The U.S. Food and Drug Administration (FDA) has approved an updated label for Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF), reinforcing its safety and efficacy profile for treating pregnant individuals with HIV-1 (PWH) who have suppressed viral loads. This approval is based on additional data from Study 5310, a Phase 1b, open-label, single-arm, multicenter clinical trial. The study evaluated the pharmacokinetics, safety, and efficacy of Biktarvy in pregnant PWH who were virologically suppressed and had no known resistance to any components of Biktarvy during their second and third trimesters and through a median of 16 weeks postpartum.
Study 5310 demonstrated that 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, with a median change of 159 cells/μL from baseline to week 12 postpartum. All 29 newborn participants had negative/nondetectable HIV-1 PCR results at birth and/or at four to eight weeks post birth. The study did not identify any new safety or tolerability concerns for individuals using Biktarvy during pregnancy and postpartum.
This label 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 for use in virologically suppressed adults who are pregnant. The U.S. Department of Health and Human Services (DHHS) perinatal guidelines recognize Biktarvy as having sufficient data to support its recommendation as an alternative complete regimen for use in pregnancy and for individuals trying to conceive. Guidelines also recommend continuing Biktarvy for PWH already on treatment who are virologically suppressed and tolerating treatment well who may become pregnant.
Jared Baeten, MD, PhD, Vice President, HIV Clinical Development at Gilead Sciences, emphasized the importance of this label update for pregnant PWH, an often understudied and vulnerable community in clinical research. The updated label now includes additional data from Study 5310, providing assurance for individuals of childbearing potential to remain on Biktarvy if they become pregnant. The Biktarvy label was also updated in February 2024 to align with Centers for Disease Control and Prevention (CDC) guidance on breastfeeding, encouraging a dialogue between individuals and their healthcare providers regarding breastfeeding.
Yolanda M. Lawson, MD, President of the National Medical Association, highlighted the progress made in personalizing HIV treatment, including this milestone that further supports the safety profile of Biktarvy use during pregnancy. William R. Short, MD, Associate Professor of Medicine at the University of Pennsylvania, noted that these additional data can help inform treatment decisions between pregnant PWH and their providers, marking a significant step forward in addressing the unique needs of PWH who are pregnant or planning to become pregnant.
Biktarvy is a complete HIV treatment that combines three powerful medicines to form the smallest 3-drug, INSTI-based STR available, offering simple once-daily dosing with or without food, with a limited drug interaction potential and a high barrier to resistance. It combines the novel, unboosted INSTI bictegravir with the Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, F/TAF) backbone. Biktarvy is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 14 kg who have no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically-suppressed on a stable ARV regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir.
