Long-Term Efficacy, Safety, and Durability of Cabotegravir and Rilpivirine as 2-Drug Oral Maintenance Therapy After 6 Years of Study.

Autor: Sutton KC; ViiV Healthcare, Research Triangle Park, North Carolina, USA., De Vente J; Long Beach Education and Research Consultants, Long Beach, California, USA., Leblanc R; Clinique OPUS Inc., Montreal, Quebec, Canada., Dejesus E; Orlando Immunology Center, Orlando, Florida, USA., Smith G; Maple Leaf Research, Toronto, Ontario, Canada., Mills A; Men's Health Foundation, Los Angeles, California, USA., Baril JG; Clinique Medicale Quartier Latin, Montreal, Quebec, Canada., St Clair M; ViiV Healthcare, Research Triangle Park, North Carolina, USA., Stancil BS; GlaxoSmithKline, Research Triangle Park, North Carolina, USA., Vandermeulen K; Janssen Research and Development, Beerse, Belgium., Spreen WR; ViiV Healthcare, Research Triangle Park, North Carolina, USA.
Jazyk: angličtina
Zdroj: Open forum infectious diseases [Open Forum Infect Dis] 2022 Feb 09; Vol. 9 (4), pp. ofac067. Date of Electronic Publication: 2022 Feb 09 (Print Publication: 2022).
DOI: 10.1093/ofid/ofac067
Abstrakt: Background: In the LATTE study, daily oral cabotegravir + rilpivirine demonstrated higher rates of efficacy than efavirenz + 2 nucleoside reverse-transcriptase inhibitors (NRTIs) through Week 96 in antiretroviral therapy (ART)-naive adults with human immunodeficiency virus (HIV)-1. We present the results from 6 years of continued treatment with oral cabotegravir + rilpivirine.
Methods: LATTE was a phase IIb, randomized, multicenter, partially blinded, dose-ranging study in ART-naive adults with HIV-1. After a 24-week induction phase with cabotegravir + 2 NRTIs, participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL were randomized to receive cabotegravir (10, 30, or 60 mg) + rilpivirine (25 mg) in the maintenance phase through Week 96 and switched to cabotegravir 30 mg + rilpivirine 25 mg in the open-label phase through Week 312.
Results: Of 160 participants who entered the maintenance phase, 111 completed the study at Week 312. At Week 312, 105 (66%) participants maintained HIV-1 RNA <50 copies/mL, 15 (9%) had HIV-1 RNA ≥50 copies/mL, and 40 (25%) had no virologic data. Eight participants met protocol-defined virologic failure criteria through Week 312, 2 of whom met protocol-defined virologic failure criteria after Week 144. Six participants developed treatment-emergent resistance to 1 or both agents during the study, 3 of whom developed integrase inhibitor resistance substitutions. Two participants (1%) reported drug-related serious adverse events. Few adverse events led to withdrawal during the open-label phase (n = 5, 3%).
Conclusions: Oral cabotegravir + rilpivirine demonstrated efficacy in the majority of participants and an acceptable safety profile through 6 years of treatment, demonstrating its durability as maintenance therapy for HIV-1.
(© The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)
Databáze: MEDLINE
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