1584. CARISEL A Hybrid III Implementation Effectiveness Study of implementation of Cabotegravir plus Rilpivirine Long Acting (CAB+RPV LA) in EU Health Care Settings Key Clinical and Implementation Outcomes by Implementation Arm

作者：Stéphane De Wit, Agathe Rami, Fabrice Bonnet, Rebecca DeMoor, Gilda Bontempo, Christine M. Latham, Martin Gill, Monica Hadi, Owen Cooper, Savita Bakhshi Anand, Cassidy A. Gutner, Mounir Ait‐Khaled, Jean A van Wyk, Maggie Czarnogorski · 发表于：Open Forum Infectious Diseases · 年份：2022 · DOI：10.1093/ofid/ofac492.107 · 被引用次数：11 · 研究领域：HIV/AIDS drug development and treatment、Hepatitis C virus research、Hepatitis B Virus Studies

Abstract Background Cabotegravir + Rilpivirine Long Acting (CAB+RPV LA) every 2 months is a recommended regimen in European and US treatment guidelines for PLWH with virological suppression and no known resistance to CAB or RPV. CARISEL, an implementation study, is the first study where all participants switched from standard oral therapy to 2 monthly CAB+RPV. Key clinical and implementation secondary endpoints are reported. Methods This single arm study enrolled virologically-suppressed PLWH to receive CAB+RPV LA 2-monthly at 18 clinics in 5 EU countries, conducted from Sept 2020-Feb 2022. Clinics with no prior experience with CAB+RPV LA were preferentially selected. Sites were randomized to standard implementation (Arm-S) or enhanced implementation (Arm-E) which included additional implementation strategies. Proportion of participants with plasma HIV-1 RNA ≥50c/mL and < 50c/mL at Month 12 (FDA Snapshot algorithm, ITT-E) were reported. Adverse events, COVID-related events, clinic visit length, and safety were analyzed by implementation arm. Results 72% of clinics (13/18) had no experience with CAB+RPV LA at study start. 430 enrolled and treated participants were included with 25% female, 18% black, and a mean baseline age of 44 yrs (30% > 50 years). At Month 12, 87% of participants maintained virologic suppression in each implementation arm (Table 1) and 1 participant (1/430; 0.23%) in Arm-E experienced confirmed virologic failure. Grade 1–2 AEs were reported i...