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Bictegravir-Lenacapavir (Bixlenvo)
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Common TitleARTISTRY-1 Industry
Official Title An Operationally Seamless Phase 2/3 Randomized, Open-label, Multicenter, Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Stable Baseline Regimen in Virologically Suppressed People With HIV-1 on Stable Complex Treatment Regimens
Phase Phase III
ClinicalTrials.gov NCT05502341
Treatments
Bictegravir-Lenacapavir
Bictegravir-Lenacapavir
Tradename:BixlenvoClass:Single-Tablet RegimensFunding
IndustryGilead Sciences
References
- Orkin C, Ruane PJ, Hedgcock M, et al. Switch to single-tablet bictegravir-lenacapavir from a complex HIV regimen (ARTISTRY-1): a randomised, open-label, phase 3 clinical trial. Lancet. 2026;407:1249-58.
Common TitleARTISTRY-2 Industry
Official Title 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
Phase Phase III
ClinicalTrials.gov NCT06333808
Treatments
Bictegravir-Lenacapavir
Bictegravir-Lenacapavir
Tradename:BixlenvoClass:Single-Tablet RegimensFunding
IndustryGilead Sciences
References
- Meissner EG, Ramgopal M, Ruane PJ, et al. Safety and efficacy of switching to bictegravir-lenacapavir versus continuing bictegravir-emtricitabine-tenofovir alafenamide in virologically suppressed people with HIV-1 (ARTISTRY-2): a double-blind, multicentre, randomised, controlled, phase 3, non-inferiority trial. Lancet HIV. 2026;13:e538-e547.