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Hepatology. 2019 Jan 28. doi: 10.1002/hep.30527. [Epub ahead of print]

JNJ-4178 (AL-335, Odalasvir, and Simeprevir) for 6 or 8 Weeks in Hepatitis C Virus-Infected Patients Without Cirrhosis: OMEGA-1.

Author information

1
Department of Medicine, J.W. Goethe University Hospital, Frankfurt am Main, Germany.
2
Department of Gastroenterology and Hepatology, ZNA Antwerp, Antwerp, Belgium.
3
Toronto Digestive Disease Associates, Inc., Vaughan, ON, Canada.
4
Hospital Vall d'Hebron and Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas (CIBERehd), Barcelona, Spain.
5
Humanitas University and Research Hospital, Rozzano, Italy.
6
CRC "AM e A Migliavacca," Division of Gastroenterology and Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università di Milano, Milan, Italy.
7
Outpatients Clinic for Hepatology, ID Clinic, Myslowice, Poland.
8
Medical University of Silesia, School of Public Health in Bytom, Department of Basic Medical Sciences, Bytom, Poland.
9
Division of Gastroenterology and Hepatology, Department of Medicine, Yong Loo Lin School of Medicine, National University Health System, Singapore.
10
CUB Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium.
11
Institute for Interdisciplinary Medicine, Hamburg, Germany.
12
LAIR Centre, Vancouver, BC, Canada.
13
Janssen Research & Development, Janssen Pharmaceutica NV, Beerse, Belgium.
14
Janssen Research & Development, LLC, Titusville, NJ.

Abstract

The combination of three direct-acting antiviral agents (AL-335, odalasvir, and simeprevir: JNJ-4178 regimen) for 6 or 8 weeks demonstrated good efficacy and safety in a phase IIa study in chronic hepatitis C virus (HCV) genotype (GT)-1-infected patients without cirrhosis and has now been evaluated in a larger phase IIb study, OMEGA-1. This multicenter, randomized, open-label study (NCT02765490) enrolled treatment-naïve and interferon (±ribavirin) treatment-experienced patients with HCV GT1, 2, 4, 5, or 6 infection. Patients with HCV GT3 infection and/or liver cirrhosis were excluded. Patients received AL-335 800 mg, odalasvir 25 mg, and simeprevir 75 mg once daily for 6 or 8 weeks. The primary endpoint was sustained virologic response 12 weeks after the end of treatment (SVR12). In total, 365 patients (GT1a, 29.3%; GT1b, 42.5%; GT2, 12.3%; GT4, 14.2%; GT5, 1.4%; GT6, 0%) were randomized to receive 6 weeks (n = 183) or 8 weeks (n = 182) of treatment. SVR12 rates after 6 weeks (98.9%) or 8 weeks (97.8%) of treatment were noninferior to a historical control (98%). Viral relapse occurred in 5 patients (1.4%; 4 with HCV GT2c; 1 with GT1a). With the exception of 4 patients in the 8-week group, including 3 patients with missing data at the SVR24 timepoint, all patients who achieved SVR12 also achieved SVR24. One GT1a-infected patient experienced late viral relapse after achieving SVR18. Most adverse events (AEs) were mild with no treatment-related serious AEs. All randomized patients completed treatment. Conclusion: In HCV-infected patients, 6 and 8 weeks of treatment with JNJ-4178 resulted in SVR12 rates of 98.9% and 97.8%, respectively, and was well tolerated.

PMID:
30693573
DOI:
10.1002/hep.30527

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