Long-Acting Injectable Cabotegravir plus Rilpivirine for HIV Maintenance Therapy: Week 48 Pooled Analysis of Phase 3 ATLAS and FLAIR Trials

Background: Long-acting (LA) injectable regimens are a potential therapeutic option in people living with HIV-1. Setting: ATLAS (NCT02951052) and FLAIR (NCT02938520) were 2 randomized, open-label, multicenter, multinational phase 3 studies. Methods: Adult participants with virologic suppression (pla...

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Detalles Bibliográficos
Autores: Rizzardini, G, Overton, ET, Orkin, C, Swindells, S, Arasteh, K, Hernández-Mora, MG, Pokrovsky, V, Girard, PM, Oka, S, Andrade-Villanueva, JF, Richmond, GJ, Baumgarten, A, Masiá, M, Latiff, G, Griffith, S, Harrington, CM, Hudson, KJ, St Clair, M, Talarico, CL, Patel, P, Cutrell, A, Van Eygen, V, D'Amico, R, Mrus, JM, Wu, S, Ford, SL, Chow, K, Roberts, J, Wills, A, Walters, N, Vanveggel, S, Van Solingen-Ristea, R, Crauwels, H, Smith, KY, Spreen, WR, Margolis, DA
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2020
País:España
Institución:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
Repositorio:r-FISABIO. Repositorio Institucional de Producción Científica
OAI Identifier:oai:fisabio.fundanetsuite.com:p18147
Acceso en línea:https://fisabio.portalinvestigacion.com/publicaciones/18147
Access Level:acceso abierto
Palabra clave:long-acting
antiretroviral therapy
injectable
cabotegravir
rilpivirine
HIV
Descripción
Sumario:Background: Long-acting (LA) injectable regimens are a potential therapeutic option in people living with HIV-1. Setting: ATLAS (NCT02951052) and FLAIR (NCT02938520) were 2 randomized, open-label, multicenter, multinational phase 3 studies. Methods: Adult participants with virologic suppression (plasma HIV-1 RNA <50 copies/mL) were randomized (1:1) to continue with their current antiretroviral regimen (CAR) or switch to the long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). In the LA arm, participants initially received oral CAB + RPV once-daily for 4 weeks to assess individual safety and tolerability, before starting monthly injectable therapy. The primary endpoint of this combined analysis was antiviral efficacy at week 48 (FDA Snapshot algorithm: noninferiority margin of 4% for HIV-1 RNA >= 50 copies/mL). Safety, tolerability, and confirmed virologic failure (2 consecutive plasma HIV-1 RNA >= 200 copies/mL) were secondary endpoints. Results: The pooled intention-to-treat exposed population included 591 participants in each arm [28% women (sex at birth), 19% aged >= 50 years]. Noninferiority criteria at week 48 were met for the primary (HIV-1 RNA >= 50 copies/mL) and key secondary (HIV-1 RNA <50 copies/mL) efficacy endpoints. Seven individuals in each arm (1.2%) developed confirmed virologic failure; 6/7 (LA) and 3/7 (CAR) had resistance-associated mutations. Most LA recipients (83%) experienced injection site reactions, which decreased in incidence over time. Injection site reactions led to the withdrawal of 6 (1%) participants. The serious adverse event rate was 4% in each arm. Conclusion: This combined analysis demonstrates monthly injections of CAB + RPV LA were noninferior to daily oral CAR for maintaining HIV-1 suppression.

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