a p r i l 2 0 1 0 T H E S O U T H E R N A F R I C A N J O U R N A L O F H I V M E D I C I N E The purpose of the changes to the guidelines is not just to meet the Presidential mandates, but also to bring the guidelines in line with international recommendations and ensure the use of more efficacious drugs, including the phasing out of stavudine from the national ART pro- gramme. Electronic versions of the treatment guidelines are available on the SANAC website (www.sanac.org.za). The following is a brief summary of the key changes. PRIORITY GROUPS Owing to the high cost associated with ART, and the high burden of people in need of ART in South Africa, eligibility criteria have been adapted only for priority groups. These are: n HIV-infected pregnant women n HIV-infected infants n People with both tuberculosis (TB) and HIV infec- tion n People with multidrug-resistant (MDR) or exten- sively drug-resistant (XDR) TB. ELIGIBILITY TO START ART n CD4 count <200 cells/µl, irrespective of clinical stage, OR n CD4 count <350 cells/µl in patients with TB/HIV co-infection, or pregnant women, OR n WHO stage 4 disease, irrespective of CD4 count, OR n MDR/XDR TB, irrespective of CD4 count. In addition, certain patients are fast-tracked to be initiated on ART, which means they should be started within 2 weeks of receiving their CD4 result and choos- ing to start lifelong ART: n Pregnant women n Patients with a CD4 count below 100 cells/µl n Any patient with WHO stage 4 disease n Any patient with MDR or XDR TB. NATIONAL REGIMENS National regimens for children and adolescents are set out in Table I. National regimens for mothers and infants are set out in Tables II and III. NATIONAL REGIMEN FOR INFANTS CHILDREN For children, eligibility criteria to start ART are: n All children under 1 year of age, irrespective of CD4 level n Children between 1 and 5 years with clinical stage 3 or 4, or a CD4 percentage of 25 or below, or an absolute CD4 count under 750 n Children over 5 and up to 15 with clinical stage 3 or 4, or CD4 350 and below. The first-line regimens for children are: n Infants and children under 3: abacavir + lamivudine + lopinavir/ritonavir n Children 3 and older: abacavir + lamivudine + efa- virenz. CHANGES TO THE ART GUIDELINES – AN OVERVIEW g u i d e l i n e s Celicia Serenata South African National AIDS Council Secretariat 28 In 2009 the South African National AIDS Council (SANAC) Treatment Technical Task Team (TTT) finalised recom- mendations for changes to the national standard treatment guidelines for adult and paediatric management and treatment, as well as changes in the prevention of mother-to-child transmission of HIV (PMTCT) guidelines, moving away from monotherapy to dual therapy. President Zuma announced changes in the national antiretro- viral therapy (ART) programme on World AIDS Day 2009. Subsequently additional changes were made to the treatment guidelines to be in line with these new Presidential mandates, which came into effect on 1 April 2010. T H E S O U T H E R N A F R I C A N J O U R N A L O F H I V M E D I C I N E a p r i l 2 0 1 0 29 If a child is currently on a stavudine-based regimen, and is not experiencing any side-effects, the regimen should be maintained. Substitutions are only made once lipodystrophy is suspected. The second-line regimens for children are: n Children 3 and older: zidovudine + didanosine + lopinavir/ritonavir n Children failing on the first-line regimen: zidovu- dine + didanosine + lopinavir/ritonavir Woman Regimen Comment Eligible for lifelong ART (i.e. CD4 ≤350/µl TDF + 3TC/FTC + NVP Start lifelong ART within 2 weeks or WHO clinical stage 3 or 4) Currently on lifelong ART Continue ART Substitute EFV with NVP if in first 12 weeks of pregnancy Contraindication to TDF (renal disease) AZT + 3TC + NVP Not eligible for ART, i.e. CD4 >350/µl and AZT from 14 weeks WHO stage 1 or 2 sdNVP + AZT 3-hrly in labour TDF + FTC single dose (stat) post-delivery Unbooked and presents in labour sdNVP + AZT 3-hrly in labour Assess maternal ART eligibility TDF + FTC single dose post-delivery before discharge TABle ii. nATiOnAl RegiMen FOR MOTHeRs Infant Regimen Comment Mother on lifelong ART NVP at birth and then daily for 6 weeks irrespective of infant feeding choice Mother on PMTCT NVP at birth and then daily for 6 weeks continued If formula fed, baby can stop NVP at as long as any breastfeeding 6 weeks Mother did not get any ARV NVP as soon as possible and daily for at least Assess ART eligibility for the mother- before or during delivery 6 weeks continued as long as any breastfeeding within 2 weeks Unknown maternal status Give NVP immediately because orphaned or abandoned Test infant with rapid HIV test. If positive, continue Follow-up 6-week HIV DNA PCR NVP for 6 weeks. If negative, discontinue NVP TABle iii. nATiOnAl RegiMen FOR inFAnTs First line All new patients needing treatment TDF + 3TC/FTC + EFV/NVP For TB co-infection EFV is preferred For pregnant women or women of child-bear- ing age, not on reliable contraception, NVP is preferred Currently on d4T-based regimen d4T + 3TC + EFV/NVP Remain on d4T if well tolerated with no side-effects Early switch with any toxicity Substitute TDF if at high risk of toxicity (high body mass index, older, female, TB treatment) Contraindication to TDF: renal disease AZT+ 3TC + EFV/NVP Second line Failing on a d4T or AZT-based first-line regimen TDF + 3TC/FTC + LPV/r Virological failure must be followed by inten- sive adherence management If repeat viral load remains >1 000 in 3 months despite adherence intervention, switch Failing on a TDF-based first-line regimen AZT + 3TC + LPV/r Virological failure must be followed by inten- sive adherence management, as re-suppression is often possible If repeat VL remains >1 000 in 3 months de- spite adherence intervention, switch. Salvage therapy Failing any second-line regimen Specialist referral Intensively explore and address issues relating to causes of non-adherence If VL remains high, refer where possible, but maintain on failing regimen TABle i. nATiOnAl RegiMens FOR CHildRen And AdOlesCenTs a p r i l 2 0 1 0 T H E S O U T H E R N A F R I C A N J O U R N A L O F H I V M E D I C I N E n Children failing on the zidovudine or didanosine-based regimen: abacavir + lamivudine + lopinavir/ritonavir HIV-INFECTED PREGNANT WOMEN WITH CD4 ABOVE 350 These women follow the new national PMTCT guide- lines, namely: n Zidovudine from 14 weeks n Single-dose nevirapine and zidovudine 3-hourly during labour n Tenofovir and emtricitabine single-dose after de- livery. If a women presents in labour without having started ei- ther ART or the PMTCT regimen at 14 weeks, she should still receive the single-dose nevirapine and zidovudine 3-hourly and tenofovir and emtricitabine as per above. FINAL COMMENTS Even though these guidelines are focused on the public sector, it is hoped that they will also be adopted in the private and NGO sectors. Implementing these new guidelines would not just be of immediate benefit to the patient needing treatment. As has been shown in recent studies, patients on ART have a decreased viral load, and this impacts on HIV transmission. This meets the major objective of what President Zuma announced on 1 December 2009 – decrease mortality, and increase HIV prevention. 30