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Gilead Sciences Inc. won U.S. approval to market its HIV treatment Truvada to prevent the virus that causes AIDS in healthy people who are at high-risk of contracting the disease.

The daily drug is the first aimed at reducing the risk of HIV in uninfected people as part of a strategy that includes other prevention methods such as safe sex practices, risk reduction counseling and regular HIV testing, the Food and Drug Administration said today in a statement. Truvada will carry a boxed warning to physicians and patients that the drug should only be used by those confirmed HIV-negative prior to prescribing the drug and at least every three months during use.

The preventative is targeted at an estimated 415,000 Americans who are among those at highest risk for contracting HIV from sex. The strategy has divided AIDS advocates as some say people wouldn’t adhere to the daily regimen or may spread resistance to the treatment. Truvada’s expanded approval and how to best use the pill will be among the topics discussed by the 20,000 activists and researchers arriving in Washington this weekend for the International AIDS Conference.

“Today’s approval marks an important milestone in our fight against HIV,” FDA Commissioner Margaret A. Hamburg said in the agency’s statement. “Every year, about 50,000 U.S. adults and adolescents are diagnosed with HIV infection, despite the availability of prevention methods and strategies to educate, test, and care for people living with the disease. New treatments as well as prevention methods are needed to fight the HIV epidemic in this country.”

Current Use

Truvada was approved in 2004 in combination with other antiretroviral agents for the treatment of HIV-infected adults and children 12 years or older. It generated $2.9 billion in revenue for Foster City, California-based Gilead last year, according to data compiled by Bloomberg. Investors don’t expect the expanded use of Truvada to add much to sales, Mark Schoenebaum, an analyst at ISI Group in New York, said in an e-mail when FDA pushed back its decision in June.

“Today’s decision is the culmination of almost 20 years of research involving investigators, academic and medical institutions, funding agencies and nearly 20,000 trial participants around the world, and Gilead is proud to have been a partner in this effort,” Norbert Bischofberger, the chief scientific officer at Gilead, said in a statement.

Risk Strategy

The FDA delayed its decision June 9 on Truvada by three months to September to review a plan by Gilead to ensure people wouldn’t misuse the drug. The drug will include a risk mitigation strategy to train prescribers to counsel people that take Truvada. Gilead will provide vouchers for free HIV testing and condoms, the company said.

The risk mitigation strategy includes information about the importance of strict adherence to the dosing regimen and emphasizes that Truvada is part of a comprehensive prevention strategy and should only be used by those who are confirmed HIV negative, Gilead said in its statement.

“Truvada alone should not be used to prevent HIV infection,” Debra Birnkrant, director of the FDA’s division of antiviral products at the Center for Drug Evaluation and Research, said today on a call with reporters.

Michael Weinstein, president of the Los Angeles-based AIDS Healthcare Foundation, the nation’s largest HIV/AIDS nonprofit medical provider, said the approval without a requirement for HIV testing “is completely reckless.”

“The FDA’s move today is negligence bordering the equivalence of malpractice which will sadly result in new infections, drug resistance and serious side effects among many, many people,” Weinstein said in a statement.

As a condition of approval, Gilead also will study the effect of the drug as a preventative on resistance to it in treating HIV, the FDA said.

(Updates with AIDS conference in third paragraph.)