title: Two-year results of a randomized, phase III comparative trial of telbivudine versus lamivudine in Chinese patients.
abstract: OBJECTIVE
  The burden of chronic hepatitis B infection is high in China, where prevalence exceeds 7 %. This was a randomized, double-blinded, phase III study of the efficacy and safety of telbivudine and lamivudine treatment at 104 weeks in Chinese patients with chronic hepatitis B.
  
  
  METHODS
  Hepatitis B e antigen-positive (n = 290) and -negative (n = 42) adults with nucleoside analog-naïve compensated chronic hepatitis B were randomized to receive telbivudine 600 mg/day or lamivudine 100 mg/day for 104 weeks. The primary endpoint was reduction from baseline in serum hepatitis B virus (HBV) DNA at week 52. Week 104 analyses included HBV DNA reductions, undetectable HBV DNA (<300 copies/mL), ALT normalization, and e-antigen loss/seroconversion. Efficacy at week 104 was also assessed as a function of week 24 HBV DNA.
  
  
  RESULTS
  In the intention-to-treat population (n = 332) at week 104, telbivudine was superior to lamivudine for reduction of HBV DNA [-5.48 vs. -4.00 log10 copies/mL; difference -1.49 log10 (95 % confidence interval -2.2, -0.8); p < 0.0001], for the proportion with undetectable HBV DNA (61.9 vs. 38.5 %; p < 0.0001), for ALT normalization (75.8 vs. 61.3 %; p = 0.0049), and for e-antigen loss (39.9 vs. 28.2 %; p = 0.0373). The cumulative probability of genotypic drug resistance was 15.4 % on telbivudine versus 23.6 % on lamivudine through week 104. Early virologic response at week 24 was associated with improved outcomes at week 104. Adverse events were similar to those seen in the GLOBE study.
  
  
  CONCLUSIONS
  Telbivudine is superior to lamivudine over 2 years of chronic hepatitis B treatment in Chinese patients.
authors.affiliation: Beijing Friendship Hospital, Capital Medical University, 95 Yong-An Road, Xicheng District, Beijing, 100050, China. jia_jd@ccmu.edu.cn.
authors.forename: Ji-Dong
authors.initials: JD
authors.lastname: Jia
authors.affiliation: Nanfang Hospital, Southern Medical University, Guangzhou, China. jlhousmu@yahoo.com.cn.
authors.forename: Jin-Lin
authors.initials: JL
authors.lastname: Hou
authors.affiliation: Shanghai Hua Shan Hospital, Shanghai, China. hshyyk@yahoo.com.cn.
authors.forename: You-Kuan
authors.initials: YK
authors.lastname: Yin
authors.affiliation: Xiang Ya Hospital, Changsha, China. dmt2008@yahoo.com.cn.
authors.forename: De-Ming
authors.initials: DM
authors.lastname: Tan
authors.affiliation: Beijing Ditan Hospital, Beijing, China. xudaozhen@126.com.
authors.forename: Daozhen
authors.initials: D
authors.lastname: Xu
authors.affiliation: First Hospital, University of Jilin, Changchun, China. junqiniu@yahoo.com.cn.
authors.forename: Jun-Qi
authors.initials: JQ
authors.lastname: Niu
authors.affiliation: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. rjzhouxiaqiu@hotmail.com.
authors.forename: Xia-Qiu
authors.initials: XQ
authors.lastname: Zhou
authors.affiliation: Southwest Hospital, Third Military Medical University, Chongqing, China. wym417@mail.tmmu.com.cn.
authors.forename: Yu-Ming
authors.initials: YM
authors.lastname: Wang
authors.affiliation: Tianjin Infectious Diseases Hospital, Tianjin, China. zhuliminidh@yahoo.com.cn.
authors.forename: Li-Min
authors.initials: LM
authors.lastname: Zhu
authors.affiliation: Shanghai Liver Research Centre, Nanjing Military Command, Shanghai, China. ccw2@163.com.
authors.forename: Cheng-Wei
authors.initials: CW
authors.lastname: Chen
authors.affiliation: Xie He Hospital, Wuhan, China. hyw581441@yahoo.com.cn.
authors.forename: Yong-Wen
authors.initials: YW
authors.lastname: He
authors.affiliation: The Second Affiliated Hospital, Chongqing Medical University, Chongqing, China. renhong0531@vip.sina.com.cn.
authors.forename: Hong
authors.initials: H
authors.lastname: Ren
authors.affiliation: Shanghai Changhai Hospital, Shanghai, China. mobinwan@yahoo.com.cn.
authors.forename: Mo-Bin
authors.initials: MB
authors.lastname: Wan
authors.affiliation: Shanghai Public Health Center, Shanghai, China. wusm96@yahoo.com.cn.
authors.forename: Shan-Ming
authors.initials: SM
authors.lastname: Wu
authors.affiliation: First Hospital of Peking University, Beijing, China. wangqh2008@163.com.
authors.forename: Qin-Huan
authors.initials: QH
authors.lastname: Wang
authors.affiliation: Peking University People's Hospital, Beijing, China. weelai@163.com.
authors.forename: Lai
authors.initials: L
authors.lastname: Wei
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. weibin.bao@novartis.com.
authors.forename: Weibin
authors.initials: W
authors.lastname: Bao
authors.affiliation: Novartis Pharma AG, Basel, Switzerland. yuhong.dong@novartis.com.
authors.forename: Yuhong
authors.initials: Y
authors.lastname: Dong
authors.affiliation: Novartis Pharma AG, Basel, Switzerland. aldo.trylesinski@novartis.com.
authors.forename: Aldo
authors.initials: A
authors.lastname: Trylesinski
keywords: China; Chronic hepatitis B; Lamivudine; Nucleoside analogs; Randomized clinical trial; Telbivudine