| 1
Optimising treatment for life-long management of HIV
Symposium at the 2019 INTEREST Congress Accra, Ghana
Artwork Credit: Martin Freeman, Universal
Diagnosed with AIDS in 1990, Martin lives in
San Francisco where he continues to create new pieces.
PHGH/HIV/0519/106
| 2
Introduction
Kwasi TorpeySchool of Public Health, University of Ghana, Accra, Ghana
Optimising treatment for life-long management of HIV
Artwork Credit: Martin Freeman, Universal
Diagnosed with AIDS in 1990, Martin lives in
San Francisco where he continues to create new pieces.
PHGH/HIV/0519/106
| 3
Faculty and disclosures
Michelle MoorhouseWits Reproductive Health and HIV InstituteJohannesburg, South Africa• Speaker fees and honoraria from Gilead Sciences,
AbbVie, Cipla and Janssen, and has received
conference sponsorship from BD, Gilead, Merck,
Cipla and Mylan
• Part of ART optimisation collaborations
• Funding from USAID, UNITAID and study drug
donations from ViiV and Gilead
Kwasi TorpeySchool of Public Health, University of Ghana, Accra, Ghana• Johnson & Johnson – Speakers Bureau
and Scientific Advisory Board
Lloyd MulengaUniversity of Zambia, Lusaka, Zambia• Johnson & Johnson – Scientific Advisory
Board and honoraria
Serge Paul EholieUniversity Felix Houphuet-Boigny, Abidjan, Ivory Coast• No reported conflict of interest
PHGH/HIV/0519/106
Fafa Addo BoatengJohnson & Johnson Global Public Health• Johnson & Johnson employee
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Learning outcomes
After completing the session, delegates will be able to:
• Review the main challenges around long-term management of HIV adult and
pediatric patients throughout Africa (SOLO3)
‒ Discuss the issues relating specifically to long-term use of PIs in HIV
management
• Describe the latest developments around antiretroviral therapy (ART) and how this
affects local clinical management (SOLO3)
‒ Discuss management options in managing second- and third-line treatment
• Apply the latest clinical data and HIV treatment guidelines to clinical practice in their
own countries (SOLO4)
‒ Discuss optimal treatment strategies available in West Africa
PHGH/HIV/0519/106
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Program overview
PHGH/HIV/0519/106
Time Topic Speaker
13:30 Welcome, introduction and objectives followed by
WHO technical update and 2018 guidelinesKwasi Torpey (Ghana) (Chair)
13:40
Faculty discussion: Understanding the role of PIs in antiretroviral
treatment in Africa
• Describe optimizing best practice with PIs around second- and third-
line treatment in Africa as part of long-term strategic anti-HIV therapy in
adult and paediatric patients
All faculty
(led by Kwasi Torpey)
14:10 Case study 1: Second-line treatment
• Selecting a PI in second line in clinical practice in AfricaLloyd Mulenga (Zambia)
14:25 Case study 2: Third-line treatment
• Switching to a PI in third line in clinical practice in Africa
Michelle Moorhouse
(South Africa)
14:40 New Horizons Advancing Pediatric HIV Care initiative
followed by
Discussion: Implementing New Horizons in Africa
Fafa Addo Boateng
(J&J Global Public Health)
Led by Lloyd Mulenga
15:00 Close Kwasi Torpey
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Keypad voting
• Please make your selection (s)
• Then press OK
| 7
Which of the following colours are in the Ghanaian flag? (select three)
1. Blue
2. Yellow
3. Red
4. Orange
5. Green
| 8
Ghanaian flag
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Disclaimer
• The meeting is organized and supported by Janssen Pharmaceutical
Companies of Johnson & Johnson
• The views expressed in these slides are those of the individual
faculty members and do not necessarily reflect the views of Janssen
Pharmaceutical Companies of Johnson & Johnson
• The program and the content of the presentations is owned by the
Scientific Third Party Committee and the respective faculty members
and may include discussions on off-label data of products and
therapies
PHGH/HIV/0519/106
Confidential | 10
World Health Organization; 2018.
https://www.who.int/hiv/pub/guidelines/ARV2018update/en/
WHO technical update and 2018 guidelines
Kwasi TorpeySchool of Public Health, University of Ghana,
Accra, Ghana
Confidential | 11
WHO ARV guideline development
Recommendations are formulated following WHO standards
for guideline development and based on:
• Supporting evidence
– Up-to-date systematic reviews of the evidence
– Information regarding values and preferences
• Cost and cost-effectiveness
• Simplicity
World Health Organization; 2018.
