FDA Approves Label Update for Biktarvy as Treatment of HIV in Pregnant Adults


The approval is based on data from Study 5310, evaluating the pharmacokinetics, safety, and efficacy of Biktarvy (Gilead Sciences Inc) in pregnant individuals.

The FDA has approved an updated label based on additional data, further reinforcing the safety and efficacy profile of bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets (B/F/TAF, Biktarvy; Gilead Sciences Inc) to treat pregnant individuals with HIV who have suppressed viral loads. The additional data is based on findings from Study 5310, which evaluated the pharmacokinetics, safety, and efficacy of the drug in pregnant individuals with no known resistance to any components of the drug.1

The update makes B/F/TAF the only second-generation integrase strand transfer inhibitor-based single tablet approved by the FDA for pregnant adults.1

3d illustration of HIV virus. Medical concept | Image Credit: artegorov3@gmail - stock.adobe.com

Image Credit: artegorov3@gmail - stock.adobe.com

“This label update marks an important milestone for Biktarvy, reinforcing its efficacy profile for pregnant [adults with HIV], an often understudied and most vulnerable community in clinical research,” said Jared Baeten, MD, PhD, vice president of HIV Clinical Development at Gilead Sciences, in the 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."1

According to the National Library of Medicine, approximately 5000 women who are HIV positive give birth every year in the United States. Further, Black infants have a 5 times increased incidence of perinatal HIV compared to White infants. With the introduction and availability of antiretroviral therapy for pregnant women, new cases of HIV among children globally have decreased by 47% since 2010.2

Data presented at the 12th International AIDS Society Conference on HIV Sciences showed that B/F/TAF facilitated virological suppression in pregnant women with HIV. In the open label study presented at the conference, the once-daily treatment was shown to be well tolerated and showed no observable mother-to-child disease transmission, according to a Pharmacy Times article.3

In Study 5310, investigators evaluated the drug for patients in their second or third trimester through a median of 16 weeks postpartum. According to the results, investigators found that all 32 individuals who completed the study maintained viral suppression during pregnancy, at delivery, and through week 18 postpartum, and all 29 newborn individuals had negative or nondetectable HIV results at birth and/or at 4 to 8 weeks post-birth.1

There were no new safety or tolerability concerns for those who used the drug during pregnancy or postpartum and the adverse events (AEs) were consistent with those expected for the study population. The most common AEs included diarrhea, nausea, and headache.1

Recently in February 2024, the FDA also approved a new and expanded indication for B/F/TAF to treat patients with HIV who have suppressed viral loads with known or suspected M184V/I resistance, a common form of resistance.4

  1. FDA Approves Biktarvy Label Update With Data for Pregnant Adults With HIV. News release. Gilead Sciences. 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. Irshad U, Mahdy H, Tonismae T. HIV in Pregnancy. National Library of Medicine. StatPearls [Internet]. July 29, 2023. Accessed April 25, 2024. https://www.ncbi.nlm.nih.gov/books/NBK558972/
  3. Hunter E. Multiple Studies Reinforce Biktarvy as Treatment for Diverse Range of Patients With HIV. Pharmacy Times. July 24, 2023. Accessed April 25, 2024. https://www.pharmacytimes.com/view/multiple-studies-reinforce-biktarvy-as-treatment-for-diverse-range-of-patients-with-hiv
  4. Gallagher A. FDA Approves Expanded Indication for Biktarvy for HIV Treatment. Pharmacy Times. February 26, 2024. Accessed April 25, 2024. https://www.pharmacytimes.com/view/fda-approves-expanded-indication-for-bikatarvy-for-hiv-treatment
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