Cabotegravir plus Rilpivirine for Persons with HIV and Adherence Challenges

作者：Aadia I. Rana, Lu Zheng, Jose R. Castillo-Mancilla, Yajing Bao, Sara B. Sieczkarski, Kristina M. Brooks, JE Lake, Carl Fichtenbaum, S. S. Heath, Pablo F. Belaunzaran-Zamudio, Karin Klingman, Lawrence K. Fox, Tia Morton, Michael J. Stirratt, Jonathan Z. Li, E P Acosta, Charles S. Venuto, Omar Galáarraga, Steven Shoptaw, David Wohl, Madison Green, Ceora Beijer, Kathie G. Ferbas, Cheryl Jennings, Katherine Shin, Romina Collahua, Michael Dorosh, Paul Wannamaker, Ronald D’Amico, Kimberly Smith, William Spreen, Kati Vandermeulen, Rodica Van Solingen-Ristea, Chanelle Wimbish, Karen T. Tashima, Raphael J. Landovitz · 发表于：New England Journal of Medicine · 年份：2026 · DOI：10.1056/nejmoa2508228 · 被引用次数：19 · 研究领域：HIV/AIDS drug development and treatment、HIV/AIDS Research and Interventions、HIV Research and Treatment

BACKGROUND: Randomized trials of long-acting injectable antiretroviral therapy (ART) in persons with human immunodeficiency virus (HIV) who face challenges with adherence to oral medication are lacking. METHODS: We conducted an open-label, randomized trial involving persons with HIV who had inadequate adherence to ART (a persistent HIV-1 RNA level of >200 copies per milliliter or loss to follow-up). Participants received up to 24 weeks of adherence support, conditional economic incentives, and standard care with oral ART (step 1). Participants who had an HIV-1 RNA level of 200 copies per milliliter or lower in step 1 were randomly assigned in a 1:1 ratio to either continue standard care or switch to monthly injections of long-acting cabotegravir plus rilpivirine with or without oral lead-in therapy (step 2). The primary outcome was regimen failure, defined as confirmed virologic failure (two consecutive HIV-1 RNA measurements of >200 copies per milliliter) or treatment discontinuation during step 2. RESULTS: In step 1 of the trial, we enrolled 453 participants; the median age was 40 years, 63% were Black, and 29% had been assigned female sex at birth. In step 2, a total of 306 participants underwent randomization; 152 were assigned to receive cabotegravir-rilpivirine and 154 to receive standard care. Step 2 randomization was stopped early on the basis of the superiority of cabotegravir-rilpivirine to standard care in secondary outcomes at a prespecified analysis performed aft...