviewed

bull LPVr 520 mg130 mg oral solution (65 mL) twice daily with food

PregnancyPKs in Pregnancybull With twice-daily dosing LPV exposure is

reduced in pregnant women who receive standard adult doses increasing the dose by 50 results in exposure equivalent to that seen in nonpregnant adults receiving standard doses

bull No PK data are available for once-daily dosing in pregnancy

Dosing in Pregnancybull Once-daily dosing is not recommended during

pregnancy bull Some experts recommend that an increased

dose (ie LPVr 600 mg150 mg twice daily without regard to meals or LPVr 500 mg125 mg twice daily without regard to meals) should be used in the second and third trimesters es-pecially in PI-experienced pregnant women and women who start treatment during pregnancy with a baseline viral load gt50 copiesmL

bull When standard dosing is used monitor virolog-ic response and if possible LPV drug levels


54



G-21




Reviewed

Entry and Attachment InhibitorsEntry and attachment inhibitors block viral binding or fusion of HIV to host cellsFostemsavir(FTR)Rukobia

Extended Release Tablet 600 mg

Standard Adult Doses(FTR) Rukobiabull FTR 600 mg twice daily with or without

food

PregnancyPK in Pregnancy bull No PK studies in human pregnancy


recommendation

No human data are available regarding placental passage A study in rats demonstrates placental passage of temsavir or other metabolites


December 29 2020

Ibalizumab-uiyk(IBA)Trogarzo

IBA (Trogarzo)bull Solution for IV

infusion is available in single-dose vials

Standard Adult DosesIBA 2000-mg loading dose followed by IBA 800-mg maintenance doses administered every 2 weeks



recommendations

No data available but placental transfer of IBA a monoclonal antibody is possible

Insufficient data to assess for teratogenicity in humans

December 29 2020


55



G-22




Reviewed

Maraviroc(MVC)Selzentry

MVC (Selzentry)Tabletsbull 150 mgbull 300 mg

Standard Adult Dosesbull MVC 300 mg twice daily with or without

foodbull MVC should be used only for patients

with CCR5-tropic virus (and no X4-tropic virus)

Dose Adjustments bull Increase to MVC 600 mg twice daily when

used with the potent CYP3A inducers EFV ETR and rifampin

bull Decrease to MVC 150 mg twice daily when used with CYP3A inhibitors which includes all PIs except TPVr and itraconazole

PregnancyPKs in Pregnancy bull A PK study in human pregnancy

demonstrated a 20 to 30 overall decrease in MVC AUC but Ctrough exceeded the recommended minimum concentration of 50 ngmL

Dosing in Pregnancy bull Adjusting the standard adult MVC dose for

concomitant use with ARV drugs seems appropriate


No evidence of teratogenicity in rats or rabbits insufficient data to assess for teratogenicity in humans

December 29 2020


56




Reviewed

INSTIsINSTIs the viral enzyme that catalyzes the two-step process that inserts HIV DNA into the genome of the host cellBictegravir EmtricitabineTenofovir Alafenamide(BICFTCTAF)Biktarvy

Note BIC is only available as part of an FDC tablet

BICFTCTAF (Biktarvy) bull BIC 50 mgFTC


Standard Adult Dosesbull One tablet once daily with or without food



recommendations

For guidance about use of combination products in pregnancy please see the specific sections on other components (ie FTC TAF)

No data are available on placental transfer of BIC


BIC can be taken with food at the same time as any preparation containing iron or calcium including prenatal vitamins but should not be administered within 2 hours of these preparations when taken on an empty stomach BIC can be taken at least 2 hours before or 6 hours after antacids containing aluminum or magnesium

December 29 2020

Dolutegravir(DTG)TivicayTivicay PD

(DTG3TC)Dovato

(DTGRPV)Juluca

DTG (Tivicay)bull DTG 10 mg 25

mg and 50 mg film coated tablets

DTG (Tivicay PD)bull DTG 5 mg

dispersible tablet for oral suspension

Standard Adult DosesIn ARV-Naive or ARV Experienced (but INSTI-Naive) Patients DTG (Tivicay) bull One 50 mg tablet once daily without regard to

foodDTG (Tivicay PD) bull Six 5 mg tablets (30 mg) dissolved in water

once daily without regard to foodDTG3TC (Dovato)bull One tablet once daily without regard to food


No evidence of teratogenicity in rats or rabbits In pregnancy surveillance data from Botswana there was a slightly increased risk of NTDs in infants born to women who initiated DTG prior to pregnancy and who were receiving it at the time of conception

December 29 2020


57




Reviewed

(DTGABC3TC)Triumeq

DTG film-coated tablets and DTG dispersible tablets are not bioequivalent and are not interchangeable

DTG3TC (Dovato)bull DTG 50 mg

3TC 300 mg tablet

DTGRPV (Juluca)bull DTG 50 mg

RPV 25 mg tablet

DTGABC3TC (Triumeq)bull DTG 50 mg

ABC 600 mg3TC 300 mg tablet

DTGRPV (Juluca) bull One tablet once daily with foodDTGABC3TC (Triumeq) bull One tablet once daily without regard to food

In ARV-Naive or ARV Experienced (but INSTI-Naive) Patients Who Are Also Receiving EFV FPVr TPVr or Rifampin DTG (Tivicay) bull One 50 mg tablet twice daily without regard to


twice daily without regard to food

In INSTI-Experienced PatientsDTG (Tivicay) bull One tablet twice daily without regard to food

PregnancyPKs in Pregnancybull AUC may be decreased during the third trimes-

ter compared with postpartum but exposures during pregnancy are well above those needed to inhibit viral replication

Dosing in Pregnancy bull No change in dose indicated For guidance about the use of combination products in pregnancy please see the specific sections on other components (ie ABC 3TC RPV)

DTG may be used as part of a Preferred regimen in all pregnant women at all gestational ages and as part of an Alternative regimen in women who are trying to conceive Clinicians should discuss the risks and benefits of DTG use with the patient For more information see Updated Guidance About the Use of Dolutegravir in Pregnancy in Recommendations for Use of Antiretroviral Drugs During Pregnancy

To maximize DTG absorption doses should not be administered within 2 hours of ingesting any preparation that contains such minerals as iron or calcium including prenatal vitamins


58




Reviewed

Elvitegravir(EVG)

Note As of October 2017 the single-drug formulation of EVG (Vitekta) is no longer available

(EVGcFTCTAF)Genvoya

(EVGcFTCTDF)Stribild

EVGcFTCTAF (Genvoya) bull EVG 150 mg


EVGcFTCTDF (Stribild) bull EVG 150 mg

COBI 150 mg FTC 200 mg TDF 300 mg tablet

Standard Adult DosesGenvoya and Stribildbull One tablet once daily with food

PregnancyPKs in Pregnancy bull PK studies in women who received EVGc

demonstrated significant reduction in EVG plasma exposure during pregnancy

Dosing in Pregnancybull EVG plasma concentrations are reduced with

use of standard adult doses during pregnancy however higher-than-standard doses of EVG have not been studied Insufficient data are available to recommend a dose for use in pregnancy

For guidance about use of combination products in pregnancy please see the specific sections on other components (ie COBI FTC TAF)

Evidence of high placental transfer of EVG and low transfer of COBIb


EVGc is not recommended for use in pregnancy For women who become pregnant while taking EVGc consider frequent viral load monitoring or switching to a more effective recommended regimen If a woman continues taking a regimen that contains EVGc doses should be administered with a meal and should not be administered within 2 hours of ingesting any preparation that contains such minerals as iron or calcium including prenatal vitamins

December 29 2020


59



G-26




Reviewed

Raltegravir(RAL)IsentressIsentress HD

RAL (Isentress)Film-Coated Tabletsbull 400 mg

Chewable Tabletsbull 25 mgbull 100 mg

RAL (Isentress HD)Film-Coated Tabletsbull 600 mg

Standard Adult DosesIn Patients Who Are Not Receiving Rifampinbull RAL 400 mg film-coated tablets twice daily

without regard to foodbull Two RAL 600 mg film-coated tablets (1200

mg) once daily without regard to food for ARV-naive patients or patients who are already virologically suppressed on an initial regimen of RAL 400 mg twice daily

bull Chewable tablets and oral suspension doses are not interchangeable with either film-coated tablets or each other

In Patients Who Are Receiving Rifampinbull Two RAL 400 mg film-coated tablets (800 mg)


PregnancyPK in Pregnancy bull Decreased drug concentrations in the third tri-

mester are not of sufficient magnitude to war-rant a change in dosing

Dosing in Pregnancy bull No change in dose is indicatedbull Once-daily dosing (ie two RAL 600 mg

film-coated tablets) should not be used in pregnant women until more information is available



There is a case report of markedly elevated liver transaminases with RAL use in late pregnancy Severe potentially life-threatening and fatal skin and HSRs have been reported in nonpregnant adults

RAL chewable tablets contain phenylalanine

To maximize RAL absorption doses should not be administered within 2 hours of ingestion of any preparation containing minerals such as iron or calcium including prenatal vitamins

December 29 2020


60



G-27




Reviewed

PharmacoenhancersPharmacoenhancers reduce the metabolism of antiretroviral drugs and prolong their presence in plasma allowing for more convenient dosing regimensCobicistat(COBI)Tybost

(ATVc)Evotaz

(EVGcFTCTAF)Genvoya

(DRVc)Prezcobix


(DRVcFTCTAF)Symtuza

COBI (Tybost)Tabletbull COBI 150 mg

ATVc (Evotaz)bull ATV 300 mg COBI 50 mg tablet

EVGcFTCTAF (Genvoya)bull EVG 150 mg

COBI 150 mg FTC 200 mgTAF 10 mg tablet

DRVc (Prezcobix)bull DRV 800 mg

COBI 150 mg tablet

EVGcFTCTDF (Stribild)bull EVG 150 mg

COBI 150 mgFTC 200 mgTDF 300 mg tablet


Standard Adult Doses COBI (Tybost) bull When used as an alternative PK booster with ATV or DRV the dose is one tablet once daily with food

ATVc (Evotaz)bull One tablet once daily with food

EVGcFTCTAF (Genvoya)bull One tablet once daily with food


EVGcFTCTDF (Stribild)bull One tablet once daily with food


PregnancyPKs in Pregnancy bull Based on limited data COBI exposure and its

pharmacoenhancing effect on ATV DRV and EVG are markedly reduced in pregnancy

bull When coadministered with COBI TAF exposure is not significantly different between pregnancy and the postpartum period



Use of COBI-boosted ATV DRV or EVG is not recommended in pregnancy

December 29 2020


61




Reviewed

COBI 150 mgFTC 200 mgTAF 10 mg tablet

Dosing in Pregnancybull Although COBI exposure is markedly reduced

during pregnancy higher-than-standard doses have not been studied The Panel recommends RTV as the preferred pharmacoenhancer for PIs and INSTIs during pregnancy until more data are available on COBI activity during pregnancy

For guidance about the use of combination products in pregnancy please see the specific sections on other components (ie FTC TAF TDF ATV DRV EVG)

Ritonavir(RTV)Norvir

(LPVr)Kaletra

RTV (Norvir)Capsulesbull RTV 100 mg

Tabletsbull RTV 100 mg

Oral Solutionbull RTV 80 mgmL

Powderbull RTV 100 mgsachet



mg

Standard Adult Dose of RTV (Norvir) When Used as PK Booster for Other PIsbull RTV 100ndash400 mg per day in one or two

divided doses (refer to other PI sections for specific dosing recommendations)

Tablet bull Take with food

Capsule or Oral Solutionbull To improve tolerability take with food if

possible

Standard Adult Doses of LPVr (Kaletra)bull LPVr 400 mg100 mg twice daily orbull LPVr 800 mg200 mg once daily



No evidence of increased risk of human teratogenicity (can rule out 15-fold increase in overall birth defects)

RTV should only be used as low-dose booster for other PIs

RTV oral solution contains 43 alcohol and therefore is not recommended for use during pregnancy because no safe level of alcohol exposure during pregnancy is known LPVr oral solution contains 42 alcohol and 15 propylene glycol and is not recommended for use in pregnancy

December 29 2020


62



G-29




Reviewed


LPVr 400 mg100 mg





PregnancyPKs in Pregnancybull Lower RTV levels are seen during pregnancy

than during postpartum which may reduce the pharmaco-enhancing effect of RTV in pregnancy

RTV Dosing in Pregnancybull No dose adjustment is necessary when RTV is

used as booster

LPVr Dosing in Pregnancybull Once-daily dosing is not recommended during


dose (ie LPVr 600 mg150 mg twice daily without regard to meals or LPVr 500 mg125 mg twice daily without regard to meals) should be used in the second and third trimesters especially in PI-experienced pregnant women



63




Reviewed

and in women who start treatment during pregnancy with a baseline viral load gt50 copiesmL

bull When standard dosing is used monitor virologic response and if possible LPV drug levels

For guidance about use of combination products in pregnancy please see the specific sections on other components (ie LPVr)

a Individual ARV drug doses may need to be adjusted in patients with renal or hepatic insufficiency (for details see the Adult and Adolescent Antiret-roviral Guidelines Appendix B Table 10)b Placental transfer categories are determined by mean or median cord bloodmaternal delivery plasma drug ratioHigh gt06Moderate 03ndash06Low lt03

c Only indicated for use in chronic HBV virus infection in adultsd Generic product available

Key 3TC = lamivudine ABC = abacavir ART = antiretroviral therapy ARV = antiretroviral ATV = atazanavir ATVc = atazanavircobicistat ATVr = atazanavirritonavir AUC = area under the curve BIC = bictegravir CD4 = CD4 T lymphocyte COBI = cobicistat CYP = cytochrome P DOR = doravirine DRV = darunavir DRVc = darunavircobicistat DRVr = darunavirritonavir DTG = dolutegravir EFV = efavirenz ETR = etravirine EVG = elvitegravir EVGc = elvitegravircobicistat FDA = Food and Drug Administration FDC = fixed-dose combination FTC = emtricitabine FTR = fostemsavir HBV = hepatitis b virus HSR = hypersensitivity reaction IBA =ibalizumab INSTI = integrase strand transfer inhibitor IV = intravenous LPV = lopinavir LPVr = lopinavirritonavir MVC = maraviroc NNRTI = non-nucleoside reverse transcriptase inhibitor NRTI = nucleoside reverse transcriptase inhibitor NTD = neural tube defect NVP = nevirapine PI = protease inhibitor PK = pharmacokinetic PPI = proton pump inhibitor RAL = raltegravir RPV = rilpivirine RTV = ritonavir TAF = tenofovir alafenamide TDF = tenofovir disoproxil fumarate TPV = tipranavir TPVr = tipranavirritonavir WHO = World Health Organization ZDV = zidovudine


