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Phase 3 Double-blind Multicenter Randomized Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Biktarvy® (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People With HIV-1

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Trial Profile

Phase 3 Double-blind Multicenter Randomized Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Biktarvy® (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People With HIV-1

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 06 Mar 2026

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At a glance

  • Drugs Bictegravir/lenacapavir (Primary) ; Bictegravir/emtricitabine/tenofovir alafenamide; Lenacapavir
  • Indications HIV-1 infections
  • Focus Registrational; Therapeutic Use
  • Acronyms ARTISTRY-2
  • Sponsors Gilead Sciences

Most Recent Events

  • 25 Feb 2026 According to a Gilead Sciences media release, The 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.
  • 17 Feb 2026 According to a Gilead Sciences media release, data from this study will be presented at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI 2026) being held from February 22-25 in Denver, Colorado.
  • 15 Dec 2025 According to a Gilead Sciences media release, the company plans to share full Phase 3 data from the ARTISTRY-1 and ARTISTRY-2 trials next year, which will form the basis of regulatory submissions and be presented at a scientific congress.

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