FDA approves updated label for Biktarvy against HIV-1


Gilead Sciences has announced FDA approval of an updated Biktarvy label, showcasing safety and efficacy data from a phase 1b trial, positioning it as a pivotal treatment option for pregnant individuals with HIV-1 and suppressed viral load.

FDA approves updated label for Biktarvy against HIV-1 | Image Credit: © muh - © muh - stock.adobe.com.

FDA approves updated label for Biktarvy against HIV-1 | Image Credit: © muh - © muh - stock.adobe.com.

The FDA has approved an updated label with data supporting the safety and efficacy of Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide; Gilead Sciences, Inc.) for treating HIV-1 with suppressed viral load in pregnant patients, according to Gilead Sciences.

Biktarvy is a treatment regimen against HIV-1 for adult and pediatric patients with a weight of 14 kg or more. The regimen may be employed in patients with no history of antiretroviral (ARV) treatment or as a replacement for any current ARV regimen in virologically suppressed patients without suspected substitutions linked to bictegravir or tenofovir resistance.

The new safety and efficacy data was collected during Study 5310, a phase 1b, open-label, single-arm, multicenter clinical trial assessing safety, efficacy, and pharmacokinetics in pregnant people with HIV-1 (PWH). Participants were second and third trimester PWH with suppressed viral loads and no known resistances to any part of Biktarvy.

Biktarvy was administered once per day from the second or third trimester through a median 16 weeks postpartum. Lower plasma Biktarvy exposures were reported during pregnancy vs postpartum. Additionally, viral suppression was reported in all participants at delivery and through 18 weeks postpartum.

At baseline, a median CD4+ cell count of 558 cells/μL was reported. Between baseline and week 12 postpartum, the CD4+ cell count had a median change of 159 cells/μL.

Negative or nondetectable HIV-1 polymerase chain reaction results were reported at birth or 4 to 8 weeks following delivery in all newborn participants. There were no new safety or tolerability issues observed following Biktarvy use during pregnancy and postpartum, and incidence and types of adverse events were consistent with those expected.

With this label, Biktarvy is the first second-generation integrase strand transfer inhibitor-based single-tablet regimen to receive FDA approval for use in pregnant virologically suppressed adults. It is recognized by the US Department of Health and Human Services as an alternative regimen for pregnant patients and those attempting to conceive.


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

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