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FDA Delays Decision on Gilead’s Truvada to Prevent HIV

Gilead Sciences Inc., the world’s largest maker of AIDS drugs, said U.S. regulators delayed by three months a decision on whether the company can expand use of its HIV treatment Truvada as a therapy to prevent the virus.

The Food and Drug Administration moved the target date to Sept. 14 so it can review a plan by Gilead to ensure people wouldn’t misuse the drug, the Foster City, California-based company said yesterday in an e-mail. Gilead provided the agency a modified risk strategy on June 4, Cara Miller, a spokeswoman for the company, said in the e-mail.

The $14,000-a-year treatment would be the first approved to prevent healthy people from getting the virus that causes AIDS. It’s aimed at an estimated 415,000 Americans who are among those at highest risk for contracting HIV from sex, according to the Atlanta-based Centers for Disease Control and Prevention. While some advocates have said Truvada is an important tool to reduce infection, others have argued that users may gain a false sense of security from the pill and engage in riskier behavior.

Truvada, which makes it harder for HIV to multiply, was approved in 2004 to treat people infected with the virus. The drug will eventually get the FDA’s blessing for use as a preventative, said Ira Loss, a health policy analyst at Washington Analysis LLC. The announcement yesterday “just delays the inevitable,” he said in a telephone interview.

HIV Testing

Gilead rose 1.3 percent to $49.64 at the close of New York trading yesterday. Investors don’t expect the expanded use of Truvada to add much its existing sales, Mark Schoenebaum, an analyst at ISI Group in New York, said in an e-mail. Truvada generated $2.9 billion in revenue last year, according to data compiled by Bloomberg.

Gilead told an FDA panel of advisers in May that it plans to give educational material to doctors and patients about the proper use of the drug and offer free HIV testing and condoms. Advisers said they would like mechanisms in place to stop people already infected with the virus from taking the drug for prevention. Such a use may increase the risk of developing immunity from Truvada’s benefits to treat HIV.

The FDA should require HIV testing of people taking the medicine for prevention, said Michael Weinstein, president of the Los Angeles-based AIDS Healthcare Foundation, the largest HIV/AIDS nonprofit medical provider in the U.S.

About 50,000 people are infected with HIV each year in the U.S., with gay and bisexual men accounting for 61 percent of new cases, the CDC said.

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