Experts available for comment on controversy over a nevirapine

Apr 7 2005

The controversy over a nevirapine clinical trial conducted in the late 1990s threatens to limit the use of a drug that has saved hundreds of thousands of babies in the developing world from HIV infection, according to experts from the HIV Medicine Association (HIVMA) of the Infectious Diseases Society of America (IDSA).

A series of media reports last December raised questions about the conduct of a study in Uganda funded by the National Institutes of Health that found a single dose of nevirapine can dramatically cut the risk of mother-to-child HIV transmission. The Institute of Medicine will soon issue a report reviewing the study.

Each day, more than 1300 infants are infected with HIV through mother-to-child transmission, according to United Nations estimates. Several studies have shown that nevirapine is the simplest, most cost-effective way to slash the risk of infection nearly in half. In most countries in the developing world, nevirapine is the only clinical option available to prevent transmission of the virus from mother to child. The controversy over the Uganda study does not change that fact. It does, however, leave false impressions about the drug’s safety and efficacy.

“The bottom line is, if we lose nevirapine to prevent mother-to-child transmission, a whole lot more kids will get infected,” says W. Michael Scheld, MD, past-president of IDSA and part of an HIVMA co-sponsored program in Uganda training African doctors in AIDS care. “In a perfect world, everyone would have access to combination antiretroviral therapy. That’s the goal. In the meantime, it would be a big mistake to abandon a drug that can keep millions of children free from HIV infection.”