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学科主题: 基础医学
题名:
Randomized, three-arm study to optimize lamivudine efficacy in hepatitis B e antigen-positive chronic hepatitis B patients
作者: Liang, Xieer1; Cheng, Jun3; Sun, Yongtao9; Chen, Xinyue4; Li, Tong6; Wang, Hao7; Jiang, Jianning10; Chen, Xiaoping2; Long, Hui11; Tang, Hong12; Yu, Yanyan8; Sheng, Jifang13; Chen, Shijun15; Niu, Junqi16; Ren, Hong17; Shi, Junping14; Dou, Xiaoguang18; Wan, Mobin19; Jiang, Jiaji23; Xie, Qing20; Shi, Guangfeng21; Ning, Qin24; Chen, Chengwei22; Tan, Deming25; Ma, Hong5; Sun, Jian1; Jia, Jidong5; Zhuang, Hui6; Hou, Jinlin1
关键词: adefovir dipivoxil ; hepatitis B e antigen ; lamivudine ; optimization strategy ; virological response
刊名: JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY
发表日期: 2015-04-01
DOI: 10.1111/jgh.12835
卷: 30, 期:4, 页:748-755
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]: ADEFOVIR DIPIVOXIL ; THERAPY ; TELBIVUDINE ; MANAGEMENT ; ENTECAVIR ; TENOFOVIR ; ROADMAP ; SAFETY
英文摘要:

Background and AimData about the efficacy of de novo combination therapies, or optimization strategy by adding the other drug based on the virological response at week 24 of low genetic barrier antiviral agents is still limited. This study aimed to compare the efficacy at week 104 of lamivudine monotherapy (MONO), lamivudine plus adefovir dipivoxil (ADV) combination therapy (COMBO), and lamivudine optimization strategy (OPTIMIZE).

MethodsAdult patients without antiviral therapy within 6 months before screening with hepatitis B virus (HBV)-DNA10(5) copies/mL, alanine aminotransferase 1.3-10 times upper limit of normal and compensated hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB) were randomized into three groups with 1:1:1 ratio. Patients in OPTIMIZE group started with lamivudine 100mg q.d., and ADV 10mg q.d. was added to suboptimal responders (HBV-DNA >1000 copies/mL at week 24) from week 30 to week 104, whereas patients with early virological response (HBV-DNA1000 copies/mL at week 24) continued MONO until week 104. For all the patients receiving MONO, ADV would be added if virological breakthrough was confirmed.

ResultsAt week 104, more patients in COMBO and OPTIMIZE groups achieved HBV-DNA<300 copies/mL (53.3% [64/120] and 48.3% [58/120]), with less lamivudine resistance (0.8% and 6.7%) compared with MONO group (HBV-DNA<300 copies/mL 34.8% [41/118], lamivudine resistance 58.5%). Patients under MONO with early virological response showed superior efficacy at week 104 (HBV-DNA<300 copies/mL 73.1% [38/52], HBeAg seroconversion 40.4% [21/52]). All regimens were well tolerated.

ConclusionCombination therapy of lamivudine plus ADV exhibited effective viral suppression and relatively low resistance in HBeAg-positive CHB patients. In lamivudine-treated patients with suboptimal virological response at week 24, promptly adding on ADV is necessary to prevent resistance development.

语种: 英语
所属项目编号: 2012ZX10002003
项目资助者: National Science and Technology Major Project of China
WOS记录号: WOS:000351403200023
Citation statistics:
内容类型: 期刊论文
版本: 出版稿
URI标识: http://ir.bjmu.edu.cn/handle/400002259/66868
Appears in Collections:基础医学院_病原生物学系_期刊论文

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作者单位: 1.Southern Med Univ, Nanfang Hosp, Guangdong Prov Key Lab Viral Hepatitis Res, State Key Lab Organ Failure Res,Dept Infect Dis, Guangzhou 510515, Guangdong, Peoples R China
2.Guangdong Gen Hosp, Dept Infect Dis, Guangzhou, Guangdong, Peoples R China
3.Capital Med Univ, Beijing Ditan Hosp, Beijing, Peoples R China
4.Capital Med Univ, Beijing Youan Hosp, Beijing, Peoples R China
5.Capital Med Univ, Beijing Friendship Hosp, Liver Res Ctr, Beijing, Peoples R China
6.Peking Univ, Hlth Sci Ctr, Dept Microbiol, Beijing, Peoples R China
7.Peking Univ, Peoples Hosp, Hepatol Unit, Beijing, Peoples R China
8.Peking Univ, Hosp 1, Dept Infect Dis, Beijing 100871, Peoples R China
9.Fourth Mil Med Univ, Tangdu Hosp, Dept Infect Dis, Xian 710032, Peoples R China
10.First People Hosp Foshan, Dept Infect Dis, Foshan, Peoples R China
11.6th Peoples Hosp, Hangzhou, Zhejiang, Peoples R China
12.Jinan Infect Dis Hosp, Jinan, Peoples R China
13.Guangxi Med Univ, Affiliated Hosp 1, Dept Infect Dis, Nanning, Peoples R China
14.Sichuan Univ, West China Hosp, Ctr Infect Dis, Chengdu 610064, Peoples R China
15.Zhejiang Univ, Affiliated Hosp 1, Dept Infect Dis, Hangzhou 310003, Zhejiang, Peoples R China
16.Jilin Univ, Affiliated Hosp 1, Hepatol Unit, Changchun 130023, Peoples R China
17.Chongqing Med Univ, Affiliated Hosp 2, Dept Infect Dis, Chongqing, Peoples R China
18.China Med Univ, Shengjing Hosp, Dept Infect Dis, Shenyang 110001, Peoples R China
19.Second Mil Med Univ, Changhai Hosp, Dept Infect Dis, Shanghai, Peoples R China
20.Shanghai Jiao Tong Univ, Sch Med, Ruijin Hosp, Dept Infect Dis, Shanghai 200030, Peoples R China
21.Fudan Univ, Huashan Hosp, Dept Infect Dis, Shanghai, Peoples R China
22.85th Peoples Liberat Army Hosp, Dept Infect Dis, Shanghai, Peoples R China
23.Fujian Med Univ, Affiliated Hosp 1, Ctr Liver, Fuzhou, Peoples R China
24.Huazhong Univ Sci & Technol, Tongji Med Coll, Tongji Hosp, Dept Infect Dis, Wuhan 430074, Peoples R China
25.Cent S Univ, Xiangya Hosp, Dept Infect Dis, Changsha, Hunan, Peoples R China

Recommended Citation:
Liang, Xieer,Cheng, Jun,Sun, Yongtao,et al. Randomized, three-arm study to optimize lamivudine efficacy in hepatitis B e antigen-positive chronic hepatitis B patients[J]. JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY,2015,30(4):748-755.
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