Gilead’s Truvada gets expanded indication

BY David Salazar

The Food and Drug Administration has approved an expanded indication for Gilead Sciences’ Truvada. The combination of emtricitabine and tenofovir disoproxil fumarate is now approved to reduce the risk of HIV transmission in adolescents weighing at least 35 kg in combination with safer sex practices.

The expanded indication is in addition to Truvada’s previous indication as pre-exposure prophylaxis, or PrEP, in adults that was granted in 2012. Gilead said it sought expanded indication for the drug based on a study from the Centers for Disease Control and Prevention that found young adults between 13 and 24 years old comprised 21% of new infections in 2016, with young men who have sex with men making up 81% of new cases.

“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, chief medical officer at Gilead Sciences. “Gilead is committed to addressing unmet needs in HIV prevention and treatment and we look forward to continuing that work with our research and advocacy partners.”

The expanded indication was based on a clinical trial by the Adolescent Medicine Trials Network for HIV/AIDS, in which young men who have sex with men ages 15 to 17 years old received Truvada once daily for PrEP. The drug demonstrated a similar safety profile in participants as in adults in Truvada trials the company said.

The company noted that Truvada is not meant to replace such prevention tools as condoms and that patients who receive the drug should be counseled to strictly adhere to the daily dosing schedule. Additionally, patients should receive HIV screening to confirm a negative status immediately before starting treatment, and every three months while being treated with Truvada.

“We must make use of all available options when considering HIV prevention strategies, and we welcome the development that Truvada for PrEP is now available for younger people who are at risk of HIV,” said Matthew Rose, policy and advocacy manager at HIV/AIDS advocacy organization NMAC. “We will continue to build awareness and understanding of the role of Truvada for PrEP as part of a comprehensive HIV prevention plan for all who may benefit from it, particularly among communities disproportionately impacted by the disease, including young Black and Latino men in the United States.”


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