FDA Approves Expanded Indication for Biktarvy for HIV Treatment in Young Children

Gilead Sciences announced today that the US Food and Drug Administration (FDA) has approved their low-dose tablet Biktarvy (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg tablets) for pediatric HIV patients.

Biktarvy’s supplemental New Drug Application (sNDA) was approved for young children weighing 30.9-55.1 lbs. (14-25 kgs.) who are virologically suppressed or new to antiretroviral therapy (ART).

Recent developments in treatments for pregnant women living with HIV have lowered mother-to-child incidence, but 850 children still become infected with HIV each day.

Gilead Sciences voiced their hope that Biktarvy will help close the gap in HIV treatment options between children and adults. “To address this unmet need, innovations in pediatric formulations must strive towards expanding treatment options for children. The 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,” said Merdad Parsey, MD, PhD, and Chief Medical Officer of Gilead Sciences.

The FDA approved Biktarvy based upon its phase 2-3 open-label, single-arms study (NCT02881320), finding the low-dose tablets effective and fairly well-tolerated through 24 weeks. Cohort 3 of the phase 1-2 trials included 22 participants 14-25 kgs, 20 of whom (91%) remained virally suppressed at week 24. The average change in CD4 count was 0.2%.

Biktarvy is a single-tablet ART indicated as a complete HIV-1 treatment regimen for adults and now children living with HIV. Biktarvy is safe for virologically suppressed patients (HIV-1 RNA less than 50 copies per mL) with no ART history or as a replacement for current ART.

Biktarvy combines 3 medicines, bictegravir 30 mg, emtricitabine 120 mg, and tenofovir alafenamide 15 mg, and is the smallest single-tablet regimen (STR) with an integrase strand transfer inhibitor (INSTI). Biktarvy has limited drug interaction potential and a high barrier to resistance, and is taken once a day with or without food. Biktarvy comes with a warning for post treatment acute exacerbation of hepatitis B.

“Finding an efficacious treatment option is paramount, but tolerability and safety are keys to ensuring treatment success,” said Carina Rodriguez, MD, Professor of Pediatrics and Division Chief of Pediatric Infectious Diseases at the University of South Florida Morsani College of Medicine. “With this expanded approval, clinicians can add Biktarvy to their arsenal of options to help ensure these children maintain virologic suppression with a treatment option that makes sense for them.”