THE SOUTH AFRICAN ANTIRETROVIRAL TREATMENT GUIDELINES 2010

The South African Antiretroviral Treatment Guidelines 2010

Goals of the programme Achieve best health outcomes in the most cost-efficient manner Implement nurse-initiated treatment Decentralise service delivery to PHC facilities Integrate services for HIV, TB, MCH, SRH and wellness Diagnose HIV earlier Prevent HIV disease progression Avert AIDS-related deaths Retain patients on lifelong therapy Prevent new infections among children, adolescents, and adults Mitigate the impact of HIV & AIDS Objectives To contribute to strengthening of the public and private health sectors capacity to deliver high quality integrated health and wellness services To ensure timely initiation of ARVs for treatment and prevention according to the Presidential mandates To minimize unnecessary drug toxicities

Specific Objectives To prioritise ARVs for: Patients with CD4 counts < 200cells/mm3 or with severe HIV disease irrespective of CD4 Patients co-infected with TB/HIV Pregnant women with CD4 < 350cells/mm3 for lifelong ART and CD4 >350cells/mm3 for prophylaxis To test all HIV exposed children under one year and treat all those found to be infected with HIV To standardise first and second line therapy for children, adolescents, and adults in the public and private sector To reduce the use of stavudine To expand the use of fixed-dose and co-packaged formulations To enable nurses to initiate ARVs for treatment and prevention To enable PHC facilities to initiate, manage, monitor and refer patients

1.

Standardised national eligibility criteria for starting ART regimens for Adults and Adolescents
Eligible to start ART CD4 count <200cells/mm3 irrespective of clinical stage OR CD4 count <350cells/mm3 o In patients with TB/HIV o Pregnant women OR

WHO stage IV irrespective of CD4 count OR MDR/XDR irrespective of CD4 Require fast track (i.e. ART initiation within 2 weeks of being eligible Pregnant women eligible for lifelong ART OR Patients with very low CD4 (<100) OR Stage 4, CD4 count not yet available OR MDR/XDR TB Not yet eligible for ART Transfer to a wellness programme for regular follow up and repeat CD4 testing 6-monthly. Advice on how to avoid HIV transmission to sexual partners and children Initiate INH prophylaxis if asymptomatic for TB Contraceptives and annual Pap smear

2.

Standardised national ART regimens for adults and adolescents

1 Line
st

All new patients needing treatment, including pregnant women

TDF + 3TC/FTC + EFV/NVP

For TB co-infection EFV is preferred. For women of child bearing age, not on reliable contraception, NVP is preferred.

Currently on d4T based regimen with no side-effects

d4T + 3TC + EFV

Remain on d4T if well tolerated. Early switch with any toxicity Substitute TDF if at high risk of toxicity (high BMI, low Hb, older female)

Contraindication to TDF: renal disease Failing on a d4T or AZT-based 1 line regimen Failing on a TDFbased 1 line regimen
st st

AZT+ 3TC +EFV/NVP 2 LPV/r AZT+3TC+ LPV/r

nd

line

TDF + 3TC/FTC +

Salvage Failing any 2 regimen

nd

line

Specialist referral

3.

Standardized National Monitoring for Adults and Adolescents with HIV

At initial Diagnosis of HIV Check HIV result Clinical staging if HIV positive Ask if pregnant or planning to conceive Screen for TB symptoms Do the CD4 count Hb or FBC if available At Routine Follow-Up Visits Check that CD4 has been done in the last 6 months WHO clinical staging Screen for TB symptoms If Eligible for ART Serum Creatinine if starting on a TDF based regimen ALT if starting on a NVPbased regimen Hb or FBC if available if starting on an AZT-based regimen. for ART

Purpose Ensure that national testing algorithm has been followed To assess eligibility for ART To assess eligibility for fast-tracking To identify women who need ART or ARV for PMTCT (see section 6) To identify TB/HIV co-infected To identify eligibility for ART or ARVs if pregnant To detect anaemia or neutropenia Purpose To see if they have become eligible To see if they have become eligible for ART To identify TB/HIV co-infection Purpose Refer if estimated creatinine clearance is less than 50 If ALT raised, do HepBSAg and avoid NVP If less than 8g/dl refer to doctor

On ART Clinical stage CD4 at month 6, 1 year on ART and then every 12 months VL at month 6, 1 year on ART and then every 12 months ALT if on NVP and develops rash or symptoms of hepatitis FBC at month 1, 2, 3 and 6 if on AZT Creatinine at month 3 and 6 then every 12 months if on TDF Fasting cholesterol and triglycerides at month 3 if on LPV/r

Purpose To monitor response to ART To monitor response to ART

To monitor response to ART To identify problems with adherence To identify NVP toxicity To identify AZT toxicity To identify TDF toxicity

To identify LPV/r toxicity

Standardised national eligibility criteria for starting ART regimens for infants and children
Eligible to Start ART All children less than 1 year of age Children 1 5 years with clinical stage 3 or 4 or CD4 25 % or absolute CD4 count < 750 cells/l Children > 5 years to 15 years with clinical stage 3 or 4 or CD4 < 350 cells/l Require Fast-Track (i.e. start ART within 2 weeks of being eligible) Children less than 1 year of age Stage 4 MDR or XDR-TB

4.

