FDA Approves Biktarvy for Young Children with HIV

The FDA has approved a new low-dose tablet dosage form of Gilead’s Biktarvy (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg) for pediatric patients living with HIV-1 infection.

The approval is based on data from a cohort of patients in a phase 2/3 study, which found Biktarvy low-dose tablets to be effective and generally well-tolerated through 24 weeks in virologically suppressed children living with HIV-1. Cohort 3 enrolled 22 participants weighing between 14 kg and 25 kg who continued on treatment for 48 weeks and could then continue to receive study drug through an extension phase.

Nearly 3 million children worldwide under the age of 19 are living with HIV. An estimated 120,000 children and adolescents died from AIDS-related causes in 2020. About 72% of these deaths occurred among children under 10 years old.

Carina Rodriguez, M.D.

In February 2018, the FDA approved Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets) as a once-daily single-tablet regimen for the treatment of HIV-1 infection in adults. In June 2019, the FDA approved labeling revisions to Biktarvy, expanding the patient population to include pediatric patients weighing at least 25 kg.

“Finding an efficacious treatment option is paramount, but tolerability and safety are keys to ensuring treatment success. 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,” Carina Rodriguez, M.D., professor of pediatrics and division chief of pediatric infectious diseases at the University of South Florida Morsani College of Medicine, said in a statement.