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Regulator Seems to Back HIV Drug


The Food and Drug Administration on Tuesday appeared to support the use of a Gilead Sciences Inc. HIV drug in healthy people to help prevent them from contracting the virus that causes AIDS.

Gilead is seeking FDA approval to market an HIV drug called Truvada to prevent HIV infection in people who are considered at high risk of getting the virus. Truvada, one of the most widely used HIV drugs on the market, is currently approved to treat HIV in combination with other drugs.

An FDA advisory panel is expected to decide Thursday whether to recommend that the agency approve the drug for preventive use. It would be the first time the agency approved a drug to help prevent HIV.

In a background memo the FDA released Tuesday, the agency said people at risk for HIV "may be spared infection with a serious and life-threatening illness" if they use Truvada in combination with other HIV-prevention strategies.

The FDA didn't directly state whether it thought Truvada should be approved as a prevention tool. It has asked the advisory panel to vote Thursday on whether the product should be approved for use in gay or bisexual men and by heterosexual couples in cases where one partner is infected with HIV and the other isn't. Such groups are considered at high risk of becoming HIV infected.

The FDA said a "multipronged" approach to preventing new HIV infections is needed and that currently approved HIV drugs offer the potential to augment other prevention strategies such as condom use and behavioral counseling. The FDA noted that efforts to develop a vaccine "to prevent against HIV infection have thus far been unsuccessful."

The FDA said data from clinical trials evaluating Truvada as a prevention measure showed it was effective at cutting the risk of HIV infections as long as patients took the pills daily. In terms of Truvada's safety, the FDA said the drug "appeared to be well tolerated among HIV-uninfected individuals" in clinical trials looking at use of the product as a prevention measure. One concern about the drug is the potential for kidney problems. The agency said increased creatinine levels were seen in 2% of people in both the Truvada and placebo treatment groups but remained stable for the majority of patients.

In the U.S., about 1.2 million people are infected with HIV and about 50,000 new infections are diagnosed each year.

Truvada is already being used by doctors off-label to prevent HIV infection in some cases, such as when heterosexual couples with one HIV-positive partner want to try to conceive a child.

Wall Street analysts don't expected official FDA approval for a prevention tool to add much to the drug's sales. The product is estimated to cost about $14,000 a year.

Write to Jennifer Corbett Dooren at


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Information in this article was accurate in May 8, 2012. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.