近日，英国伦敦玛丽女王大学Chloe Orkin团队研究了从复杂的HIV治疗方案切换到比克替拉韦-来那卡韦单一片剂方案对HIV患者的疗效与安全性。相关论文发表在2026年2月25日出版的《柳叶刀》杂志上。

单一片剂方案彻底改变了HIV-1的治疗格局，改善了依从性与临床结局。然而，由于耐药、禁忌症或药物相互作用，许多患者无法使用这些方案，不得不依赖复杂的多片剂方案。因此，新型单一片剂方案的需求日益迫切。该研究旨在评估新型单一片剂方案比克替拉韦-来那卡韦在HIV-1感染者中的疗效与安全性。

ARTISTRY-1是一项在15个国家医院与诊所开展的随机、开放标签、活性药物对照、非劣效性3期试验，招募接受复杂方案治疗且实现病毒学抑制的HIV-1感染者。采用交互式技术按2:1的比例（根据地理区域分层）将受试者随机分配，转换为每日一次口服比克替拉韦-来那卡韦75 mg/50 mg单一片剂方案，或继续原有复杂方案治疗。主要终点是第48周时HIV-1 RNA病毒载量≥50拷贝/mL的受试者比例（采用美国食品药品监督管理局快照算法），分析纳入所有接受随机分配且服用至少一次研究药物的受试者。该试验（处于活跃状态，入组已完成）已在ClinicalTrials.gov注册（NCT05502341）。

2024年1月29日至9月26日期间，共筛选729名受试者；557名受试者被随机分配并接受治疗（比克替拉韦-来那卡韦组371例，复杂方案组186例）。基线时，中位年龄60岁（范围22-84岁），HIV治疗时长28年（IQR 22-32）；受试者每日服用抗逆转录病毒药物中位数为3片（范围2-11片）。第48周时，比克替拉韦-来那卡韦组有3例（1%）受试者、复杂方案组有2例（1%）受试者出现HIV-1 RNA病毒载量≥50拷贝/mL（差值−0.3%；95.002% CI −2.3至1.8），达到预设4%的非劣效性界值。未出现耐药情况。不良事件发生率组间相似。因不良事件停药者，比克替拉韦-来那卡韦组6例（2%），复杂方案组1例（1%）。比克替拉韦-来那卡韦组发生5例死亡，均判定与研究药物无关。受试者转换至比克替拉韦-来那卡韦后治疗满意度有所提升。

研究结果表明，比克替拉韦-来那卡韦单一片剂方案在疗效上非劣效于复杂方案，且安全性特征相似、治疗满意度更高。比克替拉韦-来那卡韦为正在接受复杂方案治疗的HIV-1感染者优化治疗提供了新选择。

附：英文原文

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

Author: Chloe Orkin, Peter J Ruane, Malcolm Hedgcock, Cyril Gaultier, Marcelo H Losso, Benoit Trottier, Thomas Lutz, Mark OReilly, 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 Cahn, Simiso Sokhela, Yashna Singh, Yoshiyuki Yokomaku, Takuma Shirasaka, Shin-Woo Kim, Jun Yong 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, 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 J Prelutsky, Moti N Ramgopal, Peter J Ruane, William Sanchez, Anita Scribner, Michael Sension, Peter Shalit, James Sims, Gary I Sinclair, Marcus Tellez, Blair Thedinger, Lok Yung, Christine Zurawski, James McMahon, Mark Bloch, Mark OReilly, Andrew Carr, Isabel L Cassetti, Pedro Cahn, Marcelo H Losso

Issue&Volume: 2026-02-25

Abstract:

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); participants were taking a median of three antiretroviral pills per day (range 2–11). At week 48, an HIV-1 RNA viral load of 50 copies per mL or higher was observed in three (1%) participants receiving bictegravir–lenacapavir and two (1%) receiving a complex regimen (difference 0·3%; 95·002% CI 2·3 to 1·8), meeting the non-inferiority margin of 4%. No resistance emerged. Adverse event rates were similar between groups. Six (2%) participants discontinued bictegravir–lenacapavir and one (1%) discontinued their complex regimen due to adverse events. There were five deaths in the bictegravir–lenacapavir group, none of which were deemed related to study drug. Participants reported increased treatment satisfaction after switching to bictegravir–lenacapavir.

Interpretation

Bictegravir–lenacapavir STR demonstrated non-inferior efficacy to complex regimens, with a similar safety profile and increased treatment satisfaction. Bictegravir–lenacapavir offers new opportunities for HIV-1 treatment optimisation for people taking complex regimens.

DOI: 10.1016/S0140-6736(26)00307-7

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)00307-7/abstract