https://www.who.int/hiv/pub/guidelines/ARV2018update/en/
Confidential | 12
WHO ARV guidelines – timelines
2016 Dec 2018
Updated
consolidated
guidelines on
use of ARV
drugs for
treating and
preventing
HIV infection
Latest guidelines
provide updated
recommendations
May 2018
Drug safety alert
indicating that to
consider avoiding
DTG use during the
peri-conception
period until more
evidence is
available
/
World Health Organization; 2016. http://www.who.int/hiv/pub/arv/arv-2016/en
World Health Organization; 2018. https://www.who.int/hiv/pub/guidelines/ARV2018update/en/
Confidential | 13
Recommendations on choice of first- and second-line ART
First-line
• Preferred: EFV (600 mg)-based regimen
• Alternative: DTG- or EFV (400 mg)-based regimen
• Limited efficacy and safety data in pregnancy
• Limited data with concomitant TB treatment
• TAF was not recommended because of unclear efficacy or safety benefits
over TDF, and concerns over limited clinical experience when used in
pregnancy or with rifampicin-based TB treatment
• ART recommendations for children were unchanged in 2016 from 2013
because of lack of approved DTG dosing for use in children
WHO ARV 2016 guidelines –Considerations at the time
2016
World Health Organization; 2016. http://www.who.int/hiv/pub/arv/arv-2016/en
World Health Organization; 2018. https://www.who.int/hiv/pub/guidelines/ARV2018update/en/
Confidential | 14
WHO technical update and 2018 ARV guidelines
• Updated findings have shown DTG can be
more effective than EFV-based regimens in
treatment-naïve adults
‒ Higher viral suppression and CD4 cell count
recovery rates
• DTG also has a lower potential for drug-drug
interactions than EFV, and is protective against HIV-2
‒ Some concerns exist surrounding the use of DTG
in women and girls
World Health Organization. HIV treatment interim guidance. Accessed August 2018
World Health Organization; 2018. https://www.who.int/hiv/pub/guidelines/ARV2018update/en/
Confidential | 15
WHO ARV 2018 guidelines – first line
Populations Preferred Alternative Special
situations
Adult men and adolescent boys
TDF + 3TC
(or FTC) +
DTG
TDF + 3TC
(or FTC) +
EFV 600mg
TDF + 3TC
(or FTC) +
EFV 400mg
AZT + 3TC +
EFV 600mg
TDF + 3TC (or
FTC) + PI/rAdult
women
and
adolescent
girls
Pregnant or breastfeedinga
Not of childbearing potential
Of
childbearing
potential
Offered and using effective
contraception
Offered but not
using effective
contraception
OR
without access to
contraception
OR
want to become
pregnant
Choose to use
DTG after
informed
choice
Choose to use
EFV after
informed
choice
TDF + 3TC
(or FTC) +
EFV 600mg
TDF + 3TC
(or FTC) +
EFV 400mg
TDF + 3TC (or
FTC) + ATV/rb
AZT + 3TC +
EFV 600mg
TDF + 3TC (or
FTC) + RAL
a) Based on programmatic practicality and uncertainty surrounding possible DTG effects after the neural tube closes at 28 days of gestation as noted by the originator and FDA, previous
safe period after 8 weeks is now extended to after the first trimester. In practice, the majority of women will not yet know that they are pregnant during the first 8‒12 weeks of pregnancy
b) If the national prevalence of pre-treatment resistance to EFV or NVP is 10% or higher or if no other alternatives are available
World Health Organization; 2018. https://www.who.int/hiv/pub/guidelines/ARV2018update/en/
Confidential | 16
Population Preferred Alternative Special situations
Children ABC + 3TC + DTGa
ABC + 3TC + LPV/r
ABC + 3TC + RALb
ABC + 3TC +
EFVc (or NVP)
AZT + 3TC +
EFVc (or NVP)
AZT + 3TC +
LPV/r (or RAL)
Neonates AZT + 3TC + RAL AZT + 3TC + NVP AZT + 3TC + LPV/rd
http://www.who.int/hiv/pub/arv/arv-2016/en/
WHO ARV 2018 guidelines – first line (cont’d)
a) For age and weight groups with approved DTG dosing
b) RAL can be used as an alternative regimen if LPV/r solid formulations are not available
c) EFV should not be used for children younger than three years of age
