FDA Expands the Use of HIV-1 Medication to Include Children

The US Food and Drug Administration has approved bictegravir, 30 mg/emtricitabine, 120 mg/tenofovir alafenamide, 15 mg tablets (a low-dose formulation of biktarvy) for children with HIV-1 who weigh 14 to 25 kg and are virologically suppressed or are initiating antiretroviral therapy.

The new low-dose tablet formulation is an extension of the full-form biktarvy, which is FDA approved for adults with HIV-1. Gilead, the drug manufacturer of biktarvy, says the approval “will help to close the gap between HIV treatment options available for adults and children.”

“Children living with HIV are in need of effective and accessible formulations of antiretroviral therapy,” said Merdad Parsey, MD, PhD, chief medical officer at Gilead Sciences, in a press release. “To address this unmet need, innovations in pediatric formulations must strive towards expanding treatment options for children. The [supplemental New Drug Application] approval is an important step in fulfilling Gilead’s commitment to a goal of bringing pediatric formulations of Biktarvy to children living with HIV around the world.”

—Amanda Balbi


U.S. Food and Drug Administration Approves Expanded Indication of Gilead’s Biktarvy® for Treatment of HIV-1 in Pediatric Populations. News Release. Gilead; October 18, 2021. Accessed December 2, 2021.

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