Safety and Effectiveness From the Cabotegravir and Rilpivirine Implementation Study in European Locations Study: Phase 3b Hybrid Type III Implementation Study Integrating Cabotegravir + Rilpivirine Long-Acting Into European Clinical Settings

• Published in: Journal of acquired immune deficiency syndromes (1999) Vol. 96; no. 5; pp. 472 - 480
• Main Authors: Jonsson-Oldenbüttel, Celia, Ghosn, Jade, van der Valk, Marc, Florence, Eric, Vera, Francisco, De Wit, Stéphane, Rami, Agathe, Bonnet, Fabrice, Hocqueloux, Laurent, Hove, Kai, Ait-Khaled, Mounir, DeMoor, Rebecca, Bontempo, Gilda, Latham, Christine L, Gutner, Cassidy A, Iyer, Supriya, Gill, Martin, Czarnogorski, Maggie, D'Amico, Ronald, van Wyk, Jean
• Format: Journal Article
• Language: English
• Published: United States Lippincott Williams & Wilkins Ovid Technologies 15-08-2024; JAIDS Journal of Acquired Immune Deficiency Syndromes
• Subjects: Adult; Age; Algorithms; Anti-HIV Agents - administration & dosage; Anti-HIV Agents - therapeutic use; Antiretroviral drugs; Clinical outcomes; Diketopiperazines; Drug Therapy, Combination; Effectiveness; Europe; Female; HIV; HIV Infections - drug therapy; HIV-1 - drug effects; HIV-1 - genetics; Human immunodeficiency virus; Humans; Implementation Science; Male; Middle Aged; Pyridones - therapeutic use; Ribonucleic acid; Rilpivirine - administration & dosage; Rilpivirine - therapeutic use; RNA; Safety; Sexually transmitted diseases; STD; Treatment Outcome; Viral Load - drug effects; Virology; Womens health; Europe
• ISSN: 1525-4135; 1944-7884; 1944-7884
• DOI: 10.1097/QAI.0000000000003448

Cabotegravir + rilpivirine long-acting (CAB + RPV LA) dosed every 2 months (Q2M) is a complete regimen for the maintenance of HIV-1 virologic suppression. In this study, we report month 12 clinical outcomes in patient study participants (PSPs) in the CAB and RPV Implementation Study in European Locations (CARISEL) study.
CARISEL is a phase 3b implementation-effectiveness study.
CARISEL was designed as a 2-arm, unblinded study with centers randomized to either enhanced or standard implementation arms. For PSPs, this study is single arm, unblinded, and interventional; all PSPs switched from daily oral therapy to CAB + RPV LA dosed Q2M. The primary objective was to evaluate the perceived acceptability, appropriateness, and feasibility of CAB + RPV LA implementation for staff participants (presented separately). Clinical secondary endpoints assessed through month 12 included the proportion of PSPs with plasma HIV-1 RNA ≥50 and <50 copies/mL (Snapshot algorithm), incidence of confirmed virologic failure (CVF; 2 consecutive plasma HIV-1 RNA levels ≥200 copies/mL), adherence to injection visit windows, and safety and tolerability.
Four hundred thirty PSPs were enrolled and treated; the mean age was 44 years (30% ≥50 years), 25% were women (sex at birth), and 22% were persons of color. At month 12, 87% (n = 373/430) of PSPs maintained HIV-1 RNA <50 copies/mL, with 0.7% (n = 3/430) having HIV-1 RNA ≥50 copies/mL. One PSP had CVF. The safety profile was consistent with previous findings. Overall, the results were similar between implementation arms.
CAB + RPV LA Q2M was well tolerated and highly effective in maintaining virologic suppression with a low rate of virologic failure.