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Abstract Details
JNJ-4178 (AL-335, Odalasvir, and Simeprevir) for 6 or 8 Weeks in Hepatitis C Virus-infected Patients without Cirrhosis: OMEGA-1
Shah ND1, Ventura-Cots M2, Abraldes JG3, Alboraie M4, Alfadhli A5, Argemi J6, Badia-Aranda E7, Soler EA8, Barritt AS 4th1, Bessone F9, Biryukova M10, Carrilho FJ11, Fernández MC8, Guiridi ZD10, El Kassas M12, Eng-Kiong T13, Farias A11, George J14, Gui W15, Thurairajah PH13, Hsiang JC13, Husic-Selimovic A16, Isakov V10, Karoney M17, Kim W18, Kluwe J19, Kochhar R20, Dhaka N20, Costa PM21, Nabeshima MA11, Ono SK11, Reis D21, Rodil A11, Domech CR8, Sáez-Royuela F7, Scheurich C19, Siow W14, Sivac-Burina N16, Dos Santos Traquino ES8, Some F17, Spreckic S16, Tan S22, Vorobioff J9, Wandera A17, Wu P22, Yakoub M12, Yang L15, Yu Y22, Zahiragic N16, Zhang C22, Cortez-Pinto H21, Bataller R23. Clin Gastroenterol Hepatol. 2019 Jan 29. pii: S1542-3565(19)30073-4. doi: 10.1016/j.cgh.2019.01.026. [Epub ahead of print]
Author information
1 Department of Medicine, JW 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, USA.
Abstract
The combination of 3 direct-acting antiviral agents (AL-335, odalasvir and simeprevirJNJ-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 (N = 183) or 8 weeks (N = 182) of treatment. SVR12 rates after 6 (98.9%) or 8 weeks of treatment (97.8%) were non-inferior to a historical control (98%). Viral relapse occurred in 5 (1.4%) patients (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.