29 April 2024: Biktarvy gains expanded label use for HIV+ pregnant patients.

Gilead’s HIV therapy, Biktarvy, received Food & Drug Administration(FDA) approval for the updated label for pregnant women with HIV-1 (PWH) with suppressed viral loads. This would be the second label expansion after the March 2024 approval for patients suffering from M184V/I resistance.

The expanded label was based on Study 5310 which evaluated pharmacokinetics and safety of bictegravir-emtricitabine-tenofovir alafenamide (Biktarvy) in pregnant patients with suppressed loads and no known resistance, from second trimester through a median of 16 weeks post-partum.

All participating patients maintained viral suppression through pregnancy, delivery, and week 18 post-partum. The newborn participants had negative HIV-1 PCR results at birth to 8 weeks of age.

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Yolanda M. Lawson, President of the National Medical Association stated: “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.”

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Source: Gilead Sciences &?IDSE