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.
[1]Capital Med Univ, Beijing Ditan Hosp, Beijing 100015, Peoples R China;
[2]Southwest Hosp Affiliated Third Mil Med Univ, Chongqing 400038, Peoples R China;
[3]Guangzhou Nanfang Hosp, Guangzhou 510515, Guangdong, Peoples R China;
[4]Huazhong Univ Sci & Technol, Xiehe Hosp Affiliated Tongji Med Coll, Wuhan 430022, Peoples R China;
[5]Shanghai Ruijin Hosp Affiliated Shanghai Jiao Ton, Shanghai 200025, Peoples R China;
[6]Huazhong Univ Sci & Technol, Tongji Hosp Affiliated Tongji Med Coll, Wuhan 430030, Peoples R China;
[7]Chongqing Med Univ, Affiliated Hosp 2, Chongqing 400010, Peoples R China;
[8]Capital Med Univ, Beijing Youan Hosp, Beijing 100069, Peoples R China;
[9]Zhejiang Univ, Coll Med, Affiliated Hosp 1, Hangzhou 310003, Zhejiang, Peoples R China;
[10]Peking Univ, Peoples Hosp, Beijing 100044, Peoples R China;
[11]Jinan Infect Dis Hosp, Jinan 250021, Peoples R China;
[12]Chongqing Med Univ, Hosp 1, Chongqing 400016, Peoples R China;
[13]Fuzhou Infect Dis Hosp, Fuzhou 350025, Peoples R China;
[14]Sun Yat Sen Univ, Affiliated Hosp 3, Guangzhou 510630, Guangdong, Peoples R China;
[15]Fudan Univ, Huashan Hosp, Shanghai 200040, Peoples R China;
[16]Shenzhen Donghu Hosp, Shenzhen 518020, Peoples R China;
[17]Beijing 302 Hosp, Beijing 100039, 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
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