South African Medicines Control Council Has No Immediate Plans to Ban Nevirapine
The South African Medicines Control Council said Friday that nevirapine has not been banned in the country, although MCC officials added that initial tests indicate that the drug is "less effective than many people believe," Reuters reports. MCC registrar Precious Matsoso said that the council is currently reviewing the process by which nevirapine was approved for use in preventing vertical HIV transmission (Boyle, Reuters, 8/16). The MCC announced earlier this month that it would conduct a clinical review of nevirapine over concerns about the drug's safety and effectiveness in reducing the risk of mother-to-child HIV transmission. Boehringer-Ingelheim, the drug's manufacturer, in March pulled its U.S. FDA application for the new indication for nevirapine after FDA regulators said they had uncovered problems with a 1999 study performed in Uganda by Johns Hopkins University researchers. The questions related to the procedure and not the validity of the study, which found that use of the drug during childbirth can reduce the rate of HIV transmission to infants. 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 for that indication (Kaiser Daily HIV/AIDS Report, 8/6).
Matsoso said that there has been no new evidence of adverse events or drug resistance related to nevirapine after the initial trials in Uganda and a follow-up trial conducted in South Africa. Matsoso "dismissed reports" that the MCC might ban the drug, stating, "Nevirapine is not banned ... nevirapine remains registered for use for the reduction of the risk of mother-to-child transmission of HIV" (Reuters, 8/16). But Matsoso said she could not predict whether the council would eventually vote to withdraw the drug's approval, noting that the review is ongoing (South Africa Press Association/AllAfrica.com, 8/16). In addition, MCC official Jonathan Levin said that research on nevirapine has shown that it is "slightly less effective" at preventing vertical transmission than a triple-drug antiretroviral regimen. Levin said that vertical transmission occurs in approximately 18% of births to HIV-positive mothers when no drug therapy is given, compared to 13% of births when nevirapine is administered and 6% of births when triple-drug therapy is given. AIDS activists, however, disputed this claim. Zackie Achmat, chair of the Treatment Action Campaign, said that the MCC statistics only account for births occurring "under close medical care" and that vertical transmission occurs in more than 18% of births to HIV-positive women in poorer communities (Reuters, 8/16).
Government Has No Plans to Obtain Free Nevirapine
The South African government has told provinces to make nevirapine available through the public health system, but it has not accepted Boehringer-Ingelheim's offer to provide the drug for free "and has no plans to do so in the near future," Cape Argus/AllAfrica.com reports. The national government has directed provincial health ministers to draw up plans to make nevirapine available, although the plans might not be implemented until the end of the year. South African Health Minister Manto Tshabalala-Msimang said that there has not been a "rapid escalation in demand and uptake" of nevirapine since the government was ordered to make the drug available through its public health system. Because the demand has remained low, the government can currently afford to provide the drug throughout the country, but Tshabalala-Msimang said that cost "may be an issue" as the plan for national access to nevirapine unfolds (Caelers, Cape Argus/AllAfrica.com, 8/16).