{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,4]],"date-time":"2026-01-04T02:44:47Z","timestamp":1767494687211,"version":"3.40.5"},"reference-count":32,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2022,10,10]],"date-time":"2022-10-10T00:00:00Z","timestamp":1665360000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["JGH Open"],"published-print":{"date-parts":[[2022,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background and Aim<\/jats:title><jats:p>Ropeginterferon alfa\u20102b is a novel mono\u2010pegylated, extra\u2010long\u2010acting interferon. It is administered infrequently and showed good tolerability and clinical activity for the chronic hepatitis B or C treatment in our previous Phase 2 clinical trials. This study aims to validate the potency and safety of this novel agent in a Phase 3 chronic viral hepatitis setting.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients with chronic hepatitis C genotype 2 were randomized to receive subcutaneous injections of ropeginterferon alfa\u20102b biweekly or the conventional pegylated interferon alfa\u20102b weekly for 24\u2009weeks, combined with ribavirin. The primary endpoint was to assess the safety and antiviral potency of ropeginterferon alfa\u20102b by the non\u2010inferiority in sustained virologic response at 12\u2009weeks after treatment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 222 patients were enrolled. Ropeginterferon alfa\u20102b group showed a favorable safety profile. Side effects that were generally associated with prior interferon therapies, including neutropenia, asthenia, fatigue, alopecia, dizziness, decreased appetite, nausea, flu\u2010like symptoms including myalgia, pyrexia, and headache, and administration site reactions, were notably less in the ropeginterferon alfa\u20102b group. The cumulative incidence of adverse events of special interest was also notably higher in the control group. The primary endpoint was met and ropeginterferon alfa\u20102b showed a better SVR12 rate of 79.8% than 71.9% of the control group.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Ropeginterferon alfa\u20102b is efficacious and has a favorable safety profile as compared with the conventional pegylated interferon alfa\u20102b. This study together with previous Phase 2 data validated ropeginterferon alfa\u20102b to be a new treatment option for chronic hepatitis C genotype 2.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jgh3.12825","type":"journal-article","created":{"date-parts":[[2022,10,11]],"date-time":"2022-10-11T05:46:15Z","timestamp":1665467175000},"page":"782-791","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["A Phase 3 clinical trial validating the potency and safety of an innovative, <scp>extra\u2010long\u2010acting<\/scp> interferon in chronic hepatitis C"],"prefix":"10.1002","volume":"6","author":[{"given":"Chi\u2010Yi","family":"Chen","sequence":"first","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Department of Medicine Ditmanson Medical Foundation Chiayi Christian Hospital  Chiayi City 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