Press release
Gilead’s Investigational Single-Tablet Regimen of Bictegravir and Lenacapavir for HIV Treatment Meets Primary Endpoint in Phase 3 ARTISTRY-2 Trial
– Investigational Treatment Regimen Could Expand Options for Virologically Suppressed Adults – – Positive Phase 3 Results from Both ARTISTRY-2 and ARTISTRY-1
About this update from Gilead Sciences, Inc.
[{"type":"text","content":"\n– Investigational Treatment Regimen Could Expand Options for Virologically Suppressed Adults –\n\n– Positive Phase 3 Results from Both ARTISTRY-2 and ARTISTRY-1 Trials will Form the Basis of Regulatory Submissions –\n\n FOSTER CITY, Calif.--(BUSINESS WIRE)--\nGilead Sciences, Inc. (Nasdaq: GILD) today announced positive topline results from the Phase 3 ARTISTRY-2 trial. The double-blind trial evaluated the treatment responses of adults with HIV who are virologically suppressed switching from BIKTARVY® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) to a fixed-dose combination of bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN). BIC/LEN efficacy was found to be statistically non-inferior to BIKTARVY. Gilead plans to file the Phase 3 results from the ARTISTRY trials with regulatory authorities and submit the detailed findings for presentation at a future scientific congress.\n\nIn ARTISTRY-2, the once-daily single tablet regimen of BIC/LEN met the primary success criterion for non-inferiority to BIKTARVY. 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. The novel combination of BIC/LEN was generally well tolerated, with no significant or new safety concerns identified during the trial.\n\nThe investigational regimen combines bictegravir, a global guidelines-recommended integrase strand transfer inhibitor with a high barrier to resistance, and lenacapavir, a first-in-class capsid inhibitor with no overlapping resistance to other existing drug classes. A single-tablet regimen combining bictegravir and lenacapavir would potentially further transform the treatment landscape, expanding options to enable people with HIV to sustain virologic suppression while taking one of the latest advances in HIV drug development.\n\n“Recent breakthroughs in medical research have led to the approval of new treatments that can help people with HIV sustain viral suppression, facilitating improved health outcomes while also helping to reduce spread of the virus,” said Eric Meissner, MD, PhD, Associate Professor, Director of HIV and Hepatitis Patient Care and Research, Medical University of South Carolina. “The findings from ARTISTRY-2 provide evidence that the investigational combination of bictegravir—a standard-of-...