FDA Approves Label Update for Gilead’s Biktarvy to Include Pregnant Adults With HIV

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Gilead Sciences announced that the FDA has granted a label update to Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) to include use in pregnant individuals with HIV-1 who have suppressed viral loads. The FDA based the regulatory action on results from Study 5310, a Phase 1b, open-label, single-arm, multicenter clinical trial evaluating the pharmacokinetics, safety, and efficacy of Biktarvy during pregnancy and postpartum periods. Reportedly, the treatment is the only integrase strand transfer inhibitor (INSTI)-based regimen with in-label clinical trial data approved by the FDA for virologically suppressed pregnant individuals.

Thirty-two participants with HIV completed a study in which they were treated with Biktarvy once daily from the second or third trimester through postpartum. The results showed that all of these participants maintained viral suppression during pregnancy, at delivery, and through week 18 postpartum. Additionally, all 29 newborns had negative/nondetectable HIV-1 PCR results at birth and/or at four to eight weeks post birth, with no new safety or tolerability concerns reported.¹

“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, VP, HIV clinical development, Gilead Sciences, in a press release. “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.”

According to the Centers for Disease Control and Prevention (CDC), an estimated 1.2 million people were living with HIV at the end of 2021, with 36,136 new cases reported. Despite the new cases, the annual diagnosis rate decreased by 7% between 2017 and 2021. African Americans accounted for 40% of all new cases in the United States, Hispanic and Latinos were at 29%, and Caucasians were at 25%, with prevalence of the virus most common in the Northeast.²

“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, in the press release. “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.”

The World Health Organization (WHO) reports that approximately 39 million people were living with HIV globally in 2022. By the end of the year, around 630,000 people died as a result of HIV-related causes; however, global rates have decreased 51% since 2010. HIV has claimed over 40 million lives around the world.³

“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, in the press release. “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.”

References

1. FDA Approves Biktarvy® Label Update With Data for Pregnant Adults With HIV. Gilead. April 26, 2024. Accessed April 26, 2024. https://www.gilead.com/news-and-press/press-room/press-releases/2024/4/fda-approves-biktarvy-label-update-with-data-for-pregnant-adults-with-hiv

2. HIV. CDC. Accessed April 26, 2024. https://www.cdc.gov/hiv/basics/statistics.html

3. HIV data and statistics. WHO. Accessed April 26, 2024. https://www.who.int/teams/global-hiv-hepatitis-and-stis-programmes/hiv/strategic-information/hiv-data-and-statistics