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TREATMENT ACCESS

New PMTCT guidelines for South Africa

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On the 11 February 2008 the South African National Department of Health finally released their new PMTCT guidelines, which had not been revised since 2003.

The main change to the protocol is the addition of short course AZT from 28 weeks to the current single dose NVP regimen for women CD4 >200 cells/mm3 (unless they are severely anaemic, Hb<7g/dl). Unlike the World Health Organisation (WHO) guidelines they do not recommend maternal “tail” coverage of AZT/3TC for 7 days post partum.

Additional recommendations are:

• Women attending antenatal clinics with unknown status to be routinely offered an HIV test and a CD4 test on the same day if positive diagnosis. Women testing negative to be offered a repeat test at 34 weeks and women refusing the test offered again at subsequent antenatal visits.
• Women </= 200 CD4 cells/mm3 or WHO stage 4 are indicated for HAART and should start as soon as possible. This too differs from the WHO, who recommend initiation at <350 cells mm3 for women in WHO stage 3. The guidelines also recommend women with <200 cells/mm3 who have not initiated HAART in pregnancy do so immediately post partum – which may be the worst possible scenario for treatment failure, in the absence of a strategy to protect women from NVP resistance.
• Women initiating HAART will receive the South African regimen 1B – d4T/3TC/NVP. This again goes against most guidelines, which recommend an AZT containing regimen where possible for pregnant women.
• Pregnant women already receiving EFV-containing HAART should be switched to NVP if identified early enough. If identified after the first trimester they should continue the EFV and receive foetal anomaly scans.
• Infants whose mothers received the recommended regimens should receive single dose NVP and 8 days AZT. Infants of mothers receiving no only maternal NVP, <4 weeks AZT or HAART, or no maternal prophylaxis or treatment should receive 28days AZT.

Although pleased that the guidelines had been updated the Treatment Action Campaign (TAC) wrote:

“We regret that the Department of Health’s new protocol, while better than the 2003 one, is still out of sync with WHO’s strongest recommendations for the prevention-of-mother-to-child-transmission of HIV. Specifically, the revised protocol fails to include any mention of the antiretroviral drug 3TC, a safe, effective and inexpensive addition to AZT. The 2006 WHO guidelines for preventing HIV infection in infants recommend that 3TC be administered to the mother, in conjunction with AZT, both during birth as an HIV prophylaxis as well as postpartum as a means of reducing the risk of nevirapine resistance…Another serious shortcoming in the new PMTCT policy guidelines is that pregnant women who test positive for HIV will only be started on antiretroviral therapy once their CD4 count has dropped to or below 200 cells/mm3. Once again this puts the new guidelines out of step with current international best practice. Compelling scientific evidence points to significant health advantages for pregnant women who initiate antiretroviral therapy at CD4 cell counts of 350 cells/mm3 rather than 200 cells/mm3.”

Meanwhile the Southern African HIV Clinicians Society guidelines for antiretroviral therapy in adults are due to be released at the end of March. These guidelines include recommendations for ART in special populations. Notably they recommend all identified HIV-positive pregnant women should be initiated on HAART irrespective of CD4 count and viral load.

The recommendations include:

• HIV testing with the aim to initiate treatment within two weeks of first visit.
• NVP based HAART for women <250 CD4 cells/mm3.
• Boosted PI (LPV/r) based HAART for women with >CD4 250 cells/mm3.
• Women initiating HAART with <350 cells/mm3 to continue treatment indefinitely.
• Women initiating HAART with >350 cells/mm3 who elect to formula feed should stop treatment after delivery. Those who choose to breastfeed should continue until after the infant is weaned.
• Women presenting in labour should receive single dose NVP with 7 days ‘tail” coverage.

Francois Venter, president of the Southern African HIV/AIDS Clinicians Society said: “South Africa is a middle income country; we have the resources to treat below CD4 <350 cells/mm3 and it is a lost opportunity not to increase this bar. It is also unclear why 3TC and the tail are being omitted and again seems to be a confused reaction to pressure to change the guidelines. I think the new Society guidelines set an international bar we can aim for - the South African ones are nowhere near aspirational enough.”

References
Policy and guidelines for the implementation of the PMTCT programme. South African National Department of Health:
http://www.doh.gov.za/docs/policy/pmtct-f.html
TAC statement
http://www.tac.org.za/nl20080130b.html
Southern African HIV Clinicians Society guidelines for antiretroviral therapy in adults
http://www.sahivsoc.org

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