FDA panel recommends approval of drug to prevent HIV infection
The panel told the agency Thursday that it should approve the drug Truvada for HIV prevention in men who have sex with men, HIV-negative partners of people with HIV and “other individuals at risk for acquiring HIV through sexual activity.”
If the FDA does approve Truvada for HIV prevention — its decision is expected this summer — it would mark a watershed moment in the 30-year battle against an epidemic that causes 2.7 million new HIV infections each year, according to the United Nations Program on HIV/AIDS.
Truvada is already FDA-approved for the treatment of HIV infections. That means physicians are free to prescribe it “off label” for prevention of HIV; reports indicate some already do.
However, if the FDA approves Truvada for prevention, the company that makes the drug, Gilead Sciences, Inc., would be free to market the drug for that use.
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 heterosexual partners of people who are HIV positive.
Those prevention rates would have been higher if all study participants took the pills daily as directed, Gilead representatives told the committee. Blood tests found that a large proportion of participants did not take the pills regularly, despite their enrollment in studies that included frequent visits with health care providers.
Among participants who did take the pills daily, prevention rates were above 90 percent in three large international studies.
A Gilead study of women in Kenya, South Africa and Tanzania was stopped early for “futility,” as the drug was not preventing new infections. The researchers concluded many women in the study were not taking the pills.
Approval of Truvada for HIV prevention would be an “important moment” in the 30-year-old epidemic, said Jennifer Kates, an HIV/AIDS policy expert at the Kaiser Family Foundation. Still, she added, “there’s no single thing that’s going to change the trajectory of the epidemic. It’s multiple things together. [Truvada] will have to be used as indicated and adhered to.”
Mitchell Warren, executive director of AVAC: Global Advocacy for HIV Prevention, told the committee: “No one thinks [Truvada] is a magic pill. It will help some people, some of the time. We still need more options.”
One local HIV/AIDS researcher, Richard Elion of the Whitman-Walker clinic in the District, agreed. “The need for prevention is incredibly, incredibly important,” he said. He pointed to young men he sees at the clinic who continue having anal sex without condoms despite counseling to the contrary. “They need a new care plan, a new approach that works.”