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Telbivudine versus lamivudine in Chinese patients with chronic hepatitis B: Results at 1 year of a randomized, double‐blind trial
Author(s) -
Hou Jinlin,
Yin YouKuan,
Xu Daozhen,
Tan Deming,
Niu Junqi,
Zhou Xiaqiu,
Wang Yuming,
Zhu Limin,
He Yongwen,
Ren Hong,
Wan Mobin,
Chen Chengwei,
Wu Shanming,
Chen Yagang,
Xu Jiazhang,
Wang Qinhuan,
Wei Lai,
Chao George,
Constance Barbara Fielman,
Harb George,
Brown Nathaniel A.,
Jia Jidong
Publication year - 2008
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.22075
Subject(s) - telbivudine , lamivudine , medicine , hbeag , gastroenterology , hepatitis b virus , hepatitis b , nucleoside analogue , seroconversion , immunology , virology , virus , hbsag , nucleoside , biology , biochemistry
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. Conclusion: In Chinese patients with chronic hepatitis B, telbivudine treatment for 52 weeks provided greater antiviral and clinical efficacy than lamivudine, with less resistance. (H EPATOLOGY 2007.)