KHOPOTSO: Two aspects of the new protocol are causing dissatisfaction among doctors. The first is the omission in the policy of what doctors call the ‘€œtail’€ regimen. Dr Ashraf Coovadia, a paediatrician working at Coronation Hospital in Johannesburg, says it’€™s crucial that the ‘€œtail’€ ‘€“ a week-long dose of AZT and 3TC ‘€“ be administered to women after giving birth to reduce their risk of developing resistance to Nevirapine when they start taking antiretrovirals for their own survival later.    

Dr ASHRAF COOVADIA: Nevirapine resistance in them compromises their treatment in their own right’€¦ as you know the first line (of) treatment in South Africa is AZT, 3TC and either Nevirapine or Stocrin. So, with Stocrin, it would be 1(A) and with Nevirapine it would be 1(B). So, both options are already compromised in women who have had single-dose Nevirapine, particularly in the first six months’€¦ Our major concern now is what about within the first six months who are going to need treatment? We would have to either delay treatment ‘€“ to be on six months ‘€“ or if they are very sick and need treatment more urgently we would have to offer them another option other than either Nevirapine or Stocrin as part of their triple therapy regimen.

KHOPOTSO: Coovadia explains why resistance to either Nevirapine or Stocrin normally occurs.  

Dr ASHRAF COOVADIA: Remember Stocrin and Nevirapine are both drugs in the same class. So, if you have resistance against Nevirapine you automatically have resistance against Stocrin ‘€“ our first line regimens. Unless we are honest and we let women know in the first six months that this regimen is not going to be as effective because you have received Nevirapine.

KHOPOTSO: In the revised protocol, HIV-positive women now receive two drugs – AZT from 28 weeks of pregnancy until labour and then, a single dose of Nevirapine is added during delivery. But half of the women who receive a single dose of Nevirapine develop resistance to the drug in the first six months after child-birth. The ‘€œtail’€, which reduces resistance significantly, is part of guidelines set by the World Health Organisation in 2006.  

Dr ASHRAF COOVADIA: The rationale of adding the tail ‘€“ so, you give single dose Nevirapine and you add AZT and 3TC ‘€“ the risk of developing resistance to Nevirapine is then greatly reduced because the other two drugs assist in lowering the virus’€™ replication. By potentiating the treatment and decreasing the amount of virus that is present Nevirapine is no longer on its own fighting the virus. You have two other drugs that are lowering the viral load.  

KHOPOTSO: The second omission doctors are unhappy about is that the guidelines have not altered the CD4 measure at which pregnant HIV-positive women should start taking antiretrovirals.

Dr ASHRAF COOVADIA: We initially recommended quite strongly that we’€¦ use the 350 cut-off point that WHO has recommended – in line with many other countries in order to widen the net so as to get more women on to antiretroviral therapy because we know that antiretroviral therapy reduces transmission. But also, probably more importantly, is to get pregnant women with higher CD4 counts on to treatment for their own right – in other words, to keep maternal health in a good shape.      

KHOPOTSO: The Chief Director for the TB, STIs and HIV Directorate in the national Department of Health, Dr Nomonde Xundu explains why this was not taken into account.

Dr NOMONDE XUNDU: As far as I understand it, it’€™s not specific to pregnant women, that recommendation from the WHO. It is a recommendation across the board ‘€“ (for) adults. And there is no specific requirement in pregnancy that will indicate an earlier institution of ART. We looked at that and said, ‘€œwhy don’€™t we then, if there is no specific indication in pregnancy, look at the review of the adult guideline as a programme itself and then we will adapt the PMTCT protocol as soon as the adult HIV HAART guidelines have been reviewed to consider that’€?

KHOPOTSO: PMTCT experts presented to the Department of Health evidence supporting the inclusion of the ‘€œtail’€ element of AZT and 3TC in the revised protocol. But Xundu says the evidence was not sufficient.              

Dr NOMONDE XUNDU: Unfortunately, those were on drugs other than the ones that they, themselves, had recommended. So, it was not enough to support the specific drugs for the tail that were recommended by the experts. We couldn’€™t use that evidence specifically for the use of 3TC and AZT in the tail aspect of the protocol.

KHOPOTSO: According to Xundu, there was only one study presented to the Department which spoke to the safety and efficacy of AZT and 3TC as a ‘€œtail’€ regimen. It was conducted by Prof. James McIntyre. She was also not convinced by the WHO’€™s 2006 recommendation that a ‘€œtail’€ using AZT and 3TC follow a PMTCT course.

Dr NOMONDE XUNDU: Now the approach to policy formulation is you would need a study that is supported by evidence from elsewhere, which is what we are struggling to get. Even the study that was done at Chris Hani Baragwanath by Prof. McIntyre, the sample is small to go by’€¦ I’€™m not involved with how the WHO works in terms of coming together with these recommendations. But we looked at that and we wanted to satisfy ourselves as to the requirements for evidence for a large-scale programme. And we didn’€™t find it.

KHOPOTSO: But while there is a difference of opinion with regard to the two omissions, all stakeholders agree that the implementation of the new protocol involving dual-therapy for the prevention of mother-to-child HIV transmission cannot be held back.