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学科主题: 临床医学
题名:
The 104-Week Efficacy and Safety of Telbivudine-Based Optimization Strategy in Chronic Hepatitis B Patients: A Randomized, Controlled Study
作者: Sun, Jian1; Xie, Qing2; Tan, Deming3; Ning, Qin4; Niu, Junqi5; Bai, Xuefan6; Fan, Rong1; Chen, Shijun7; Cheng, Jun8; Yu, Yanyan9; Wang, Hao10; Xu, Min11; Shi, Guangfeng12; Wan, Mobin13; Chen, Xinyue14; Tang, Hong15; Sheng, Jifang16; Dou, Xiaoguang17; Shi, Junping18; Ren, Hong19; Wang, Maorong20; Zhang, Hongfei21; Gao, Zhiliang22; Chen, Chengwei23; Ma, Hong24; Jia, Jidong24; Hou, Jinlin1
刊名: HEPATOLOGY
发表日期: 2014-04-01
DOI: 10.1002/hep.26885
卷: 59, 期:4, 页:1283-1292
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]: PARTIAL VIROLOGICAL RESPONSE ; VIRUS INFECTION ; ENTECAVIR ; MANAGEMENT ; LAMIVUDINE ; THERAPY ; ADEFOVIR ; TRIAL ; TENOFOVIR ; ROADMAP
英文摘要:

An optimization strategy based on the Roadmap concept is supposed to improve the clinical outcomes of patients with suboptimal antiviral response. The aim of this study was to prove the concept with a multicenter, open-label, randomized, controlled study. In all, 606 hepatitis B e antigen (HBeAg)-positive, nucleos(t)ide-naive chronic hepatitis B patients were randomized to the Optimize or Mono group. Patients in the Optimize group were treated with telbivudine for 24 weeks, after which those suboptimal responders with HBV DNA >= 300 copies/mL at week 24 received telbivudine plus adefovir until week 104, while the early virological responders continued telbivudine monotherapy. Patients in theMono group received telbivudine monotherapy. All patients with telbivudine monotherapy had adefovir added if viral breakthrough developed. Sixty-eight percent (204/300) of patients in theOptimize group had adefovir added due to suboptimal response. At week 104, compared to theMono group, more patients in the Optimize group achieved HBV DNA <300 copies/ml (76.7% versus 61.2%, P < 0.001) with less genotypic resistance (2.7% versus 25.8%, P < 0.001). The rates of HBeAg seroconversion and alanine aminotransferase (ALT) normalization were comparable between the two groups (23.7% versus 22.1%; 80.7%versus 79.2%). For week 24 suboptimal responders, telbivudine plus adefovir showed an additive antiviral potency, with 71.1% achieving virological response at week 104 and only 0.5% developing genotypic resistance, compared with 46.6% who achieved virological response and 37.8% who developed genotypic resistance with telbivudinemonotherapy. Both treatment regimens were well tolerated, with an observed persistent increase of the glomerular filtration rate. Conclusion: For suboptimal virological responders to telbivudine at week 24, adjusting the treatment strategy is recommended. Adding adefovir can benefit these patients with additive antiviral potency and low resistance without increased side effects. (HEPATOLOGY 2014;59:1283-1292)

语种: 英语
项目资助者: Novartis
WOS记录号: WOS:000333249800013
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/60592
Appears in Collections:北京大学第一临床医学院_感染疾病科_期刊论文

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作者单位: 1.Beijing Ditan Hosp, Beijing, Peoples R China
2.8th Peoples Hosp, Guangzhou, Guangdong, Peoples R China
3.Beijing Youan Hosp, Beijing, Peoples R China
4.West China Hosp, Dept Infect Dis, Chengdu, Peoples R China
5.6th Peoples Hosp, Hangzhou, Zhejiang, Peoples R China
6.81st PLA Hosp, Dept Infect Dis, Nanjing, Jiangsu, Peoples R China
7.302nd PLA Hosp, Beijing, Peoples R China
8.85th PLA Hosp, Dept Infect Dis, Shanghai, Peoples R China
9.Southern Med Univ, Nanfang Hosp, Hepatol Unit, Guangzhou 510515, Guangdong, Peoples R China
10.Ruijin Hosp, Dept Infect Dis, Shanghai, Peoples R China
11.Cent S Univ, Xiangya Hosp, Dept Infect Dis, Changsha, Hunan, Peoples R China
12.Huazhong Univ Sci & Technol, Tongji Hosp, Dept & Inst Infect Dis, Tongji Med Coll, Wuhan 430074, Peoples R China
13.Jilin Univ, Hepatol Unit, Affiliated Hosp 1, Changchun 130023, Peoples R China
14.Tangdu Hosp, Dept Infect Dis, Xian, Peoples R China
15.Jinan Infect Dis Hosp, Jinan, Peoples R China
16.Peking Univ, Hosp 1, Dept Infect Dis, Beijing 100871, Peoples R China
17.Peking Univ, Peoples Hosp, Hepatol Unit, Beijing 100871, Peoples R China
18.Fudan Univ, Huashan Hosp, Dept Infect Dis, Shanghai 200433, Peoples R China
19.Changhai Hosp, Dept Infect Dis, Shanghai, Peoples R China
20.Zhejiang Univ, Affiliated Hosp 1, Dept Infect Dis, Hangzhou 310003, Zhejiang, Peoples R China
21.China Med Univ, Dept Infect Dis, Shengjing Hosp, Shenyang, Peoples R China
22.Chongqing Med Univ, Affiliated Hosp 2, Dept Infect Dis, Chongqing, Peoples R China
23.Sun Yat Sen Univ, Affiliated Hosp 3, Dept Infect Dis, Guangzhou 510275, Guangdong, Peoples R China
24.Capital Med Univ, Beijing Friendship Hosp, Liver Res Ctr, Beijing, Peoples R China

Recommended Citation:
Sun, Jian,Xie, Qing,Tan, Deming,et al. The 104-Week Efficacy and Safety of Telbivudine-Based Optimization Strategy in Chronic Hepatitis B Patients: A Randomized, Controlled Study[J]. HEPATOLOGY,2014,59(4):1283-1292.
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