MCC softens stance on Nevirapine

South Africa's Medicines Control Council (MCC) has given pharmaceutical company Boehringer-Ingelheim a further six months to provide new data to avoid the de-registration of Nevirapine for use in prevention of mother-to-child transmission (MTCT) of HIV. The decision came almost two months after the regulatory body threatened to withdraw the use of the antiretroviral (ARV) if its manufacturers failed to come up with new evidence supporting the use of the drug. The MCC has been conducting its own investigations into the Ugandan HIVNET 012 clinical trials of Nevirapine, after procedural flaws in the Ugandan project last year led to Boehringer-Ingelheim withdrawing an application to have the medication approved in the United States. The Uganda trials, the first to demonstrate the safety and efficacy of Nevirapine in preventing MTCT of HIV, began in 1997 and the results were published two years later. A single dose of the drug, given at the onset of labour, and a single dose to the newborn within 72 hours of birth, has been shown to reduce mother-to-child transmission by 50 percent. At a meeting in July, the MCC decided to reject the Ugandan study. But a statement released by the MCC on Friday pointed out that "additional data from South African researchers is available that may support the continued use of Nevirapine for this indication." Studies presented at the country's first national AIDS conference, held in Durban last month, also provided new evidence that the drug works. Of 600 HIV-positive women at Chris Hani-Baragwanath Hospital who received Nevirapine, only 11.9 percent transmitted HIV to their babies, while in a study of 300 HIV positive mothers at Coronation Hospital, the transmission rate was 8.9 percent. The MCC had "recognised the importance of the new information" and decided to extend the deadline. Discussions were held with Boehringer-Ingelheim and researchers in the field to determine what the MCC required. One of these requirements was additional information on the use of Nevirapine in combination with other antiretroviral drugs to reduce the risk of MTCT. "We had constructive discussions and we now understand what the MCC requires, and the way forward is clear," Boehringer-Ingelheim spokesman Kevin McKenna told PlusNews. "We're very gratified that we reached this agreement," McKenna added. This would ensure that the government's MTCT programme - currently serving an estimated 80,000 women and their babies - was not disrupted, he noted. The MCC stressed that the drug would remain registered as part of combination therapy for treating adults, and "it is not, and has never been, 'banned', and it is still approved" for the prevention of MTCT. PlusNews factsheet on Nevirapine