A Phase 3 clinical trial validating the potency and safety of an innovative, extra-long-acting interferon in chronic hepatitis C.

Abstract

Background and Aim:

Ropeginterferon alfa-2b is a novel mono-pegylated, extra-long-acting 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.

Methods:

Patients with chronic hepatitis C genotype 2 were randomized to receive subcutaneous injections of ropeginterferon alfa-2b biweekly or the conventional pegylated interferon alfa-2b weekly for 24 weeks, combined with ribavirin. The primary endpoint was to assess the safety and antiviral potency of ropeginterferon alfa-2b by the non-inferiority in sustained virologic response at 12 weeks after treatment.

Results:

A total of 222 patients were enrolled. Ropeginterferon alfa-2b 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-like symptoms including myalgia, pyrexia, and headache, and administration site reactions, were notably less in the ropeginterferon alfa-2b 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-2b showed a better SVR12 rate of 79.8% than 71.9% of the control group.

Conclusion:

Ropeginterferon alfa-2b is efficacious and has a favorable safety profile as compared with the conventional pegylated interferon alfa-2b. This study together with previous Phase 2 data validated ropeginterferon alfa-2b to be a new treatment option for chronic hepatitis C genotype 2.

• Authors: Chi-Yi Chen, Wan-Long Chuang, Albert Qin, Wen-Hua Zhang, Li-Ying Zhu, Guo-Qiang Zhang, Jyh-Jou Chen, Ching-Chu Lo, Xinmin Zhou, Xiaorong Mao, Jia Shang, Hsing-Tao Kuo, Wen Xie, Chien-Hung Chen, Gin-Ho Lo, Dae W Jun, Shuangsuo Dang, Chan-Yen Tsai, Ting-Fang Wang, Hsin-Hui Lai, Kuan-Chiao Tseng, Yi-Wen Huang, Pei-Jer Chen
• Journal: JGH open : an open access journal of gastroenterology and hepatology (JGH Open) Vol. 6 Issue 11 Pg. 782-791 (Nov 2022) ISSN: 2397-9070 [Electronic] Australia
• PMID: 36406648 (Publication Type: Journal Article)
• Copyright: © 2022 The Authors. JGH Open published by Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.