64

Downloaded from httpsaidsinfonihgovguidelines on 1102020

Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States F-3

was a large randomized clinical trial that demonstrated that daily infant nevirapine and maternal ART have similar safety and efficacy for prevention of perinatal transmission during breastfeeding in women with CD4 cell counts ge350 cellsmm31832 At 6 to 14 days postpartum the study randomized participants to receive either infant nevirapine or maternal ART until 18 months after delivery or breastfeeding cessation The rates of perinatal transmission were similar (058 5 infections among 1211 infants receiving nevirapine vs 057 7 infections among 1219 infants whose mothers received ART) both strategies were safe and infant HIV-1ndashfree survival was high across both arms (977 with infant nevirapine vs 971 with maternal ART at 24 months)

Hypothetically maternal triple-drug prophylaxis may be less effective than infant prophylaxis if the maternal regimen is first started postpartum or late in pregnancy because it takes several weeks to months to achieve full viral suppression in breast milk2733 Importantly although prophylaxis significantly lowers the risk of postnatal infection neither infant nor maternal postpartum ARV prophylaxis eliminates the risk of HIV transmission through breast milk Therefore breastfeeding is not recommended for women living in the United States (including those receiving combination ARV drug regimens)22 Finally both infant nevirapine prophylaxis and maternal ART during breastfeeding may be associated with the development of ARV drug resistance in infants who acquire HIV despite prophylaxis multiclass drug resistance has been described in breastfeeding infants with HIV despite maternal triple-drug prophylaxis34-38

Supplemental Table 1 Results of Major Studies on Antiretroviral Interventions to Prevent Perinatal HIV Transmission (page 1 of 7)

Study Name Location(s)

Mode of Infant Feeding

Antiretroviral Drugs

Antepartum and Intrapartum

Interventions

Postpartum Interventions Perinatal Transmission Rate and Efficacy

PACTG 076 United States France1 Formula feeding

ZDV vs placebo Long (from 14 weeks)

IV IP

Long (6 weeks) infant only

Perinatal transmission at 18 months was 83 in ZDV arm vs 255 in placebo arm (68 efficacy)

CDC Short-Course ZDV Trial Thailand12 Formula feeding

ZDV vs placebo Short (from 36 weeks)

Oral IP

None Perinatal transmission at 6 months was 94 in ZDV arm vs 189 in placebo arm (50 efficacy)

DITRAME (ANRS 049a) Trial Ivory Coast Burkina Faso1139 Breastfeeding


Oral IP

Short (1 week) mother only



Perinatal transmission was 225 in ZDV arm vs 302 in placebo arm in pooled analysis at 24 months (26 efficacy)

CDC Short-Course ZDV Trial Ivory Coast1011 Breastfeeding


Oral IP



PETRA Trial South Africa Tanzania Uganda5 Breastfeeding and formula feeding

APIPPP ZDV plus 3TCvsIPPP ZDV plus 3TCvsIP-only ZDV plus 3TCvs

Placebo

Short (from 36 weeks)

Oral IP

Short (1 week) mother and infant

Perinatal transmission at 6 weeks was 57 for APIPPP ZDV plus 3TC 89 for IPPP ZDV plus 3TC 142 for IP-only ZDV plus 3TC and 153 for placebo (efficacy compared with placebo 63 42 and 0 respectively)

Perinatal transmission at 18 months was 149 for APIPPP ZDV plus 3TC 181 for IPPP ZDV plus 3TC 200 for IP-only ZDV plus 3TC and 222 for placebo (efficacy compared with placebo 34 18 and 0 respectively)


65Downloaded from httpsaidsinfonihgovguidelines on 1102020







Interventions


HIVNET 012 Trial Uganda4 Breastfeeding

SD NVP vs ZDV No AP ARV drugs

Oral IP bull SD NVP vs oral

ZDV

SD NVP within 72 hours of birth infant onlyvs ZDV for 1 week infant only

Perinatal transmission at 6ndash8 weeks was 118 in NVP arm vs 200 in ZDV arm (42 efficacy) and 157 in NVP arm vs 258 in ZDV arm at 18 months (41 efficacy)

SAINT Trial South Africa6 Breastfeeding and formula feeding

SD NVP vs ZDV plus 3TC

No AP ARV drugs

Oral IP bull SD NVP vs ZDV

plus 3TC

SD NVP within 48 hours of birth mother and infant vs ZDV plus 3TC for 1 week mother and infant

Perinatal transmission at 8 weeks was 123 in SD NVP arm vs 93 in ZDV plus 3TC arm (difference not statistically significant P = 011)

PHPT-1 Thailand13 Formula feeding

4 ZDV regimens with different durations of AP and infant PP administration no placebo

Long (from 28 weeks) or short (from 36 weeks)

Oral IP

Long (6 weeks) or short (3 days) infant only

Perinatal transmission rate was 105 in the short-short arm This arm was stopped at interim analysis

Perinatal transmission at 6 months was 65 in long-long arm vs 47 in long-short arm and 86 in short-long arm (no statistical difference) In utero transmission was significantly higher with short vs long maternal therapy regimens (51 vs 16)

PACTG 316 Trial Bahamas Belgium Brazil France Germany Italy Spain Sweden Switzerland United Kingdom United States21 Formula feeding

SD NVP vs placebo among women already receiving ZDV alone (23) or ZDV plus other ARV drugs (77 combination therapy)

Nonstudy ARV regimen

Oral IP bull Placebo vs SD

NVP plus IV ZDV

Placebo vs SD NVP within 72 hours of birth plus nonstudy ARV drugs (ZDV) infant only

77 of women received dual- or triple-combination ARV regimens during pregnancy

Trial stopped early because of very low perinatal transmission in both arms 14 in SD NVP arm vs 16 in placebo arm (53 of perinatal transmission was in utero)


ZDV alone vsZDV plus maternal and infant SD NVPvsZDV plus maternal SD NVP

ZDV from 28 weeks

Oral IP bull ZDV alone orbull ZDV plus SD NVP

ZDV for 1 week with or without SD NVP infant only

ZDV-alone arm was stopped because the rate of perinatal transmission was higher in this arm than in the ZDVNVP arm (63 vs 11 respectively) In arms in which the mother received SD NVP the perinatal transmission rate did not differ significantly whether the infant received SD NVP or not (20 vs 28 respectively)

DITRAME Plus (ANRS 12010) Trial Ivory Coast15 Breastfeeding and formula feeding

Open label ZDV plus SD NVP

ZDV from 36 weeks

Oral IP bull ZDV plus SD NVP

SD NVP plus ZDV for 1 week infant only

Perinatal transmission at 6 weeks was 65 (95 CI 39 to 91) perinatal transmission for historical control group receiving short ZDV (98 of whom were breastfed) was 128


Open label ZDV plus 3TC plus SD NVP

ZDV plus 3TC from 32 weeks (stopped at 3 days PP)

Oral IP bull ZDV plus 3TC plus

SD NVP











Interventions


NVAZ Trial Malawi7 Breastfeeding

Neonatal SD NVP vs SD NVP plus ZDV

No AP or IP ARV drugs

SD NVP with or without ZDV for 1 week infant only

Perinatal transmission at 6ndash8 weeks was 153 in SD NVP plus ZDV arm vs 209 in SD NVP-only arm

Perinatal transmission rates at 6ndash8 weeks among infants without HIV at birth were 77 and 121 respectively (36 efficacy)

Postnatal NVP plus ZDV Trial Malawi8 Breastfeeding

Neonatal SD NVP vsSD NVP plus ZDV

No AP ARV

Oral IP bull SD NVP


Perinatal transmission at 6ndash8 weeks was 163 in NVP plus ZDV arm vs 141 in SD NVP-only arm (difference not statistically significant)

Perinatal transmission rates at 6ndash8 weeks among infants without HIV at birth were 65 and 169 respectively

Post-Exposure Infant Prophylaxis South Africa9

Breastfeeding and formula feeding

Neonatal SD NVP vsZDV for 6 weeks


SD NVP vs ZDV for 6 weeks

For formula-fed infants only perinatal transmission at 6 weeks was 143 in SD NVP arm vs 141 in ZDV arm (not significant P = 030) For breastfed infants only perinatal transmission was 122 in SD NVP arm vs 196 in ZDV arm (P = 003)

Mashi Botswana4142 Breastfeeding and formula feeding

Initial bull Short-course

ZDV withwithout maternal and infant SD NVP and withwithout breastfeeding

Revised bull Short-course ZDV

plus infant SD NVP withwithout maternal SD NVP and withwithout breastfeeding women with CD4 counts lt200 cellsmm3 received combination therapy

First Randomizationbull ZDV from 34

weeks

Oral IP bull ZDV plus either SD

NVP or placebo

Second Randomization bull Breastfeeding

plus ZDV (infant) 6 months plus SD NVP infant only vs

bull Formula feeding plus ZDV (infant) 4 weeks plus SD NVP infant only

Initial Design bull In formula-feeding arm perinatal transmission at

1 month was 24 in maternal and infant SD NVP arm vs 83 in placebo arm (P = 005)

bull In breastfeeding plus infant ZDV arm perinatal transmission at 1 month was 84 in SD NVP arm vs 41 in placebo arm (difference not statistically significant)

Revised Design bull Perinatal transmission at 1 month was 43 in

maternal plus infant SD NVP arm vs 37 in maternal placebo plus infant SD NVP arm (no significant difference no interaction with mode of infant feeding)

Perinatal transmission at 7 months was 91 in breastfeeding plus ZDV arm vs 56 in formula-feeding arm mortality at 7 months was 49 in breastfeeding plus ZDV arm vs 93 in formula-feeding arm HIV-free survival at 18 months was 156 in the breastfeeding plus ZDV arm vs 142 in the formula-feeding arm

SWEN Uganda Ethiopia India24 Breastfeeding

SD NVPvsNVP for 6 weeks

No AP ARV drugs

Oral IP bull SD NVP

Infant SD NVP vs NVP for 6 weeks

Postnatal Infection in Infants Without HIV at Birthbull Perinatal transmission at 6 weeks was 53 in SD

NVP arm vs 25 in extended NVP arm (risk ratio 054 P = 0009)

bull Perinatal transmission at 6 months was 90 in SD NVP arm vs 69 in extended NVP arm (risk ratio 080 P = 016)

HIV-free survival was significantly lower in extended NVP arm at both 6 weeks and 6 months of age









Interventions


PEPI-Malawi Trial Malawi23 Breastfeeding

SD NVP plus ZDV for 1 week (control) vs 2 extended infant regimens (NVP or NVPZDV) for 14 weeks

No AP ARV drugs

Oral IP bull SD NVP (if mother

presents in time)

Infant SD NVP plus ZDV for 1 week (control) vs Control plus NVP for 14 weeks vsControl plus NVPZDV for 14 weeks

Postnatal Infection in Infants Without HIV at Birthbull Perinatal transmission at 6 weeks was 51 in

control arm vs 17 in extended NVP arm (67 efficacy) and 16 in extended NVPZDV arm (69 efficacy)

bull Perinatal transmission at 9 months was 106 in control arm vs 52 in extended NVP arm (51 efficacy) and 64 in extended NVPZDV arm (40 efficacy)

No significant difference in perinatal transmission between the extended prophylaxis arms however more hematologic toxicity with NVPZDV

MITRA Tanzania26 Breastfeeding

Infant 3TC for 6 months (observational)

ZDV3TC from 36 weeks through labor

Maternal ZDV3TC for 1 week infant 3TC for 6 months

Perinatal transmission at 6 months was 49 (postnatal perinatal transmission between 6 weeks and 6 months was 12)

Kisumu Breastfeeding Study Kenya29 Breastfeeding

Maternal triple-drug prophylaxis (observational)

ZDV3TCNVP (NFV if CD4 count gt250 cellsmm3) from 34 weeks through labor

Maternal ZDV3TCNVP (NFV if CD4 count gt250 cellsmm3) for 6 months infant SD NVP

Perinatal transmission at 6 months was 50 (postnatal perinatal transmission between 7 days and 6 months was 26)

MITRA-PLUS Tanzania25 Breastfeeding



Maternal ZDV3TCNVP (NFV if CD4 count gt200 cellsmm3) for 6 months infant ZDV3TC for 1 week

Perinatal transmission at 6 months was 50 (postnatal perinatal transmission between 6 weeks and 6 months was 09) not significantly different from 6-month infant prophylaxis in MITRA

Kesho Bora Multi-African28 Breastfeeding primarily

AP ZDVSD NVP with no postnatal prophylaxis vs Maternal triple-drug prophylaxis in women with CD4 counts 200ndash500 cellsmm3

Arm 1 bull ZDV3TCLPVr

Arm 2 bull ZDV plus SD NVP

From 28 weeks through labor

Arm 1 bull Maternal ZDV3TC

LPVr for 6 months infant SD NVP plus ZDV for 1 week


for 1 week (no further postnatal prophylaxis) infant SD NVP plus ZDV for 1 week (no further postnatal prophylaxis)

Perinatal transmission at birth was 18 with maternal triple-drug prophylaxis (Arm 1) vs 25 with ZDVSD NVP (Arm 2) not significantly different In women with CD4 counts 350ndash500 cellsmm3 perinatal transmission at birth was 17 in both arms

Perinatal transmission at 12 months was 54 with maternal triple-drug prophylaxis (Arm 1) vs 95 with ZDVSD NVP (with no further postnatal prophylaxis after 1 week) (Arm 2) (P = 0029)

Mma Bana Botswana2 Breastfeeding

Compared 2 maternal triple-drug prophylaxis regimens in women with CD4 counts gt200 cellsmm3

Arm 1 bull ZDV3TCABC




ABC for 6 months infant SD NVP plus ZDV for 4 weeks


LPVr for 6 months infant SD NVP plus ZDV for 4 weeks

Perinatal transmission at 6 months overall was 13 21 in ZDV3TCABC Arm 1 vs 04 in ZDV3TCLPVr Arm 2 (P = 053)









Interventions


BAN Malawi2743 Breastfeeding

Postpartum maternal triple-drug prophylaxis vs infant NVP in women with CD4 counts ge250 cellsmm3