Standardised national ART regimens for infants and children

1 Line
st

All infants and children under 3 years Children 3 years or over Currently on d4Tbased regimen with no side-effects

ABC + 3TC + LPV/r

ABC + 3TC + EFV Can continue Substitute once lipodystrophy suspected 2

nd

line

Children above 3 years Failed ABC +3TC + EFV Failed on AZT or ddIbased regimen Failed on LPV-based regimen Infants under 3 years failing 1 line
st

AZT + ddI +LPV/r

ABC + 3TC + LPV/r Refer Specialist advice necessary and/or hospital referral Refer Specialist advice necessary and/or hospital referral Salvage

Failing any 2

nd

line

Specialist referral

5.

Standardized national monitoring for infants and children with HIV

At initial Diagnosis of HIV Check HIV result

Purpose Ensure that national testing algorithm including HIV DNA PCR and HIV viral load (RNA) for infants and children less than 18 months has been followed

Document weight and height Screen for TB symptoms Do the CD4 count Hb or FBC is available At Routine Follow-Up Visits Document weight and height

To monitor growth and development + identify eligibility for ART To identify TB/HIV co-infected To identify eligibility for ART or ARVs To detect anaemia or neutropenia Purpose To monitor growth and development and to see if they have become eligible for ART

Check that CD4 has been done in the last 6 months WHO clinical staging Screen for TB symptoms If eligible for ART ALT if starting on a NVPbased regimen Hb or FBC if available if starting on an AZT-based regimen

To see if they have become eligible for ART To see if they have become eligible for ART To identify TB/HIV co-infection Purpose If ALT raised, do HepBSAg and avoid NVP If less than 8g/dl refer

On ART Height + weight + development Clinical stage CD4 at month 6, 1 year into ART, and then every 12 months VL at month 6, 1 year into ART, then every 12 months ALT if on NVP an develops rash or jaundice FBC at month 1, 2,and 3 if on AZT

Purpose To monitor response to ART To monitor response to ART To monitor response to ART To monitor response to ART To identify problems with adherence to identify NVP toxicity To identify AZT toxicity

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6.

Standardised national ART and ARV regimens for women who are HIV positive and pregnant and their infants
Maternal Regimens

Eligible for ART (i.e. CD4 < 350 or clinical stage 3 or 4) Currently on ART

TDF + 3TC/FTC + NVP Continue ART

Start lifelong ART within 2 weeks Substitute EFV with NVP if in first 12 weeks of pregnancy

Contraindication to TDF (renal disease) Not eligible for ART i.e. CD4 > 350

AZT+ 3TC + NVP AZT from 14 weeks sdNVP during labour TDF + FTC single dose after delivery

Unbooked and presents in labour

sdNVP during labour TDF + FTC single dose after delivery

Assess for ART eligibility before discharge

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Infant Regimens Mother on lifelong ART NVP at birth and then daily for 6 weeks irrespective of infant feeding choice Mother on AZT for MTCT prophylaxis NVP at birth and then daily for 6 weeks continued as long as any breastfeeding Mother did not get any ARV before or during delivery NVP as soon as possible and daily for at least 6 weeks continued as long as any breastfeeding Unknown maternal status, orphaned or abandoned HIV antibody test Give immediate NVP if baby is HIV antibody positive (i.e. HIV exposed) Follow up 6 week HIV DNA PCR If formula fed baby can stop NVP at 6 weeks Assess for ART eligibility within 2 weeks

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Acronym glossary 3TC ABC AIDS ALT ART ARV AZT CD4 D4T ddI DNA PCR EFV FBC FTC Hb HepBSAg HIV LPV/r MCH MDR/XDR TB NVP PHC SRH TB TDF WHO Lamivudine Abacavir Acquired Immune Deficiency Syndrome Alanine Aminotransferase Antiretroviral Treatment Antiretroviral Zidovudine Cluster of Differentiation 4 Stavudine Didanosine DNA Polymerase Chain Reaction Efavirenz Full Blood Count Emtricitabine Haemoglobin Hepatitis B Surface Antigen Human Immunodeficiency Virus Lopinavir/ritonavir Maternal-Child Health Multi-Drug Resistant / Extensively Drug Resistant Tuberculosis Nevirapine Primary Health Care Sexual and Reproductive Health Tuberculosis Tenofovir World Health Organization
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