Gilead Sciences announced that the Food and Drug Administration (FDA) has approved Truvada (emtricitabine 200mg, tenofovir disoproxil fumarate 300mg) in combination with safer sex practices to lower the risk of sexually acquired HIV-1 in at-risk adolescents weighing ≥35kg. 

Truvada contains a combination of two HIV-1 nucleoside analog reverse transcriptase inhibitors. It was initially approved for pre-exposure prophylaxis in adults in 2012. Eligible patients must have a negative HIV test right before starting Truvada for PrEP. If symptoms consistent with acute viral infection are present and recent exposure (<1 month) are suspected, PrEP should be delayed for ≥1 month and HIV-1 status should be reconfirmed.

The use of Truvada for PrEP in the adolescent population was based on a single-arm, open-label clinical study (ATN113) among 67 HIV-1 negative young men (aged 15 to 17 years) who have sex with men (YMSM). Study patients received Truvada orally once daily for PrEP. The safety and efficacy profiles in at-risk adolescents were supported by well-controlled studies of Truvada for PrEP in adult patients. Data from other safety and pharmacokinetic studies of Emtriva (emtricitabine) and Viread (tenofovir disoproxil fumarate) in HIV-1 infected adults and children also supported Truvada for PrEP in at-risk adolescents. 

Headache, abdominal pain, and weight loss were the most common adverse effects reported; this was similar to the safety profile observed in adult trials of Truvada for PrEP. In addition, 4 patients had a decrease in bone mineral density (BMD) through Week 48. 

“By expanding the number of at-risk individuals who can consider Truvada as a prevention option, we have taken another important step toward helping to reduce HIV transmission rates and improve public health in the United States,” said Andrew Cheng, MD, PhD, Chief Medical Officer, Gilead Sciences. 

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Truvada is also indicated for the treatment of HIV-1 infection, in combination with other antiretroviral agents, in adults and pediatric patients weighing ≥17kg

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