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Switch to single-tablet bictegravir-lenacapavir from a complex HIV regimen (ARTISTRY-1): a randomised, open-label, phase 3 clinical trial
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U.S. FDA Approves Gilead’s Bixlenvo™, A New Once-Daily Single Tablet Option For Virologically Suppressed Adults With HIV, Including Those On Complex Regimens - (08/27/26)
CROI2026: Switch to BIC + LEN in Virologically Suppressed People With HIV on Complex Regimens: Week 96 Outcomes
CROI2026: Phase 3 Efficacy and Safety of Switch From Complex Regimen to Single-Tablet BIC/LEN in ARTISTRY-1
CROI2026: Phase 3 Efficacy and Safety of Switch From B/F/TAF to Single-Tablet BIC/LEN in ARTISTRY-2
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Treatment satisfaction at baseline was similar between groups (mean HIVTSQs total score at baseline was 55 [SD 10·4] in the bictegravir-lenacapavir group and 55 [9·4] in the complex regimen group; available range 0 to 66; appendix p 20). At week 48, participants in the bictegravir-lenacapavir group reported improvement from baseline in treatment satisfaction (mean change in HIVTSQs total score, +7 [SD 10·6]), while those in the complex regimen group reported no change (0 [9·6]; appendix p 20). After switching to bictegravir-lenacapavir, mean HIVTSQc total score at week 48 was +27 (SD 9·1; available range −33 to 33).
At week 48, fasting total cholesterol, triglyceride, and LDL cholesterol concentrations, and total cholesterol:HDL cholesterol ratio improved from baseline in the bictegravir-lenacapavir versus the complex regimen group. Median changes from baseline to week 48 in the bictegravir-lenacapavir versus complex regimen groups were: total cholesterol, −15 mg/dL versus +2 mg/dL (nominal p<0·0001); LDL cholesterol, −9 mg/dL versus +2 mg/dL (nominal p<0·0001); triglycerides, −15 mg/dL versus +4 mg/dL (nominal p=0·0008); total cholesterol:HDL cholesterol ratio, −0·3 mg/dL versus 0 mg/dL (nominal p<0·0001). HDL cholesterol remained stable in both groups (appendix p 24). Reductions in total cholesterol, LDL cholesterol, and triglyceride concentrations, and total cholesterol:HDL cholesterol ratio, with bictegravir-lenacapavir compared with complex regimens were observed from the first assessment at week 12 onwards. Bodyweight remained stable in both treatment groups through 48 weeks (median change from baseline +0·6 kg [IQR −1·1 to 2·6] and 0·0 kg [−2·0 to 2·4] in the bictegravir-lenacapavir and complex regimens groups, respectively).
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
Aug 2026
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Laboratory abnormalities of grade 3 or higher occurred in 93 (24%) of 382 participants in the bictegravir-lenacapavir group and 44 (23%) of 190 in the bictegravir-emtricitabine-tenofovir alafenamide group. The most frequent grade 3 or higher laboratory abnormalities were decreased creatinine clearance (23 [6%] in the bictegravir-lenacapavir group vs 21 [11%] in the bictegravir-emtricitabine-tenofovir alafenamide group) and increased direct bilirubin concentration (36 [9%] vs seven [4%]; appendix p 16). Fasting total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, and total cholesterol to HDL cholesterol ratio remained stable at week 48 compared with baseline in both treatment groups (table 4). Bodyweight also remained stable up to and including week 48 in both treatment groups (median change −0·2 kg [IQR −2·5 to 1·8] in the bictegravir-lenacapavir group vs 0·0 kg [−2·2 to 2·3] in the bictegravir-emtricitabine-tenofovir alafenamide group).
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