No AP drugs

IP Regimens

Arm 1 (Control)bull ZDV3TC plus SD

NVP

Arm 2bull ZDV3TC plus SD

NVP

Arm 3 bull ZDV3TC plus SD

NVP

Arm 1 (Control) bull Maternal ZDV

3TC for 1 week infant SD NVP plus ZDV3TC for 1 week

Arm 2 bull Control as above

then maternal ZDV3TCLPVr for 6 months


then infant NVP for 6 months

Postnatal Infection in Infants Without HIV at 2 Weeksbull Perinatal transmission at 28 weeks was 57

in control Arm 1 29 in maternal triple-drug prophylaxis Arm 2 (P = 0009 vs control) and 17 in infant NVP Arm 3 (P lt 0001 vs control)

bull Perinatal transmission at 48 weeks was 70 in control Arm 1 40 in maternal triple-drug prophylaxis Arm 2 (P = 00273 vs control) and 4 in infant NVP Arm 3 (P = 00027 vs control)

No significant difference between maternal triple-drug prophylaxis (Arm 2) and infant NVP (Arm 3) (P = 012 at 28 weeks and P = 0426 at 48 weeks)

HPTN 046 South Africa Tanzania Uganda Zimbabwe3844 Breastfeeding

Postpartum prophylaxis to prevent breast milk transmission of HIV with 6 weeks of infant NVP vs 6 months of infant NVP

AP drugs allowed if required for maternal health

All infants received daily NVP from birth through age 6 weeks

Arm 1 bull Daily infant NVP

from 6 weeks through 6 months

Arm 2 bull Daily infant

placebo from 6 weeks through 6 months

In infants without HIV at age 6 weeks the 6-month infant HIV infection rate was 11 (03 to 18) in the extended NVP arm vs 24 (13 to 36) in the placebo arm (P = 0048)

18-month postnatal infection rates were 22 (11 to 33) in the extended NVP arm vs 31 (19 to 44) in the placebo arm (P = 028) HIV infection and mortality rates did not differ between arms at any age through 18 months

At infant randomization at age 6 weeks 29 of mothers in each arm were receiving a triple-drug ARV regimen for the treatment of HIV

For mothers receiving triple-drug ARV regimens at the time of randomization in infants without HIV at age 6 weeks the 6-month infant HIV infection rate was 02 and not statistically different from the rates seen in the extended NVP arm (05) and placebo arm (0)

For mothers with CD4 counts gt350 cellsmm3 who were not receiving triple-drug ARV regimens in infants without HIV at age 6 weeks the 6-month infant HIV infection rate was 07 (0 to 15) in the extended NVP arm vs 28 (13 to 44) in the placebo arm (P = 0014)









Interventions


NICHD-HPTN 040PACTG 1043 Trial Brazil Argentina South Africa United States45 Formula feeding

Infant prophylaxis with 6 weeks of ZDVvs6 weeks of infant ZDV plus 3 doses of NVP in first week of lifevs6 weeks of infant ZDV plus 2 weeks 3TCNFV

No AP drugs

If mother presented early enough IV ZDV during labor through delivery

Arm 1 (Control) bull Infant ZDV for 6

weeks


plus NVP with first dose within 48 hours of birth second dose 48 hours later and third dose 96 hours after second dose


plus 3TC and NFV from birth through age 2 weeks

IP HIV transmission among infants with negative HIV test at birth 48 (32 to 71) with ZDV (Arm 1) vs 22 (12 to 39) with ZDV plus NVP (Arm 2) (P = 0046 compared with Arm 1) vs 24 (14 to 43) with ZDV plus 3TCNFV (Arm 3) (P = 0046 compared with Arm 1)

Overall HIV transmission rates including in utero infection 110 (87 to 140) with ZDV (Arm 1) vs 71 (52 to 96) with ZDV plus NVP (Arm 2) (P = 0035 compared with Arm 1) vs 74 (54 to 99) with ZDV plus 3TCNFV (Arm 3) (P = 0035 compared with Arm 1)

Grade 3 or 4 neutropenia more frequent in ZDV3TCNFV Arm 3 (70 infants) than in ZDV-alone Arm 1 (33 infants) or ZDVNVP Arm 2 (32 infants) (P lt 0001)

ANRS 12174 Trial Burkina Faso South Africa Uganda Zambia3031 Breastfeeding

Compared 2 infant ARV prophylaxis regimens during breastfeeding infants tested PCR-negative at birth and were born to mothers with CD4 counts gt350 cellsmm3

As per standard of care

Arm 1 bull Daily infant LPVr

from 1 week through 50 weeks of age

Arm 2 bull Daily infant 3TC


Postnatal Infection in Infants Without HIV at Birthbull Postnatal transmission at age 50 weeks was 14

(070ndash276) in Arm 1 vs 15 (080ndash291) in Arm 2 (P = 083)

bull HIV-free survival was 965 (846ndash977) in Arm 1 vs 963 (944ndash975) in Arm 2 (P = 085)

PROMOTE Uganda46 Breastfeeding

Compared 2 triple-ARV regimens no CD4 restriction


Arm 2 bull ZDV3TCEFV bull ARVs started at 12ndash28 weeksrsquo gestation and continued through labor

Randomized regimen continued postpartum through 1 year of breastfeeding

HIV-free survival was 929 in the LPVr arm vs 972 in the EFV arm (P = 010) Only 2 of 374 liveborn infants acquired infection both in the LPVr arm

PROMISE India Malawi South Africa Tanzania Uganda Zambia Zimbabwe18

Breastfeeding and formula feeding (antepartum component)

Compared ZDV prophylaxis and 2 ART regimens during pregnancy among women at gt14 weeksrsquo gestation and with CD4 counts ge350 cellsmm3

Arm 1 bull ZDV during

pregnancy plus SD NVP plus TDF plus FTC at delivery

Arm 2 bull ZDV plus 3TC plus

LPVr

Arm 3 bull TDF plus FTC plus

LPVr

Arm 1 bull TDFFTC tail

continued for 6ndash14 days postpartum

Arms 2 and 3 bull ART regimen


Infants received once-daily NVP for 6 weeks

Infant HIV Infection Rates by Age 14 DaysArm 1bull 18 (251386)

Arm 2bull 05 (71385)

Arm 3bull 06 (2325)

Combined ART arms vs ZDV arm difference in perinatal transmission risk-13 (95 CI -21 to -04)




Key to Acronyms 3TC = lamivudine ABC = abacavir AP = antepartum ARV = antiretroviral ART = antiretroviral therapy CD4 = CD4 T lymphocyte CDC = Centers for Disease Control and Prevention CI = confidence interval EFV = efavirenz FTC = emtricitabine IP = intrapartum IV = intravenous LPVr = lopinavirritonavir NFV = nelfinavir NVP = nevirapine PCR = polymerase chain reaction PP = postpartum SD = single-dose TDF = tenofovir disoproxil fumarate ZDV = zidovudine


References1 Connor EM Sperling RS Gelber R et al Reduction of maternal-infant transmission of human immunodeficiency virus

type 1 with zidovudine treatment Pediatric AIDS Clinical Trials Group Protocol 076 Study Group N Engl J Med 1994331(18)1173-1180 Available at httpwwwncbinlmnihgovpubmed7935654

2 Shapiro RL Hughes MD Ogwu A et al Antiretroviral regimens in pregnancy and breast-feeding in Botswana N Engl J Med 2010362(24)2282-2294 Available at httpwwwncbinlmnihgovpubmed20554983

3 Kesho Bora Study Group Eighteen-month follow-up of HIV-1-infected mothers and their children enrolled in the kesho bora study observational cohorts J Acquir Immune Defic Syndr 201054(5)533-541 Available at httpwwwncbinlmnihgovpubmed20543706

4 Jackson JB Musoke P Fleming T et al Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala Uganda 18-month follow-up of the HIVNET 012 randomised trial Lancet 2003362(9387)859-868 Available at httpwwwncbinlmnihgovpubmed13678973

5 Petra Study Team Efficacy of three short-course regimens of zidovudine and lamivudine in preventing early and late transmission of HIV-1 from mother to child in Tanzania South Africa and Uganda (Petra study) a randomised double-blind placebo-controlled trial Lancet 2002359(9313)1178-1186 Available at httpwwwncbinlmnihgovpubmed11955535

6 Moodley D Moodley J Coovadia H et al A multicenter randomized controlled trial of nevirapine versus a combination of zidovudine and lamivudine to reduce intrapartum and early postpartum mother-to-child transmission of human immunodeficiency virus type 1 J Infect Dis 2003187(5)725-735 Available at httpwwwncbinlmnihgovpubmed12599045

7 Taha TE Kumwenda NI Gibbons A et al Short postexposure prophylaxis in newborn babies to reduce mother-to-child transmission of HIV-1 NVAZ randomised clinical trial Lancet 2003362(9391)1171-1177 Available at httpwwwncbinlmnihgovpubmed14568737

8 Taha TE Kumwenda NI Hoover DR et al Nevirapine and zidovudine at birth to reduce perinatal transmission of HIV in an African setting a randomized controlled trial JAMA 2004292(2)202-209 Available at httpwwwncbinlmnihgovpubmed15249569





Interventions


PROMISE India Malawi South Africa Tanzania Uganda Zambia Zimbabwe18 Breastfeeding (postpartum component)

Compared infant NVP and maternal ART during breastfeeding among infants born to women with CD4 counts ge350 cellsmm3

This was a postpartum study intervention only

Eligible women included women enrolled in PROMISE antepartum (see above) and women who received no ARV drugs during pregnancy

Arm 1 bull Mothers received

TDF plus FTC plus LPVr

Arm 2 bull Once-daily infant

NVP

Regimens were continued until 42 days after last breastmilk exposure or age 18 months whichever came first

Infant Infection RatesArm 1 bull 057 (71219)

Arm 2 bull 058 (71211)

Rates of Infant HIV-1ndashFree Survival at 24 MonthsArm 1 bull 971

Arm 2 bull 977


2

Table of Contents

Table 1 Outline of the Guidelines Development Process3Table 2 Rating Scheme for Recommendations5Table 3 Drug Interactions Between Antiretroviral Agents and Hormonal Contraceptives6Table 4 What to Start Initial Combination Regimens for the Antiretroviral-Naive Pregnant Women 16Table 5 Situation-Specific Recommendations for Use of Antiretroviral Drugs in Pregnant Womenand Nonpregnant Women Who Are Trying to Conceive20Table 6 HIV-Related Laboratory Monitoring Schedule for Pregnant Women with HIV24Table 7 Intrapartum Care and Recommended Interventions to Prevent Perinatal HIV Transmission for Women with HIV Based on Maternal HIV RNA Levels at the Time of Delivery26Table 8 Newborn Antiretroviral Management According to Risk of HIV Infection in theNewborn29Table 9 Newborn Antiretroviral Dosing Recommendations31Table 10 Antiretroviral Drug Use in Pregnant Women with HIV Infection Pharmacokinetic and Toxicity Data in Human Pregnancy and Recommendations for Use in Pregnancy34Supplemental Table 1 Results of Major Studies on Antiretroviral Prophylaxis to PreventPerinatal HIV Transmission 64


3













4








5



A-6






III Expert opinion

References












6


ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation

NNRTIsEFV COC





levels2628



















7

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation


concentration 45





concentrations29










rate36






8

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation




EE darr 5956







COCNo ovulations59






No data on POPs


9

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation


change in EE AUC61

NE AUC darr 1860



change26




on NVP levels586062





COCbull No increase







in pregnancy rate48










10

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation










No data on POPs






No clinical data











11

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation


NE AUC darr 1470






No data on POPS


NE AUC darr 17





5253

COCbull Increased




and no ovulations38










12

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation






in pregnancy rate48




23-fold


42






No data on POPs


EE AUC darr 3043





No data on POPs


13

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation


















No data on POPs


14

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation

INSTIsBICFTCTAF






No clinical data









No data on POPs


uarr 126







No data on POPs


1475







15

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation







16









ABC3TC


TDFFTCor

TDF3TC



DTGABC3TC (FDC)or




17











TAFFTC


ZDV3TC



18


EFVTDFFTC (FDC)or

EFVTDF3TC (FDC)or



RPVTDFFTC (FDC) or







DRVc (FDC) or

DRVcFTCTAF (FDC)


EVGcFTCTAF (FDC)




19







NVP






20






the First Time








Conceiveab



EVGcd
















C-1



21











NRTI Drugscg














C-2


22







EVGcFTCTDFd



(EVGc)




EVGcFTCTAFd



(EVGc)




DRVcFTCTAFd



(DRVc)




DTG3TCAs a complete

regimenj


additional agents



regimenj


additional agentse







23










24



Laboratory Test





MonthlyEvery 3



At 34 to 36 Weeks



Regimen

HIV RNA Levelsb



Until HIV


At least every 3

monthsc

CD4 Countd

For women




Resistance Testinge

Standard Glucose

Screeningf

For women on

ARTf


C-5


25


Or as needed


Toxicitiesg








C-10




ART Adherencea



gt1000 copiesmL






Intrapartum IV ZDV


















27


ART Adherencea



gt1000 copiesmL




















C-12





29







ZDV for 4 weeksa











Newborn with HIVe





30






C-5
















Weight Band





C-6


















33





DTG



Pediatric

Body Weight

Recommended Dosee


Number of tablets





34






Reviewed


(ABC3TC)Epzicom

(ABCDTG3TC)Triumeq

(ABC3TCZDV)Trizivir


ABC (Ziagen)d

Tabletbull 300 mg


ABC3TC (Epzicom)d

















December 29 2020


35




Reviewed


(FTCEFVTDF)Atripla

(FTCBICTAF)Biktarvy

(FTCRPVTDF)Complera

(FTCTAF)Descovy

(FTCEVGcTAF)Genvoya

(FTCRPVTAF)Odefsey


(FTCDRVcTAF)Symtuza

(FTCTDF)Truvada


bull 200 mg









25 mg tablet


to food












December 29 2020


36




Reviewed










FTCTDF (Truvada)d




pregnancy




37




Reviewed


(3TCTDF)Cimduo

(3TCZDV)Combivir


(3TCDTG)Dovato

(3TCABC)Epzicom

(3TCEFVTDF)Symfi

(3TCEFVTDF)Symfi Lo

(3TCTDF)Temixys

(3TCABCDTG)Triumeq

3TC (Epivir)d




300 mg tablet

3TCZDV (Combivir)d





50 mg tablet

3TCABC (Epzicom)d

















December 29 2020


38




Reviewed

(3TCABCZDV)Trizivir







300 mg tablet










39




Reviewed


(TAFBICFTC)Biktarvy

(TAFFTC)Descovy

(TAFEVGcFTC)Genvoya

(TAFFTCRPV)Odefsey

(TAFDRVcFTC)Symtuza



mgFTC 200 mg tablet


200 mg tablet















pregnancy






December 29 2020


40




Reviewed


(TDFEFVFTC)Atripla

(TDF3TC)Cimduo

(TDFFTCRPV)Complera



(TDFEFV3TC)Symfi

(TDFEFV3TC)Symfi Lo

(TDF3TC)Temixys

(TDFFTC)Truvada

TDF (Viread)Tabletd

bull 300 mg


powder




3TC 300 mg tablet





















December 29 2020


41




Reviewed









300 mg tablet


200 mg tablet







42




Reviewed


(ZDV3TC)Combivir

(ZDVABC3TC)Trizivir



Tabletbull 300 mg




150 mg tablet













December 29 2020


43




Reviewed










recommendations




December 29 2020


(EFVFTCTDF)Atripla

(EFV3TCTDF)Symfi

EFV (Sustiva)d


Tabletbull 600 mg


effects


effects



December 29 2020


44




Reviewed

(EFV3TCTDF)Symfi Lo

















45



G-12




Reviewed










December 29 2020
















December 29 2020


46




Reviewed





(RPVFTCTDF)Complera

(RPVDTG)Juluca

(RPVFTCTAF)Odefsey





50 mg tablet








December 29 2020


47




Reviewed









48




Reviewed




(ATVc)Evotaz



bull 200 mgd

bull 300 mgd



150-mg tablet










food







December 29 2020


49




Reviewed












50




Reviewed






51



G-18




Reviewed



(DRVc)Prezcobix

(DRVcFTCTAF)Symtuza




150 mg tablet













DRVr





December 29 2020


52




Reviewed









mg


LPVr 400 mg100 mg










December 29 2020


53



G-20




Reviewed










54



G-21




Reviewed




food



recommendation



December 29 2020







recommendations



December 29 2020


55



G-22




Reviewed















December 29 2020


56




Reviewed








recommendations





December 29 2020


(DTG3TC)Dovato

(DTGRPV)Juluca










December 29 2020


57




Reviewed

(DTGABC3TC)Triumeq



3TC 300 mg tablet


RPV 25 mg tablet














58




Reviewed

Elvitegravir(EVG)


