Provinces delay on Nevirapine research
Concerns around the efficacy of the drug Nevirapine in preventing mother-to-child transmission of HIV causes delays in provinces responding to an October 1 deadline for identifying their own sites for testing. KERRY CULLINAN reports.
Few provinces appear to have responded to an October 1 deadline for identifying their own sites for testing the efficacy of the drug Nevirapine in preventing mother-to-child transmission (MTCT) of HIV.
Gauteng announced two weeks ago that it would be extending its testing of Nevirapine to a further four hospitals and four clinics in the province. This follows trials of the drug at Chris Hani-Baragwanath and Coronation Hospitals.
Meanwhile, the Western Cape has already launched a MTCT programme based on the drug AZT, but Dr Fareed Abdullah, head of the province’s health department, said the programme was “not wedded to one drug” and it researching the use of Nevirapine.
Health department spokesperson Lulu Sebake said the complete list of all provincial research sites would only be available on 20 October.
The announcement will be made after a meeting of the National Steering Committee for MTCT, which is due to be held in Cape Town on 18 October.
Results released in July from SA Intrapartum Nevirapine Trial (SAINT) conducted in Gauteng and KwaZulu-Natal showed that the drug is as effective as, and far cheaper than, AZT in preventing mother-to-child transmission.
A special meeting between Health Minister Manto Tshabalala-Msimang and provincial health MECs to discuss the SAINT results set 1 October as the deadline for provinces to identify sites where Nevirapine could be offered to HIV positive pregnant mothers.
According to Tshabalala-Msimang, the provincial sites will “focus on the operational challenges” of offering Nevirapine to pregnant women.
At the release of the SAINT results, researcher Glenda Gray indicated that while her study had shown that Nevirapine was highly effective, the major challenges for government lay in setting up the infrastructure necessary for administering the drug, particularly HIV testing and counselling for pregnant women.
For the past 18 months, the Western Cape has been piloting an MTCT programme in Khayelitsha based on the antiretroviral drug AZT. Abdullah has offered to send task teams to other provinces to help them to set up MTCT programmes.
Dr Eric Goemaere, who works for the humanitarian group Medicins Sans Frontieres (MSF), estimates that the Khayelitsha programme has saved the lives of 200 babies. MSF is supporting health workers who manage the programme in Khayelitsha.
Goemaere believes that the Khayelitsha programme, which is run entirely by local staff at the three day hospitals, shows that it is viable to offer the drugs using existing infrastructure.
“But is it important to get the staff to understand the programme otherwise they will see it as an additional task,” says Goemaere. “Staff need proper training. Once they understand that they can help to save the lives of babies, they develop a sense of pride and a sense of duty.”
Aside from being given the drugs, HIV positive women are encouraged not to breastfeed as the virus can be transmitted via breast milk. The province supplies infant formula for nine months at a cost of R832 per child.
The Western Cape has since resolved to extend the MTCT programme to five other areas next year Gugulethu, Langa, Bonteheuwel, George and Worcester — at a cost of R6-million.
At present, the Western Cape spends R539 per woman on AZT whereas the Nevirapine regimen would cost less than R30.
However, Nevirapine has not yet been approved for MTCT by the Medicines Control Council (MCC). It is only registered as an anti-retroviral drug for people with HIV/AIDS.
MCC chairperson Dr Helen Rees said the council was “currently reviewing the available data” on Nevirapine and that this would be discussed at a meeting later this month.
The Treatment Action Group (TAC) has accused the MCC of stalling the registration of Nevirapine as part of the government’s ploy to resist giving drugs to citizens.
However, Rees says much of the SAINT research “was not in a peer reviewed or written up format, so the MCC had to first obtain this from the trialists”.
The health department is concerned about drug resistance to Nevirapine, and has asked the World Health Organisation (WHO) for advice on the matter.
According to Ugandan research, some 22 percent of women developed resistance to Nevirapine after just one dose. This means if the woman were to be given AIDS treatment or to fall pregnant again, another drug would have to be used as Nevirapine would no longer work.
However, as it is unlikely that the government would be willing or able to afford to offer antiretroviral drugs to all citizens, the issue of resistance is not as pressing here as in Western countries that offer free drugs to citizens.
Rees says studies on resistance had just started in South Africa.
“To date, resistant viruses have been of concern to countries where antiretroviral drugs are widely available,” said Rees. “The significance of resistance in the Southern African environment would have to be closely studied if Nevirapine were to be registered for MTCT.”
Another headache for health officials interested in implementing a MTCT programme is the question of breastfeeding. About 10 percent of HIV positive babies got the virus via breast milk.
Despite the fact that the Western Cape is spending R1 390 per HIV positive woman, Abdullah says “basic calculations’ ‘ show that the MTCT programme is cost effective when compared to the average hospital costs for HIV positive babies, who are guaranteed free health care until the age of five.