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学科主题: 临床医学
题名:
Peginterferon alfa-2b in the treatment of Chinese patients with HBeAg-positive chronic hepatitis B: A randomized trial
作者: Cheng, Jun1; Wang, Yuming2; Hou, Jinlin3; Luo, Duande4; Xie, Qing5; Ning, Qin6; Ren, Hong7; Ding, Huiguo8; Sheng, Jifang9; Wei, Lai10; Chen, Shijun11; Fan, Xiaoling1; Huang, Wenxiang12; Pan, Chen13; Gao, Zhiliang14; Zhang, Jiming15; Zhou, Boping16; Chen, Guofeng17; Wan, Mobin18; Tang, Hong19; Wang, Guiqiang20; Yang, Yuxiu21; Mohamed, Rosmawati22; Guan, Richard23; Lee, Tzong-Hsi24; Chang, Wen-Hsiung25; Huang Zhenfei26; Ye, Zhang26; Xu, Daozhen1
关键词: Peginterferon ; Hepatitis B ; Randomized
刊名: JOURNAL OF CLINICAL VIROLOGY
发表日期: 2014-12-01
DOI: 10.1016/j.jcv.2014.08.008
卷: 61, 期:4, 页:509-516
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Virology
研究领域[WOS]: Virology
关键词[WOS]: E-ANTIGEN ; PEGYLATED INTERFERON-ALPHA-2B ; VIROLOGICAL RESPONSE ; SURFACE-ANTIGEN ; THERAPY
英文摘要:

Background: In mainland China, peginterferon (PEG-IFN) alfa-2b 1.0 mu g/kg/wk for 24 weeks is the approved treatment for HBeAg-positive chronic hepatitis B.

Objective: This multicenter, randomized trial evaluated the safety and efficacy of regimens utilizing increased dose or treatment duration in treatment-naive Chinese patients with chronic hepatitis B.

Study design: 670 HBeAg-positive patients from China, Malaysia, Taiwan area, Singapore, and Thailand were enrolled. Patients received PEG-IFN alfa-2b 1.0 mu g/kg/wk (arm A) or 1.5 mu g/kg/wk (arm B) for 24 weeks, or 1.5 mu g/kg/wk for 48 weeks (arm C). The primary end point was loss of HBeAg 24 weeks after end of treatment.

Results: At the end of follow-up, HBeAg loss was significantly greater in arm C compared with arm A (31.3% vs. 17.3%; P = 0.001) and arm B (31.3% vs. 18.1%; P = 0.001). No significant difference in the rate of HBeAg loss was observed between arms A and B. The proportions of patients with HBe seroconversion, HBV DNA levels <20,000 IU/mL, and ALT normalization at the end of follow-up were significantly higher in arm C compared with arm A and arm B. In arms A, B, and C, rates of early treatment discontinuation were 6.3%, 4.9%, and 8.9%; of discontinuation due to an AE, 2%, 3%, and 3%; and of AEs requiring dose modification, 3%, 6%, and 10%, respectively.

Conclusions: In Chinese patients with HBeAg-positive chronic hepatitis B, PEG-IFN alfa-2b 1.5 mu g/kg/wk for 48 weeks is more efficacious compared with 1.0 and 1.5 mu g/kg/wk for 24 weeks. (C) 2014 The Authors. Published by Elsevier B.V.

语种: 英语
项目资助者: Schering-Plough Corporation
WOS记录号: WOS:000345579900006
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/51628
Appears in Collections:北京大学第二临床医学院_期刊论文

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作者单位: 1.Guangzhou Nanfang Hosp, Guangzhou 510515, Guangdong, Peoples R China
2.Peking Univ, Peoples Hosp, Beijing 100044, Peoples R China
3.Jinan Infect Dis Hosp, Jinan 250021, Peoples R China
4.Fuzhou Infect Dis Hosp, Fuzhou 350025, Peoples R China
5.Fudan Univ, Huashan Hosp, Shanghai 200040, Peoples R China
6.Shenzhen Donghu Hosp, Shenzhen 518020, Peoples R China
7.Beijing 302 Hosp, Beijing 100039, Peoples R China
8.Capital Med Univ, Beijing Ditan Hosp, Beijing 100015, Peoples R China
9.Southwest Hosp Affiliated Third Mil Med Univ, Chongqing 400038, Peoples R China
10.Huazhong Univ Sci & Technol, Xiehe Hosp Affiliated Tongji Med Coll, Wuhan 430022, Peoples R China
11.Shanghai Ruijin Hosp Affiliated Shanghai Jiao Ton, Shanghai 200025, Peoples R China
12.Huazhong Univ Sci & Technol, Tongji Hosp Affiliated Tongji Med Coll, Wuhan 430030, Peoples R China
13.Chongqing Med Univ, Affiliated Hosp 2, Chongqing 400010, Peoples R China
14.Capital Med Univ, Beijing Youan Hosp, Beijing 100069, Peoples R China
15.Zhejiang Univ, Coll Med, Affiliated Hosp 1, Hangzhou 310003, Zhejiang, Peoples R China
16.Chongqing Med Univ, Hosp 1, Chongqing 400016, Peoples R China
17.Sun Yat Sen Univ, Affiliated Hosp 3, Guangzhou 510630, Guangdong, Peoples R China
18.Shanghai Changhai Hosp, Shanghai 200433, Peoples R China
19.Sichuan Univ, Huaxi Hosp, Chengdu 610041, Peoples R China
20.Peking Union Med Coll, Hosp 1, Beijing 100034, Peoples R China
21.Henan Prov Peoples Hosp, Zhengzhou 450003, Peoples R China
22.Univ Malaya, Med Ctr, Clin Investigat Ctr, Kuala Lumpur 59100, Malaysia
23.Mt Elizabeth Med Ctr, Med Clin 1, Singapore 228510, Singapore
24.Far Eastern Mem Hosp, New Taipei City 22060, Taiwan
25.Mackay Mem Hosp, Taipei 10449, Taiwan
26.Merck Sharp & Dohme Ltd, Shanghai 200040, Peoples R China

Recommended Citation:
Cheng, Jun,Wang, Yuming,Hou, Jinlin,et al. Peginterferon alfa-2b in the treatment of Chinese patients with HBeAg-positive chronic hepatitis B: A randomized trial[J]. JOURNAL OF CLINICAL VIROLOGY,2014,61(4):509-516.
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