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

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JNJ‐4178 (AL‐335, Odalasvir, and Simeprevir) for 6 Or 8 Weeks in Hepatitis C Virus‐Infected Patients Without Cirrhosis: OMEGA‐1 - Zeuzem - - Hepat JNJ‐4178 (AL‐335, Odalasvir, and Simeprevir) for 6 or 8 Weeks in Hepatitis C Virus‐infected Patients without Cirrhosis: OMEGA‐1 - Zeuzem - - Hepat... RelatedAbout Information This Journal Search Login / Register Hepatology Original Article JNJ‐4178 (AL‐335, Odalasvir, and Simeprevir) for 6 or 8 Weeks in Hepatitis C Virus‐infected Patients without Cirrhosis: OMEGA‐1 Stefan Zeuzem Stefan Bourgeois Susan Greenbloom Maria Buti Alessio Aghemo Pietro Lampertico Ewa Janczewska Seng Gee Lim Christophe Moreno Peter Buggisch Edward Tam Chris Corbett Wouter Willems Leen Vijgen Bart Fevery Sivi Ouwerkerk‐Mahadevan Oliver Ackaert Maria Beumont Ronald Kalmeijer Rekha Sinha Michael Biermer The OMEGA‐1 study team First published: 28 January 2019 https://doi.org/10.1002/hep.30527 This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1002/hep.30527 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 https://aasldpubs.onlinelibrary.wiley.com/doi/abs/10.1002/hep.30527[2019/02/16 20:05:18] JNJ‐4178 (AL‐335, Odalasvir, and Simeprevir) for 6 or 8 Weeks in Hepatitis C Virus‐infected Patients without Cirrhosis: OMEGA‐1 - Zeuzem - - Hepat... 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. This article is protected by copyright. All rights reserved. Supporting Information Accepted Articles Accepted, unedited articles published online and citable. The final edited and typeset version of record will appear in the future. https://aasldpubs.onlinelibrary.wiley.com/doi/abs/10.1002/hep.30527[2019/02/16 20:05:18] JNJ‐4178 (AL‐335, Odalasvir, and Simeprevir) for 6 or 8 Weeks in Hepatitis C Virus‐infected Patients without Cirrhosis: OMEGA‐1 - Zeuzem - - Hepat... AASLD.org Membership Contact Us © 2019 American Association for the Study of Liver Diseases About Wiley Online Library Privacy Policy Terms of Use Cookies Accessibility Help & Support Contact Us Opportunities Subscription Agents Advertisers & Corporate Partners Connect with Wiley The Wiley Network Wiley Press Room Copyright © 1999-2019 John Wiley & Sons, Inc. All rights reserved https://aasldpubs.onlinelibrary.wiley.com/doi/abs/10.1002/hep.30527[2019/02/16 20:05:18].
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