FDA Approves Gilead’s Biktarvy for Treating HIV-1 in Children

Gilead Sciences has won expanded FDA approval of Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) for treating HIV-1 infection in children who weigh at least 30.9 lbs. but no more than 55.1 lbs.

The new indication was supported by data from a phase 2/3 study, which showed the drug’s low-dose tablets were effective and generally well-tolerated in virologically suppressed children through 24 weeks of treatment.

Biktarvy, which was first approved for treating HIV-1 in adults in February 2018, carries a Boxed Warning that the drug may cause acute exacerbation of hepatitis B in patients who also suffer from that infection.