d) If starting after 2 weeks of age
World Health Organization; 2018. https://www.who.int/hiv/pub/guidelines/ARV2018update/en/
Confidential | 17
Population Failing first-line
regimen
Preferred second-line
regimenb
Alternative second-line
regimens
Adults and
adolescents
(incl. women and
adolescent girls who
are of childbearing
potential or are
pregnant)a
2 NRTIs + DTGb 2 NRTIs + ATV/r
or LPV/r
DRV/rg,h ± DTGi b +
1–2 NRTIs
(if possible, consider
optimization
using genotyping)
2 NRTIs + EFVc 2 NRTIs + DTGb
Children
2 NRTIs + DTG2 NRTIs + ATV/rd
or LPV/r
2 NRTIs + LPV/r 2 NRTIs + DTGe
2 NRTIs + NNRTI 2 NRTIs + DTGf
a) An optimized NRTI backbone should be used such as AZT following TDF or ABC failure and vice versa
b) Women and adolescent girls of childbearing potential with consistent and effective contraception and who are fully informed of the benefits and risks can use DTG
c) If population-level pretreatment resistance to EFV or NVP is ≥10%, the choice of alternative options to EFV needs to be made weighing the drug availability and toxicity profile
d) ATV/r can be used as an alternative to LPV/r among children older than 3 months
e) This applies to children for whom approved DTG dosing is available. RAL should remain preferred second-line regimen for the children for whom approved DTG dosing is not available
f) ATV/r or LPV/r should remain the preferred second-line treatment for the children for whom approved DTG dosing is not available
g) For PI-experienced people, the recommended DRV/r dose should be 600 mg/100 mg bd
h) Children <3 years should not use DRV/r
i) DTG-based third-line ART following the use of integrase inhibitors must be administered with DTG twice daily
WHO ARV 2018 guidelines – second line
World Health Organization; 2018.
https://www.who.int/hiv/pub/guidelines/ARV2018update/en/
Confidential | 18
• WHO will also incorporate these guidelines into the next full
update of the WHO consolidated ARV guidelines planned
for 2019
‒ WHO will closely monitor data on the potential
association between DTG and neural tube defects and
regularly review emerging data
‒ WHO will update recommendations related to DTG
use as soon as relevant evidence becomes available
• Uptake of the recommendations in national guidelines will
be assessed in 2020
WHO ARV guidelines – next update
World Health Organization; 2018. https://www.who.int/hiv/pub/guidelines/ARV2018update/en/
| 19
Optimising treatment for life-long management of HIV
Symposium at the 2019 INTEREST CongressAccra, Ghana
PHEM/HIV/0818/0004c
Artwork Credit: Martin Freeman, Universal
Diagnosed with AIDS in 1990, Martin lives in
San Francisco where he continues to create new pieces.
| 20
Optimising treatment for life-long management of HIV
Faculty discussion: Understanding the role of PIs in antiretroviral treatment in Africa
PHEM/HIV/0818/0004c
Artwork Credit: Martin Freeman, Universal
Diagnosed with AIDS in 1990, Martin lives in
San Francisco where he continues to create new pieces.
| 21
Which guidelines do you most closely follow when prescribing ART? (select one)
1. WHO
2. National guidelines
3. Local hospital guidelines
4. Other
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When would you consider a PI as part of ART? (select up to three)
1. When initiating treatment – first line
2. At second line
3. At third line
4. I never use PIs
| 23
Which WHO-recommended PIs do you have available to prescribe? (select up to three)
1. ATV/r
2. DRV/r
3. LPV/r
4. I have none of these PIs available
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Optimising treatment for life-long management of HIV
Symposium at the 2019 INTEREST Congress, Accra, Ghana
Artwork Credit: Martin Freeman, Universal
Diagnosed with AIDS in 1990, Martin lives in
San Francisco where he continues to create new pieces.