(EVGcFTCTAF)Genvoya















December 29 2020


59



G-26




Reviewed




















December 29 2020


60



G-27




Reviewed


(ATVc)Evotaz

(EVGcFTCTAF)Genvoya

(DRVc)Prezcobix


(DRVcFTCTAF)Symtuza






COBI 150 mg tablet
















December 29 2020


61




Reviewed






(LPVr)Kaletra







mg





possible







December 29 2020


62



G-29




Reviewed


LPVr 400 mg100 mg








used as booster






63




Reviewed








64










Interventions




IV IP





Oral IP




Oral IP







Oral IP





Placebo


Oral IP












Interventions





ZDV





No AP ARV drugs


plus 3TC






Oral IP








NVP plus IV ZDV






ZDV from 28 weeks






ZDV from 36 weeks








SD NVP











Interventions










No AP ARV

Oral IP bull SD NVP
















weeks


NVP or placebo












No AP ARV drugs

Oral IP bull SD NVP














Interventions




No AP ARV drugs


presents in time)


















































Interventions




No AP drugs

IP Regimens


NVP


NVP


NVP
































Interventions




No AP drugs



weeks






























LPVr


LPVr







Arm 2bull 05 (71385)

Arm 3bull 06 (2325)




















Interventions









NVP



Arm 2 bull 058 (71211)


Arm 2 bull 977


3













4








5



A-6






III Expert opinion

References












6


ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation

NNRTIsEFV COC





levels2628



















7

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation


concentration 45





concentrations29










rate36






8

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation




EE darr 5956







COCNo ovulations59






No data on POPs


9

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation


change in EE AUC61

NE AUC darr 1860



change26




on NVP levels586062





COCbull No increase







in pregnancy rate48










10

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation










No data on POPs






No clinical data











11

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation


NE AUC darr 1470






No data on POPS


NE AUC darr 17





5253

COCbull Increased




and no ovulations38










12

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation






in pregnancy rate48




23-fold


42






No data on POPs


EE AUC darr 3043





No data on POPs


13

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation


















No data on POPs


14

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation

INSTIsBICFTCTAF






No clinical data









No data on POPs


uarr 126







No data on POPs


1475







15

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation







16









ABC3TC


TDFFTCor

TDF3TC



DTGABC3TC (FDC)or




17











TAFFTC


ZDV3TC



18


EFVTDFFTC (FDC)or

EFVTDF3TC (FDC)or



RPVTDFFTC (FDC) or







DRVc (FDC) or

DRVcFTCTAF (FDC)


EVGcFTCTAF (FDC)




19







NVP






20






the First Time








Conceiveab



EVGcd
















C-1



21











NRTI Drugscg














C-2


22







EVGcFTCTDFd



(EVGc)




EVGcFTCTAFd



(EVGc)




DRVcFTCTAFd



(DRVc)




DTG3TCAs a complete

regimenj


additional agents



regimenj


additional agentse







23










24



Laboratory Test





MonthlyEvery 3



At 34 to 36 Weeks



Regimen

HIV RNA Levelsb



Until HIV


At least every 3

monthsc

CD4 Countd

For women




Resistance Testinge

Standard Glucose

Screeningf

For women on

ARTf


C-5


25


Or as needed


Toxicitiesg








C-10




ART Adherencea



gt1000 copiesmL






Intrapartum IV ZDV


















27


ART Adherencea



gt1000 copiesmL




















C-12





29







ZDV for 4 weeksa











Newborn with HIVe





30






C-5
















Weight Band





C-6


















33





DTG



Pediatric

Body Weight

Recommended Dosee


Number of tablets





34






Reviewed


(ABC3TC)Epzicom

(ABCDTG3TC)Triumeq

(ABC3TCZDV)Trizivir


ABC (Ziagen)d

Tabletbull 300 mg


ABC3TC (Epzicom)d

















December 29 2020


35




Reviewed


(FTCEFVTDF)Atripla

(FTCBICTAF)Biktarvy

(FTCRPVTDF)Complera

(FTCTAF)Descovy

(FTCEVGcTAF)Genvoya

(FTCRPVTAF)Odefsey


(FTCDRVcTAF)Symtuza

(FTCTDF)Truvada


bull 200 mg









25 mg tablet


to food












December 29 2020


36




Reviewed










FTCTDF (Truvada)d




pregnancy




37




Reviewed


(3TCTDF)Cimduo

(3TCZDV)Combivir


(3TCDTG)Dovato

(3TCABC)Epzicom

(3TCEFVTDF)Symfi

(3TCEFVTDF)Symfi Lo

(3TCTDF)Temixys

(3TCABCDTG)Triumeq

3TC (Epivir)d




300 mg tablet

3TCZDV (Combivir)d





50 mg tablet

3TCABC (Epzicom)d

















December 29 2020


38




Reviewed

(3TCABCZDV)Trizivir







300 mg tablet










39




Reviewed


(TAFBICFTC)Biktarvy

(TAFFTC)Descovy

(TAFEVGcFTC)Genvoya

(TAFFTCRPV)Odefsey

(TAFDRVcFTC)Symtuza



mgFTC 200 mg tablet


200 mg tablet















pregnancy






December 29 2020


40




Reviewed


(TDFEFVFTC)Atripla

(TDF3TC)Cimduo

(TDFFTCRPV)Complera



(TDFEFV3TC)Symfi

(TDFEFV3TC)Symfi Lo

(TDF3TC)Temixys

(TDFFTC)Truvada

TDF (Viread)Tabletd

bull 300 mg


powder




3TC 300 mg tablet





















December 29 2020


41




Reviewed









300 mg tablet


200 mg tablet







42




Reviewed


(ZDV3TC)Combivir

(ZDVABC3TC)Trizivir



Tabletbull 300 mg




150 mg tablet













December 29 2020


43




Reviewed










recommendations




December 29 2020


(EFVFTCTDF)Atripla

(EFV3TCTDF)Symfi

EFV (Sustiva)d


Tabletbull 600 mg


effects


effects



December 29 2020


44




Reviewed

(EFV3TCTDF)Symfi Lo

















45



G-12




Reviewed










December 29 2020
















December 29 2020


46




Reviewed





(RPVFTCTDF)Complera

(RPVDTG)Juluca

(RPVFTCTAF)Odefsey





50 mg tablet








December 29 2020


47




Reviewed









48




Reviewed




(ATVc)Evotaz



bull 200 mgd

bull 300 mgd



150-mg tablet










food







December 29 2020


49




Reviewed












50




Reviewed






51



G-18




Reviewed



(DRVc)Prezcobix

(DRVcFTCTAF)Symtuza




150 mg tablet













DRVr





December 29 2020


52




Reviewed









mg


LPVr 400 mg100 mg










December 29 2020


53



G-20




Reviewed










54



G-21




Reviewed




food



recommendation



December 29 2020







recommendations



December 29 2020


55



G-22




Reviewed















December 29 2020


56




Reviewed








recommendations





December 29 2020


(DTG3TC)Dovato

(DTGRPV)Juluca










December 29 2020


57




Reviewed

(DTGABC3TC)Triumeq



3TC 300 mg tablet


RPV 25 mg tablet














58




Reviewed

Elvitegravir(EVG)


(EVGcFTCTAF)Genvoya















December 29 2020


59



G-26




Reviewed




















December 29 2020


60



G-27




Reviewed


(ATVc)Evotaz

(EVGcFTCTAF)Genvoya

(DRVc)Prezcobix


(DRVcFTCTAF)Symtuza






COBI 150 mg tablet
















December 29 2020


61




Reviewed






(LPVr)Kaletra







mg





possible







December 29 2020


62



G-29




Reviewed


LPVr 400 mg100 mg








used as booster






63




Reviewed








64










Interventions




IV IP





Oral IP




Oral IP







Oral IP





Placebo


Oral IP












Interventions





ZDV





No AP ARV drugs


plus 3TC






Oral IP








NVP plus IV ZDV






ZDV from 28 weeks






ZDV from 36 weeks








SD NVP











Interventions










No AP ARV

Oral IP bull SD NVP
















weeks


NVP or placebo












No AP ARV drugs

Oral IP bull SD NVP














Interventions




No AP ARV drugs


presents in time)


















































Interventions




No AP drugs

IP Regimens


NVP


NVP


NVP
































Interventions




No AP drugs



weeks






























LPVr


LPVr







Arm 2bull 05 (71385)

Arm 3bull 06 (2325)




















Interventions









NVP



Arm 2 bull 058 (71211)


Arm 2 bull 977


4








5



A-6






III Expert opinion

References












6


ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation

NNRTIsEFV COC





levels2628



















7

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation


concentration 45





concentrations29










rate36






8

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation




EE darr 5956







COCNo ovulations59






No data on POPs


9

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation


change in EE AUC61

NE AUC darr 1860



change26




on NVP levels586062





COCbull No increase







in pregnancy rate48










10

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation










No data on POPs






No clinical data











11

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation


NE AUC darr 1470






No data on POPS


NE AUC darr 17





5253

COCbull Increased




and no ovulations38










12

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation






in pregnancy rate48




23-fold


42






No data on POPs


EE AUC darr 3043





No data on POPs


13

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation


















No data on POPs


14

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation

INSTIsBICFTCTAF






No clinical data









No data on POPs


uarr 126







No data on POPs


1475







15

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation







16









ABC3TC


TDFFTCor

TDF3TC



DTGABC3TC (FDC)or




17











TAFFTC


ZDV3TC



18


EFVTDFFTC (FDC)or

EFVTDF3TC (FDC)or



RPVTDFFTC (FDC) or







DRVc (FDC) or

DRVcFTCTAF (FDC)


EVGcFTCTAF (FDC)




19







NVP






20






the First Time








Conceiveab



EVGcd
















C-1



21











NRTI Drugscg














C-2


22







EVGcFTCTDFd



(EVGc)




EVGcFTCTAFd



(EVGc)




DRVcFTCTAFd



(DRVc)




DTG3TCAs a complete

regimenj


additional agents



regimenj


additional agentse







23










24



Laboratory Test





MonthlyEvery 3



At 34 to 36 Weeks



Regimen

HIV RNA Levelsb



Until HIV


At least every 3

monthsc

CD4 Countd

For women




Resistance Testinge

Standard Glucose

Screeningf

For women on

ARTf


C-5


25


Or as needed


Toxicitiesg








C-10




ART Adherencea



gt1000 copiesmL






Intrapartum IV ZDV


















27


ART Adherencea



gt1000 copiesmL




















C-12





29







ZDV for 4 weeksa











Newborn with HIVe





30






C-5
















Weight Band





C-6


















33





DTG



Pediatric

Body Weight

Recommended Dosee


Number of tablets





34






Reviewed


(ABC3TC)Epzicom

(ABCDTG3TC)Triumeq

(ABC3TCZDV)Trizivir


ABC (Ziagen)d

Tabletbull 300 mg


ABC3TC (Epzicom)d

















December 29 2020


35




Reviewed


(FTCEFVTDF)Atripla

(FTCBICTAF)Biktarvy

(FTCRPVTDF)Complera

(FTCTAF)Descovy

(FTCEVGcTAF)Genvoya

(FTCRPVTAF)Odefsey


(FTCDRVcTAF)Symtuza

(FTCTDF)Truvada


bull 200 mg









25 mg tablet


to food












December 29 2020


36




Reviewed










FTCTDF (Truvada)d




pregnancy




37




Reviewed


(3TCTDF)Cimduo

(3TCZDV)Combivir


(3TCDTG)Dovato

(3TCABC)Epzicom

(3TCEFVTDF)Symfi

(3TCEFVTDF)Symfi Lo

(3TCTDF)Temixys

(3TCABCDTG)Triumeq

3TC (Epivir)d




300 mg tablet

3TCZDV (Combivir)d





50 mg tablet

3TCABC (Epzicom)d

















December 29 2020


38




Reviewed

(3TCABCZDV)Trizivir







300 mg tablet










39




Reviewed


(TAFBICFTC)Biktarvy

(TAFFTC)Descovy

(TAFEVGcFTC)Genvoya

(TAFFTCRPV)Odefsey

(TAFDRVcFTC)Symtuza



mgFTC 200 mg tablet


200 mg tablet















pregnancy






December 29 2020


40




Reviewed


(TDFEFVFTC)Atripla

(TDF3TC)Cimduo

(TDFFTCRPV)Complera



(TDFEFV3TC)Symfi

(TDFEFV3TC)Symfi Lo

(TDF3TC)Temixys

(TDFFTC)Truvada

TDF (Viread)Tabletd

bull 300 mg


powder




3TC 300 mg tablet





















December 29 2020


41




Reviewed









300 mg tablet


200 mg tablet







42




Reviewed


(ZDV3TC)Combivir

(ZDVABC3TC)Trizivir



Tabletbull 300 mg




150 mg tablet













December 29 2020


43




Reviewed










recommendations




December 29 2020


(EFVFTCTDF)Atripla

(EFV3TCTDF)Symfi

EFV (Sustiva)d


Tabletbull 600 mg


effects


effects



December 29 2020


44




Reviewed

(EFV3TCTDF)Symfi Lo

















45



G-12




Reviewed










December 29 2020
















December 29 2020


46




Reviewed





(RPVFTCTDF)Complera

(RPVDTG)Juluca

(RPVFTCTAF)Odefsey





50 mg tablet








December 29 2020


47




Reviewed









48




Reviewed




(ATVc)Evotaz



bull 200 mgd

bull 300 mgd



150-mg tablet










food







December 29 2020


49




Reviewed












50




Reviewed






51



G-18




Reviewed



(DRVc)Prezcobix

(DRVcFTCTAF)Symtuza




150 mg tablet













DRVr





December 29 2020


52




Reviewed









mg


LPVr 400 mg100 mg










December 29 2020


53



G-20




Reviewed










54



G-21




Reviewed




food



recommendation



December 29 2020







recommendations



December 29 2020


55



G-22




Reviewed















December 29 2020


56




Reviewed








recommendations





December 29 2020


(DTG3TC)Dovato

(DTGRPV)Juluca










December 29 2020


57




Reviewed

(DTGABC3TC)Triumeq



3TC 300 mg tablet


RPV 25 mg tablet














58




Reviewed

Elvitegravir(EVG)


