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Gilead Sciences Wins FDA Approval for HIV Pill Bixlenvo

Gilead Sciences Wins FDA Approval for HIV Pill Bixlenvo

MT newswireMT newswire2026/08/27 23:36
07:36 PM EDT, 08/27/2026 (MT Newswires) -- Gilead Sciences (GILD) said on Thursday the US Food and Drug Administration approved BixlenvoTM, bictegravir/lenacapavir, the first once-daily single tablet regimen for adults with HIV who are virologically suppressed, meaning their virus is controlled. The pill combines bictegravir, an integrase inhibitor that blocks HIV replication with a high resistance barrier, and lenacapavir, a capsid inhibitor that targets the virus's protective shell with no cross-resistance to other drugs, the company said. Approval was based on Phase 3 ARTISTRY trials showing maintained viral suppression at Week 48, with common side-effects including headache, nausea and diarrhea, according to the company. Gilead said Bixlenvo is designed for patients on complex regimens who cannot take existing STRs, offering a simplified daily option.
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