A Phase 3 clinical trial validating the potency and safety of an innovative, extra‐long‐acting interferon in chronic hepatitis C
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
Affiliations
Chi‐Yi Chen
Division of Gastroenterology and Hepatology, Department of Medicine Ditmanson Medical Foundation Chiayi Christian Hospital Chiayi City Taiwan
Wan‐Long Chuang
Hepatobiliary Division, Department of Internal Medicine and Hepatitis Center Kaohsiung Medical University Hospital, Kaohsiung Medical University Kaohsiung City Taiwan
Albert Qin
PharmaEssentia Corporation Taipei City Taiwan
Wen‐Hua Zhang
Department of Cancer Epidemiology, Wuwei Cancer Registry Gansu Wuwei Tumor Hospital Wuwei China
Li‐Ying Zhu
Department of Infectious Disease The Fourth Hospital of Harbin Medical University Harbin China
Guo‐Qiang Zhang
Department of Infectious Disease Luoyang Central Hospital Luoyang China
Jyh‐Jou Chen
Division of Gastroenterology and Hepatology, Department of Internal Medicine Tainan City Taiwan
Ching‐Chu Lo
Department of Internal Medicine St. Martin De Porres Hospital Chiayi City Taiwan
Xinmin Zhou
Department of Gastroenterology Xijing Hospital, Air Force Medical University Xi'an China
Xiaorong Mao
Departments of Infectious Diseases, The First Clinical Medical College Lanzhou University Lanzhou China
Jia Shang
Department of Infectious Diseases Henan Provincial People's Hospital Zhengzhou China
Hsing‐Tao Kuo
Division of Gastroenterology and Hepatology, Department of Internal Medicine Chi‐Mei Medical Center – Yongkang Tainan City Taiwan
Wen Xie
Center of Liver Diseases, Beijing Ditan Hospital Capital Medical University Beijing China
Chien‐Hung Chen
Division of Hepatogastroenterology, Department of Internal Medicine Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine Kaohsiung City Taiwan
Gin‐Ho Lo
Department of Medical Research, Digestive Center E‐Da Hospital Kaohsiung City Taiwan
Dae W Jun
Department of Internal Medicine Hanyang University, College of Medicine Seoul South Korea
Shuangsuo Dang
Department of Infectious Diseases Second Affiliated Hospital of Xi'an Jiaotong University Xi'an China
Chan‐Yen Tsai
PharmaEssentia Corporation Taipei City Taiwan
Ting‐Fang Wang
PharmaEssentia Corporation Taipei City Taiwan
Hsin‐Hui Lai
PharmaEssentia Corporation Taipei City Taiwan
Kuan‐Chiao Tseng
PharmaEssentia Corporation Taipei City Taiwan
Yi‐Wen Huang
PharmaEssentia Corporation Taipei City Taiwan
Pei‐Jer Chen
Graduate Institute of Clinical Medicine National Taiwan University College of Medicine Taipei City Taiwan
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.
