Washington : A panel of experts has recommended that the Food and Drug Administration approve a drug to give to healthy people to protect against HIV infection.
The panel urged Thursday that the agency approve the drug Truvada for preventing HIV in men who have sex with men, HIV-negative partners of HIV-postive people and “other individuals at risk for acquiring HIV through sexual activity.”
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, the Washington Post reported.
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. For somebody living with HIV for 23 years, I’m tired of seeing the ongoing infection rate,” said Matthew V. Sharp, a patient advocate on the committee who voted for approval.
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.
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.
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.
Those prevention rates would have been higher if all of the study participants had taken the pills daily as directed, Gilead representatives told the committee.
Among participants who did take the pills daily, prevention rates were above 90 percent in three large international studies.
Andrew Cheng, Gilead senior vice president, told the committee that Truvada would be added to the “existing toolbox” of prevention methods, including education about safe sex, condom use and clean-needle programs.
Truvada has been a blockbuster for Gilead, with sales of 758 million dollars in the first quarter of 2012. The FDA approved Truvada in 2004 to treat HIV in combination with other drugs. Truvada is a combination of two drugs, Viread and Emtriva, which interfere with HIV’s ability to reproduce.