Gilead HIV combo pill meets goal in second phase 3 trial

 – Investigational Treatment Regimen Could Expand Options for Virologically Suppressed Adults –

– Positive Phase 3 Results from Both ARTISTRY-2 and ARTISTRY-1 Trials will Form the Basis of Regulatory Submissions –\

Gilead 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.

https://www.gilead.com/news/news-details/2025/gileads-investigational-single-tablet-regimen-of-bictegravir-and-lenacapavir-for-hiv-treatment-meets-primary-endpoint-in-phase-3-artistry-2-trial