Approval of HIV-Prevention Drug Recommended


Yesterday a panel of experts recommended that the Food and Drug Administration approve a drug to give to healthy people to protect against HIV infection. Truvada is designed to prevent HIV in men who have sex with men, HIV-negative partners of HIV-positive people and "other individuals at risk for acquiring HIV through sexual activity."


The Washington Post reports that the testimony revealed tensions between those who believe FDA approval would mark a watershed moment in the fight against the epidemic and those with safety concerns about the drug and its possible negative impact on condom use.

“I really think this provides for an amazing opportunity to turn the tide of the epidemic,” said Matthew V. Sharp, a patient advocate on the committee who voted for approval. “For somebody living with HIV for 23 years, I’m tired of seeing the ongoing infection rate.”

The committee wrestled all day with safety concerns, including fears that men taking the drug would see it as an excuse to stop using condoms, and worries that healthy people would not take the drug daily. The series of three votes, one for each category of user, was not unanimous, with dissents and abstentions ranging from two of the 22 committee members on the first vote to 10 on the third.

“I have significant safety concerns,” said committee member Lauren V. Wood of the National Cancer Institute, who voted against approval each time. Wood said Truvada can cause kidney problems. She also objected to the lack of U.S. women in the pivotal studies, which were largely conducted in Africa. “I want to make the committee aware that there is not a single African American female in any one of the studies put forward for approval. I think that’s unacceptable,” she said.

Truvada is already FDA-approved for the treatment of HIV. That means physicians are free to prescribe it “off label” for prevention; reports indicate that some already do. But a new FDA approval will free the company that makes the drug, Gilead Sciences, to market Truvada for prevention, too.

The FDA usually follows the advice of its advisory committees, which are made up of experts from outside the agency. A decision on approval is expected by June 15.


Read more at the Washington Post.