18 May 2018 - - Foster City, California-based global research-based biopharmaceutical company Gilead Sciences, Inc. (NASDAQ: GILD) has received US Food and Drug Administration approval of once-daily oral Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) to reduce the risk of sexually acquired HIV-1 in at-risk adolescents, the company said.
The safety and efficacy profile of Truvada for HIV prevention in uninfected adults, a strategy called pre-exposure prophylaxis (PRep), is well established. Truvada for PrEP is now indicated in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 in at-risk adults and adolescents weighing at least 35 kg.
The addition of the adolescent indication is based on a single-arm, open-label clinical tria in HIV-negative individuals 15 to 17 years of age.
The Truvada safety profile in the study was similar to the safety profile that has been observed in adult trials of Truvada for PrEP, in which the most common side effects were headache, abdominal pain and weight loss.
Gilead Sciences discovers, develops and commercializes innovative therapeutics in areas of unmet medical need.
The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Gilead has operations in more than 40 countries worldwide.