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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: 17 Jun 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

  • 08 Jun 2026 Last checked against ClinicalTrials.gov: US National Institutes of Health record.
  • 29 Apr 2026 According to a Gilead Sciences media release, the U.S. FDA has accepted its New Drug Application (NDA) submission for bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN) for the treatment of HIV in adults who are virologically suppressed based on the data from ARTISTRY-1 (NCT05502341) and ARTISTRY-2 (NCT06333808) trials.
  • 29 Apr 2026 According to a Gilead Sciences media release, based on the data from ARTISTRY-1 (NCT05502341) and ARTISTRY-2 (NCT06333808) trials, The FDA has granted priority review of the application and assigned a Prescription Drug User Fee Act (PDUFA) action date of August 27, 2026.

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