Telbivudine versus lamivudine in Chinese patients with chronic hepatitis B: Results at 1 year of a randomized, double-blind trial

被引：140

作者：

Hou, Jinlin ^{[1
]}

Yin, You-Kuan ^{[2
]}

Xu, Daozhen ^{[3
]}

Tan, Deming ^{[4
]}

Niu, Junqi ^{[5
]}

Zhou, Xiaqiu ^{[6
]}

Wang, Yuming ^{[7
]}

Zhu, Limin ^{[8
]}

He, Yongwen ^{[9
]}

Ren, Hong ^{[10
]}

Wan, Mobin ^{[11
]}

Chen, Chengwei ^{[12
]}

Wu, Shanming ^{[13
]}

Chen, Yagang ^{[14
]}

Xu, Jiazhang ^{[15
]}

Wang, Qinhuan ^{[16
]}

Wei, Lai ^{[17
]}

Chao, George ^{[18
]}

Constance, Barbara Fielman ^{[18
]}

Harb, George ^{[20
]}

Brown, Nathaniel A. ^{[18
]}

Jia, Jidong ^{[19
]}

机构：

[1] Nanfang Hosp, Guangzhou, Peoples R China

[2] Shanghai Hua Shan Hosp, Shanghai, Peoples R China

[3] Beijing Ditan Hosp, Beijing, Peoples R China

[4] Xiang Ya Hosp, Changsha, Peoples R China

[5] No 1 Hosp, Changchun, Peoples R China

[6] Shanghai Jiao Tong Univ, Sch Med, Ruijin Hosp, Dept Infect Dis, Shanghai 200030, Peoples R China

[7] Xi Nan Hosp, Chongqing, Peoples R China

[8] Tianjin Infect Dis Hosp, Tianjin, Peoples R China

[9] Xie He Hosp, Wuhan, Peoples R China

[10] Chongqing Med Univ, Affiliated Hosp 2nd, Chongqing, Peoples R China

[11] Shanghai Changhai Hosp, Shanghai, Peoples R China

[12] Nanjing Mil Command, Shanghai Liver Res Ctr, Shanghai, Peoples R China

[13] Shanghai Publ Hlth Ctr, Shanghai, Peoples R China

[14] First Affiliated Hosp, Hangzhou, Peoples R China

[15] 81st PLA Hosp, Nanjing, Peoples R China

[16] Peking Univ, First Hosp, Beijing 100871, Peoples R China

[17] Peking Univ, Peoples Hosp, Peking Univ Hepatol Inst, Beijing 100871, Peoples R China

[18] Idenix Pharmaceut, Cambridge, MA USA

[19] Capital Med Univ, Beijing Friendship Hosp, Liver Res Ctr, Beijing 100050, Peoples R China

[20] Novartis Pharmaceut, E Hanover, NJ USA

来源：

HEPATOLOGY | 2008年 / 47卷 / 02期

关键词：

HEPATOCELLULAR-CARCINOMA; NATURAL-HISTORY; VIRUS INFECTION; ENTECAVIR; RISK; COMBINATION; RESISTANCE; DNA;

D O I：

10.1002/hep.22075

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

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 larnivudine 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.

引用

页码：447 / 454

页数：8

共 35 条

[1]

BEASLEY RP, 1981, LANCET, V2, P1129

[2] Telbivudine preclinical safety studies suggest minimal risk of chronic toxicity, reproductive toxicity or carcinogenicity [J].