title: Telbivudine versus lamivudine in Chinese patients with chronic hepatitis B: Results at 1 year of a randomized, double-blind trial.
abstract: Chronic hepatitis B and its life-threatening sequelae are highly prevalent in China. There is a need for effective new therapies to suppress hepatitis B virus (HBV) replication and ameliorate liver disease. In this study, we compared the efficacy of telbivudine, a nucleoside analogue, with lamivudine in Chinese patients. In this phase III, double-blind, multicenter trial conducted in China, 332 patients with compensated hepatitis B e antigen (HBeAg)-positive or HBeAg-negative chronic hepatitis B were randomly assigned to treatment with 600 mg of telbivudine or 100 mg of lamivudine daily for 104 weeks. The primary efficacy endpoint was reduction in serum HBV DNA levels at week 52 of treatment. Secondary endpoints included clearance of HBV DNA to undetectable levels, HBeAg loss and seroconversion, therapeutic response, and alanine aminotransferase (ALT) normalization. Viral resistance and safety were assessed. At week 52, among 290 HBeAg-positive patients, mean reductions of serum HBV DNA were significantly greater in telbivudine recipients than lamivudine recipients (6.3 log(10) versus 5.5 log(10), P < 0.001), and HBV DNA was polymerase chain reaction-negative in significantly more telbivudine recipients than lamivudine recipients (67% versus 38%, P < 0.001). ALT normalization (87% versus 75%, P = 0.007), therapeutic response (85% versus 62%, P = 0.001), and HBeAg loss (31% versus 20%, P = 0.047) were also significantly more common in the telbivudine group. Treatment effects showed similar patterns in the smaller HBeAg-negative group (n = 42). Viral resistance in telbivudine recipients was approximately half that observed with lamivudine; however, this difference was not statistically significant. Clinical adverse events were similar in the two treatment groups.
  
  
  CONCLUSIONS
  In Chinese patients with chronic hepatitis B, telbivudine treatment for 52 weeks provided greater antiviral and clinical efficacy than lamivudine, with less resistance.
authors: Nanfang Hospital, Guangzhou, China.
authors: Jinlin
authors: J
authors: Hou
authors: You-Kuan
authors: YK
authors: Yin
authors: Daozhen
authors: D
authors: Xu
authors: Deming
authors: D
authors: Tan
authors: Junqi
authors: J
authors: Niu
authors: Xiaqiu
authors: X
authors: Zhou
authors: Yuming
authors: Y
authors: Wang
authors: Limin
authors: L
authors: Zhu
authors: Yongwen
authors: Y
authors: He
authors: Hong
authors: H
authors: Ren
authors: Mobin
authors: M
authors: Wan
authors: Chengwei
authors: C
authors: Chen
authors: Shanming
authors: S
authors: Wu
authors: Yagang
authors: Y
authors: Chen
authors: Jiazhang
authors: J
authors: Xu
authors: Qinhuan
authors: Q
authors: Wang
authors: Lai
authors: L
authors: Wei
authors: George
authors: G
authors: Chao
authors: Barbara Fielman
authors: BF
authors: Constance
authors: George
authors: G
authors: Harb
authors: Nathaniel A
authors: NA
authors: Brown
authors: Jidong
authors: J
authors: Jia
mesh_terms: D000293:Adolescent; D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D002681:China; D004279:DNA, Viral / Q000032:analysis; D004311:Double-Blind Method; D005260:Female; D005838:Genotype; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000187:drug effects / Q000235:genetics; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D019259:Lamivudine / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009705:Nucleosides / Q000627:therapeutic use*; D011744:Pyrimidinones / Q000627:therapeutic use*; D000077712:Telbivudine; D013936:Thymidine / Q000031:analogs & derivatives
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D009705:Nucleosides; D011744:Pyrimidinones; D000077712:Telbivudine; D019259:Lamivudine; D013936:Thymidine