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学科主题: 临床医学
题名:
Tenofovir disoproxil fumarate vs adefovir dipivoxil in Chinese patients with chronic hepatitis B after 48 weeks: a randomized controlled trial
作者: Hou, J. L.1,2; Gao, Z. L.3; Xie, Q.4; Zhang, J. M.5; Sheng, J. F.6; Cheng, J.7; Chen, C. W.8; Mao, Q.9; Zhao, W.10; Ren, H.11; Tan, D. M.12; Niu, J. Q.13; Chen, S. J.14; Pan, C.15; Tang, H.16; Wang, H.17; Mao, Y. M.18; Jia, J. D.19; Ning, Q.20; Xu, M.21; Wu, S. M.22; Li, J.23; Zhang, X. X.4; Ji, Y.24; Dong, J.25; Li, J.25
关键词: antiviral therapy ; chronic hepatitis B ; efficacy ; tenofovir disoproxil fumarate
刊名: JOURNAL OF VIRAL HEPATITIS
发表日期: 2015-02-01
DOI: 10.1111/jvh.12313
卷: 22, 期:2, 页:85-93
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Gastroenterology & Hepatology ; Infectious Diseases ; Virology
研究领域[WOS]: Gastroenterology & Hepatology ; Infectious Diseases ; Virology
关键词[WOS]: VIRUS ; LAMIVUDINE ; SUSCEPTIBILITY ; RESISTANCE ; MUTATIONS ; INFECTION ; CIRRHOSIS ; THERAPY ; RISK
英文摘要:

Tenofovir disoproxil fumarate (TDF) has demonstrated long-term efficacy and a high barrier to resistance in multiple chronic hepatitis B (CHB) populations outside of China. This study aimed to evaluate the efficacy and safety of TDF compared with adefovir dipivoxil (ADV) in Chinese patients with CHB during 48 weeks of treatment (ClinicalTrial.gov number, NCT01300234). A Phase 3, multicentred, randomized, double-blind, controlled trial compared the efficacy and safety of TDF with ADV in Chinese patients with CHB. The primary endpoint was the proportion of patients with HBV DNA <400 copies/mL in each treatment group at Week 48, using an unpooled Z-test for superiority. Secondary endpoints included viral suppression, serologic response, histological improvement, normalization of alanine aminotransferase (ALT) levels and the emergence of resistance mutations. A total of 509 patients, 202 hepatitis B e antigen (HBeAg)-positive and 307 HBeAg-negative, with HBV DNA >= 10(5) copies/mL received either TDF 300 mg od or ADV 10 mg od. At Week 48, TDF demonstrated superior viral suppression compared with ADV in both HBeAg-positive (76.7% vs 18.2%, P < 0.0001) and HBeAg-negative (96.8% vs 71.2%, P < 0.0001) patients. The majority of patients in both treatment arms achieved ALT normalization (>85%). No resistance to TDF was observed. The frequency of adverse events was comparable between treatment arms (TDF 3.9% vs ADV 4.8%). In this double-blind, randomized, clinical trial, TDF demonstrated superiority over ADV with respect to viral suppression in Chinese patients with CHB at 48 weeks of treatment and without the development of resistance.

语种: 英语
项目资助者: GlaxoSmithKline
WOS记录号: WOS:000350545800002
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/55796
Appears in Collections:北京大学第二临床医学院_北京大学肝病研究所_期刊论文

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作者单位: 1.Ruijin Hosp, Dept Infect Dis, Shanghai, Peoples R China
2.Huashan Hosp, Dept Infect Dis, Shanghai, Peoples R China
3.Nanfang Hosp, Dept Infect Dis, Guangzhou, Guangdong, Peoples R China
4.Nanfang Hosp, Hepatol Unit, Guangzhou, Guangdong, Peoples R China
5.Sun Yat Sen Univ, Affiliated Hosp 3, Dept Infect Dis, Guangzhou 510275, Guangdong, Peoples R China
6.Zhejiang Univ, Coll Med, Affiliated Hosp 1, Dept Infect Dis, Hangzhou 310003, Zhejiang, Peoples R China
7.Capital Med Univ, Beijing Ditan Hosp, Ctr Liver Dis, Beijing, Peoples R China
8.Nanjing Mil, Hosp 85, Liver Dis Res Ctr, Shanghai, Peoples R China
9.Southwest Hosp, Dept Infect Dis, Chongqing, Peoples R China
10.Second Hosp Nanjing, Dept Liver Dis, Nanjing, Jiangsu, Peoples R China
11.Chongqing Med Univ, Affiliated Hosp 2, Dept Infect Dis, Chongqing, Peoples R China
12.Cent S Univ, Xiangya Hosp, Dept Infect Dis, Changsha, Hunan, Peoples R China
13.Jilin Univ, Affiliated Hosp 1, Dept Hepatol, Changchun 130023, Peoples R China
14.Jinan Hosp Infect Dis, Dept Liver Dis, Jinan, Peoples R China
15.Fuzhou Infect Dis Hosp, Dept Hepatol, Fuzhou, Peoples R China
16.Sichuan Univ, West China Hosp, Ctr Infect Dis, Chengdu 610064, Peoples R China
17.Peking Univ, Peoples Hosp, Inst Hepatol, Beijing 100871, Peoples R China
18.Renji Hosp, Dept Gastroenterol, Shanghai, Peoples R China
19.Capital Med Univ, Beijing Friendship Hosp, Liver Res Ctr, Beijing, Peoples R China
20.Huazhong Univ Sci & Technol, Tongji Med Coll, Tongji Hosp, Dept Infect Dis, Wuhan 430074, Peoples R China
21.Guangzhou 8th Peoples Hosp, Dept Liver Dis, Guangzhou, Guangdong, Peoples R China
22.Shanghai Publ Hlth Clin Ctr, Dept Liver Dis, Shanghai, Peoples R China
23.Zhongshan Hosp, Shanghai, Peoples R China
24.Nanjing Med Univ, Affiliated Hosp 1, Dept Infect Dis, Nanjing, Jiangsu, Peoples R China
25.GlaxoSmithKline R&D China, China Med Dev, Shanghai, Peoples R China

Recommended Citation:
Hou, J. L.,Gao, Z. L.,Xie, Q.,et al. Tenofovir disoproxil fumarate vs adefovir dipivoxil in Chinese patients with chronic hepatitis B after 48 weeks: a randomized controlled trial[J]. JOURNAL OF VIRAL HEPATITIS,2015,22(2):85-93.
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