Switch to single-tablet bictegravir–lenacapavir from a complex HIV regimen (ARTISTRY-1): a randomised, open-label, phase 3 clinical trial

作者：Chloe Orkin, Chloe Orkin, Peter J Ruane, Malcolm Hedgcock, Cyril Gaultier, Marcelo H Losso, Benoit Trottier, Thomas Lutz, Mark O'Reilly, Mark Bloch, Jihad Slim, Moti Ramgopal, Simiso Sokhela, Karam Mounzer, Hung-Chin Tsai, Jorge Santana Bagur, Xu Zhang, Keith Aizen, Kwanza Price, Nicolas Margot, Jairo M. Montezuma-Rusca, Peter Sklar, Martin Rhee, Pedro Enrique Cahn, Simiso Sokhela, Yashna Singh, Yoshiyuki Yokomaku, Takuma Shirasaka, Shin-Woo Kim, Jun Won Choi, Po-Liang Lu, Shu-Hsing Cheng, Hung-Chin Tsai, Carlos Adon Moreta, Jorge L Santana Bagur, Lizette Santiago, Eric Cua, Jade Ghosn, Valerie Pourcher, Emma Rubenstein, Christoph Boesecke, Stephan Grunwald, Christian Hoffmann, Celia Jonsson-Oldenbüttel, Thomas Lutz, Andrea Antinori, Antonella Castagna, Giovanni Di Perri, Maria Vittoria Cossu, Cristina Mussini, José Ignacio Bernardino de la Serna, Vicente Estrada, Luis Fernando Lopez Cortes, Josep Mallolas Masferrer, Santiago Moreno Guillén, Amanda Clarke, Mark Nelson, Chloe Orkin, Chloe Orkin, Frank Post, Stephen Taylor, Alexander Wong, Bertrand Lebouche, Jason Brunetta, Malcolm Hedgcock, Benoit Trottier, Jonathan Angel, Karam Mounzer, Onyema Ogbuagu, Jihad Slim, Alexandra Stang, Jeffrey L Stephens, Jeffrey Burack, Paul Benson, Mezgebe Berhe, Cynthia Brinson, Catherine M Creticos, Edwin DeJesus, Edward Gardner, Joseph C Gathe, Cyril Gaultier, Cindy Gay, Linda Gorgos, Ricky K Hsu, Dushyantha Jayaweera, Susan Little, Cheryl McDonald, Eric Meissner, Anthony Mills, Godson Oguchi, Olayemi Osiyemi, David James Prelutsky, Moti N Ramgopal, Peter J Ruane, William E Sanchez, Anita Scribner, Michael Sension, P Shalit, James L. Sims, Gary I Sinclair, Marcus Tellez, Blair Thedinger, Lok Yung, Christine Zurawski, James McMahon, Mark Bloch, Mark O'Reilly, Andrew Carr, Isabel L Cassetti, Pedro Cahn, Marcelo H Losso · 发表于：The Lancet · 年份：2026 · DOI：10.1016/s0140-6736(26)00307-7 · 被引用次数：3 · 研究领域：HIV/AIDS drug development and treatment、HIV-related health complications and treatments、Drug-Induced Adverse Reactions

BACKGROUND: Single-tablet regimens (STRs) revolutionised HIV-1 treatment, improving adherence and clinical outcomes; however, many people cannot take these due to resistance, contraindications, or drug-drug interactions, instead relying on complex multi-tablet regimens. Novel STRs are therefore needed. We aimed to evaluate the efficacy and safety of a novel STR, bictegravir-lenacapavir, in people with HIV-1. METHODS: ARTISTRY-1 was a randomised, open-label, active-controlled, non-inferiority phase 3 trial conducted at hospitals and clinics across 15 countries that enrolled people with HIV-1 with virological suppression on complex regimens. Participants were randomly assigned (using interactive technology, 2:1, stratified by geographical region) to switch to once-daily oral bictegravir-lenacapavir 75 mg/50 mg STR or continued complex regimen. The primary outcome was the proportion of participants with an HIV-1 RNA viral load of 50 copies per mL or higher at week 48 (US Food and Drug Administration Snapshot algorithm), assessed in all randomly assigned participants who received any dose of assigned treatment. This trial (active; enrolment complete) was registered with ClinicalTrials.gov (NCT05502341). FINDINGS: Between Jan 29 and Sept 26, 2024, 729 participants were screened; 557 were randomly assigned and treated (bictegravir-lenacapavir n=371; complex regimen n=186). At baseline, median age was 60 years (range 22-84), HIV treatment duration was 28 years (IQR 22-32); participa...