FOSTER CITY, Calif., November 13, 2025 — Gilead Sciences, Inc. (NASDAQ: GILD) today announced positive topline results from the Phase 3 ARTISTRY-1 trial. The open-label trial evaluated the treatment responses of adults with HIV who are virologically suppressed switching from a multi-tablet regimen to an investigational single-tablet regimen of bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN). BIC/LEN efficacy was found to be statistically non-inferior to multi-tablet regimens. Gilead plans to file the Phase 3 data from the ARTISTRY trials with regulatory authorities and submit the detailed findings for presentation at a future scientific congress.
In ARTISTRY-1, the once-daily single-tablet regimen of BIC/LEN met the primary success criterion for non-inferiority to baseline multi-tablet antiretroviral therapy regimens. The primary efficacy endpoint was the percentage of participants with HIV-1 RNA levels ≥50 copies/mL at Week 48, defined by the FDA snapshot algorithm. In the trial, BIC/LEN was generally well tolerated, with no significant or new safety concerns identified.
Read the full company press release here.
Source : Gilead Sciences, Inc.
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