PHGH/HIV/0519/106
CASE PRESENTATIONSwitching patient to an effective 2nd line
Lloyd Mulenga, MD
Associate Professor of Infectious Diseases
University of Zambia, School of Medicine, Lusaka, Zambia
Vanderbilt University, Nashville, USA
History• Male, 16 years old
• HIV diagnosis• November 2012 at age of 9 years
• Stays with mother who is on second-line ART• Mother reportedly doing well, although VL and CD4 are unknown• Mother denies taking ART or sdNVP prior to or during pregnancy • She was only tested for HIV after husband died
• Father died when he was 5 years old
• Has 3 older siblings all HIV negative
sdNVP = single-dose nevirapine
ART history and rationale Date Regimen Rationale Comments
15/12/2012 AZT/3TC/NVP Initial • Mother assured HCW of good adherence• Boy stayed with grandmother
15/08/2015 TDF/3TC/EFV Transition to adult regimen at age 12
• No clinical failure• No immunological failure• VL = not available
15/12/2018 TDF/3TC/EFV Routine VL done during VL scale up
• VL = 99,968 copies/mL• No clinical failure• No immunological failure• Enhanced adherence counselling
25/02/2019 TDF/3TC/EFV Repeat VL done • VL = 117,092 copies/mL• No clinical failure• No immunological failure
Reported good adherence
Available resultsDate Hb (g/dL) CD4 cell count/µL (CD4 %) Viral load (copies/mL)
Nov 2012 10.2 167 (13%) ‒
Jun 2013 11.2 360 (24%) ‒
May 2014 11.6 323 (25%) ‒
Feb 2015 10.3 300 (24%) ‒
Aug 2015 10.8 314 (22%) ‒
Aug 2016 11.4 398 (25%)
Aug 2017 11.0 402 (22%)
Dec 2018 10.8 368 (19%) 99,968
Feb 2019 11.8 117,019
Sputum GeneXpert-Rif negative
ALT: 32.9 mmol/L
CREAT: 38 µmol/L
NOTE: Collected samples for resistance test (genotype) in Feb 2019
What is most likely to be the issue?(select one)
1. Resistance to NNRTIs
2. Resistance to NRTI backbone regimen
3. Resistance to both NRTIs and NNRTIs
4. Sub-optimal adherence
What could you have done differently in transitioning this patient from AZT/3TC/NVP to TDF/3TC/EFV? (select as many answers as you wish)
1. Switch to a PI rather than continue an NNRTI
2. Viral load testing before switching
3. Switch away from 3TC
4. Have adherence counselling earlier
5. Other
How would you construct the second-line in this patient in the absence of genotyping?(select one)
Switch from TDF/3TC/EFV to:
1. TDF/3TC + bPI
2. AZT/3TC + bPI
3. DTG/3TC+ bPI
4. AZT/3TC + DTG
5. TDF/3TC/DTG
6. Other regimen
Follow-up
• Switched to • DTG 50mg OD + 3TC 300mg OD + ATV/r 300/100 OD
• April 2019• VL: <20 copies/mL
GENOTYPE RESULT
ADULT INFECT DISEASE CENTER
Referred by MWALE
UNIVERSITY TEACHING HOSPITALPRIVATE BAG RW 1XLUSAKA
Tests ordered: HIV V/load, Drug Resist
DRUG RESISTANCE TESTING
Protease inhibitors
Nucleoside RTI
Non-nucleoside RTI
PI resistance mutations
NRTI resistance mutations
NNRTI resistance mutations
HIV VIRAL LOAD
HIV Viral Load 117092 copies/mL
Atazanavir/r (ATV/r) SusceptibleDarunavir/r (DRV/r) SusceptibleFosamprenavir/r (FPV/r) SusceptibleIndinavir/r (IDV/r) SusceptibleLopinavir/r (LPV/r) SusceptibleNelfinavir (NFV) SusceptibleSaquinavir/r (SQV/r) SusceptibleTipravavir (TPV/r) Susceptible
Abacavir (ABC) High-level resistanceZidovudine (AZT) SusceptibleStavudine (D4T) High-level resistanceDidanosine (DDI) High-level resistance Emtricitabine (FTC) High-level resistanceLamivudine (3TC) High-level resistance Tenofovir (TDF) High-level resistance
Doravirine (DOR) High-level resistanceEfavirenz (EFV) High-level resistance Etravirine (ETR) High-level resistanceNevirapine (NVP) High-level resistance Rilpivirine (RPV) High-level resistance
K65R, D67HN, T69D, Y115F, M184V, K219KE
A98G, K103KN, V106VM, Y181C, G190A
Lab No. ZUA0062809Reference5040-024028955-9Specimen BloodReceived 25/02/2019 09:48
NONE
Our question…
• How do you interpret the above results in view of this history?
| 35
Optimising treatment for life-long management of HIV
Symposium at the 2019 INTEREST CongressAccra, Ghana
Artwork Credit: Martin Freeman, Universal
Diagnosed with AIDS in 1990, Martin lives in
San Francisco where he continues to create new pieces.
