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FDA Approves 1st Pill to Help Prevent HIV Infection
Once-daily Truvada intended for at-risk individuals, and agency says side effects must be monitored
By Randy Dotinga
HealthDay Reporter
MONDAY, July 16 (HealthDay News) -- For the first time, the U.S. Food and Drug Administration has approved the use of a pill to help prevent HIV infection in uninfected, high-risk people.
"[The] FDA is approving Truvada, taken daily for pre-exposure prophylaxis, or PReP, in combination with safer sex practices, to reduce the risk of sexually acquired HIV infection in at-risk adults," Dr. Debra Birnkrant, director of the division of antiviral products at the FDA's Center for Drug Evaluation and Research, said during a Monday news conference. "This is the first drug approved for PReP in combination with safer sex practices to reduce the risk of sexually acquired HIV infection."
The safer sex practices recommended by the FDA include HIV testing every three months, strict adherence to recommended dosing and counseling.
"Truvada alone should not be used to prevent HIV infection," Birnkrant stressed, adding that studies have shown that condom use increased in people using Truvada while the rate of other sexually transmitted diseases (STDs) either remained stable or also decreased.
Birnkrant added that she anticipated that Truvada, along with accompanying safer sex messages, will help achieve the federal government's National HIV/AIDS Strategy goal of reducing the number of new infections in the United States by 25 percent by 2015.
The decision comes two months to the day after an FDA advisory panel voted for approval of Truvada for use by healthy, at-risk individuals, including gay and bisexual men and heterosexual couples with one HIV-infected person.
It also comes before the biennial International AIDS Conference, slated to start Sunday in Washington, D.C.
Truvada has been available since 2004 to treat people already infected with HIV.
However, some experts believe that there are potential drawbacks to using the medication as a way to try to prevent HIV infection. Truvada -- which combines two HIV-fighting drugs, tenofovir (Viread) and emtricitabine (Emtriva) -- is very expensive and may cause side effects. And although doctors can already prescribe it to people trying to avoid HIV infection, some critics contend that it's too early to officially allow it to be promoted for that use.
