Clinical effect and safety of pegylated interferon-α-2b injection (Y shape, 40 kD) in treatment of HBeAg-positive chronic hepatitis B patients

Fengqin Hou; Yalin Yin; Lingying Zeng; Jia Shang; Guozhong Gong; Chen Pan; Mingxiang Zhang; Chibiao Yin; Qing Xie; Yanzhong Peng; Shijun Chen; Qing Mao; Yongping Chen; Qianguo Mao; Dazhi Zhang; Tao Han; Maorong Wang; Wei Zhao; Jiajun Liu; Ying Han; Longfeng Zhao; Guanghan Luo; Jiming Zhang; Jie Peng; Deming Tan; Zhiwei LI; Hong Tang; Hao Wang; Yuexin Zhang; Jun LI; Lunli Zhang; Liang Chen; Jidong Jia; Chengwei Chen; Zhen Zhen; Baosen LI; Junqi Niu; Qinghua Meng; Hong Yuan; Yongtao Sun; Shuchen LI; Jifang Sheng; Jun Cheng; Li Sun; Guiqiang Wang

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Clinical effect and safety of pegylated interferon-α-2b injection (Y shape, 40 kD) in treatment of HBeAg-positive chronic hepatitis B patients

VernacularTitle: 聚乙二醇干扰素α-2b (Y型，40 kD）注射液治疗HBeAg阳性慢性乙型肝炎患者的疗效和安全性分析
Author: Fengqin HOU ¹ ; Yalin YIN ² ; Lingying ZENG ² ; Jia SHANG ³ ; Guozhong GONG ⁴ ; Chen PAN ⁵ ; Mingxiang ZHANG ⁶ ; Chibiao YIN ⁷ ; Qing XIE ⁸ ; Yanzhong PENG ⁹ ; Shijun CHEN ¹⁰ ; Qing MAO ¹¹ ; Yongping CHEN ¹² ; Qianguo MAO ¹³ ; Dazhi ZHANG ¹⁴ ; Tao HAN ¹⁵ ; Maorong WANG ¹⁶ ; Wei ZHAO ¹⁷ ; Jiajun LIU ¹⁸ ; Ying HAN ¹⁹ ; Longfeng ZHAO ²⁰ ; Guanghan LUO ²¹ ; Jiming ZHANG ²² ; Jie PENG ²³ ; Deming TAN ²⁴ ; Zhiwei LI ²⁵ ; Hong TANG ²⁶ ; Hao WANG ²⁷ ; Yuexin ZHANG ²⁸ ; Jun LI ²⁹ ; Lunli ZHANG ³⁰ ; Liang CHEN ³¹ ; Jidong JIA ³² ; Chengwei CHEN ³³ ; Zhen ZHEN ³⁴ ; Baosen LI ³⁵ ; Junqi NIU ³⁶ ; Qinghua MENG ³⁷ ; Hong YUAN ³⁸ ; Yongtao SUN ³⁹ ; Shuchen LI ⁴⁰ ; Jifang SHENG ⁴¹ ; Jun CHENG ⁴² ; Li SUN ² ; Guiqiang WANG ¹
Author Information

