Document Detail

Peginterferon alfa-2b in the treatment of Chinese patients with HBeAg-positive chronic hepatitis B: A randomized trial.
MedLine Citation:
PMID:  25200354     Owner:  NLM     Status:  Publisher    
BACKGROUND: In mainland China, peginterferon (PEG-IFN) alfa-2b 1.0μg/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 1.0μg/kg/wk (arm A) or 1.5μg/kg/wk (arm B) for 24 weeks, or 1.5μg/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 <20,000IU/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 1.5μg/kg/wk for 48 weeks is more efficacious compared with 1.0 and 1.5μg/kg/wk for 24 weeks.
Jun Cheng; Yuming Wang; Jinlin Hou; Duande Luo; Qing Xie; Qin Ning; Hong Ren; Huiguo Ding; Jifang Sheng; Lai Wei; Shijun Chen; Xiaoling Fan; Wenxiang Huang; Chen Pan; Zhiliang Gao; Jiming Zhang; Boping Zhou; Guofeng Chen; Mobin Wan; Hong Tang; Guiqiang Wang; Yuxiu Yang; Rosmawati Mohamed; Richard Guan; Tzong-Hsi Lee; Wen-Hsiung Chang; Huang Zhenfei; Zhang Ye; Daozhen Xu
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2014-8-18
Journal Detail:
Title:  Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology     Volume:  -     ISSN:  1873-5967     ISO Abbreviation:  J. Clin. Virol.     Publication Date:  2014 Aug 
Date Detail:
Created Date:  2014-9-9     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9815671     Medline TA:  J Clin Virol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2014. Published by Elsevier B.V.
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