[AASLD 2012]慢性和肝硬化患者超过4年恩替卡韦单药治疗

肝胆速递

CONTROL ID: 1422542
PRESENTATION TYPE: Oral or Poster
CURRENT CATEGORY: Hepatitis B
CURRENT DESCRIPTORS: I01. Patient-centered, Natural History and Effectiveness Research
TITLE: Entecavir monotherapy in NA naive chronic hepatitis B and cirrhosis patients: A retrospective and prospective cohort study over 4 years of treatment
AUTHORS (FIRST NAME, LAST NAME): Yi Liu1, Zhenghong Yuan2, Hong Tang3, Xiaohui Miao4, Lungen Lu6, Jianqi Lian5, Yunjian Sheng1, Junying Liu1, Huaidong Hu1, Yixuan Yang1, Dazhi Zhang1, Hong Ren1
Institutional Author(s):
INSTITUTIONS (ALL): 1. Department of Infectious Diseases, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, China.
2. Public Health Clinical Center Affiliated to Fudan University, Shanghai, China.
3. West China Hospital , Sichuan University, Chengdu, China.
4. Shanghai Changzheng Hospital, Second Military Medical University, Shanghai, China.
5. Tangdu Hospital, the Fourth Military Medical University, Xian, China.
6. Shanghai First People’s Hospital, Shanghai Jiao Tong University, Shanghai, China.
ABSTRACT BODY: Background and aims: To evaluate effectiveness and safety of Entecavir (ETV) in NA naïve patients with chronic hepatitis B and cirrhosis in a real life retrospective and prospective chinese cohort over 4 years.Methods:Six hundred and three consecutive NA naive patients with chronic hepatitis B and cirrhosis, including 507 prospective and 96 retrospective, were recruited in 10 clinical centers in China and treated with ETV 0.5 mg (including various generic and branded ETV)over 4 years. At baseline, median age was 39 years, 75.62% males, 70.48% HBeAg positive, 10.28% cirrhotics. Median HBV DNA was 6.93 log copies/ml (2.73-11.8) and ALT were 82.0 IU/L (5.2-4557.8). Liver function tests and HBV DNA, assessed by a sensitive assays, were performed non-interventional . Clinical data were collected if patients had medical records at 12, 24, 36, 48, 96, 144, 192 weeks post-treatment, according to follow-up period of the patients, and was analyzed using Statistically Package for Social Science 13.0 (SPSS, Inc., Chicago, IL). Continuous data with normal distribution was presented as mean (standard deviation), while abnormal distribution was presented as median.Results:The follow-up data of the patients undergoing ETV monotherapy was showed in Table 1, there are different varying patients population at every timepoint .The virological response rate (undetectable HBV DNA), progressively increased over time, from 22.78%(54/237) at month 6, to 31.47% (73/232)at year 1, 42.21% (111/263)at year 2, 52.8%(85/161) at year 3 and 45.31%(29/64) at years 4. The median period for patients achieved virological response was 12 months. The median level of serum HBV-DNA loads decreased from the baseline were 2.98 log copies/ml at month 6, 3.76 log copies/ml at year 1, 3.52 log copies/ml at year 2, 4.11 log copies/ml at year 3 and 5.20 log copies/ml at years 4. The biochemical response rates (ALT normalization) were 49.88% at month 6, 54.42% at year 1, 45.90% at year 2, 41.07% at year 3 and 57.97% at years 4. The rates of HBeAg seroconversion were 10.26% at month 6, 16.54% at year 1, 20.83% at year 2, 17.53% at year 3 and 24.39% at years 4, respectively. Conclusion:ETV suppressed HBV replication in most NA-naïve patients in real life practice over 4 years, with a favourable safety profile.
Acknowledgements: This work was supported by National S&T Major Project (2008ZX10002-006,2012ZX10002007), Program for Changjiang Scholars and Innovative Research Team in University (No.IRT 0872) and NSFC (No.30930082, 30972584, 81171560).

肝胆速递

当前类别：B型肝炎
描述符：I01。以病人为中心，自然历史博物馆和有效性研究
标题：NA天真的慢性乙型肝炎和肝硬化患者恩替卡韦单药治疗：超过4年的治疗，回顾性和前瞻性队列研究
香港（姓氏，名字），正虹Liu1易渊，，，香港Tang3，小辉Miao4，Lungen LU6，剑气Lian5，云间生，军营Liu1，淮东HU1，轩洋1，大智Zhang1，香港REN1
机构（S）：
机构（ALL）：1。部传染病，附属第二医院，重庆医科大学，重庆，重庆，中国。
2。附属公共卫生临床中心，复旦大学，上海，中国。
3。中国西部医院，四川大学，成都，中国。
4。上海长征医院，第二军医大学，上海，中国。
5。唐都医院，第四军医大学，西安，中国。
6。上海市第一人民医院，上海交通大学，上海，中国。
抽象的身体：背景与目的：NA初治患者与慢性乙肝和肝硬化在现实生活中回顾与前瞻中国队列超过4岁。方法：连续六百元以上三NA初治患者恩替卡韦（ETV）的有效性和安全性评价慢性乙肝和肝硬化，其中包括507前瞻性和96追溯，在中国的10个临床中心招募和恩替卡韦0.5毫克（包括各种通用化和品牌化ETV）超过4年的治疗。在基线，平均年龄为39岁，75.62％为男性，70.48％，HBeAg阳性，10.28％，肝硬化患者。中位数HBV DNA为6.93日志拷贝/ ml（2.73-11.8）和ALT分别为82.0 IU / L（5.2-4557.8）。肝功能检查和HBV DNA，通过一个敏感的检测评估，进行非介入。收集临床资料，如果患者的医疗记录，12，24，36，48，96，144，192周治疗后，根据随访期间的患者，并进行了分析据统计软件包社会科学13.0（SPSS公司，芝加哥，IL）。正态分布的连续数据以均数（标准差），而异常分布作为median.Results提出：ETV单药治疗的患者的随访数据显示在表1中，不同的患者有不同的人口在每一个时间点的病毒学应答率（检测不到HBV DNA），随着时间的推移逐渐增加，从6个月时的22.78％（54/237），第2年第1年的31.47％（73/232），42.21％（111/263） ，52.8％（85/161），第3年和45.31％（29/64）年4。取得病毒学应答的患者的中位随访时间为12个月。的中位数水平从基线血清HBV-DNA载量下降2.98 log拷贝/毫升6个月时，3.76日志拷贝/ ml，在第1年，第2年3.52日志拷贝/ ml，4.11日志拷贝/ ml在3年及5.20年4日志拷贝/毫升。生化反应率（ALT正常化）在6个月的49.88％，54.42％，第1年，第2年的45.90％，41.07％，第3年和57.97年4％。 HBeAg血清学转换率分别为6个月时的10.26％，16.54％，第1年，第2年为20.83％，17.53％，第3年和24.39年4％，分别。结论：ETV抑制HBV复制的最NA初治患者超过4年的做法在现实生活中，良好的安全性。
致谢：这项工作是国家科技重大专项（2008ZX10002-006，2012ZX10002007），大学（No.IRT 0872）和国家自然科学基金（No.30930082，30972584，81171560）长江学者和创新团队发展计划为支持。

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