1. Department of Infectious Diseases, Center for Liver Diseases, Peking University First Hospital, Beijing 100034, China
2. Xiamen Amoytop Biotech Co., Ltd, Xiamen 361028, China
3. Henan Provincial People’s Hospital, Zhengzhou 450003, China
4. The Second Xiangya Hospital of Central South University, Changsha 410011, China
5. Fuzhou Infectious Disease Hospital, Fuzhou 350025, China
6. The Sixth People's Hospital of Shenyang, Shenyang 110006, China
7. Guangzhou Eighth People's Hospital, Guangzhou 510060, China
8. Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China
9. Peking University Shenzhen Hospital, Shenzhen 518036, China
10. Jinan Infectious Disease Hospital, Jinan 250021, China
11. Southeast Hospital, Third Military Medical University, Chongqing 400038, China
12. The First Affiliated Hospital of Wenzhou Medical University, Wenzhou 325000, China
13. Xiamen Hospital of T.C.M, Xiamen 361001, China
14. The Second Affiliated Hospital of Chongqing Medical University, Chongqing 400010, China
15. Tianjin Third Central Hospital, Tianjin 300170, China
16. 81th Hospital of People's Liberation Army, Nanjing 210002, China
17. The Second Affiliated Hospital of the Southeast University, Nanjing 210003, China
18. The First Affiliated Hospital of Xiamen University, Xiamen 361003, China
19. Xijing Hospital, Fourth Military Medical University, Xi’an 710032, China
20. The First Affiliated Hospital of Shanxi University, Taiyuan 030001, China
21. The First Affiliated Hospital of Guangxi Medical Universtiy, Nanning 530021, China
22. Huashan Hospital, Shanghai 200040, China
23. Nangfang Hospital, Southern Medical University, Guangzhou 510510, China
24. Xiangya Hospital Central South University, Changsha 410008, China
25. Shengjing Hospital of China Medical University, Shenyang 110022, China
26. West China Hospital, Sichuan University, Chengdu 610041, China
27. Peking University People's Hospital, Beijing 100044, China
28. The First Affiliated Hospital of Xinjiang Medical University, Urumqi 830054, China
29. Jiangsu Provincial People's Hospital, Nanjing 210029, China
30. The First Affiliated Hospital of Nanchang University, Nanchang 360102, China
31. Shanghai Public Health Clinical Center, Shanghai 201508, China
32. Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
33. 85th Hospital of People's Liberation Army, Shanghai 200052, China
34. The Third Affiliated Hospital of Hebei Medical University, Shijiazhuang 050051, China
35. 302 Military Hospital of China, Beijing 100039, China
36. The First Bethune Hospital of Jilin University, Chanchun 130062, China
37. Beijing Youan Hospital, Captial Medical University, Beijing 100069, China
38. The First Hospital of Lanzhou University, Lanzhou 730000, China
39. Tangdu Hospital, Fourth Military Medical University, Xi'an 710038, China
40. The 2nd Affiliated Hospital of Harbin Medical University, Harbin 150001, China
41. The First Affiliated Hospital of Zhejiang University, Hangzhou 310003, China
42. Beijing Ditan Hospital Capital Medical University, Beijing 100015, China
Publication Type:Journal Article
Keywords: Hepatitis B, chronic; Peginterferon; HBeAg seroconversion; Clinical trial
From: Chinese Journal of Hepatology 2017;25(8):589-596
CountryChina
Language:Chinese
Abstract: Objective:To investigate the clinical effect and safety of long-acting pegylated interferon-α-2b (Peg-IFN-α-2b) (Y shape, 40 kD) injection (180 μg/week) in the treatment of HBeAg-positive chronic hepatitis B (CHB) patients, with standard-dose Peg-IFN-α-2a as positive control.
Methods:This study was a multicenter, randomized, open-label, and positive-controlled phase III clinical trial. Eligible HBeAg-positive CHB patients were screened out and randomized to Peg-IFN-α-2b (Y shape, 40 kD) trial group and Peg-IFN-α-2a control group at a ratio of 2:1. The course of treatment was 48 weeks and the patients were followed up for 24 weeks after drug withdrawal. Plasma samples were collected at screening, baseline, and 12, 24, 36, 48, 60, and 72 weeks for centralized detection. COBAS® Ampliprep/COBAS® TaqMan® HBV Test was used to measure HBV DNA level by quantitative real-time PCR. Electrochemiluminescence immunoassay with Elecsys kit was used to measure HBV markers (HBsAg, anti-HBs, HBeAg, anti-HBe). Adverse events were recorded in detail. The primary outcome measure was HBeAg seroconversion rate after the 24-week follow-up, and non-inferiority was also tested. The difference in HBeAg seroconversion rate after treatment between the trial group and the control group and two-sided confidence interval (CI) were calculated, and non-inferiority was demonstrated if the lower limit of 95% CI was > -10%. The t-test, chi-square test, or rank sum test was used according to the types and features of data.
Results:A total of 855 HBeAg-positive CHB patients were enrolled and 820 of them received treatment (538 in the trial group and 282 in the control group). The data of the full analysis set showed that HBeAg seroconversion rate at week 72 was 27.32% in the trial group and 22.70% in the control group with a rate difference of 4.63% (95% CI -1.54% to 10.80%, P = 0.1493). The data of the per-protocol set showed that HBeAg seroconversion rate at week 72 was 30.75% in the trial group and 27.14% in the control group with a rate difference of 3.61% (95% CI -3.87% to 11.09%, P = 0.3436). 95% CI met the non-inferiority criteria, and the trial group was non-inferior to the control group. The two groups had similar incidence rates of adverse events, serious adverse events, and common adverse events.
Conclusion:In Peg-IFN-α regimen for HBeAg-positive CHB patients, the new drug Peg-IFN-α-2b (Y shape, 40 kD) has comparable effect and safety to the control drug Peg-IFN-α-2a.