The U.S. Food and Drug Administration (FDA) has approved an updated label for Biktarvy, extending its safety and efficacy to pregnant individuals with HIV-1. This update stems from a clinical trial (Study 5310) that assessed Biktarvy’s effectiveness in pregnant individuals with suppressed viral loads in their second and third trimesters and postpartum.

The trial revealed that Biktarvy’s plasma levels were lower during pregnancy compared to postpartum, but all participants maintained viral suppression throughout the study period. The median CD4+ cell count also increased from baseline to postpartum.

Notably, no new safety concerns were identified for Biktarvy use during pregnancy or postpartum. The overall incidence and types of adverse events were consistent with expectations for the study population.

This update makes Biktarvy the only second-generation integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) with clinical trial data and FDA approval for virologically suppressed pregnant adults. The U.S. Department of Health and Human Services (DHHS) perinatal guidelines now recognize Biktarvy as an alternative regimen for pregnancy and for those attempting to conceive.

Importantly, individuals already on Biktarvy and achieving viral suppression can continue the treatment if they become pregnant. This update highlights Gilead Sciences’ commitment to addressing the needs of pregnant individuals with HIV and ensuring access to safe and effective treatment options.

Source link: http://www.businesswire.com/news/home/20240426676086/en/FDA-Approves-Biktarvy%C2%AE-Label-Update-With-Data-for-Pregnant-Adults-With-HIV

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Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.