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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
immunology and microbiology
Efficacy and safety of a two-drug direct-acting antiviral agent regimen ruzasvir 180 mg and uprifosbuvir 450 mg for 12 weeks in adults with chronic hepatitis C virus genotype 1, 2, 3, 4, 5 or 6
Journal of Viral Hepatitis, Volume 26, No. 9, Year 2019
Notification
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Description
Ruzasvir (MK-8408, an NS5A inhibitor) and uprifosbuvir (MK-3682, a nonstructural protein 5B nucleotide inhibitor) are highly potent direct-acting antiviral agents for the treatment of hepatitis C virus (HCV) infection. A phase III clinical trial evaluating the two-drug combination of ruzasvir 60 mg plus uprifosbuvir 450 mg suggested suboptimal efficacy in certain HCV genotypes (C-BREEZE 1; NCT02759315). The aim of the present study was to evaluate the efficacy and safety of ruzasvir in combination with uprifosbuvir administered at a higher dose than that assessed in the earlier study (C-BREEZE 2: NCT02956629/Merck protocol PN041). Treatment-naïve or interferon (with or without ribavirin)-experienced participants with or without compensated cirrhosis were enrolled. All participants received ruzasvir 180 mg plus uprifosbuvir 450 mg once daily for 12 weeks. The primary objectives were the proportion of participants with HCV RNA <15 lU/mL at 12 weeks after the end of study therapy (SVR12), and safety and tolerability of the study drug. Overall, 282 participants were enrolled. SVR12 (n/N) was 91.3% (42/46) in participants infected with HCV genotype (GT) 1a; GT1b, 96.7% (29/30); GT2, 91.5% (43/47); GT3, 73.8% (45/61); GT4, 98.2% (55/56); GT5, 100.0% (18/18); and GT6, 90.9% (20/22). Adverse events (AEs) were reported by 61.3% of participants; drug-related AEs were reported by 33.3%. The most frequent (≥5% of participants) drug-related AEs in all participants were fatigue (7.8%) and headache (7.4%). In conclusion, the two-drug combination of ruzasvir 180 mg plus uprifosbuvir 450 mg for 12 weeks was highly effective and well tolerated in participants infected with HCV GT1, GT2, GT4, GT5 and GT6, with a lower efficacy in GT3-infected persons. © 2019 John Wiley & Sons Ltd
Authors & Co-Authors
Lawitz, Eric J.
United States, San Antonio
University of Texas Health Science Center at San Antonio
Gane, Edward John
New Zealand, Auckland
Auckland Clinical Studies
Feld, Jordan J.
Canada, Toronto
University of Toronto
Butí, María Asunción
Spain, Madrid
Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas
Foster, Graham R.
United Kingdom, London
Queen Mary University of London
Katchman, Helena
Israel, Tel Aviv-yafo
Tel Aviv Sourasky Medical Center
Tomasiewicz, Krzysztof
Poland, Lublin
Medical University of Lublin
Jackson, Beth E.
United States, Rahway
Merck & Co., Inc.
Robertson, Michael N.
United States, Rahway
Merck & Co., Inc.
Hanna, George J.
United States, Rahway
Merck & Co., Inc.
Barr, Eliav
United States, Rahway
Merck & Co., Inc.
Gordon, Stuart C.
Unknown Affiliation
Ruane, Peter Jerome
Unknown Affiliation
Terrault, Norah A.
Unknown Affiliation
Ghesquiere, Wayne
Unknown Affiliation
Conway, Brian
Unknown Affiliation
Cooper, Curtis L.
Unknown Affiliation
Thompson, Alex Cargill
Unknown Affiliation
Calleja-Panero, José Luis
Unknown Affiliation
Brown, Ashley S.M.
Unknown Affiliation
Cramp, M. E.
Unknown Affiliation
Zuckerman, Elimelech
Unknown Affiliation
Lurie, Yoav
Unknown Affiliation
Ben-Ari, Ziv
Unknown Affiliation
Janczewska, Ewa
Unknown Affiliation
Halota, Waldemar
Unknown Affiliation
Flisiak, Robert
Unknown Affiliation
Mahomed, Adam D.
Unknown Affiliation
Sonderup, Mark Wayne
Unknown Affiliation
Kgomo, M. Klaas
Unknown Affiliation
Bernhardi, David C.
Unknown Affiliation
Statistics
Citations: 8
Authors: 31
Affiliations: 10
Identifiers
Doi:
10.1111/jvh.13132
ISSN:
13520504
Research Areas
Genetics And Genomics
Infectious Diseases