/ 16 December 2004

TAC warns against ‘misleading’ drug comments

The safety of single-dose nevirapine is not in question, the Treatment Action Campaign (TAC) reiterated on Wednesday, following comments by the Department of Health.

The Aids action group was concerned that ”misleading” comments by the department could result in people discontinuing their treatment, and suffering harm.

”Tens of thousands of pregnant women and infants have taken single-dose nevirapine. Not a single life-threatening adverse event has been recorded,” the TAC said in a statement.

Zachie Achmat — head of the TAC, who himself uses nevirapine and other drugs to treat his illness — pleaded with the department not to issue inaccurate statements on this matter.

The department had earlier welcomed international reports that research into the drug was flawed.

It appears that the methods of a key nevirapine research project, conducted by United States research agency the National Institute for Health, were questionable.

On Wednesday, the Department of Health said these reports support its cautious attitude to the drug — which is used in South Africa both as a way of preventing mother-to-child transmission and as a treatment for HIV/Aids.

However, the TAC pointed out that no new evidence has been offered to question the safety and efficacy of the drug. The news reports had been questioning the reliability of the research, not of the drug itself, as the Department of Health implied.

Although sparks flew on Wednesday, the differences between the department and the TAC over the controversial Aids drug do not seem to be too large.

Both entities agree that there are more effective treatments available, and recommend that public health facilities should switch to these as soon as possible.

In fact, the Medicines Control Council recommended in June that a combination of anti-retrovirals be used instead of a single dose of nevirapine (monotherapy) to reduce the chance of mother-to-child transmission of HIV.

This is because, although single-dose nevirapine does not have serious side effects, it can cause resistance to future treatments, the TAC was at pains to clarify.

The TAC urged the government to follow the example of the Western Cape and switch to combination regimens using AZT and nevirapine, but the department said it will continue providing nevirapine as monotherapy (a single drug) to mothers and babies ”until a new approach has been decided upon”. — Sapa