(EVGcFTCTAF)Genvoya















December 29 2020


59



G-26




Reviewed




















December 29 2020


60



G-27




Reviewed


(ATVc)Evotaz

(EVGcFTCTAF)Genvoya

(DRVc)Prezcobix


(DRVcFTCTAF)Symtuza






COBI 150 mg tablet
















December 29 2020


61




Reviewed






(LPVr)Kaletra







mg





possible







December 29 2020


62



G-29




Reviewed


LPVr 400 mg100 mg








used as booster






63




Reviewed








64










Interventions




IV IP





Oral IP




Oral IP







Oral IP





Placebo


Oral IP












Interventions





ZDV





No AP ARV drugs


plus 3TC






Oral IP








NVP plus IV ZDV






ZDV from 28 weeks






ZDV from 36 weeks








SD NVP











Interventions










No AP ARV

Oral IP bull SD NVP
















weeks


NVP or placebo












No AP ARV drugs

Oral IP bull SD NVP














Interventions




No AP ARV drugs


presents in time)


















































Interventions




No AP drugs

IP Regimens


NVP


NVP


NVP
































Interventions




No AP drugs



weeks






























LPVr


LPVr







Arm 2bull 05 (71385)

Arm 3bull 06 (2325)




















Interventions









NVP



Arm 2 bull 058 (71211)


Arm 2 bull 977


5



A-6






III Expert opinion

References












6


ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation

NNRTIsEFV COC





levels2628



















7

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation


concentration 45





concentrations29










rate36






8

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation




EE darr 5956







COCNo ovulations59






No data on POPs


9

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation


change in EE AUC61

NE AUC darr 1860



change26




on NVP levels586062





COCbull No increase







in pregnancy rate48










10

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation










No data on POPs






No clinical data











11

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation


NE AUC darr 1470






No data on POPS


NE AUC darr 17





5253

COCbull Increased




and no ovulations38










12

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation






in pregnancy rate48




23-fold


42






No data on POPs


EE AUC darr 3043





No data on POPs


13

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation


















No data on POPs


14

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation

INSTIsBICFTCTAF






No clinical data









No data on POPs


uarr 126







No data on POPs


1475







15

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation







16









ABC3TC


TDFFTCor

TDF3TC



DTGABC3TC (FDC)or




17











TAFFTC


ZDV3TC



18


EFVTDFFTC (FDC)or

EFVTDF3TC (FDC)or



RPVTDFFTC (FDC) or







DRVc (FDC) or

DRVcFTCTAF (FDC)


EVGcFTCTAF (FDC)




19







NVP






20






the First Time








Conceiveab



EVGcd
















C-1



21











NRTI Drugscg














C-2


22







EVGcFTCTDFd



(EVGc)




EVGcFTCTAFd



(EVGc)




DRVcFTCTAFd



(DRVc)




DTG3TCAs a complete

regimenj


additional agents



regimenj


additional agentse







23










24



Laboratory Test





MonthlyEvery 3



At 34 to 36 Weeks



Regimen

HIV RNA Levelsb



Until HIV


At least every 3

monthsc

CD4 Countd

For women




Resistance Testinge

Standard Glucose

Screeningf

For women on

ARTf


C-5


25


Or as needed


Toxicitiesg








C-10




ART Adherencea



gt1000 copiesmL






Intrapartum IV ZDV


















27


ART Adherencea



gt1000 copiesmL




















C-12





29







ZDV for 4 weeksa











Newborn with HIVe





30






C-5
















Weight Band





C-6


















33





DTG



Pediatric

Body Weight

Recommended Dosee


Number of tablets





34






Reviewed


(ABC3TC)Epzicom

(ABCDTG3TC)Triumeq

(ABC3TCZDV)Trizivir


ABC (Ziagen)d

Tabletbull 300 mg


ABC3TC (Epzicom)d

















December 29 2020


35




Reviewed


(FTCEFVTDF)Atripla

(FTCBICTAF)Biktarvy

(FTCRPVTDF)Complera

(FTCTAF)Descovy

(FTCEVGcTAF)Genvoya

(FTCRPVTAF)Odefsey


(FTCDRVcTAF)Symtuza

(FTCTDF)Truvada


bull 200 mg









25 mg tablet


to food












December 29 2020


36




Reviewed










FTCTDF (Truvada)d




pregnancy




37




Reviewed


(3TCTDF)Cimduo

(3TCZDV)Combivir


(3TCDTG)Dovato

(3TCABC)Epzicom

(3TCEFVTDF)Symfi

(3TCEFVTDF)Symfi Lo

(3TCTDF)Temixys

(3TCABCDTG)Triumeq

3TC (Epivir)d




300 mg tablet

3TCZDV (Combivir)d





50 mg tablet

3TCABC (Epzicom)d

















December 29 2020


38




Reviewed

(3TCABCZDV)Trizivir







300 mg tablet










39




Reviewed


(TAFBICFTC)Biktarvy

(TAFFTC)Descovy

(TAFEVGcFTC)Genvoya

(TAFFTCRPV)Odefsey

(TAFDRVcFTC)Symtuza



mgFTC 200 mg tablet


200 mg tablet















pregnancy






December 29 2020


40




Reviewed


(TDFEFVFTC)Atripla

(TDF3TC)Cimduo

(TDFFTCRPV)Complera



(TDFEFV3TC)Symfi

(TDFEFV3TC)Symfi Lo

(TDF3TC)Temixys

(TDFFTC)Truvada

TDF (Viread)Tabletd

bull 300 mg


powder




3TC 300 mg tablet





















December 29 2020


41




Reviewed









300 mg tablet


200 mg tablet







42




Reviewed


(ZDV3TC)Combivir

(ZDVABC3TC)Trizivir



Tabletbull 300 mg




150 mg tablet













December 29 2020


43




Reviewed










recommendations




December 29 2020


(EFVFTCTDF)Atripla

(EFV3TCTDF)Symfi

EFV (Sustiva)d


Tabletbull 600 mg


effects


effects



December 29 2020


44




Reviewed

(EFV3TCTDF)Symfi Lo

















45



G-12




Reviewed










December 29 2020
















December 29 2020


46




Reviewed





(RPVFTCTDF)Complera

(RPVDTG)Juluca

(RPVFTCTAF)Odefsey





50 mg tablet








December 29 2020


47




Reviewed









48




Reviewed




(ATVc)Evotaz



bull 200 mgd

bull 300 mgd



150-mg tablet










food







December 29 2020


49




Reviewed












50




Reviewed






51



G-18




Reviewed



(DRVc)Prezcobix

(DRVcFTCTAF)Symtuza




150 mg tablet













DRVr





December 29 2020


52




Reviewed









mg


LPVr 400 mg100 mg










December 29 2020


53



G-20




Reviewed










54



G-21




Reviewed




food



recommendation



December 29 2020







recommendations



December 29 2020


55



G-22




Reviewed















December 29 2020


56




Reviewed








recommendations





December 29 2020


(DTG3TC)Dovato

(DTGRPV)Juluca










December 29 2020


57




Reviewed

(DTGABC3TC)Triumeq



3TC 300 mg tablet


RPV 25 mg tablet














58




Reviewed

Elvitegravir(EVG)


(EVGcFTCTAF)Genvoya















December 29 2020


59



G-26




Reviewed




















December 29 2020


60



G-27




Reviewed


(ATVc)Evotaz

(EVGcFTCTAF)Genvoya

(DRVc)Prezcobix


(DRVcFTCTAF)Symtuza






COBI 150 mg tablet
















December 29 2020


61




Reviewed






(LPVr)Kaletra







mg





possible







December 29 2020


62



G-29




Reviewed


LPVr 400 mg100 mg








used as booster






63




Reviewed








64










Interventions




IV IP





Oral IP




Oral IP







Oral IP





Placebo


Oral IP












Interventions





ZDV





No AP ARV drugs


plus 3TC






Oral IP








NVP plus IV ZDV






ZDV from 28 weeks






ZDV from 36 weeks








SD NVP











Interventions










No AP ARV

Oral IP bull SD NVP
















weeks


NVP or placebo












No AP ARV drugs

Oral IP bull SD NVP














Interventions




No AP ARV drugs


presents in time)


















































Interventions




No AP drugs

IP Regimens


NVP


NVP


NVP
































Interventions




No AP drugs



weeks






























LPVr


LPVr







Arm 2bull 05 (71385)

Arm 3bull 06 (2325)




















Interventions









NVP



Arm 2 bull 058 (71211)


Arm 2 bull 977


6


ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation

NNRTIsEFV COC





levels2628



















7

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation


concentration 45





concentrations29










rate36






8

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation




EE darr 5956







COCNo ovulations59






No data on POPs


9

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation


change in EE AUC61

NE AUC darr 1860



change26




on NVP levels586062





COCbull No increase







in pregnancy rate48










10

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation










No data on POPs






No clinical data











11

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation


NE AUC darr 1470






No data on POPS


NE AUC darr 17





5253

COCbull Increased




and no ovulations38










12

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation






in pregnancy rate48




23-fold


42






No data on POPs


EE AUC darr 3043





No data on POPs


13

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation


















No data on POPs


14

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation

INSTIsBICFTCTAF






No clinical data









No data on POPs


uarr 126







No data on POPs


1475







15

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation







16









ABC3TC


TDFFTCor

TDF3TC



DTGABC3TC (FDC)or




17











TAFFTC


ZDV3TC



18


EFVTDFFTC (FDC)or

EFVTDF3TC (FDC)or



RPVTDFFTC (FDC) or







DRVc (FDC) or

DRVcFTCTAF (FDC)


EVGcFTCTAF (FDC)




19







NVP






20






the First Time








Conceiveab



EVGcd
















C-1



21











NRTI Drugscg














C-2


22







EVGcFTCTDFd



(EVGc)




EVGcFTCTAFd



(EVGc)




DRVcFTCTAFd



(DRVc)




DTG3TCAs a complete

regimenj


additional agents



regimenj


additional agentse







23










24



Laboratory Test





MonthlyEvery 3



At 34 to 36 Weeks



Regimen

HIV RNA Levelsb



Until HIV


At least every 3

monthsc

CD4 Countd

For women




Resistance Testinge

Standard Glucose

Screeningf

For women on

ARTf


C-5


25


Or as needed


Toxicitiesg








C-10




ART Adherencea



gt1000 copiesmL






Intrapartum IV ZDV


















27


ART Adherencea



gt1000 copiesmL




















C-12





29







ZDV for 4 weeksa











Newborn with HIVe





30






C-5
















Weight Band





C-6


















33





DTG



Pediatric

Body Weight

Recommended Dosee


Number of tablets





34






Reviewed


(ABC3TC)Epzicom

(ABCDTG3TC)Triumeq

(ABC3TCZDV)Trizivir


ABC (Ziagen)d

Tabletbull 300 mg


ABC3TC (Epzicom)d

















December 29 2020


35




Reviewed


(FTCEFVTDF)Atripla

(FTCBICTAF)Biktarvy

(FTCRPVTDF)Complera

(FTCTAF)Descovy

(FTCEVGcTAF)Genvoya

(FTCRPVTAF)Odefsey


(FTCDRVcTAF)Symtuza

(FTCTDF)Truvada


bull 200 mg









25 mg tablet


to food












December 29 2020


36




Reviewed










FTCTDF (Truvada)d




pregnancy




37




Reviewed


(3TCTDF)Cimduo

(3TCZDV)Combivir


(3TCDTG)Dovato

(3TCABC)Epzicom

(3TCEFVTDF)Symfi

(3TCEFVTDF)Symfi Lo

(3TCTDF)Temixys

(3TCABCDTG)Triumeq

3TC (Epivir)d




300 mg tablet

3TCZDV (Combivir)d





50 mg tablet

3TCABC (Epzicom)d

















December 29 2020


38




Reviewed

(3TCABCZDV)Trizivir







300 mg tablet










39




Reviewed


(TAFBICFTC)Biktarvy

(TAFFTC)Descovy

(TAFEVGcFTC)Genvoya

(TAFFTCRPV)Odefsey

(TAFDRVcFTC)Symtuza



mgFTC 200 mg tablet


200 mg tablet















pregnancy






December 29 2020


40




Reviewed


(TDFEFVFTC)Atripla

(TDF3TC)Cimduo

(TDFFTCRPV)Complera



(TDFEFV3TC)Symfi

(TDFEFV3TC)Symfi Lo

(TDF3TC)Temixys

(TDFFTC)Truvada

TDF (Viread)Tabletd

bull 300 mg


powder




3TC 300 mg tablet





















December 29 2020


41




Reviewed









300 mg tablet


200 mg tablet







42




Reviewed


(ZDV3TC)Combivir

(ZDVABC3TC)Trizivir



Tabletbull 300 mg




150 mg tablet













December 29 2020


43




Reviewed










recommendations




December 29 2020


(EFVFTCTDF)Atripla

(EFV3TCTDF)Symfi

EFV (Sustiva)d


Tabletbull 600 mg


effects


effects



December 29 2020


44




Reviewed

(EFV3TCTDF)Symfi Lo

















45



G-12




Reviewed










December 29 2020
















December 29 2020


46




Reviewed





(RPVFTCTDF)Complera

(RPVDTG)Juluca

(RPVFTCTAF)Odefsey





50 mg tablet








December 29 2020


47




Reviewed









48




Reviewed




(ATVc)Evotaz



bull 200 mgd

bull 300 mgd



150-mg tablet










food







December 29 2020


49




Reviewed












50




Reviewed






51



G-18




Reviewed



(DRVc)Prezcobix

(DRVcFTCTAF)Symtuza




150 mg tablet













DRVr





December 29 2020


52




Reviewed









mg


LPVr 400 mg100 mg










December 29 2020


53



G-20




Reviewed










54



G-21




Reviewed




food



recommendation



December 29 2020







recommendations



December 29 2020


55



G-22




Reviewed















December 29 2020


56




Reviewed








recommendations





December 29 2020


(DTG3TC)Dovato

(DTGRPV)Juluca










December 29 2020


57




Reviewed

(DTGABC3TC)Triumeq



3TC 300 mg tablet


RPV 25 mg tablet














58




Reviewed

Elvitegravir(EVG)


