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学科主题: 临床医学
题名:
Two-year results of a randomized, phase III comparative trial of telbivudine versus lamivudine in Chinese patients
作者: 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
发表日期: 2014
DOI: 10.1007/s12072-013-9488-2
卷: 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
项目资助者: Novartis Pharma AG
WOS记录号: WOS:000330808600010
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/64193
Appears in Collections:北京大学第一临床医学院_期刊论文

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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

Recommended Citation:
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.
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