Originally published by our sister publication Infectious Disease Special Edition

By IDSE News Staff

The FDA approved an updated label with additional data reinforcing the safety and efficacy profile of bictegravir-emtricitabine-tenofovir alafenamide (B/F/TAF; Biktarvy, Gilead) for people with HIV-1 (PWH) with suppressed viral loads to use during pregnancy. 

“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, an associate professor of medicine in the Perelman School of Medicine at the University of Pennsylvania, in Philadelphia. “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.”

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

This update makes B/F/TAF the only second-generation integrase strand transfer inhibitor–based single-tablet regimen with in-label clinical trial data and FDA approval in virologically suppressed adults who are pregnant. The Department of Health and Human Services perinatal guidelines recognize B/F/TAF as having sufficient data to support being recommended as an alternative complete regimen for use during pregnancy and for when people are trying to conceive. The guidelines also recommend continuing B/F/TAF for PWH already on treatment who are virologically suppressed and tolerating treatment well who may become 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 B/F/TAF in pregnant PWH who were virologically suppressed (HIV-1 RNA <50 copies/mL) and had no known resistance to the components of the drug. Participants were administered B/F/TAF once daily from the second or third trimester through postpartum.

Lower plasma exposures of B/F/TAF were observed during pregnancy compared with the postpartum period; 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/mcL, and the median change in CD4+ cell count from baseline to week 12 postpartum was 159 cells/mcL. 

All 29 newborn participants had negative/nondetectable HIV-1 polymerase chain reaction results at birth and/or at 4 to 8 weeks of age. Furthermore, the study did not identify any new safety or tolerability concerns for people who use B/F/TAF during pregnancy and postpartum, as the overall incidence and types of adverse events observed were consistent with those expected for the population studied.

The label was also updated in February to align with CDC guidance on breastfeeding, which encourages a dialogue between a patient 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, the president of the 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.”