TUESDAY, July 17 -- Truvada (emtricitabine/tenofovir disoproxil fumarate) is the first drug to be approved by the U.S. Food and Drug Administration to reduce the risk of contracting HIV among adults at higher risk of acquiring the AIDS-causing virus.
In a statement, the agency said Truvada was meant to be taken daily to reduce the chances of becoming HIV-infected among adults exposed to the virus. The agency previously approved Truvada in combination with other anti-viral drugs to treat HIV-infected people 12 years and older.
The FDA said it would strengthen the drug's label to warn that people who take the drug as a preventive should confirm they are not already HIV infected.
Truvada's safety and effectiveness were clinically evaluated among 2,499 HIV-negative gay men and transgender women "with evidence of high risk behavior for HIV infection," the agency said. Results showed the drug reduced HIV infection by 42 percent, compared with those who took a placebo.
A second study involved 4,758 heterosexual couples where one partner was infected, while the other was not. Truvada reduced the risk of transmitting infection by 75 percent, compared to those who took a placebo, the FDA said.
The most common side effects reported were diarrhea, nausea, abdominal pain, headache and weight loss. Most serious but less common adverse reactions included kidney or bone toxicity.
Drugmaker Gilead Sciences, based in Foster City, Calif., is required to conduct follow-up studies to evaluate long-term HIV resistance, and the drug's effects among pregnant women, the FDA said.