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FDA approves HIV-prevention drug

WASHINGTON -- The Food and Drug Administration has approved the first drug shown to reduce the risk of HIV infection, a milestone in the 30-year battle against the virus that causes AIDS.

Gilead Sciences' pill Truvada was approved Monday as a preventive measure for healthy people at high risk of acquiring HIV through sexual activity, such as those who have HIV-infected partners. The decision comes less than two weeks after the agency approved another landmark product: the first over-the-counter HIV test that can be developed at home.

The developments are seen as the biggest steps in years toward curbing the spread of HIV in the United States, which has held steady at about 50,000 new infections a year for 15 years. An estimated 1.2 million Americans have HIV, which develops into AIDS unless treated with antiviral drugs. An estimated 240,000 HIV carriers are unaware they are infected.

Public health advocates said Truvada represents a major breakthrough, both as a medical treatment and as a means of expanding other preventive measures.

Patients who get a prescription for Truvada will be expected to take part in a comprehensive HIV prevention plan, which experts say will enhance the drug's impact.

"It really marks a new era in HIV prevention because in adding Truvada as a prevention strategy, what comes with it is expanded access to HIV testing, condoms and prevention counseling and support," said James Deluca, vice president of the San Francisco AIDS Foundation.

HIV experts have raised concerns that patients might not use the drug correctly. Dr. Tom Giordano of Baylor College of Medicine said the drug must be taken every day to be effective, and would be most effective for a relatively small group of people.

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"It's been most effective in people who are at very high risk and are able to take the drug on a regular basis," said Giordano, who was on the FDA panel that recommended approval. "When you really boil it down, that's going to be a relatively focused population, but it's an important population to treat."

Gilead Sciences Inc. has marketed Truvada since 2004 for people already infected with the virus. The once-a-day pill is a combination of two older HIV drugs, Emtriva and Viread.

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