Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
Summary
The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC)/lenacapavir (LEN), fixed-dose combination (FDC) versus current therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC in people living with HIV-1 (PWH). The primary objective of this study is to learn how effective it is to switch to BIC/LEN FDC tablets versus continuing on B/F/TAF FDC tablets in virologically suppressed PWH.
Timeline
- Start
- 2024-03-25
- Primary completion
- 2025-10-27
- Completion
- 2029-12
Outcome
Met primary endpoint
paper percentage difference 0·3% [95·002% CI -1·9 to 2·4]), meeting the non-inferiority criteria. PMID 42105781 ↗
release “BIC/LEN met its primary endpoints demonstrating non-inferiority to baseline multi-tablet antiviral regimens (ARTISTRY-1) and Biktarvy (ARTISTRY-2).” gilead.com ↗
Publications
- Meissner EG, Ramgopal M, Ruane PJ, Sanchez W, Crofoot G, Routy JP, Brinson C, DeJesus E, Martorell CT, Tellez M, Yokomaku Y, O'Reilly M, Lupo S, Schellberg S, Lezama-Mora JI, Chin B, Aizen K, D'Antoni ML, Huang H, Mponponsuo K, Montezuma-Rusca JM, Sklar P, Rhee M, Hung CC; ARTISTRY-2 Study Group. 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 May 6:S2352-3018(26)00078-0. doi: 10.1016/S2352-3018(26)00078-0. Online ahead of print.
- Arora P, Hindman JT, West S, Ling J, Palaparthy R, Marathe DD. The effect of antacid and mineral supplements on bictegravir pharmacokinetics: results from a Phase 1, open-label, drug-drug interaction study. Antimicrob Agents Chemother. 2026 Jan 7;70(1):e0078125. doi: 10.1128/aac.00781-25. Epub 2025 Nov 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bictegravir | Small molecule | 50 mg | Oral |
| Subject | Bictegravir | Small molecule | 75 mg | Oral |
| Subject | Lenacapavir | Small molecule | 50 mg | Oral |
| Subject | emtricitabine | Other / unclassified | 200 mg | Oral |
| Subject | tenofovir alafenamide | Small molecule | 25 mg | Oral |