MTCT pilot programme under threat

The use of nevirapine to prevent mother-to-child transmission (MTCT) of HIV in South Africa has come under threat after reports last week of irregularities during trials of the drug in Uganda.

The antiretroviral drug could be de-registered by the country's regulatory body, the Medicines Control Council (MCC), after procedural flaws in the Ugandan trial led to its manufacturer, Boehringer-Ingelheim, withdrawing an application to have it approved in the United States.

The MCC announced on Friday that it was conducting a review of nevirapine specifically for its use in the reduction of MTCT of HIV.

"There is no reason why they [the MCC] should [withdraw registration for nevirapine] as one would think that their independence would be compromised," Treatment Action Campaign (TAC) spokesman Nathan Geffen told PlusNews on Monday.

The implications for the government's MTCT pilot projects were raised on Friday in the Pretoria High Court, where the state was seeking to overturn a court order which required them to make nevirapine available to all HIV-positive pregnant women.

The government's advocate, Marumo Moerane, told the court the state would shut down the its pilot sites if nevirapine's registration was withdrawn or if new investigations revealed fraudulent reporting and documentation in the Ugandan study.

Today, however, the court ruled that although a Constitutional Court appeal is pending, the government must obey the order to supply the drug.

In a statement released on Friday, the World Health Organisation (WHO) and UNAIDS said last week's findings by the United States' National Institute 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.

Following the consultation, it was concluded that the safety and effectiveness of nevirapine in preventing mother-to-child HIV transmission had been clearly documented and that the use of the drug was "thus warranted for preventing mother-to-child HIV transmission," the statement added.

"If the WHO are saying the drug is safe and can still be used, then we will stand by that," Geffen said. TAC had found "no evidence whatsoever" to suggest that the drug was unsafe, he added.

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

The HIVNet 012 study is a multi-site Ugandan study on the use of nevirapine to reduce MTCT and was critical to South Africa's MCC approving the drug's registration in the country.