MCC not banning nevirapine

2002-08-16 15:10

Brendan Boyle

Cape Town - South Africa's Medicines Control Council (MCC) dismissed reports on Friday it might ban the anti-Aids drug nevirapine, telling legislators it was reviewing only technical details of early trials.

But officials of the state-appointed body told parliament's health committee that initial tests indicated the drug was less effective than many people believed.

"Nevirapine is not banned. Nevirapine remains registered for use for the reduction of the risk of mother-to-child transmission of HIV," said MCC drugs registrar Precious Matsoso.

She said the council was reviewing the process of the drug's March 2001 approval for use in mother-to-child prevention after its unlisted German manufacturer, Boehringer Ingelheim, reported concerns about the data management of trials in Uganda.

In March this year, Boehringer told the MCC it had withdrawn its US application for registration because of problems with reporting and documentation in the Ugandan trial.

The MCC had already received an audit of HIVNET012 carried out by Boehringer and the US National Institutes for Health. It was now awaiting the institutes' "re-monitoring report" on the trial, which should come in September, and would be used to finalise the matter.

Welcomed by Zackie Achmat

Matsoso said there had been no new evidence of unacceptable side effects or resistance since the initial trials in Uganda, and a follow-up trial in South Africa.

South Africa has more people living with HIV/Aids than any other country in the world - an estimated 4.7 million people - and activists estimate that up to 100 000 babies are born with the virus every year.

The MCC's investigation has fuelled speculation that President Thabo Mbeki's governnment, widely accused of dragging its feet in acknowledging the threat of Aids, was still fighting a Constitutional Court order to start prescribing nevirapine to expectant mothers in state hospitals.

Aids activist Zachie Achmat, who headed a campaign by the independent Treatment Action Campaign (TAC) to force the government to make nevirapine available at state expense to pregnant women, welcomed the MCC statement.

"It is the first time that the MCC has clearly stated that nevirapine is safe for mother-to-child prevention and also that it is still safe and effective," he told reporters after the meeting.

Less effective

MCC doctor Jonathan Levin told the health committee research on the drug had shown it to be slightly less effective than the more conventional triple-therapy given over a longer period before and after childbirth.

In an analysis partly challenged by Aids activists in the room, Levin said around 18% of babies born without any intervention contracted HIV within the first six weeks of life.

This figure dropped to 13% with the use of nevirapine and as low as 6% with the most aggressive use of multiple drug therapy.

Achmat, who attended the meeting, said the figure for infection without intervention was based on controlled births under close medical care and said the real figure was much higher in poor communities.

He urged the government to accept the need for drug therapy to slow the rate of birth of HIV-positive babies, and not to use debate about the relative values of different therapies to delay treatment.

Achmat, who is himself HIV-positive, is refusing to take antiretroviral drugs until the government decides to provide them at its expense to those infected. - Sapa and Reuters

- SAPA