title: Peginterferon alfa-2b in the treatment of Chinese patients with HBeAg-positive chronic hepatitis B: a randomized trial.
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.
  
  
  METHODS
  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.
authors.affiliation: Beijing Ditan Hospital, Capital Medical University, No. 8, East Jingshun Street, Beijing 100015, China. Electronic address: jun.cheng.ditan@gmail.com.
authors.forename: Jun
authors.initials: J
authors.lastname: Cheng
authors.affiliation: Southwest Hospital Affiliated Third Military Medical University, No. 29, Gao Tan Yan Zhengjie, Shapingba, Chongqing 400038, China.
authors.forename: Yuming
authors.initials: Y
authors.lastname: Wang
authors.affiliation: Guangzhou Nanfang Hospital, No. 1838, N. Guangzhou Avenue, Guangzhou 510515, China.
authors.forename: Jinlin
authors.initials: J
authors.lastname: Hou
authors.affiliation: Xiehe Hospital Affiliated Tongji Medical College of Huazhong University of Science & Technology, No. 1277, Jiefang Avenue, Wuhan 430022, China.
authors.forename: Duande
authors.initials: D
authors.lastname: Luo
authors.affiliation: Shanghai Ruijin Hospital Affiliated Shanghai Jiao Tong University, No. 197, Ruijiner Rd., Shanghai 200025, China.
authors.forename: Qing
authors.initials: Q
authors.lastname: Xie
authors.affiliation: Tongji Hospital Affiliated Tongji Medical College of Huazhong University of Science & Technology, No. 1095, Jiefang Avenue, Wuhan 430030, China.
authors.forename: Qin
authors.initials: Q
authors.lastname: Ning
authors.affiliation: The Second Affiliated Hospital, Chongqing Medical University, No. 76, Linjiang Rd., Chongqing 400010, China.
authors.forename: Hong
authors.initials: H
authors.lastname: Ren
authors.affiliation: Beijing You'an Hospital, Capital Medical University, No. 8, You An Men Wai Street, Fengtai District, Beijing 100069, China.
authors.forename: Huiguo
authors.initials: H
authors.lastname: Ding
authors.affiliation: The First Affiliated Hospital of Zhejiang University Medical College, No. 79, Qingchun Rd., Hangzhou 310003, China.
authors.forename: Jifang
authors.initials: J
authors.lastname: Sheng
authors.affiliation: Peking University People's Hospital, No. 11 Xizhimen South Street, Beijing, 100044, China.
authors.forename: Lai
authors.initials: L
authors.lastname: Wei
authors.affiliation: Jinan Infectious Disease Hospital, No. 173, Jingshi Rd., Jinan 250021, China.
authors.forename: Shijun
authors.initials: S
authors.lastname: Chen
authors.affiliation: Beijing Ditan Hospital, Capital Medical University, No. 8, East Jingshun Street, Beijing 100015, China.
authors.forename: Xiaoling
authors.initials: X
authors.lastname: Fan
authors.affiliation: No. 1 Hospital of Chongqing Medical University, No. 1, Youyi Rd., Chongqing 400016, China.
authors.forename: Wenxiang
authors.initials: W
authors.lastname: Huang
authors.affiliation: Fuzhou Infectious Disease Hospital, No. 312, Xihong Rd., Gulou District, Fuzhou 350025, China.
authors.forename: Chen
authors.initials: C
authors.lastname: Pan
authors.affiliation: The Third Affiliated Hospital of Sun Yat-sen University, No. 600, Tianhe Rd., Guangzhou 510630, China.
authors.forename: Zhiliang
authors.initials: Z
authors.lastname: Gao
authors.affiliation: Huashan Hospital, Fudan University, No. 12, Middle Wurumuqi Rd., Shanghai 200040, China.
authors.forename: Jiming
authors.initials: J
authors.lastname: Zhang
authors.affiliation: Shenzhen Donghu Hospital, No. 2019, Buxin Rd., Shenzhen 518020, China.
authors.forename: Boping
authors.initials: B
authors.lastname: Zhou
authors.affiliation: Beijing 302 Hospital, No. 100, Xi Si Huan Zhong Lu, Beijing 100039, China.
authors.forename: Guofeng
authors.initials: G
authors.lastname: Chen
authors.affiliation: Shanghai Changhai Hospital, No. 174, Changhai Rd., Shanghai 200433, China.
authors.forename: Mobin
authors.initials: M
authors.lastname: Wan
authors.affiliation: Huaxi Hospital of Sichuan University, No. 37, Guo Xue Xiang, Chengdu 610041, China.
authors.forename: Hong
authors.initials: H
authors.lastname: Tang
authors.affiliation: Peking University First Hospital, No. 8, Xicheng Xishiku Street, Beijing 100034, China.
authors.forename: Guiqiang
authors.initials: G
authors.lastname: Wang
authors.affiliation: Henan Provincial People's Hospital, No. 7, Weiwu Rd., Zhengzhou 450003, China.
authors.forename: Yuxiu
authors.initials: Y
authors.lastname: Yang
authors.affiliation: University Malaya Medical Centre, Malaysia, Clinical Investigation Centre, 13th Floor, Main Tower, University Malaya Medical Centre, Lembah Pantai 59100, Malaysia.
authors.forename: Rosmawati
authors.initials: R
authors.lastname: Mohamed
authors.affiliation: Medical Clinic One, Mount Elizabeth Medical Centre, Singapore, #17-02, 3 Mt. Elizabeth, 228510 Singapore, Singapore.
authors.forename: Richard
authors.initials: R
authors.lastname: Guan
authors.affiliation: Far Eastern Memorial Hospital, Taiwan, No. 21, Sec. 2, Nanya S. Rd., Banciao District, New Taipei City 22060, Taiwan.
authors.forename: Tzong-Hsi
authors.initials: TH
authors.lastname: Lee
authors.affiliation: Mackay Memorial Hospital, Taiwan, 92, Section 2, Chung Shan North Rd., Taipei City 10449, Taiwan.
authors.forename: Wen-Hsiung
authors.initials: WH
authors.lastname: Chang
authors.affiliation: Merck, Sharp & Dohme, Shanghai, China, 20/F Park Place, 1601 Nanjing Rd. (w), Shanghai 200040, China.
authors.forename: Huang
authors.initials: H
authors.lastname: Zhenfei
authors.affiliation: Merck, Sharp & Dohme, Shanghai, China, 20/F Park Place, 1601 Nanjing Rd. (w), Shanghai 200040, China.
authors.forename: Zhang
authors.initials: Z
authors.lastname: Ye
authors.affiliation: Beijing Ditan Hospital, Capital Medical University, No. 8, East Jingshun Street, Beijing 100015, China. Electronic address: xudaozhen@126.com.
authors.forename: Daozhen
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authors.lastname: Xu
mesh_terms: D000293:Adolescent; D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D044466:Asian People; D004279:DNA, Viral / Q000097:blood; D005260:Female; D006513:Hepatitis B e Antigens / Q000097:blood*; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D000410:Alanine Transaminase; C417083:peginterferon alfa-2b
keywords: Hepatitis B; Peginterferon; Randomized