South African Press Association (Johannesburg) - March 23, 2002

In a joint statement from Geneva, the WHO and Unaid said the findings last week by an audit by the United States' National Institutes of Health (NIH), "did not warrant any change" in the recommendations issued following a WHO technical consultation on mother-to-child HIV transmission in October 2000.

The NIH audit, which had been commissioned by US Food and Drug Administration (FDA), had found that some reporting and documentation in clinical trial HIVNET 012, had been flawed.

This has raised questions about the reporting and documentation of the HIVNet 012 study on the use of Viramune (an active nevirapine ingredient) monotherapy to reduce mother-to-child transmission of HIV in Uganda.

The HIVNet 012 study is a multi-site Ugandan study on the use of nevirapine to reduce transmission of the disease from a pregnant HIV-positive mother to an unborn baby.

This study was critical to South Africa's Medicines Control Council (MCC) approving the drug's registration in the country.

The MCC -- a South African equivalent of the FDA -- has since informed Health Minister Nkosazana Zuma that it considers reviewing the registration of nevirapine.

WHO spokesman Bernard Schwartlander and Unaids' Anne Winter said on Saturday an expert group, convened by the two organisations' organs, had concluded that the efficacy of antiretrovirals, including nevirapine, in preventing mother-to-child HIV transmission had been clearly documented and that their use was thus warranted for that purpose.

"The NIH statement has emphasised that, according to available information, there has been no evidence the scientific data from the HIVNET012 study demonstrating the safety and effectiveness of nevirapine is invalid," they said.

Meanwhile the Treatment Action Campaign on Saturday disputed media reports that US pharmaceutical Boehringer Ingelheim's (BI) decision to withdraw its application for approval for the use of nevirapine in that country was prompted by the (Ugandan) findings.

TAC leader Nathan Geffen said BI had opted for a temporary withdrawal after failing to meet certain administrative requirements.

Nathan, who claimed to be in constant contact with both the BI and NIH, said the BI's withdrawal in the US was due to the FDA's stringent requirements for registering medicines and had nothing to do with the safety and efficacy of the nevirapine.

"The safety and efficacy of the drug were not questioned by the FDA. The application was withdrawn entirely for administrative reasons. This is not unusual in the difficult FDA registration process," he said.

But media reports had earlier quoted John Wecker of BI as saying the withdrawal followed the findings of the FAD audit on the Ugandan human trials.
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