FDA approves Truvada for preventing HIV infection

The Food and Drug Administration on Monday approved Truvada for prevention of HIV infection in HIV-negative people who are at high risk of contracting the disease, the first time a drug has been approved for reducing that risk. The approval follows on the heels of three studies published last week in the New England Journal of Medicine which showed that daily use of the drug could reduce transmission of the virus by as much as 75% in heterosexual couples. The drug has also been shown to be effective in gay couples.

Truvada, manufactured by Gilead Sciences Inc. of Foster City, Calif., is a combination of the anti-AIDS drugs emtricitabine and tenofovir, and has heretofore been used to treat HIV-positive individuals. But research showed that its use appeared to limit transmission of the virus and researchers began investigating whether HIV-negative people who took it could be protected from the virus. The answer has proved to be, uniformly, yes, although the efficacy declines when it is not taken regularly.

Side effects of the drug include diarrhea, nausea, abdominal pain, headache and weight loss. More serious side effects were uncommon.

“Today’s approval marks an important milestone in our fight against HIV,” said FDA Commissioner Dr. Margaret A. Hamburg. “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.”

The FDA is recommending that patients be tested to prove that they are HIV-negative before receiving the drug and then at three-month intervals.

Several AIDS groups had lobbied against the approval, citing the high price of the drug -- about $10,000 for a year’s supply -- and fears that it will lead to less usage of condoms, which are more effective in preventing virus transmission.

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