WHO Backs AIDS Drug Nevirapine Despite FDA Warning

The World Health Organisation (WHO) said it will continue recommending the use of nevirapine (Viramune) in AIDS patients despite a U.S. regulatory warning, because the benefits are greater than toxicity problems.

"We are aware of the toxicity profile, but at the moment we believe the benefits outweigh any problems," Charles Gilks, director of WHO's AIDS treatment and prevention scale-up team, told Reuters on Thursday. All antiretrovirals are toxic to some extent and require monitoring, according to the WHO expert.

Germany's Boehringer Ingelheim said on Thursday that it expects no impact on its AIDS drug-donation programme for poor countries from a warning by the U.S. Food and Drug Administration (FDA) that Viramune could cause liver damage. 

The WHO, a United Nations agency, recommends the use of nevirapine in HIV-infected patients with significantly weakened immunity systems, as well as in pregnant women with HIV infection, according to Gilks.

"It has a major use in preventing mother-to-child transmission. There is no evidence that for short periods of time this toxicity occurs in pregnant women. It takes several weeks to build up," he said.

Gilks added: "It is reassuring that there is no evidence that there is any problem in children."

Dr. Daniel Berman, coordinator of MSF's Campaign for Access to Essential Medicines, said of the FDA advisory: "This is a formalisation of something known in the medical community."

"All of the drugs have side effects and should be monitored at the beginning of treatment. Other drugs have other issues, none of them is perfect."

Fernando Pascual, a pharmacist working on MSF's campaign, said that the risks associated with Viramune are well known and occur within in the first weeks of treatment.

"We use it in our projects and pay special attention to liver toxicity and are ready to switch to other treatments in case we detect toxicity," he told Reuters.

01/21/05