Efficacy and safety of pegylated interferon α-2b injection (Y shape, 40 kD) in treatment of patients with genotype 1/6 chronic hepatitis C

Bo Feng; Jia Shang; Shuhuan WU; Hong Chen; Ying Han; Yueqi LI; Dazhi Zhang; Longfeng Zhao; Shaofeng Wei; Qing Mao; Zhibiao Yin; Tao Han; Maorong Wang; Shijun Chen; Jun LI; Qing Xie; Zhen Zhen; Zhiliang Gao; Yuexin Zhang; Guozhong Gong; Dongliang Yang; Chen Pan; Jifang Sheng; Hong Tang; Qin Ning; Guangfeng Shi; Junqi Niu; Guanghan Luo; Yongtao Sun; Hong You; Guiqiang Wang; Lunli Zhang; Jie Peng; Qin Zhang; Jiajun Liu; Chengwei Chen; Xinyue Chen; Wei Zhao; Runhua Wang; Li Sun; Lai Wei

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Efficacy and safety of pegylated interferon α-2b injection (Y shape, 40 kD) in treatment of patients with genotype 1/6 chronic hepatitis C

VernacularTitle: 聚乙二醇干扰素α-2b（Y型，40 kD）注射液治疗基因1/6型慢性丙型肝炎患者的疗效和安全性分析
Author: Bo FENG ¹ ; Jia SHANG ² ; Shuhuan WU ³ ; Hong CHEN ⁴ ; Ying HAN ⁵ ; Yueqi LI ⁶ ; Dazhi ZHANG ⁷ ; Longfeng ZHAO ⁸ ; Shaofeng WEI ⁹ ; Qing MAO ¹⁰ ; Zhibiao YIN ¹¹ ; Tao HAN ¹² ; Maorong WANG ¹³ ; Shijun CHEN ¹⁴ ; Jun LI ¹⁵ ; Qing XIE ¹⁶ ; Zhen ZHEN ¹⁷ ; Zhiliang GAO ¹⁸ ; Yuexin ZHANG ¹⁹ ; Guozhong GONG ²⁰ ; Dongliang YANG ²¹ ; Chen PAN ²² ; Jifang SHENG ²³ ; Hong TANG ²⁴ ; Qin NING ²⁵ ; Guangfeng SHI ²⁶ ; Junqi NIU ²⁷ ; Guanghan LUO ²⁸ ; Yongtao SUN ²⁹ ; Hong YOU ³⁰ ; Guiqiang WANG ³¹ ; Lunli ZHANG ³² ; Jie PENG ³³ ; Qin ZHANG ³⁴ ; Jiajun LIU ³⁵ ; Chengwei CHEN ³⁶ ; Xinyue CHEN ³⁷ ; Wei ZHAO ³⁸ ; Runhua WANG ³⁹ ; Li SUN ³⁹ ; Lai WEI ¹
Author Information

