IR@PKUHSC  > 北京大学第一临床医学院
学科主题临床医学
Two-year results of a randomized, phase III comparative trial of telbivudine versus lamivudine in Chinese patients
Jia, Ji-Dong1; Hou, Jin-Lin2; Yin, You-Kuan3; Tan, De-Ming4; Xu, Daozhen5; Niu, Jun-Qi6; Zhou, Xia-Qiu7; Wang, Yu-Ming8; Zhu, Li-Min9; Chen, Cheng-Wei10; He, Yong-Wen11; Ren, Hong12; Wan, Mo-Bin13; Wu, Shan-Ming14; Wang, Qin-Huan15; Wei, Lai16; Bao, Weibin17; Dong, Yuhong18; Trylesinski, Aldo18
关键词China Chronic hepatitis B Lamivudine Nucleoside analogs Telbivudine Randomized clinical trial
刊名HEPATOLOGY INTERNATIONAL
2014
DOI10.1007/s12072-013-9488-2
8期:1页:72-82
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Gastroenterology & Hepatology
研究领域[WOS]Gastroenterology & Hepatology
关键词[WOS]CHRONIC HEPATITIS-B ; NATURAL-HISTORY ; VIRUS INFECTION ; MANAGEMENT ; THERAPY ; OUTCOMES ; ROADMAP ; UPDATE ; MODEL ; CHB
英文摘要

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.

Hepatitis B e antigen-positive (n = 290) and -negative (n = 42) adults with nucleoside analog-na < ve 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.

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 log(10) copies/mL; difference -1.49 log(10) (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.

Telbivudine is superior to lamivudine over 2 years of chronic hepatitis B treatment in Chinese patients.

语种英语
WOS记录号WOS:000330808600010
资助机构Novartis Pharma AG
引用统计
被引频次:7[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/64193
专题北京大学第一临床医学院
北京大学第二临床医学院_北京大学肝病研究所
作者单位1.Novartis Pharma AG, Basel, Switzerland
2.Capital Med Univ, Beijing Friendship Hosp, Beijing 100050, Peoples R China
3.Southern Med Univ, Nanfang Hosp, Guangzhou, Guangdong, Peoples R China
4.Shanghai Hua Shan Hosp, Shanghai, Peoples R China
5.Xiang Ya Hosp, Changsha, Hunan, Peoples R China
6.Beijing Ditan Hosp, Beijing, Peoples R China
7.Jilin Univ, Hosp 1, Changchun 130023, Peoples R China
8.Shanghai Jiao Tong Univ, Sch Med, Ruijin Hosp, Shanghai 200030, Peoples R China
9.Third Mil Med Univ, Southwest Hosp, Chongqing, Peoples R China
10.Tianjin Infect Dis Hosp, Tianjin, Peoples R China
11.Nanjing Mil Command, Shanghai Liver Res Ctr, Nanjing, Jiangsu, Peoples R China
12.Xie He Hosp, Wuhan, Peoples R China
13.Chongqing Med Univ, Affiliated Hosp 2, Chongqing, Peoples R China
14.Shanghai Changhai Hosp, Shanghai, Peoples R China
15.Shanghai Publ Hlth Ctr, Shanghai, Peoples R China
16.Peking Univ, Hosp 1, Beijing 100871, Peoples R China
17.Peking Univ, Peoples Hosp, Beijing 100871, Peoples R China
18.Novartis Pharmaceut, E Hanover, NJ USA
推荐引用方式
GB/T 7714
Jia, Ji-Dong,Hou, Jin-Lin,Yin, You-Kuan,et al. Two-year results of a randomized, phase III comparative trial of telbivudine versus lamivudine in Chinese patients[J]. HEPATOLOGY INTERNATIONAL,2014,8(1):72-82.
APA Jia, Ji-Dong.,Hou, Jin-Lin.,Yin, You-Kuan.,Tan, De-Ming.,Xu, Daozhen.,...&Trylesinski, Aldo.(2014).Two-year results of a randomized, phase III comparative trial of telbivudine versus lamivudine in Chinese patients.HEPATOLOGY INTERNATIONAL,8(1),72-82.
MLA Jia, Ji-Dong,et al."Two-year results of a randomized, phase III comparative trial of telbivudine versus lamivudine in Chinese patients".HEPATOLOGY INTERNATIONAL 8.1(2014):72-82.
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