PHGH/HIV/0519/106
Michelle Moorhouse
15 May 2019
Clinical case:
Switching to a PI in third-line in clinical practice in Africa
3TC
Three lines of treatment in most LMICs
XTCTDF EFV
XTC, other nukes
PI/r(LPV/r or ATV/r)ZDV
Darunavir Etravirine
Failure
Failure: genotype
Dolutegravir
WHO technical update and 2018 guidelines
Population First-line regimens Second-line regimens Third-line regimens
Adults and adolescents (incl. women ofchildbearing potential and pregnant women)
2NRTIs + DTG 2NRTIs + (ATV/r or LPV/r)
DRV/r + DTG + 1–2 NRTIs (if possible, consider optimisation using
genotyping)
2NRTIs + EFV 2NRTIs + DTG
Children (0–10 years)
2NRTIs + DTG 2NRTIs + (ATV/r or LPV/r)
2NRTIs + LPV/r 2NRTIs + DTG
2NRTIs + NNRTI 2NRTIs + DTG
World Health Organization; 2018.
https://www.who.int/hiv/pub/guidelines/ARV2018update/en/
Let’s meet our patient… back in 2006
• Mr D, 45 years old
• Newly diagnosed with HIV
• Works as a security guard, occasional shift work
• Tested during hospital admission for AGE with ARF
Test Result Unit
CD4 count 108 cells/µL
Viral load 563,798 copies/mL
ALT 32 IU/L
So when to start (in 2006)?
World Health Organization. 2006. Archive of guidelines on ARVs. https://www.who.int/hiv/topics/treatment/technical/en/
And what to start (in 2006)?
Regimen Drugs Monitoring tests Frequency
1a d4T / 3TC / efavirenz ❑CD4
❑VL
❑ALT
❑Staging, 6 monthly
❑Baseline, 6 monthly
❑Symptomatic
1b d4T / 3TC / NVP ❑CD4
❑VL
❑ALT
❑Staging, 6 monthly
❑Baseline, 6 monthly
❑Baseline, week 2, 4 and 8,
thereafter 6 monthly
World Health Organization. 2006. Archive of guidelines on ARVs. https://www.who.int/hiv/topics/treatment/technical/en/
And so he starts treatment…
Three weeks later
• Itchy maculopapular rash involving limbs and trunk
• No mucosal lesions noted
• Felt slightly unwell
• Physical exam: NCS (URTI)
Test Result Unit
Temperature 37.1 ∘C
ALT 173 IU/L
Viral hepatitis studies Negative
Was it NVP hypersensitivity?
• All ARVs and co-trimoxazole interrupted
• ALT settled quickly
• Re-started on slightly different regimen: d4T + 3TC + EFV
• Tolerated regimen well
• Adherence not always optimal on account of periods of shift work
Mr D’s progress…
Date BL Mar 07 Sep 07 Jun 08 Feb 09 Aug 09 Apr 10
CD4 count(cells/µL)
108 356 294 388 401 394 153
VL(copies/mL)
563,798 LDL 3572 LDL 4461 360,237 1,134,591
PTB
PTB = pulmonary tuberculosis
What second-line regimen would you choose?(select one)
1. DTG + TDF/FTC
2. DTG + RPV
3. DRV/r + TDF/FTC
4. ATV/r + ZDV/3TC
5. LPV/r + TDF/FTC
So what to switch to (2010)?
