Gilead Sciences has announced that the U.S. Food and Drug Administration (FDA) has approved an updated label for Biktarvy. This approval includes additional data supporting the safety and efficacy of Biktarvy for pregnant individuals living with HIV-1 (PWH) who have suppressed viral loads.

Biktarvy is a complete HIV treatment that combines three powerful medicines to form the smallest 3-drug, integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) available, offering simple once-daily dosing with or without food, with a limited drug interaction potential and a high barrier to resistance. Biktarvy combines the novel, unboosted INSTI bictegravir, with the Descovy (emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, F/TAF) backbone.

The update follows the evaluation of data from Study 5310, which focused on the pharmacokinetics, safety, and efficacy of Biktarvy in pregnant PWH with suppressed viral loads. Notably, Biktarvy is now the only second-generation integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) with FDA approval and in-label clinical trial data for virologically suppressed adults who are pregnant.

“This label update marks an important milestone for Biktarvy, reinforcing its efficacy profile for pregnant PWH, an often understudied and most vulnerable community in clinical research,” said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences. “Not only is Biktarvy an alternative regimen for use in pregnancy, but people of childbearing potential can also remain on Biktarvy if they become pregnant. We continue to keep people at the center of our tireless commitment to HIV treatment research and development so that our medicines address the needs of the broad range of communities that we serve.”

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.

“As an OB-GYN and a longtime women’s health advocate, I’m incredibly passionate about helping end health disparities among women, and especially Black women who are disproportionately impacted by HIV,” said Yolanda M. Lawson, MD, President, National Medical Association. “I’m encouraged by the tremendous progress made in personalizing HIV treatment over the years, including this milestone that further supports the safety profile of Biktarvy use during pregnancy. Together, we can help bring all PWH the care they need, including those who are or may become pregnant, so they can continue to live longer, healthier lives while on HIV treatment.”

“These additional data can help to better inform treatment decisions between pregnant PWH and their providers and mark an incredible step forward in addressing the unique needs PWH have when they are pregnant or planning to become pregnant,” said William R. Short, MD, Associate Professor of Medicine, Perelman School of Medicine at the University of Pennsylvania. “As experts in perinatal care, we will continue to recommend ways pregnant PWH can maintain undetectable viral loads so they can stay healthy and prevent transmission to their baby.”

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