02.02 adult art initiation gsn

USAID APHIA IINAIROBI/CENTRAL

Module 2: Anti Retroviral Therapy in Adults and Adolescent

Unit 2: When to initiate Highly Active Anti Retroviral Therapy (HAART)

UNIT 2: Objectives

• Understand the principles and goal of successful antiretroviral therapy (ART)

• Understand the components of a Highly Active Anti Retroviral Therapy (HAART) regimen and the rationale for use of national standardized ART regimens

• Understand when ART should be initiated and who should be started on ART

• Understand drug and non-drug related considerations prior to initiating ART

SPIRITUAL

THE PERSON

EMOTIONAL PHYSICAL

SOCIAL

Holistic care

The comprehensive care team managing the patient

Spouse/partner

Other family and friends

Community services

Spiritual Care givers

Occupational therapist

Physiotherapist

Doctors Nurses

Counsellor

Nutritionist

ART is part of the comprehensive care of HIV infection

• Clinical care of HIV involves – Multidisplinary team effort– Counseling and continued support

• Diagnosis• Nutritional counseling• Adherence• Chronic illness with impact on lifestyle• Care of the dying and bereavement

– Management of OIs• Screening • Prophylaxis• Treatment

– Reproductive health care• Prevention and treatment of STIs• Contraception• Cervical Cytology• Pre and post natal care

– ART

1. Develop a treatment partnership with your patient.2. Focus on your patient’s concerns and priorities.3. Use the 5 A’s:Assess, Advise, Agree, Assist, Arrange.4. Educate patient on disease and support patient self-

management.5. Organize proactive follow-up.6. Involve peer educators and support staff in your health facility.7. Link the patient to community-based resources and support.8. Use written information—registers, Treatment Plan, treatment

cards and written information for patients—to document, monitor, and remind.

9. Work as a clinical team.10. Assure continuity of care.

AIM OF ART

Improve symptom free longevityby

maximal, sustainable & durablesuppression of viral replication

(<50 copies/ml)

Principles of ART

• Antiretroviral treatment is part of the comprehensive care of HIV infection

• Treatment should be planned and started in good time• Regular follow up and monitoring is essential • Treatment should be stopped/changed when necessary• The choice of drugs should take into account

– Efficacy– Tolerability– Dose Schedule– Affordability and availability

Principles of ART cont’d

• ARV drugs are associated with adverse events and drug-drug interactions

• Adherence is key to successful treatment • Treatment may fail despite patient’s and carer’s

best efforts• There should be commitment to continued support

of patient (and family)

Characteristics of good HAART

• Potent: should bring down viral load to an undetectable level within 3-4 months of therapy

• Acceptable regimen to maximize adherence - simple - tolerable side effects - patient commitment for life-long therapy• Reasonable options for future therapy• Affordable and sustainable

HAART…….Cont.

HAART does not cure HIV but halts viral replication,thus prevent further disease progression and immune system damage

HISTORY OF ART

1980 - 1987 - NO THERAPY1987 - 1994 - MONO THERAPY1994 - 1999 - COMBINATION THERAPY (HAART)1999 - 2002 - COMPLICATED THERAPY2002 - 2005 - SIMPLIFIED THERAPY

Goals of ART

• 1. Maximal suppression of HIV replication

• 2. Restoration and preservation of immune function

• 3. Improved Quality of Life• 4. Reduction of HIV related

Morbidity and Mortality

1. Suppression of HIV Replication

• ARVs must be taken in combination of at least 3 drugs

• Strict adherence to treatment is of the utmost importance– <95% adherence allows the rapid development of

viral resistance– Poor adherers do badly

• Fail treatment much earlier

2. Immune Reconstitution

• ART prevents CD4 destruction by HIV• CD4 cell count can recover • Improved function of CD4 cells• CD4 cells are central to the immune system

– So there is improved overall function of the immune system– It takes from 6 to 8 weeks for this to become evident clinically

