Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen
Summary
The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC) plus lenacapavir (LEN), versus current therapy (Phase 2) and BIC/LEN fixed-dose combination (FDC) versus current therapy (Phase 3) in people living with HIV (PWH).
Timeline
- Start
- 2022-08-16
- Primary completion
- 2025-09-29
- Completion
- 2028-07
Outcome
Met primary endpoint
paper complex regimen (difference -0·3%; 95·002% CI -2·3 to 1·8), meeting the non-inferiority margin of 4%. PMID 41763229 ↗
paper Bictegravir-lenacapavir STR demonstrated non-inferior efficacy to complex regimens PMID 41763229 ↗
release “BIC/LEN efficacy was found to be statistically non-inferior to multi-tablet regimens.” gilead.com ↗
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
- Orkin C, Ruane PJ, Hedgcock M, Gaultier C, Losso MH, Trottier B, Lutz T, O'Reilly M, Bloch M, Slim J, Ramgopal M, Sokhela S, Mounzer K, Tsai HC, Santana Bagur J, Zhang X, Aizen K, Price K, Margot N, Montezuma-Rusca JM, Sklar P, Rhee M, Cahn P; ARTISTRY-1 Study Group. Switch to single-tablet bictegravir-lenacapavir from a complex HIV regimen (ARTISTRY-1): a randomised, open-label, phase 3 clinical trial. Lancet. 2026 Mar 28;407(10535):1249-1258. doi: 10.1016/S0140-6736(26)00307-7. Epub 2026 Feb 25.
- 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 | 75 mg | Oral |
| Subject | Lenacapavir | Small molecule | 25 mg | Oral |
| Subject | Lenacapavir | Small molecule | 50 mg | Oral |