1. Peking University People's Hospital, Peking University Hepatology Institute, Beijing Key Laboratory of Hepatitis C and Immunotherapy for Liver Diseases, Beijing 100044, China
2. Department of Infectious Diseases, Henan Provincial People’s Hospital, Zhengzhou 450003, China
3. Department of Infectious Diseases, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China
4. Department of Infectious Diseases, The First Affiliated Hospital of Lanzhou University, Lanzhou 730000, China
5. Department of Gastroenterology, Xijing Hospital, Fourth Military Medical University, Xi’an 710032, China
6. Department of Infectious Diseases, 302 Military Hospital, Beijing 100039, China
7. Department of Infectious Diseases, Institute for Viral Hepatitis, Second Affiliated Hospital of Chongqing Medical University, Chongqing 400010, China
8. Department of Infectious Diseases, The First Affiliated Hospital of Shanxi University, Taiyuan 030001, China
9. Department of Infectious Diseases, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China
10. Department of Infectious Disease, Southeast Hospital, Third Military Medical University, Chongqing 400038, China
11. Department of Infectious Diseases, Guangzhou Eighth People's Hospital, Guangzhou 510060, China
12. Department of Hepatology, Tianjin Third Central Hospital, Tianjin Medical University, Tianjin 300170, China
13. Institute of Liver Disease, Nanjing 81 Hospital, Nanjing 210002, China
14. Department of Hepatology, Jinan Infectious Disease Hospital, Jinan 250021, China
15. Department of Infectious Diseases, Jiangsu Provincial People's Hospital, Nanjing 210029, China
16. Department of Infectious Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China
17. Department of Infectious Diseases, The Third Affiliated Hospital of Hebei Medical University, Shijiazhuang 050051, China
18. Department of Infectious Diseases, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou 510630, China
19. Department of Infectious Diseases, The First Affiliated Hospital of Xinjiang Medical University, Wulumuqi 830054, China
20. Department of Infectious Diseases, The Second Xiangya Hospital of Central South University, Changsha 410011, China
21. Department of Infectious Disease, Institute of Infectious Disease, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China
22. Department of Hepatology, Fuzhou Infectious Disease Hospital, Fuzhou, 350025, China
23. The First Affiliated Hospital of Zhengjiang University, Hangzhou 310003, China
24. Department of Infectious Diseases, Sichuan University West China Hospital, Chengdu 610041, China
25. Department of Infectious Disease, Institute of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China
26. Department of Infectious Diseases, Huashan Hospital, Shanghai 200040, China
27. Department of Infectious Diseases, The First Affiliated Hospital of Jilin University, Changchun 130062, China
28. Department of Infectious Diseases, The First Affiliated Hospital of Guangxi Medical Universtiy, Nanning 530021, China
29. Department of Infectious Diseases, Tangdu Hospital, Fourth Military Medical University, Xi'an 710038, China
30. Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
31. Department of Infectious Diseases, Peking University First Hospital, Beijing 100034, China
32. Department of Infectious Diseases, The First Affiliated Hospital of Nanchang University, Nanchang 360102, China
33. Department of Infectious Diseases, Nangfang Hospital, Southern Medical University, Guangzhou 510510, China
34. Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China
35. Department of Infectious Diseases, The First Affiliated Hospital of Xiamen University, Xiamen 361003, China
36. Nanjing Military Command Liver Disease Research Center, Shanghai 200000, China
37. Hepatology Department, Youan Hospital, Capital Medical University, Beijing 100069, China
38. Department of Hepatology, The Second Affiliated Hospital of the Southeast University, Nanjing 210003, China
39. Xiamen Amoytop Biotech Co., Ltd, Xiamen, 361022, China
Publication Type:Journal Article
Keywords: Hepatitis C, chronic; Interferons; Clinical trial
From: Chinese Journal of Hepatology 2017;25(3):187-194
CountryChina
Language:Chinese
Abstract: Objective:To investigate the efficacy and safety of the new investigational drug pegylated interferon α-2b (Peg-IFN-α-2b) (Y shape, 40 kD) injection (180 µg/week) combined with ribavirin in the treatment of patients with genotype 1/6 chronic hepatitis C (CHC), with standard-dose Peg-IFN-α-2a combined with ribavirin as a positive control.
Methods:A multicenter, randomized, open-label, and positive-controlled phase III clinical trial was performed. Eligible patients with genotype 1/6 CHC were screened out and randomly divided into Peg-IFN-α-2b(Y shape, 40kD) group and Peg-IFN-α-2a group at a ratio of 2:1. The patients in both groups were given oral ribavirin for 48 weeks in addition and then followed up for 24 weeks after drug withdrawal. Abbott Real Time HCV Genotype II was used to determine HCV genotype, and Cobas TaqMan quantitative real-time PCR was used to measure HCV RNA level at 0, 4, 12, 24, 48, and 72 weeks. Adverse events were recorded in detail. The primary efficacy endpoint was sustained virological response (SVR), and a non-inferiority test was also performed.
Results:A total of 561 patients with genotype 1/6 CHC were enrolled, among whom 529 received treatment; 90.9% of these patients had genotype 1 CHC. The data of the full analysis set showed that SVR rate was 69.80% (95% CI 65.00%-74.60%) in the trial group and 74.16% (95% CI 67.73%-80.59%) in the control group (P = 0.297 0). The data of the per protocol set (PPS) showed that SVR rate was 80.63% (95% CI 76.04%-85.23%) in the trial group and 81.33% (95% CI 75.10%-87.57%) in the control group (P = 0.849 8), and the 95% CI of rate difference conformed to the non-inferiority standard. The analysis of the PPS population showed that of all subjects, 47.9% achieved rapid virologic response, with a positive predictive value of 93.8%. The incidence rate of adverse events was 96.30% in the trial group and 94.94% in the control group, and the incidence rate of serious adverse events was 5.13% in the trail group and 5.06% in the control group.
Conclusion:In the regimen of Peg-IFN-α combined with ribavirin for the treatment of genotype 1/6 CHC, the new investigational drug Peg-IFN-α-2b(Y shape, 40 kD) has comparable clinical effect and safety to the control drug Peg-IFN-α-2a.