FDA Approves Label Update for Pregnant Adults With HIV

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New data reinforced the safety and tolerability profile of this antiretroviral therapy for this patient population who are virologically suppressed.

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This expanded 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 in virologically suppressed adults who are pregnant.

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The FDA has approved an expanded label update for bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF (Biktarvy), for pregnant adults with HIV who are virologically suppressed. This expanded label offers patients an alternative regimen for use during pregnancy and for those trying to conceive.

“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,” said Jared Baeten, MD, PhD, vice president, HIV Clinical Development, Gilead Sciences.

This update makes B/F/TAF the only second-generation integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) with in-label clinical trial data and FDA approval in virologically suppressed adults who are pregnant.

What the Data Showed
According to Gilead, 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 people with HIV (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.

According to the investigators, 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.

What You Should Know

The FDA has approved an expanded label update for Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets) for pregnant adults with HIV who are virologically suppressed.

The updated label includes additional data from Study 5310, a phase 1b clinical trial evaluating the pharmacokinetics, safety, and efficacy of Biktarvy in pregnant people with HIV who were virologically suppressed.

Biktarvy, which was first approved in 2018, has a long-established record and has been expanded into different patient groups over the years.

A Therapy’s Expanded Labels, Utilization
This ART was first approved in 2018, and has a long-established record, and has been expanded into different patient groups. In 2021, the therapy was expanded into the pediatric population for young children weighing 30.9-55.1 lbs. (14-25 kgs.) who were virologically suppressed or new to ART.

And earlier this year, the therapy received an approval for an expanded label for PWH who have suppressed viral loads with known or suspected M184V/I resistance, a common form of treatment resistance.

The company remains committed to this therapy and treating and preventing HIV. “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,” Baeten added.


Reference

FDA Approves Biktarvy® Label Update With Data for Pregnant Adults With HIV. News statement. 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



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