BRIEF—FDA approves Biktarvy label update

US antivirals specialist Gilead Sciences announced that the US Food and Drug Administration (FDA) approved an updated label with additional data reinforcing the safety and efficacy profile of Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets, B/F/TAF) to treat pregnant people with HIV-1 (PWH) with suppressed viral loads.

These additional data stem from Study 5310, which evaluated the pharmacokinetics, safety and efficacy of Biktarvy in pregnant PWH who have suppressed viral loads and no known resistance to any components of Biktarvy in their second and third trimesters and through a median of 16 weeks postpartum.

This update makes Biktarvy the only second-generation integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) with in-label clinical trial data and FDA approval in virologically suppressed adults who are pregnant.

The drug recorded global sales of $2.95 billion for the first quarter of this year, up 159% in the like 2023 quarter.

In February this year, the FDA approved Biktarvy for the treatment of people with HIV who have suppressed viral loads, with a particular form of treatment resistance.