• Starts second-line ART regimen: LPV/r + TDF/FTC
World Health Organization. 2012. Archive of guidelines on ARVs. https://www.who.int/hiv/topics/treatment/technical/en/
Mr D responds well to second-line initially
CD4 count(cells/µL)
Oct 10 Apr 11 Oct 11 May 12 Nov 13 May 14 Aug 14
VL(copies/mL)
389 475 498 527 506 364 332
CD4 count(cells/µL)
LDL LDL LDL LDL 87,772 35,626 44,620
Re-starts ARVs
Defining second-line failure
VL >1000 copies/mL on second-line >1 year
Repeat VL in 6 months
VL ≤1000 copies/mL
Continue second-line
VL >1000 copies/mL
GENOTYPE
Adherence; compliance; tolerability; drug interactions; psychological
https://sahivsoc.org/Files/ART%20Guidelines%2015052015.pdf
Mr D’s resistance scores using StanfordPI ATV/r DRV/r LPV/r
NRTI ABC AZT FTC 3TC TDF
EFV ETR NVP RPVNNRTI
What third-line regimen would you select? (select one)
1. DTG + TDF/FTC
2. ZDV + 3TC + ABC
3. DRV/r + TDF/FTC + RAL
4. DRV/r + TDF/FTC + DTG
5. DTG + TDF/FTC + ETR
So what third-line regimen in 2014?
• Mr D was started on a third-line regimen of: DRV/r + TDF/FTC + RAL*
• He tolerated the regimen well
• Despite the challenges it presented: twice-daily dosing and pill burden
*DTG not available at the time
What I didn’t tell you about Mr D…
• Mr D, now 54 years old, is hypertensive and has type 2 diabetes
• Metformin, insulin, ACE-I with diuretic, statin
• So his ART regimen was modified: DRV/r + ABC/3TC + RAL
Date Oct 14 Dec 14 Feb 15 May 15 Aug 15 Nov 15
Creatinine clearance(mL/min)
55 52 48 46 44 41
And this is not the end of his problems…
• So another genotype was done, including the integrase genes
Date Jul 16 Jan 17 Mar 17
Viral load (copies/mL)
7340 9294 2546
Mr D’s genotypePI ATV/r DRV/r LPV/r
RALEVGDTGINSTI
0.3% of adults on ART (n=37,087)
0
5
10
15
20
25
30
35
40
45
50
RAL +DRV/r
TDF +FTC +DRV/r
ETR +RAL +DRV
TDF +3TC +RAL +LPV/r
ETR +RAL +DRV/r
TDF +3TC +RAL
TDF +FTC +RAL
TDF +FTC +DRV/r
TDF +FTC +RAL +DRV/r
ZDV +3TC +ABC
ARV regimens
% o
f p
eo
ple
on
th
ird
-lin
e A
RT
Third-line in LMIC (end 2016)
Personal communication to Dr Moorhouse from World Health Organization, 2019
0.3% of adults on ART (n=37,087)
Third-line in LMIC (end 2016)
Projected to end 2019:Adult: 310,000
Paediatric: 24,000
World Health Organization projection, 2016
3TC
XTC, other nukes
PI/r(LPV/r or ATV/r)ZDV
Darunavir Etravirine
Failure: genotype
Dolutegravir
Moorhouse et al, 26th IWHDRTS; Personal communication
250,000
1800Since 2013
SA has largest ARV programme: >5 million
3TC
SA has largest ARV programme: >5 million
XTC, other nukes
PI/r(LPV/r or ATV/r)ZDV
Darunavir Etravirine
Failure: genotype
Dolutegravir*
Moorhouse et al, 26th IWHDRTS; Personal communication
250,000
1800Since 2013
3TC
Failure: genotype
Dolutegravir*
So how many adults failing PI/r-based ART are accessing third-line ART?
Moorhouse et al, 27th IWHDRTS; SAHCS 2018
Adults on third-line ART
1400
1200
1000
800
600
400
200
02013 2014 2015 2016 2017 2018
Adult patients per year Cumulative
Third-line ART algorithm
Eligible for third-line ARTPI score ≥15
TDF/ZDV 30‒59 OR DRV ≥15
TDF/ZDV >29 AND DRV ≥15 AND ETR ≤29
Add ETR
DRV + 3TC/FTC + ZDV/TDF (lowest score)
Add InSTI
Moorhouse et al, 27th IWHDRTS; SAHCS 2018
Good virologic outcomes despite high levels of PI resistance
Moorhouse M et al, J Acquir Immune Defic Syndr. 2019;80:73-78
Good virologic outcomes despite high levels of PI resistance
Moorhouse M et al, J Acquir Immune Defic Syndr. 2019;80:73-78
VL < 1000 copies/mL: 83%
VL < 400 copies/mL: 79%
Mr D’s dilemma
• Co-morbidities• DM, hypertension with end organ damage
• Polypharmacy
• Resistant virus• High-level resistance against all InSTIs
• Intermediate resistance against DRV/r and NRTIs
• No further lines of treatment available in SA public sector
Thanks
• South Africa NDoH Third-line ART Committee
| 68
Optimising treatment for life-long management of HIV
Symposium at the 2019 INTEREST CongressAccra, Ghana
Artwork Credit: Martin Freeman, Universal
Diagnosed with AIDS in 1990, Martin lives in
San Francisco where he continues to create new pieces.
