South African Medicines Control Council Reviewing Safety and Efficacy of Nevirapine

South Africa's Medicines Control Council last week announced that it is conducting a review of its approval of the antiretroviral drug nevirapine, which is used to prevent mother-to-child HIV transmission, due to "serious concerns" about the drug's safety and efficacy, the South Africa Sunday Times reports. Two weeks ago, members of the MCC asked representatives from Boehringer Ingelheim, the drug's manufacturer, to explain several deaths allegedly linked to the drug during a Ugandan study and why the company had decided to withdraw a U.S. application for approval to market the drug as a treatment for the prevention of mother-to-child HIV transmission (Jubasi, South Africa Sunday Times, 8/4). Boehringer pulled its FDA application in March after FDA regulators said they uncovered problems with a 1999 study performed in Uganda by Johns Hopkins University researchers. The questions related to procedure and not the validity of the study, which found that use of the drug during childbirth can reduce HIV transmission to infants (Kaiser Daily HIV/AIDS Report, 3/25). Precious Matsoso, the registrar of the council, said the MCC is reviewing Boehringer's "compliance" with the South African Medicines Control Act and will issue a final report in September. If the company is found to be in violation of the act, the MCC can ask it to withdraw the drug's registration. The MCC last week also established a board to monitor "adverse events" linked to antiretroviral therapy (South Africa Sunday Times, 8/4).

Advocates Accuse MCC of 'Losing Its Independence'
HIV/AIDS advocates said the MCC's review of nevirapine raised concerns about the board's motivation and signaled that it was "losing its independence," the South African Press Association reports. "There is overwhelming evidence that nevirapine is safe for [preventing] mother-to-child transmission. Not a single serious side effect has been reported when nevirapine has been used for this purpose," Nathan Geffen, national manager of the Treatment Action Campaign, said, adding that his group is "very concerned" that Matsoso and MCC Chair Peter Eagles are "not acting on the basis of ensuring access to safe and effective medicine, but rather with political motivation." He accused the two of trying to "scuttle" the implementation of a court order that requires the government to provide antiretroviral treatment to all HIV-positive pregnant women at public hospitals to reduce the odds of vertical transmission. Nevirapine is the most commonly used drug for this purpose, and the withdrawal of its registration could create a "nightmare" for MTCT programs in the country, SAPA reports. However, nevirapine is not the only drug that can be used to reduce mother-to-child HIV transmission, and the court order "clearly states that [the] government is not precluded from adapting its policy in a manner consistent with the Constitution if equally appropriate or better methods [of preventing vertical HIV transmission] become available," according to SAPA (SAPA, 8/4).