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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: 04 Sep 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

  • 27 Aug 2026 According to a Gilead Sciences media release, data from the trial were presented in The Lancet HIV.
  • 27 Aug 2026 According to a Gilead Sciences media release, company announced that the U.S. Food and Drug Administration (FDA) approved Bixlenvo (bictegravir 75 mg/lenacapavir 50 mg), the smallest once-daily single tablet regimen (STR) for the treatment of HIV in adults who are virologically suppressed.
  • 08 Jun 2026 Last checked against ClinicalTrials.gov: US National Institutes of Health record.

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