(EVGcFTCTAF)Genvoya















December 29 2020


59



G-26




Reviewed




















December 29 2020


60



G-27




Reviewed


(ATVc)Evotaz

(EVGcFTCTAF)Genvoya

(DRVc)Prezcobix


(DRVcFTCTAF)Symtuza






COBI 150 mg tablet
















December 29 2020


61




Reviewed






(LPVr)Kaletra







mg





possible







December 29 2020


62



G-29




Reviewed


LPVr 400 mg100 mg








used as booster






63




Reviewed








64










Interventions




IV IP





Oral IP




Oral IP







Oral IP





Placebo


Oral IP












Interventions





ZDV





No AP ARV drugs


plus 3TC






Oral IP








NVP plus IV ZDV






ZDV from 28 weeks






ZDV from 36 weeks








SD NVP











Interventions










No AP ARV

Oral IP bull SD NVP
















weeks


NVP or placebo












No AP ARV drugs

Oral IP bull SD NVP














Interventions




No AP ARV drugs


presents in time)


















































Interventions




No AP drugs

IP Regimens


NVP


NVP


NVP
































Interventions




No AP drugs



weeks






























LPVr


LPVr







Arm 2bull 05 (71385)

Arm 3bull 06 (2325)




















Interventions









NVP



Arm 2 bull 058 (71211)


Arm 2 bull 977


7

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation


concentration 45





concentrations29










rate36






8

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation




EE darr 5956







COCNo ovulations59






No data on POPs


9

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation


change in EE AUC61

NE AUC darr 1860



change26




on NVP levels586062





COCbull No increase







in pregnancy rate48










10

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation










No data on POPs






No clinical data











11

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation


NE AUC darr 1470






No data on POPS


NE AUC darr 17





5253

COCbull Increased




and no ovulations38










12

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation






in pregnancy rate48




23-fold


42






No data on POPs


EE AUC darr 3043





No data on POPs


13

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation


















No data on POPs


14

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation

INSTIsBICFTCTAF






No clinical data









No data on POPs


uarr 126







No data on POPs


1475







15

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation







16









ABC3TC


TDFFTCor

TDF3TC



DTGABC3TC (FDC)or




17











TAFFTC


ZDV3TC



18


EFVTDFFTC (FDC)or

EFVTDF3TC (FDC)or



RPVTDFFTC (FDC) or







DRVc (FDC) or

DRVcFTCTAF (FDC)


EVGcFTCTAF (FDC)




19







NVP






20






the First Time








Conceiveab



EVGcd
















C-1



21











NRTI Drugscg














C-2


22







EVGcFTCTDFd



(EVGc)




EVGcFTCTAFd



(EVGc)




DRVcFTCTAFd



(DRVc)




DTG3TCAs a complete

regimenj


additional agents



regimenj


additional agentse







23










24



Laboratory Test





MonthlyEvery 3



At 34 to 36 Weeks



Regimen

HIV RNA Levelsb



Until HIV


At least every 3

monthsc

CD4 Countd

For women




Resistance Testinge

Standard Glucose

Screeningf

For women on

ARTf


C-5


25


Or as needed


Toxicitiesg








C-10




ART Adherencea



gt1000 copiesmL






Intrapartum IV ZDV


















27


ART Adherencea



gt1000 copiesmL




















C-12





29







ZDV for 4 weeksa











Newborn with HIVe





30






C-5
















Weight Band





C-6


















33





DTG



Pediatric

Body Weight

Recommended Dosee


Number of tablets





34






Reviewed


(ABC3TC)Epzicom

(ABCDTG3TC)Triumeq

(ABC3TCZDV)Trizivir


ABC (Ziagen)d

Tabletbull 300 mg


ABC3TC (Epzicom)d

















December 29 2020


35




Reviewed


(FTCEFVTDF)Atripla

(FTCBICTAF)Biktarvy

(FTCRPVTDF)Complera

(FTCTAF)Descovy

(FTCEVGcTAF)Genvoya

(FTCRPVTAF)Odefsey


(FTCDRVcTAF)Symtuza

(FTCTDF)Truvada


bull 200 mg









25 mg tablet


to food












December 29 2020


36




Reviewed










FTCTDF (Truvada)d




pregnancy




37




Reviewed


(3TCTDF)Cimduo

(3TCZDV)Combivir


(3TCDTG)Dovato

(3TCABC)Epzicom

(3TCEFVTDF)Symfi

(3TCEFVTDF)Symfi Lo

(3TCTDF)Temixys

(3TCABCDTG)Triumeq

3TC (Epivir)d




300 mg tablet

3TCZDV (Combivir)d





50 mg tablet

3TCABC (Epzicom)d

















December 29 2020


38




Reviewed

(3TCABCZDV)Trizivir







300 mg tablet










39




Reviewed


(TAFBICFTC)Biktarvy

(TAFFTC)Descovy

(TAFEVGcFTC)Genvoya

(TAFFTCRPV)Odefsey

(TAFDRVcFTC)Symtuza



mgFTC 200 mg tablet


200 mg tablet















pregnancy






December 29 2020


40




Reviewed


(TDFEFVFTC)Atripla

(TDF3TC)Cimduo

(TDFFTCRPV)Complera



(TDFEFV3TC)Symfi

(TDFEFV3TC)Symfi Lo

(TDF3TC)Temixys

(TDFFTC)Truvada

TDF (Viread)Tabletd

bull 300 mg


powder




3TC 300 mg tablet





















December 29 2020


41




Reviewed









300 mg tablet


200 mg tablet







42




Reviewed


(ZDV3TC)Combivir

(ZDVABC3TC)Trizivir



Tabletbull 300 mg




150 mg tablet













December 29 2020


43




Reviewed










recommendations




December 29 2020


(EFVFTCTDF)Atripla

(EFV3TCTDF)Symfi

EFV (Sustiva)d


Tabletbull 600 mg


effects


effects



December 29 2020


44




Reviewed

(EFV3TCTDF)Symfi Lo

















45



G-12




Reviewed










December 29 2020
















December 29 2020


46




Reviewed





(RPVFTCTDF)Complera

(RPVDTG)Juluca

(RPVFTCTAF)Odefsey





50 mg tablet








December 29 2020


47




Reviewed









48




Reviewed




(ATVc)Evotaz



bull 200 mgd

bull 300 mgd



150-mg tablet










food







December 29 2020


49




Reviewed












50




Reviewed






51



G-18




Reviewed



(DRVc)Prezcobix

(DRVcFTCTAF)Symtuza




150 mg tablet













DRVr





December 29 2020


52




Reviewed









mg


LPVr 400 mg100 mg










December 29 2020


53



G-20




Reviewed










54



G-21




Reviewed




food



recommendation



December 29 2020







recommendations



December 29 2020


55



G-22




Reviewed















December 29 2020


56




Reviewed








recommendations





December 29 2020


(DTG3TC)Dovato

(DTGRPV)Juluca










December 29 2020


57




Reviewed

(DTGABC3TC)Triumeq



3TC 300 mg tablet


RPV 25 mg tablet














58




Reviewed

Elvitegravir(EVG)


(EVGcFTCTAF)Genvoya















December 29 2020


59



G-26




Reviewed




















December 29 2020


60



G-27




Reviewed


(ATVc)Evotaz

(EVGcFTCTAF)Genvoya

(DRVc)Prezcobix


(DRVcFTCTAF)Symtuza






COBI 150 mg tablet
















December 29 2020


61




Reviewed






(LPVr)Kaletra







mg





possible







December 29 2020


62



G-29




Reviewed


LPVr 400 mg100 mg








used as booster






63




Reviewed








64










Interventions




IV IP





Oral IP




Oral IP







Oral IP





Placebo


Oral IP












Interventions





ZDV





No AP ARV drugs


plus 3TC






Oral IP








NVP plus IV ZDV






ZDV from 28 weeks






ZDV from 36 weeks








SD NVP











Interventions










No AP ARV

Oral IP bull SD NVP
















weeks


NVP or placebo












No AP ARV drugs

Oral IP bull SD NVP














Interventions




No AP ARV drugs


presents in time)


















































Interventions




No AP drugs

IP Regimens


NVP


NVP


NVP
































Interventions




No AP drugs



weeks






























LPVr


LPVr







Arm 2bull 05 (71385)

Arm 3bull 06 (2325)




















Interventions









NVP



Arm 2 bull 058 (71211)


Arm 2 bull 977


8

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation




EE darr 5956







COCNo ovulations59






No data on POPs


9

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation


change in EE AUC61

NE AUC darr 1860



change26




on NVP levels586062





COCbull No increase







in pregnancy rate48










10

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation










No data on POPs






No clinical data











11

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation


NE AUC darr 1470






No data on POPS


NE AUC darr 17





5253

COCbull Increased




and no ovulations38










12

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation






in pregnancy rate48




23-fold


42






No data on POPs


EE AUC darr 3043





No data on POPs


13

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation


















No data on POPs


14

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation

INSTIsBICFTCTAF






No clinical data









No data on POPs


uarr 126







No data on POPs


1475







15

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation







16









ABC3TC


TDFFTCor

TDF3TC



DTGABC3TC (FDC)or




17











TAFFTC


ZDV3TC



18


EFVTDFFTC (FDC)or

EFVTDF3TC (FDC)or



RPVTDFFTC (FDC) or







DRVc (FDC) or

DRVcFTCTAF (FDC)


EVGcFTCTAF (FDC)




19







NVP






20






the First Time








Conceiveab



EVGcd
















C-1



21











NRTI Drugscg














C-2


22







EVGcFTCTDFd



(EVGc)




EVGcFTCTAFd



(EVGc)




DRVcFTCTAFd



(DRVc)




DTG3TCAs a complete

regimenj


additional agents



regimenj


additional agentse







23










24



Laboratory Test





MonthlyEvery 3



At 34 to 36 Weeks



Regimen

HIV RNA Levelsb



Until HIV


At least every 3

monthsc

CD4 Countd

For women




Resistance Testinge

Standard Glucose

Screeningf

For women on

ARTf


C-5


25


Or as needed


Toxicitiesg








C-10




ART Adherencea



gt1000 copiesmL






Intrapartum IV ZDV


















27


ART Adherencea



gt1000 copiesmL




















C-12





29







ZDV for 4 weeksa











Newborn with HIVe





30






C-5
















Weight Band





C-6


















33





DTG



Pediatric

Body Weight

Recommended Dosee


Number of tablets





34






Reviewed


(ABC3TC)Epzicom

(ABCDTG3TC)Triumeq

(ABC3TCZDV)Trizivir


ABC (Ziagen)d

Tabletbull 300 mg


ABC3TC (Epzicom)d

















December 29 2020


35




Reviewed


(FTCEFVTDF)Atripla

(FTCBICTAF)Biktarvy

(FTCRPVTDF)Complera

(FTCTAF)Descovy

(FTCEVGcTAF)Genvoya

(FTCRPVTAF)Odefsey


(FTCDRVcTAF)Symtuza

(FTCTDF)Truvada


bull 200 mg









25 mg tablet


to food












December 29 2020


36




Reviewed










FTCTDF (Truvada)d




pregnancy




37




Reviewed


(3TCTDF)Cimduo

(3TCZDV)Combivir


(3TCDTG)Dovato

(3TCABC)Epzicom

(3TCEFVTDF)Symfi

(3TCEFVTDF)Symfi Lo

(3TCTDF)Temixys

(3TCABCDTG)Triumeq

3TC (Epivir)d




300 mg tablet

3TCZDV (Combivir)d





50 mg tablet

3TCABC (Epzicom)d

















December 29 2020


38




Reviewed

(3TCABCZDV)Trizivir







300 mg tablet










39




Reviewed


(TAFBICFTC)Biktarvy

(TAFFTC)Descovy

(TAFEVGcFTC)Genvoya

(TAFFTCRPV)Odefsey

(TAFDRVcFTC)Symtuza



mgFTC 200 mg tablet


200 mg tablet















pregnancy






December 29 2020


40




Reviewed


(TDFEFVFTC)Atripla

(TDF3TC)Cimduo

(TDFFTCRPV)Complera



(TDFEFV3TC)Symfi

(TDFEFV3TC)Symfi Lo

(TDF3TC)Temixys

(TDFFTC)Truvada

TDF (Viread)Tabletd

bull 300 mg


powder




3TC 300 mg tablet





















December 29 2020


41




Reviewed









300 mg tablet


200 mg tablet







42




Reviewed


(ZDV3TC)Combivir

(ZDVABC3TC)Trizivir



Tabletbull 300 mg




150 mg tablet













December 29 2020


43




Reviewed










recommendations




December 29 2020


(EFVFTCTDF)Atripla

(EFV3TCTDF)Symfi

EFV (Sustiva)d


Tabletbull 600 mg


effects


effects



December 29 2020


44




Reviewed

(EFV3TCTDF)Symfi Lo

















45



G-12




Reviewed










December 29 2020
















December 29 2020


46




Reviewed





(RPVFTCTDF)Complera

(RPVDTG)Juluca

(RPVFTCTAF)Odefsey





50 mg tablet








December 29 2020


47




Reviewed









48




Reviewed




(ATVc)Evotaz



bull 200 mgd

bull 300 mgd



150-mg tablet










food







December 29 2020


49




Reviewed












50




Reviewed






51



G-18




Reviewed



(DRVc)Prezcobix

(DRVcFTCTAF)Symtuza




150 mg tablet













DRVr





December 29 2020


52




Reviewed









mg


LPVr 400 mg100 mg










December 29 2020


53



G-20




Reviewed










54



G-21




Reviewed




food



recommendation



December 29 2020







recommendations



December 29 2020


55



G-22




Reviewed















December 29 2020


56




Reviewed








recommendations





December 29 2020


(DTG3TC)Dovato

(DTGRPV)Juluca










December 29 2020


57




Reviewed

(DTGABC3TC)Triumeq



3TC 300 mg tablet


RPV 25 mg tablet














58




Reviewed

Elvitegravir(EVG)


