HealthDay News — The FDA has approved Truvada (emtricitabine/tenofovir disoproxil fumarate, Gilead Sciences) to be used in combination with safer sex practices for pre-exposure prophylaxis (PrEP) among those at high risk for sexually-acquired HIV infection.
Truvada is the first drug to receive approval for HIV PrEP. Patients who engage in sexual activity with an HIV-infected partner and others at high risk should take the drug daily to reduce their chance of contracting the virus, the agency said in a press release.
Truvada was previously approved for use in combination with other antiviral drugs to treat patients with HIV aged 12 years and older. The drug’s label will be updated to include warnings that patients using Truvada for PrEP should confirm that they do not already have HIV prior to initiating use, the FDA added.
The expanded approval came after results from a safety and effectiveness study showed Truvada reduced HIV infection by 42% compared with placebo among 2,499 HIV-negative gay men and transgender women who had evidence of high-risk behavior for HIV infection.
In a second study involving 4,758 heterosexual couples in which one partner was infected and the other was not, Truvada reduced the risk for transmitting HIV by 75% compared with placebo.
The most common reported side effects were diarrhea, nausea, abdominal pain, headache and weight loss. More serious, but less common adverse reactions included kidney or bone toxicity.
Drugmaker Gilead Sciences is required to conduct follow-up studies to evaluate long-term HIV resistance, and the drug’s effects among pregnant women, the FDA said.