Nevirapine use for mothers and newborns under threat

The use of nevirapine to prevent mother-to-child transmission (MTCT) of HIV in South Africa has come under threat after the country's drug regulatory body gave pharmaceutical company Boehringer-Ingelheim 90 days to provide new data on the safety of the drug.

The Medicines Control Council (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 it 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 last week, the MCC decided to reject the Ugandan study. If Boehringer-Ingelheim fails to come up with new evidence supporting the use of the drug, nevirapine's registration for use in MTCT will be withdrawn. The drug's registration for treating adults living with HIV/AIDS will not be affected.

"It was a problem of integrity with the data presented - it did not meet our registration requirements. So we've given them [Boehringer-Ingelheim] 90 days. We will welcome the evidence they produce," MCC registrar, Precious Matsotso, told PlusNews.

The MCC's announcement has come just days after the World Health Organisation (WHO) reconfirmed its support for the drug in MTCT programmes.

"With the wealth of scientific information available, I am surprised that the MCC has taken this particular route," Boehringer-Ingelheim spokesman Kevin McKenna, told PlusNews.

"We do not agree that 'technical defects' found in the HIVNET study are any basis at all for the de-registration of a drug with such high significance in sub-Saharan Africa," he added.

The problems raised by the MCC were "not limited to technical reporting and documentation weaknesses", and the MCC believed that these also affected the scientific validity of the study, the body said in a statement.

According to the MCC, there had been under-reporting of adverse side-effects of the drug, as well as irregularities in the informed consent process.

The drug company has pledged its full cooperation with the council's decision: "Boehringer-Ingelheim will attempt to address the issues raised. We will be looking at the pilot sites in South Africa and the Western Cape's MTCT programme - there could be some new information available," McKenna said.

What this means to pregnant HIV-positive women remains unclear. But if the drug were to be de-registered, Matsoso said, the government would have to start looking at alternative treatment for the prevention of MTCT.

PlusNews factsheet on nevirapine