3. Improvement of QOL

• Decreased hospitalizations• Decreased risk of illnesses• Increased general well-being• Reversal of weight loss • Ability to return to work

Take-home Messages about ART

• Not an emergency treatment– Benefits take 6 to 8 weeks– Should not be initiated while an inpatient

• Treat opportunistic infections first – OI’s cause >90% of morbidity in HIV– >90% of OI’s are simple to treat

• ART is only one part of HIV Care– All who require ART should first be on CPT first

• Optimize nutrition

Take-home Messages about ART

• Adherence counselling essential• Patients should be able to demonstrate an understanding of:

– Importance of strict adherence – Their ability to afford drugs long term– Life-long treatment, monthly follow-up

• The Kenyan National Guidelines should be followed– “If you don’t agree with them, campaign for a

change rather than ignoring them!”

Antiretroviral drugs: best practice

• Minimum combination of three drugs from at least 2 different classes drugs

– 2 NRTIs + NNRTI– 2 NRTIs + 2 PIs*– 2 NRTIs + PI

• Never use mono- or dual- therapy – Do not adequately suppress viral replication – Allow resistance to develop rapidly

• may adversely affect use of class of drugs involved

• Triple nucleoside therapy (ABC+3TC+AZT) – Best avoided especially in absence of viral load tests, treatment-

experienced– Utility mainly in some cases of treatment simplification/rare cases of drug

interactions*

PROTOCOL FOR ART REGIMEN

• Confirmation of HIV diagnosis• Counseling for ART• Baseline investigations • Indications of therapy• Selection of regimens• Monitoring of ART• Switching of regimens • Resistance testing

BASELINE INVESTIGATIONSTo Rule Out

Underlying O.Is X-ray chest Montoux test Sputum for AFB USG abdomen FNAC/Biopsy of

lymphnodes VDRL HbsAg

For Monitoring ARVHbCBCLFTRFTBlood sugarUrineStool &S. CholesterolS.TriglyceridesS. Uric acidS.CreatinineS. Lactic acidS. Amylase

Prognostic InvestigationsCD4

lymphocyte enumeration

PlasmaViral load assays

When to Start ART in Adults and Adolescents

Where CD4 Testing NOT available

• WHO III & IV regardless of total Lymphocyte count

• WHO II when total lymphocyte count <1200/mm3

When to Start ART in Adults and Adolescents

Where CD4 testing available

• WHO I& II when CD4 < 250/mm3

• WHO stage III when CD4 count < 350/mm3

• WHO stage IV irrespective of CD4 level

Guidance on Clinical Criteria

• In symptomatic patients with stage 3 and 4 disease CD4 is not essential for initiating treatment

The cut-off levels of CD4 count are not– A sick, deteriorating patient with a CD4 of 210 should not be

excluded from ART if otherwise able and keen to begin

– A very well, stable patient with a CD4 of 180 could reasonably opt for close follow up and deferral of ART to a later date

TB/HIV Co-infected Patients

• Always give TB treatment priority• All patients should be on cotrimoxazole prophylaxis• Optimum time to start ART in TB/HIV co-infected patients is

not known– Consider the risk of HIV progression if ART is delayed– Balance against risk of having to discontinue therapies because

of toxicities, side effects, paradoxical reactions or unforeseen drug/drug interactions if ART is started

ART and TB: When to start

CD4 Count Treatment Recommendation

CD4 <100/mm3 Start anti-TB treatmentStart ART as soon as possible

CD4 count 100-200/mm3 Start anti-TB treatmentStart ART after intensive phase

CD4 count 200-350/mm3 Start anti-TB treatmentStart ART after completion of TB treatment

CD4 count not available Start anti-TB treatmentConsider clinical status: start ART as appropriate

ART and TB

• ART is recommended for all patients with TB with CD4 counts < 200/mm3 and should be considered in patients with CD4 counts < 350/mm3