(EVGcFTCTAF)Genvoya















December 29 2020


59



G-26




Reviewed




















December 29 2020


60



G-27




Reviewed


(ATVc)Evotaz

(EVGcFTCTAF)Genvoya

(DRVc)Prezcobix


(DRVcFTCTAF)Symtuza






COBI 150 mg tablet
















December 29 2020


61




Reviewed






(LPVr)Kaletra







mg





possible







December 29 2020


62



G-29




Reviewed


LPVr 400 mg100 mg








used as booster






63




Reviewed








64










Interventions




IV IP





Oral IP




Oral IP







Oral IP





Placebo


Oral IP












Interventions





ZDV





No AP ARV drugs


plus 3TC






Oral IP








NVP plus IV ZDV






ZDV from 28 weeks






ZDV from 36 weeks








SD NVP











Interventions










No AP ARV

Oral IP bull SD NVP
















weeks


NVP or placebo












No AP ARV drugs

Oral IP bull SD NVP














Interventions




No AP ARV drugs


presents in time)


















































Interventions




No AP drugs

IP Regimens


NVP


NVP


NVP
































Interventions




No AP drugs



weeks






























LPVr


LPVr







Arm 2bull 05 (71385)

Arm 3bull 06 (2325)




















Interventions









NVP



Arm 2 bull 058 (71211)


Arm 2 bull 977


9

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation


change in EE AUC61

NE AUC darr 1860



change26




on NVP levels586062





COCbull No increase







in pregnancy rate48










10

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation










No data on POPs






No clinical data











11

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation


NE AUC darr 1470






No data on POPS


NE AUC darr 17





5253

COCbull Increased




and no ovulations38










12

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation






in pregnancy rate48




23-fold


42






No data on POPs


EE AUC darr 3043





No data on POPs


13

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation


















No data on POPs


14

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation

INSTIsBICFTCTAF






No clinical data









No data on POPs


uarr 126







No data on POPs


1475







15

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation







16









ABC3TC


TDFFTCor

TDF3TC



DTGABC3TC (FDC)or




17











TAFFTC


ZDV3TC



18


EFVTDFFTC (FDC)or

EFVTDF3TC (FDC)or



RPVTDFFTC (FDC) or







DRVc (FDC) or

DRVcFTCTAF (FDC)


EVGcFTCTAF (FDC)




19







NVP






20






the First Time








Conceiveab



EVGcd
















C-1



21











NRTI Drugscg














C-2


22







EVGcFTCTDFd



(EVGc)




EVGcFTCTAFd



(EVGc)




DRVcFTCTAFd



(DRVc)




DTG3TCAs a complete

regimenj


additional agents



regimenj


additional agentse







23










24



Laboratory Test





MonthlyEvery 3



At 34 to 36 Weeks



Regimen

HIV RNA Levelsb



Until HIV


At least every 3

monthsc

CD4 Countd

For women




Resistance Testinge

Standard Glucose

Screeningf

For women on

ARTf


C-5


25


Or as needed


Toxicitiesg








C-10




ART Adherencea



gt1000 copiesmL






Intrapartum IV ZDV


















27


ART Adherencea



gt1000 copiesmL




















C-12





29







ZDV for 4 weeksa











Newborn with HIVe





30






C-5
















Weight Band





C-6


















33





DTG



Pediatric

Body Weight

Recommended Dosee


Number of tablets





34






Reviewed


(ABC3TC)Epzicom

(ABCDTG3TC)Triumeq

(ABC3TCZDV)Trizivir


ABC (Ziagen)d

Tabletbull 300 mg


ABC3TC (Epzicom)d

















December 29 2020


35




Reviewed


(FTCEFVTDF)Atripla

(FTCBICTAF)Biktarvy

(FTCRPVTDF)Complera

(FTCTAF)Descovy

(FTCEVGcTAF)Genvoya

(FTCRPVTAF)Odefsey


(FTCDRVcTAF)Symtuza

(FTCTDF)Truvada


bull 200 mg









25 mg tablet


to food












December 29 2020


36




Reviewed










FTCTDF (Truvada)d




pregnancy




37




Reviewed


(3TCTDF)Cimduo

(3TCZDV)Combivir


(3TCDTG)Dovato

(3TCABC)Epzicom

(3TCEFVTDF)Symfi

(3TCEFVTDF)Symfi Lo

(3TCTDF)Temixys

(3TCABCDTG)Triumeq

3TC (Epivir)d




300 mg tablet

3TCZDV (Combivir)d





50 mg tablet

3TCABC (Epzicom)d

















December 29 2020


38




Reviewed

(3TCABCZDV)Trizivir







300 mg tablet










39




Reviewed


(TAFBICFTC)Biktarvy

(TAFFTC)Descovy

(TAFEVGcFTC)Genvoya

(TAFFTCRPV)Odefsey

(TAFDRVcFTC)Symtuza



mgFTC 200 mg tablet


200 mg tablet















pregnancy






December 29 2020


40




Reviewed


(TDFEFVFTC)Atripla

(TDF3TC)Cimduo

(TDFFTCRPV)Complera



(TDFEFV3TC)Symfi

(TDFEFV3TC)Symfi Lo

(TDF3TC)Temixys

(TDFFTC)Truvada

TDF (Viread)Tabletd

bull 300 mg


powder




3TC 300 mg tablet





















December 29 2020


41




Reviewed









300 mg tablet


200 mg tablet







42




Reviewed


(ZDV3TC)Combivir

(ZDVABC3TC)Trizivir



Tabletbull 300 mg




150 mg tablet













December 29 2020


43




Reviewed










recommendations




December 29 2020


(EFVFTCTDF)Atripla

(EFV3TCTDF)Symfi

EFV (Sustiva)d


Tabletbull 600 mg


effects


effects



December 29 2020


44




Reviewed

(EFV3TCTDF)Symfi Lo

















45



G-12




Reviewed










December 29 2020
















December 29 2020


46




Reviewed





(RPVFTCTDF)Complera

(RPVDTG)Juluca

(RPVFTCTAF)Odefsey





50 mg tablet








December 29 2020


47




Reviewed









48




Reviewed




(ATVc)Evotaz



bull 200 mgd

bull 300 mgd



150-mg tablet










food







December 29 2020


49




Reviewed












50




Reviewed






51



G-18




Reviewed



(DRVc)Prezcobix

(DRVcFTCTAF)Symtuza




150 mg tablet













DRVr





December 29 2020


52




Reviewed









mg


LPVr 400 mg100 mg










December 29 2020


53



G-20




Reviewed










54



G-21




Reviewed




food



recommendation



December 29 2020







recommendations



December 29 2020


55



G-22




Reviewed















December 29 2020


56




Reviewed








recommendations





December 29 2020


(DTG3TC)Dovato

(DTGRPV)Juluca










December 29 2020


57




Reviewed

(DTGABC3TC)Triumeq



3TC 300 mg tablet


RPV 25 mg tablet














58




Reviewed

Elvitegravir(EVG)


(EVGcFTCTAF)Genvoya















December 29 2020


59



G-26




Reviewed




















December 29 2020


60



G-27




Reviewed


(ATVc)Evotaz

(EVGcFTCTAF)Genvoya

(DRVc)Prezcobix


(DRVcFTCTAF)Symtuza






COBI 150 mg tablet
















December 29 2020


61




Reviewed






(LPVr)Kaletra







mg





possible







December 29 2020


62



G-29




Reviewed


LPVr 400 mg100 mg








used as booster






63




Reviewed








64










Interventions




IV IP





Oral IP




Oral IP







Oral IP





Placebo


Oral IP












Interventions





ZDV





No AP ARV drugs


plus 3TC






Oral IP








NVP plus IV ZDV






ZDV from 28 weeks






ZDV from 36 weeks








SD NVP











Interventions










No AP ARV

Oral IP bull SD NVP
















weeks


NVP or placebo












No AP ARV drugs

Oral IP bull SD NVP














Interventions




No AP ARV drugs


presents in time)


















































Interventions




No AP drugs

IP Regimens


NVP


NVP


NVP
































Interventions




No AP drugs



weeks






























LPVr


LPVr







Arm 2bull 05 (71385)

Arm 3bull 06 (2325)




















Interventions









NVP



Arm 2 bull 058 (71211)


Arm 2 bull 977


10

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation










No data on POPs






No clinical data











11

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation


NE AUC darr 1470






No data on POPS


NE AUC darr 17





5253

COCbull Increased




and no ovulations38










12

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation






in pregnancy rate48




23-fold


42






No data on POPs


EE AUC darr 3043





No data on POPs


13

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation


















No data on POPs


14

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation

INSTIsBICFTCTAF






No clinical data









No data on POPs


uarr 126







No data on POPs


1475







15

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation







16









ABC3TC


TDFFTCor

TDF3TC



DTGABC3TC (FDC)or




17











TAFFTC


ZDV3TC



18


EFVTDFFTC (FDC)or

EFVTDF3TC (FDC)or



RPVTDFFTC (FDC) or







DRVc (FDC) or

DRVcFTCTAF (FDC)


EVGcFTCTAF (FDC)




19







NVP






20






the First Time








Conceiveab



EVGcd
















C-1



21











NRTI Drugscg














C-2


22







EVGcFTCTDFd



(EVGc)




EVGcFTCTAFd



(EVGc)




DRVcFTCTAFd



(DRVc)




DTG3TCAs a complete

regimenj


additional agents



regimenj


additional agentse







23










24



Laboratory Test





MonthlyEvery 3



At 34 to 36 Weeks



Regimen

HIV RNA Levelsb



Until HIV


At least every 3

monthsc

CD4 Countd

For women




Resistance Testinge

Standard Glucose

Screeningf

For women on

ARTf


C-5


25


Or as needed


Toxicitiesg








C-10




ART Adherencea



gt1000 copiesmL






Intrapartum IV ZDV


















27


ART Adherencea



gt1000 copiesmL




















C-12





29







ZDV for 4 weeksa











Newborn with HIVe





30






C-5
















Weight Band





C-6


















33





DTG



Pediatric

Body Weight

Recommended Dosee


Number of tablets





34






Reviewed


(ABC3TC)Epzicom

(ABCDTG3TC)Triumeq

(ABC3TCZDV)Trizivir


ABC (Ziagen)d

Tabletbull 300 mg


ABC3TC (Epzicom)d

















December 29 2020


35




Reviewed


(FTCEFVTDF)Atripla

(FTCBICTAF)Biktarvy

(FTCRPVTDF)Complera

(FTCTAF)Descovy

(FTCEVGcTAF)Genvoya

(FTCRPVTAF)Odefsey


(FTCDRVcTAF)Symtuza

(FTCTDF)Truvada


bull 200 mg









25 mg tablet


to food












December 29 2020


36




Reviewed










FTCTDF (Truvada)d




pregnancy




37




Reviewed


(3TCTDF)Cimduo

(3TCZDV)Combivir


(3TCDTG)Dovato

(3TCABC)Epzicom

(3TCEFVTDF)Symfi

(3TCEFVTDF)Symfi Lo

(3TCTDF)Temixys

(3TCABCDTG)Triumeq

3TC (Epivir)d




300 mg tablet

3TCZDV (Combivir)d





50 mg tablet

3TCABC (Epzicom)d

















December 29 2020


38




Reviewed

(3TCABCZDV)Trizivir







300 mg tablet










39




Reviewed


(TAFBICFTC)Biktarvy

(TAFFTC)Descovy

(TAFEVGcFTC)Genvoya

(TAFFTCRPV)Odefsey

(TAFDRVcFTC)Symtuza



mgFTC 200 mg tablet


200 mg tablet















pregnancy






December 29 2020


40




Reviewed


(TDFEFVFTC)Atripla

(TDF3TC)Cimduo

(TDFFTCRPV)Complera



(TDFEFV3TC)Symfi

(TDFEFV3TC)Symfi Lo

(TDF3TC)Temixys

(TDFFTC)Truvada

TDF (Viread)Tabletd

bull 300 mg


powder




3TC 300 mg tablet





















December 29 2020


41




Reviewed









300 mg tablet


200 mg tablet







42




Reviewed


(ZDV3TC)Combivir

(ZDVABC3TC)Trizivir



Tabletbull 300 mg




150 mg tablet













December 29 2020


43




Reviewed










recommendations




December 29 2020


(EFVFTCTDF)Atripla

(EFV3TCTDF)Symfi

EFV (Sustiva)d


Tabletbull 600 mg


effects


effects



December 29 2020


44




Reviewed

(EFV3TCTDF)Symfi Lo

















45



G-12




Reviewed










December 29 2020
















December 29 2020


46




Reviewed





(RPVFTCTDF)Complera

(RPVDTG)Juluca

(RPVFTCTAF)Odefsey





50 mg tablet








December 29 2020


47




Reviewed









48




Reviewed




(ATVc)Evotaz



bull 200 mgd

bull 300 mgd



150-mg tablet










food







December 29 2020


49




Reviewed












50




Reviewed






51



G-18




Reviewed



(DRVc)Prezcobix

(DRVcFTCTAF)Symtuza




150 mg tablet













DRVr





December 29 2020


52




Reviewed









mg


LPVr 400 mg100 mg










December 29 2020


53



G-20




Reviewed










54



G-21




Reviewed




food



recommendation



December 29 2020







recommendations



December 29 2020


55



G-22




Reviewed















December 29 2020


56




Reviewed








recommendations





December 29 2020


(DTG3TC)Dovato

(DTGRPV)Juluca










December 29 2020


57




Reviewed

(DTGABC3TC)Triumeq



3TC 300 mg tablet


RPV 25 mg tablet














58




Reviewed

Elvitegravir(EVG)


