Gilead Sciences, Inc. announced the U.S. Food and Drug Administration (FDA) approved an updated label with additional data reinforcing the safety and efficacy profile of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg 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 updated label now includes additional data from Study 5310, a Phase 1b, open-label, single-arm, multicenter clinical trial evaluating the pharmacokinetics, safety and efficacy of Biktarvy in pregnant PWH who were virologically suppressed (HIV-1 RNA < 50 copies/mL) and had no known resistance to the components of Biktarvy. Participants were administered Biktarvy once daily from the second or third trimester through postpartum. Lower plasma exposures of Biktarvy were observed during pregnancy as compared to postpartum; all 32 participants who completed the study maintained viral suppression during pregnancy, at delivery and through week 18 postpartum.

The median CD4+ cell count at baseline was 558 cells/µL, and the median change in CD4+ cell count from baseline to week 12 postpartum was 159 cells/µL. All 29 newborn participants had negative/nondetectable HIV-1 PCR results at birth and/or at four to eight weeks post birth. Further, the study did not identify any new safety or tolerability concerns for people who use Biktarvy during pregnancy and postpartum as the overall incidence and types of adverse events observed were consistent with those expected for the population studied. This label update marks a significant milestone in Gilead?s efforts to address the individual needs of all people impacted by HIV, as these data can help to provide assurance for people of childbearing potential to remain on Biktarvy if they were to become pregnant.

The Biktarvy label was also updated in February 2024 to align with Centers for Disease Control and Prevention (CDC) guidance on breastfeeding, which encourages a dialogue between a person and their healthcare provider regarding breastfeeding.