The FDA usually follows the advice of its advisory committees, which are made up of experts from outside the agency, although it does not have to. Its decision is expected by June 15.
FDA approval would mark a watershed moment in the fight against an epidemic that still causes 50,000 new infections a year in the United States. Worldwide, according to the United Nations Program on HIV/AIDS, 2.7 million new infections occur annually.
“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.
One local HIV/AIDS researcher said the “need for prevention is incredibly, incredibly important.” Richard Elion of the Whitman-Walker clinic in the District pointed to young men he counsels who continue having anal sex without condoms despite warnings to the contrary. “They need a new care plan, a new approach that works.”
The votes mark an “important moment,” said Jennifer Kates, an HIV/AIDS policy expert at the Kaiser Family Foundation. Still, she said, “there’s no single thing that’s going to change the trajectory of the epidemic.”
Studies presented to the FDA’s Antiviral Drugs Advisory Committee show that Truvada reduced the risk of acquiring HIV by 42 to 73 percent among men who have sex with men and among HIV-negative partners of people carrying the virus.