(EVGcFTCTAF)Genvoya















December 29 2020


59



G-26




Reviewed




















December 29 2020


60



G-27




Reviewed


(ATVc)Evotaz

(EVGcFTCTAF)Genvoya

(DRVc)Prezcobix


(DRVcFTCTAF)Symtuza






COBI 150 mg tablet
















December 29 2020


61




Reviewed






(LPVr)Kaletra







mg





possible







December 29 2020


62



G-29




Reviewed


LPVr 400 mg100 mg








used as booster






63




Reviewed








64










Interventions




IV IP





Oral IP




Oral IP







Oral IP





Placebo


Oral IP












Interventions





ZDV





No AP ARV drugs


plus 3TC






Oral IP








NVP plus IV ZDV






ZDV from 28 weeks






ZDV from 36 weeks








SD NVP











Interventions










No AP ARV

Oral IP bull SD NVP
















weeks


NVP or placebo












No AP ARV drugs

Oral IP bull SD NVP














Interventions




No AP ARV drugs


presents in time)


















































Interventions




No AP drugs

IP Regimens


NVP


NVP


NVP
































Interventions




No AP drugs



weeks






























LPVr


LPVr







Arm 2bull 05 (71385)

Arm 3bull 06 (2325)




















Interventions









NVP



Arm 2 bull 058 (71211)


Arm 2 bull 977


11

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation


NE AUC darr 1470






No data on POPS


NE AUC darr 17





5253

COCbull Increased




and no ovulations38










12

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation






in pregnancy rate48




23-fold


42






No data on POPs


EE AUC darr 3043





No data on POPs


13

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation


















No data on POPs


14

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation

INSTIsBICFTCTAF






No clinical data









No data on POPs


uarr 126







No data on POPs


1475







15

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation







16









ABC3TC


TDFFTCor

TDF3TC



DTGABC3TC (FDC)or




17











TAFFTC


ZDV3TC



18


EFVTDFFTC (FDC)or

EFVTDF3TC (FDC)or



RPVTDFFTC (FDC) or







DRVc (FDC) or

DRVcFTCTAF (FDC)


EVGcFTCTAF (FDC)




19







NVP






20






the First Time








Conceiveab



EVGcd
















C-1



21











NRTI Drugscg














C-2


22







EVGcFTCTDFd



(EVGc)




EVGcFTCTAFd



(EVGc)




DRVcFTCTAFd



(DRVc)




DTG3TCAs a complete

regimenj


additional agents



regimenj


additional agentse







23










24



Laboratory Test





MonthlyEvery 3



At 34 to 36 Weeks



Regimen

HIV RNA Levelsb



Until HIV


At least every 3

monthsc

CD4 Countd

For women




Resistance Testinge

Standard Glucose

Screeningf

For women on

ARTf


C-5


25


Or as needed


Toxicitiesg








C-10




ART Adherencea



gt1000 copiesmL






Intrapartum IV ZDV


















27


ART Adherencea



gt1000 copiesmL




















C-12





29







ZDV for 4 weeksa











Newborn with HIVe





30






C-5
















Weight Band





C-6


















33





DTG



Pediatric

Body Weight

Recommended Dosee


Number of tablets





34






Reviewed


(ABC3TC)Epzicom

(ABCDTG3TC)Triumeq

(ABC3TCZDV)Trizivir


ABC (Ziagen)d

Tabletbull 300 mg


ABC3TC (Epzicom)d

















December 29 2020


35




Reviewed


(FTCEFVTDF)Atripla

(FTCBICTAF)Biktarvy

(FTCRPVTDF)Complera

(FTCTAF)Descovy

(FTCEVGcTAF)Genvoya

(FTCRPVTAF)Odefsey


(FTCDRVcTAF)Symtuza

(FTCTDF)Truvada


bull 200 mg









25 mg tablet


to food












December 29 2020


36




Reviewed










FTCTDF (Truvada)d




pregnancy




37




Reviewed


(3TCTDF)Cimduo

(3TCZDV)Combivir


(3TCDTG)Dovato

(3TCABC)Epzicom

(3TCEFVTDF)Symfi

(3TCEFVTDF)Symfi Lo

(3TCTDF)Temixys

(3TCABCDTG)Triumeq

3TC (Epivir)d




300 mg tablet

3TCZDV (Combivir)d





50 mg tablet

3TCABC (Epzicom)d

















December 29 2020


38




Reviewed

(3TCABCZDV)Trizivir







300 mg tablet










39




Reviewed


(TAFBICFTC)Biktarvy

(TAFFTC)Descovy

(TAFEVGcFTC)Genvoya

(TAFFTCRPV)Odefsey

(TAFDRVcFTC)Symtuza



mgFTC 200 mg tablet


200 mg tablet















pregnancy






December 29 2020


40




Reviewed


(TDFEFVFTC)Atripla

(TDF3TC)Cimduo

(TDFFTCRPV)Complera



(TDFEFV3TC)Symfi

(TDFEFV3TC)Symfi Lo

(TDF3TC)Temixys

(TDFFTC)Truvada

TDF (Viread)Tabletd

bull 300 mg


powder




3TC 300 mg tablet





















December 29 2020


41




Reviewed









300 mg tablet


200 mg tablet







42




Reviewed


(ZDV3TC)Combivir

(ZDVABC3TC)Trizivir



Tabletbull 300 mg




150 mg tablet













December 29 2020


43




Reviewed










recommendations




December 29 2020


(EFVFTCTDF)Atripla

(EFV3TCTDF)Symfi

EFV (Sustiva)d


Tabletbull 600 mg


effects


effects



December 29 2020


44




Reviewed

(EFV3TCTDF)Symfi Lo

















45



G-12




Reviewed










December 29 2020
















December 29 2020


46




Reviewed





(RPVFTCTDF)Complera

(RPVDTG)Juluca

(RPVFTCTAF)Odefsey





50 mg tablet








December 29 2020


47




Reviewed









48




Reviewed




(ATVc)Evotaz



bull 200 mgd

bull 300 mgd



150-mg tablet










food







December 29 2020


49




Reviewed












50




Reviewed






51



G-18




Reviewed



(DRVc)Prezcobix

(DRVcFTCTAF)Symtuza




150 mg tablet













DRVr





December 29 2020


52




Reviewed









mg


LPVr 400 mg100 mg










December 29 2020


53



G-20




Reviewed










54



G-21




Reviewed




food



recommendation



December 29 2020







recommendations



December 29 2020


55



G-22




Reviewed















December 29 2020


56




Reviewed








recommendations





December 29 2020


(DTG3TC)Dovato

(DTGRPV)Juluca










December 29 2020


57




Reviewed

(DTGABC3TC)Triumeq



3TC 300 mg tablet


RPV 25 mg tablet














58




Reviewed

Elvitegravir(EVG)


(EVGcFTCTAF)Genvoya















December 29 2020


59



G-26




Reviewed




















December 29 2020


60



G-27




Reviewed


(ATVc)Evotaz

(EVGcFTCTAF)Genvoya

(DRVc)Prezcobix


(DRVcFTCTAF)Symtuza






COBI 150 mg tablet
















December 29 2020


61




Reviewed






(LPVr)Kaletra







mg





possible







December 29 2020


62



G-29




Reviewed


LPVr 400 mg100 mg








used as booster






63




Reviewed








64










Interventions




IV IP





Oral IP




Oral IP







Oral IP





Placebo


Oral IP












Interventions





ZDV





No AP ARV drugs


plus 3TC






Oral IP








NVP plus IV ZDV






ZDV from 28 weeks






ZDV from 36 weeks








SD NVP











Interventions










No AP ARV

Oral IP bull SD NVP
















weeks


NVP or placebo












No AP ARV drugs

Oral IP bull SD NVP














Interventions




No AP ARV drugs


presents in time)


















































Interventions




No AP drugs

IP Regimens


NVP


NVP


NVP
































Interventions




No AP drugs



weeks






























LPVr


LPVr







Arm 2bull 05 (71385)

Arm 3bull 06 (2325)




















Interventions









NVP



Arm 2 bull 058 (71211)


Arm 2 bull 977


12

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation






in pregnancy rate48




23-fold


42






No data on POPs


EE AUC darr 3043





No data on POPs


13

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation


















No data on POPs


14

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation

INSTIsBICFTCTAF






No clinical data









No data on POPs


uarr 126







No data on POPs


1475







15

ARV Drug


on ART and HIV

Clinical Studies


for COCPR


for POPs


for DMPAa


Implants


Recommendation







16









ABC3TC


TDFFTCor

TDF3TC



DTGABC3TC (FDC)or




17











TAFFTC


ZDV3TC



18


EFVTDFFTC (FDC)or

EFVTDF3TC (FDC)or



RPVTDFFTC (FDC) or







DRVc (FDC) or

DRVcFTCTAF (FDC)


EVGcFTCTAF (FDC)




19







NVP






20






the First Time








Conceiveab



EVGcd
















C-1



21











NRTI Drugscg














C-2


22







EVGcFTCTDFd



(EVGc)




EVGcFTCTAFd



(EVGc)




DRVcFTCTAFd



(DRVc)




DTG3TCAs a complete

regimenj


additional agents



regimenj


additional agentse







23










24



Laboratory Test





MonthlyEvery 3



At 34 to 36 Weeks



Regimen

HIV RNA Levelsb



Until HIV


At least every 3

monthsc

CD4 Countd

For women




Resistance Testinge

Standard Glucose

Screeningf

For women on

ARTf


C-5


25


Or as needed


Toxicitiesg








C-10




ART Adherencea



gt1000 copiesmL






Intrapartum IV ZDV


















27


ART Adherencea



gt1000 copiesmL




















C-12





29







ZDV for 4 weeksa











Newborn with HIVe





30






C-5
















Weight Band





C-6


















33





DTG



Pediatric

Body Weight

Recommended Dosee


Number of tablets





34






Reviewed


(ABC3TC)Epzicom

(ABCDTG3TC)Triumeq

(ABC3TCZDV)Trizivir


ABC (Ziagen)d

Tabletbull 300 mg


ABC3TC (Epzicom)d

















December 29 2020


35




Reviewed


(FTCEFVTDF)Atripla

(FTCBICTAF)Biktarvy

(FTCRPVTDF)Complera

(FTCTAF)Descovy

(FTCEVGcTAF)Genvoya

(FTCRPVTAF)Odefsey


(FTCDRVcTAF)Symtuza

(FTCTDF)Truvada


bull 200 mg









25 mg tablet


to food












December 29 2020


36




Reviewed










FTCTDF (Truvada)d




pregnancy




37




Reviewed


(3TCTDF)Cimduo

(3TCZDV)Combivir


(3TCDTG)Dovato

(3TCABC)Epzicom

(3TCEFVTDF)Symfi

(3TCEFVTDF)Symfi Lo

(3TCTDF)Temixys

(3TCABCDTG)Triumeq

3TC (Epivir)d




300 mg tablet

3TCZDV (Combivir)d





50 mg tablet

3TCABC (Epzicom)d

















December 29 2020


38




Reviewed

(3TCABCZDV)Trizivir







300 mg tablet










39




Reviewed


(TAFBICFTC)Biktarvy

(TAFFTC)Descovy

(TAFEVGcFTC)Genvoya

(TAFFTCRPV)Odefsey

(TAFDRVcFTC)Symtuza



mgFTC 200 mg tablet


200 mg tablet















pregnancy






December 29 2020


40




Reviewed


(TDFEFVFTC)Atripla

(TDF3TC)Cimduo

(TDFFTCRPV)Complera



(TDFEFV3TC)Symfi

(TDFEFV3TC)Symfi Lo

(TDF3TC)Temixys

(TDFFTC)Truvada

TDF (Viread)Tabletd

bull 300 mg


powder




3TC 300 mg tablet





















December 29 2020


41




Reviewed









300 mg tablet


200 mg tablet







42




Reviewed


(ZDV3TC)Combivir

(ZDVABC3TC)Trizivir



Tabletbull 300 mg




150 mg tablet













December 29 2020


43




Reviewed










recommendations




December 29 2020


(EFVFTCTDF)Atripla

(EFV3TCTDF)Symfi

EFV (Sustiva)d


Tabletbull 600 mg


effects


effects



December 29 2020


44




Reviewed

(EFV3TCTDF)Symfi Lo

















45



G-12




Reviewed










December 29 2020
















December 29 2020


46




Reviewed





(RPVFTCTDF)Complera

(RPVDTG)Juluca

(RPVFTCTAF)Odefsey





50 mg tablet








December 29 2020


47




Reviewed









48




Reviewed




(ATVc)Evotaz



bull 200 mgd

bull 300 mgd



150-mg tablet










food







December 29 2020


49




Reviewed












50




Reviewed






51



G-18




Reviewed



(DRVc)Prezcobix

(DRVcFTCTAF)Symtuza




150 mg tablet













DRVr





December 29 2020


52




Reviewed









mg


LPVr 400 mg100 mg










December 29 2020


53



G-20




Reviewed










54



G-21




Reviewed




food



recommendation



December 29 2020







recommendations



December 29 2020


55



G-22




Reviewed















December 29 2020


56




Reviewed








recommendations





December 29 2020


(DTG3TC)Dovato

(DTGRPV)Juluca










December 29 2020


57




Reviewed

(DTGABC3TC)Triumeq



3TC 300 mg tablet


RPV 25 mg tablet














58




Reviewed

Elvitegravir(EVG)


(EVGcFTCTAF)Genvoya















December 29 2020


59



G-26




Reviewed




















December 29 2020


60



G-27




Reviewed


(ATVc)Evotaz

(EVGcFTCTAF)Genvoya

(DRVc)Prezcobix


(DRVcFTCTAF)Symtuza






COBI 150 mg tablet
















December 29 2020


61




Reviewed






(LPVr)Kaletra







mg





possible







December 29 2020


62



G-29




Reviewed


LPVr 400 mg100 mg








used as booster






63




Reviewed








64










Interventions




IV IP





Oral IP




Oral IP







Oral IP





Placebo


Oral IP












Interventions





ZDV





No AP ARV drugs


plus 3TC






Oral IP








NVP plus IV ZDV






ZDV from 28 weeks






ZDV from 36 weeks








SD NVP











Interventions










No AP ARV

Oral IP bull SD NVP
















weeks


NVP or placebo












No AP ARV drugs

Oral IP bull SD NVP














Interventions




No AP ARV drugs


presents in time)


















































Interventions




No AP drugs

IP Regimens


NVP


NVP


NVP
































Interventions




No AP drugs



weeks






























LPVr


LPVr







Arm 2bull 05 (71385)

Arm 3bull 06 (2325)




















Interventions









NVP



Arm 2 bull 058 (71211)


Arm 2 bull 977

Documents

Recommendations for the Use of Antiretroviral Drugs in ...2020/12/15 · Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions