Peginterferon alfa-2b in the treatment of Chinese patients with HBeAg-positive chronic hepatitis B: a randomized trial
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, 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
Abstract
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.
Keywords: Hepatitis B; Peginterferon; Randomized.
Copyright © 2014 The Authors. Published by Elsevier B.V. All rights reserved.
Source: PubMed