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Gilead’s Single-Tablet Regimen of Bictegravir and Lenacapavir Maintained Virological Suppression in People With HIV Who Switched Antiretroviral Therapy
– Novel Investigational Combination Pairs Bictegravir, a Global Guideline-Recommended Integrase Strand Transfer Inhibitor with a High Barrier to Resistance
About this update from Gilead Sciences, Inc.
[{"type":"text","content":"\n– Novel Investigational Combination Pairs Bictegravir, a Global Guideline-Recommended Integrase Strand Transfer Inhibitor with a High Barrier to Resistance with Lenacapavir, a First-in-Class Capsid Inhibitor –\n\n\n– Phase 3 ARTISTRY-1 and ARTISTRY-2 Results will Inform Regulatory Filings –\n\n\n FOSTER CITY, Calif.--(BUSINESS WIRE)--\nGilead Sciences, Inc. (Nasdaq: GILD) today announced the presentation of new Phase 3 ARTISTRY-1 and ARTISTRY-2 trial data at CROI 2026 showing a treatment switch to an investigational, single-tablet combination regimen of bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN) was effective in people living with HIV with virological suppression, including those switching from complex multi-tablet regimens or a global guideline-recommended single-tablet regimen. The novel combination of BIC/LEN was generally well tolerated, with no significant or new safety concerns identified.\n\n\n“The ARTISTRY trials represent the latest example of Gilead’s commitment to advancing HIV treatment through continuous scientific innovation,” said Jared Baeten, M.D., Ph.D., Senior Vice President, Clinical Development, Virology Therapeutic Area Head, Gilead Sciences. “This once-daily single-tablet regimen combines the durability of bictegravir with lenacapavir, a first‑in‑class capsid inhibitor. The novel treatment combination is designed to sustain virologic suppression for those seeking new options. We look forward to working with regulatory authorities to potentially bring this combination forward to people with HIV.”\n\n\nThe results demonstrate the potential of BIC/LEN to broaden HIV treatment options for adults with virological suppression, offering comparable efficacy to BIKTARVY® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF), as well as to treatment with complex multi-tablet regimens.\n\n\nThe new data, from the ARTISTRY-1 (NCT05502341) and ARTISTRY-2 (NCT06333808) trials, assessed the safety and efficacy of the once-daily single tablet regimen of BIC/LEN and were presented during late-breaker sessions at the 33rd Conference on Retroviruses and Opportunistic Infections in Denver, Colorado. The findings build on the positive topline results announced in November and December 2025.\n\n\nLate-breaking results from ARTISTRY-1\n\n\nResults presented at CROI 2026 demonstrate that a sin...