FDA OKs drug to prevent HIV

July 17, 2012 at 12:00a.m.

Baltimore Sun

BALTIMORE

The federal government has for the first time approved a drug that can prevent an HIV infection, a significant development for areas and groups with high transmission rates for the virus that can develop into AIDS.

The U.S. Food and Drug Administration approved Truvada in 2004 to treat HIV, but said Monday it also can be used to increase the odds of stopping the disease from taking hold in high-risk people such as gay men, intravenous drug users and sex workers.

“In the ’80s and early ’90s, HIV was viewed as a life-threatening disease; in some parts of the world, it still is. Medical advances, along with the availability of close to 30 approved individual HIV drugs, have enabled us to treat it as a chronic disease most of the time,” said Dr. Debra Birnkrant, director of the division of antiviral products at FDA, in a statement.

“But it is still better to prevent HIV than to treat a lifelong infection of HIV,” she said.

The FDA stressed that the drug, manufactured by Gilead Sciences, should be used in combination with other prevention methods such as testing, counseling and condom use to be most effective.

Truvada is a combination of two antiretroviral medications that now is given with a third drug to treat the virus. It can have negative effects on bones and kidneys and can worsen hepatitis B infections, so it likely won’t be prescribed widely as a preventive measure.

Two large clinical trials showed the drug reduced the risk of HIV infection by 42 percent in gay and bisexual men and transgender women, and by 75 percent in heterosexual couples where one partner was positive. Some experts say some study participants did not take the drug as directed, and the prevention rates would be higher if they had.