PHGH/HIV/0519/106
| 69
Fafa Addo BoatengJohnson & Johnson Global Public HealthAfrica
Artwork Credit: Martin Freeman, Universal
Diagnosed with AIDS in 1990, Martin lives in
San Francisco where he continues to create new pieces.
PHGH/HIV/0519/106
70
Contribute to UNAIDS 90-90-90 target
Ensure that global HIV
response addresses the
critical unmet needs of
children and adolescents
Promote treatment
equity between adults
and children
Link 5,000 pediatric patients to 2nd- and 3rd-line care,
and access to J&J treatment by 2020
Our goals
ADVANCING PEDIATRIC HIV CARE
www.newhorizonshiv.com
71
Objectives
Focus areas
Enabling
platforms
and outputs
Partners and Collaborators
Donation program: In collaboration
with country Ministries of Health
Health system strengthening: Improving care and treatment through public
health approach
Drug access Capacity building
Drug delivery – Donation, operations and formulations
Healthcare worker capacity – Tools, training, technical assistance
Operational research, cohort analysis, publications and information sharing
HIV+ youth/patient engagement
Meeting the Needs of Young People Living with HIV
ADVANCING PEDIATRIC HIV CARE
www.newhorizonshiv.com
| 72
Donations should benefit the recipient and be based
on an expressed need
Donation process should involve effective collaboration
and coordination between donor and recipient
Quality standards should be consistent across donor
and recipient countries, with no double standards
www.newhorizonshiv.com
World Health Organization. Interagency Guidelines for Medicine Donations, 2010
Aligned to WHO donation guidelines
WHO core principles Johnson & Johnson donation
Countries must submit Expression of Interest
Donation process utilizes the same distribution
mechanism used for PEPFAR-funded ARVs
Donated product is the same as the product
procured by country tenders
Operating Principles
ADVANCING PEDIATRIC HIV CARE
73
Drugs to be donated: DARUNAVIR (and/or) ETRAVIRINE1
Managed by national HIV program
Ends when patient reaches 24 years2 of age or experiences treatment failure
Patients transition to adult care to continue treatment
Patient enrollment
Product donationSept.
2014
31 Dec.
202031 Dec.
2039Enrollment
1. Formulations: PREZISTA® 600mg, PREZISTA® 150mg, PREZISTA® 75 mg, PREZISTA® 100mg/ml,
INTELENCE® 100mg, INTELENCE® 25mg
2. Specific “aging out” requirements vary by country
Product Donation Program
ADVANCING PEDIATRIC HIV CARE
www.newhorizonshiv.com
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Where do we operate?
ADVANCING PEDIATRIC HIV CARE
• The program operates in many countries across Africa
• Current participating countries:
www.newhorizonshiv.com
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Resources
✓ Pediatric HIV online training module
(PaedsHIVLearning.com)
✓ Resistance training workshops
✓ PENTA training workshops
✓ Data harmonization and capacity building
✓ Second- and third-line dosing cards
✓ Management of treatment failure algorithm
✓ Disclosure toolkit
✓ Transition and adherence tools (upcoming)
ADVANCING PEDIATRIC HIV CARE
www.newhorizonshiv.com
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Implementing Partners
ADVANCING PEDIATRIC HIV CARE
www.newhorizonshiv.com
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Optimising treatment for life-long management of HIV
Symposium at the 2019 INTEREST CongressAccra, Ghana
Artwork Credit: Martin Freeman, Universal
Diagnosed with AIDS in 1990, Martin lives in
San Francisco where he continues to create new pieces.
PHGH/HIV/0519/106
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Thank you
• Please leave your completed evaluation form and
keypad on your chair at the end of the meeting
• If you require an attendance certificate, please
collect one at the back as you leave