A newly approved drug to prevent HIV infection is creating hope for inroads in the global fight against AIDS, though questions about its cost, access and appropriate uses remain.

In July 2014, the United States Food and Drug Administration approved a drug known as Truvada — the brand name for the medication emtricitabine/tenofovir disoproxil fumarate — for daily use as a pre-exposure prophylaxis, or PrEP, “in combination with safer sex practices to reduce the risk of sexually acquired HIV infection in adults at high risk,” according to an FDA statement. While the drug is not suitable for everyone, likely candidates include members of so-called “discordant” couples in which one person is HIV-positive.

“I’m optimistic that for some people it could be very beneficial,” APHA member Ken Mayer, MD, medical director at Fenway Health in Boston and visiting professor at Harvard Medical School, told The Nation’s Health. “I don’t think of PrEP as a panacea. It’s part of a package of approaches.”

While FDA’s approval of Truvuda as a pre-exposure tool is new, the drug itself is not. In 2004, the agency approved Truvada in combination with other drugs as an antiviral to treat those already infected with HIV.

Before the drug’s latest approval, two large clinical trials looked at medication safety and effectiveness in HIV prevention. In one study, Truvada was 42 percent effective in reducing the risk of HIV infection among HIV-negative men or transgender women who have sex with men who were determined to have high risk for HIV infection. In a study of heterosexual couples, use of Truvada reduced the risk of HIV infection by 75 percent. FDA officials said the eight-year lag between Truvada approval to treat HIV-positive people and approval as a prevention tool for those who are HIV negative was due to the need for clinical studies.

The drug carries side effects, and some studies have shown the medication could be linked to kidney and bone problems. Price is also an issue, as the drug may cost as much as $10,000–$13,000 a year.


http://www.thefocusng.com/truvada-a-new-drug-to-prevent-hiv-approved/

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