FDA approves updated Biktarvy label for treating pregnant HIV-1 adults with suppressed viral loads.
Gilead Sciences announced the FDA's approval of updated Biktarvy label, providing additional data on its safety and efficacy in treating pregnant adults with HIV-1 who have suppressed viral loads. Study 5310 evaluated the drug in second and third trimesters and postpartum. This makes Biktarvy the only second-generation integrase strand transfer inhibitor-based single-tablet regimen with FDA approval in pregnant adults with HIV-1.
April 26, 2024
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