• In the absence of CD4 counts, ART is recommended for all patients with TB

Rationale Behind Standardized ARV Therapy

• Success of TB treatment program• Simplicity of prescribing• Preservation of certain ARV’s on a population

level • Simple sequencing of 1st to 2nd line• Increased efficiency in drug procurement• Cost and availability of FDC’s

National Standard 1st Line Regime for Adults and Adolescents

Lamivudine +

Stavudine/Zidovudine

+Nevirapine

Lamivudine+

Stavudine/Zidovudine

+Efavirenz

Standard 2nd Line Regime for Adults and Adolescents

Didanosine (ddI)+

Abacavir (ABC)+

Lopinavir/ritonavir• (LPV/r)

Tenofovir (TDF)+

Abacavir (ABC)+

Lopinavir/ritonavir(LPV/r)

For Patients on Non-standard 1st line Regimes…

1st LineD4T+ddI+NNRTI

AZT+3TC+PI

AZT+3TC+ABC

2nd LineAZT/ABC+3TC+LPV/r

NNRTI+ABC+ddI

NNRTI/LPV/r+ TDF+ d4T

A note on Fixed Dose Combinations (FDC’s)

• WHO Approved FDC’s are available for:– d4T/3TC/NVP– D4T/3TC– AZT/3TC

• Advantages – Decreased pill burden– Increased adherence– Mono or duo-therapy not possible– Lower cost– Simplify stock control and forcasting

• GoK has chosen these for the National roll-out

Pregnancy and ART

• Not a contraindication for ART• In general, best to defer to after the first trimester (after

organogenesis)• EFV contraindicated• ART greatly decreases vertical transmission• Also allows mother to remain well to care for her child• Avoid d4T and DDI together; increased risk of lactic

acidosis

Virological Failure and Adherence

Paterson,Swindells,Mohr. Adherence to PI therapy and outcomes in patients with HIV infection. Ann Intern Med 2000;133:21-30

>95% 82%90-95% 45%80-90% 33%70-80% 29%<70% 18%

Adherence with HAART Number with VL <500 cop/ml(% prescribed pills taken)

Patient Preparation

• Issue of lifelong continuous treatment

• Expected benefits

• Potential side effects of treatment and what to do

• Necessity for regular follow up

• Adherence and relation to outcome, drug resistance

• Adjusting to changes in lifestyle

• Recreational drug use

• Use of concomitant medication

• Medication not to be shared

• Point of contact if needed

Considerations prior to starting ART

• Logistics– Availability of ARVs

– Sustainability • Drug related

– Drug Interactions• Co-infections • Contraception• Combined toxicity Patient

factors

– Body weight• 60kg key in determining dose

of Stavudine and Didanosine• Kids

• Patient factors– Previous ART use by

patient

– Pregnancy• Not a contraindication for

ART• Effects of ARVs on

pregnant woman and fetus- largely unknown

• Delay starting ARVs until 2nd trimester

• Avoid Efavirenz during 1st trimester (and in women of child bearing potential)

When to Start: Early Initiation of Antiretroviral Therapy

• Benefits– Control of viral replication and mutation– Preservation of immune system – Decreased risk of selection of resistant virus– Possible decreased risk of viral transmission

• Risks– Drug-related reduction in quality of life– Greater cumulative drug-related adverse events– Possible earlier development of drug resistance– Limitation of future treatment options

When to Start: Delayed Initiation of Antiretroviral Therapy

• Benefits– Avoid negative effects on QOL and drug-related adverse

events– Delay development of drug resistance– Preserve future treatment options

• Risks– Possible risk of irreversible immune system destruction– Possible greater difficulty in suppressing viral replication– Greater likelihood of adverse events– Co-infections and drug interactions– Immune reconstitution– Possible increased risk of HIV transmission

Summary

• HAART should be started in good time• Patient understanding and acceptance for ART is

of utmost importance• ADHERENCE to ART is success to ART• National ART should be used for better

management of the patient (Easy referral from public-private-public set up)

THANK YOU

02.02 adult art initiation gsn

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