FDA Approves Biktarvy for Pediatric Patients With HIV

The FDA has approved a new low-dose tablet of bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg (Biktarvy; Gilead Sciences, Inc) for pediatric patients weighing between 30.8 lbs and 55.1 lbs who are virologically suppressed or new to antiretroviral therapy, according to a Gilead press release.

“Children living with HIV are in need of effective and accessible formulations of antiretroviral therapy,” Merdad Parsey, MD, PhD, chief medical officer at Gilead Sciences, said in the release. “To address this unmet need, innovations in pediatric formulations must strive towards expanding treatment options for children. The [supplement New Drug Application (sNDA)] 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.”

The low-dose tablets were effective and well-tolerated through 24 weeks. There were 22 patients who continued treatment for 48 weeks and through the extension phase.

After switching to Biktarvy, 91% of patients remained virologically suppressed at week 24.

Common adverse events (AEs) are diarrhea, nausea, and headache, with no new AEs observed.

Biktarvy is a complete regiment for the treatment of HIV-1 infection in adult and pediatric individuals. The approval was based on data from cohort 3 of a phase 2/3 open-label, single-arm study.

The approval of the sNDA expands the indication for Biktarvy to include younger patients with HIV-1 infection.

Reference

US Food and Drug Administration Approves Expanded Indication of Gilead’s Biktarvy for Treatment of HIV-1 in Pediatric Populations. Gilead. News release. October 18, 2021. Accessed on October 21, 2021. https://www.gilead.com/news-and-press/press-room/press-releases/2021/10/us-food-and-drug-administration-approves-expanded-indication-of-gileads-biktarvy-for-treatment-of-hiv1-in-pediatric-populations