机构：[1]Liver Research Center, Beijing Friendship Hospital , Capital Medical University, Beijing Key Laboratory of Translational Medicine in Liver Cirrhosis, National Clinical Research Center of Digestive Diseases , Beijing , China.首都医科大学附属北京友谊医院[2]Infectious Department , Affiliated Hospital of Yanbian University , Yanji , China.[3]Department of Gastroenterology , Zhongshan Hospital, Fudan University , Shanghai , China.[4]Department of Infectious Diseases , China-Japan Friendship Hospital , Beijing , China.[5]Department of Infectious Diseases , Nanfang Hospital, Southern Medical University , Guangzhou , China.[6]Department of Gastroenterology and Hepatology , Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine , Shanghai , China.[7]Center of Liver Diseases , Beijing Ditan Hospital, Capital Medical University , Beijing , China.[8]Institute of Infectious Diseases , Beijing Ditan Hospital, Capital Medical University , Beijing , China.[9]Department of Infectious Diseases , Third Affiliated Hospital, Zhongshan University , Guangzhou , China.中山大学附属第三医院[10]Department of Infectious Diseases , Zhengzhou University People's Hospital , Zhengzhou , China.[11]Department of Gastroenterology , Shanghai Public Health Clinical Center , Shanghai , China.[12]Department of Infectious Diseases , Ruijin Hospital , Shanghai , China.[13]Department of Gastroenterology and Hepatology , Beijing Youan Hospital, Capital Medical University , Beijing , China.[14]Department of Infectious Disease , Southwest Hospital, Third Military Medical University , Chongqing , China.[15]Department of Infectious Disease , West China Hospital, Sichuan University , Chengdu , China.四川大学华西医院[16]Department of Hepatology , The Sixth People's Hospital of Shenyang , Shenyang , China.
ABSTRACT Background: Thymosin alpha-1 (Ta-1) suppresses HBV viral replication, while the evidence of combination effect with nucleoide is still limited. We aimed to investigate the efficacy and safety of combination therapy of Ta-1 with entecavir (ETV) in patients with compensated liver cirrhosis.
A total of 690 patients were randomized to receive Ta-1 plus ETV (n = 351) or ETV monotherapy (n = 339) for 52 weeks after 26 weeks of ETV treatment, followed by continued entecavir therapy. The primary endpoint was defined as liver decompensation, hepatocellular carcinoma (HCC) or death.
The median followed up was 38.2 months. The cumulative incidence of liver decompensation, HCC, or death were similar between two groups. During the Ta-1 combination treatment, the HCC incidence was 1.7% in combination group and 2.1% in ETV group, without new HCC cases developed during week 39 to week 77 in combination group. The virologic response, serologic response, biochemical response was similar between two groups at week 104. Both therapies were well-tolerated.
There was no significant difference between two groups in endpoint events, while combination therapy with Ta-1 has a tendency to inhibit the development of HCC.
基金：
This study was supported by The National Science and Technology Major
Project (2013ZX10002004), Project of Beijing Municipal Science and
Technology Commission (D121100003912003, Z151100004015237) and
National Key Technologies R&D Program (2015BAI13B09).
语种：
外文
被引次数：
WOS：
PubmedID：
中科院(CAS)分区：
出版当年[2018]版：
大类|2 区医学
小类|3 区生物工程与应用微生物3 区医学：研究与实验
最新[2023]版：
大类|3 区医学
小类|2 区生物工程与应用微生物3 区医学：研究与实验
JCR分区：
出版当年[2018]版：
Q2MEDICINE, RESEARCH & EXPERIMENTALQ2BIOTECHNOLOGY & APPLIED MICROBIOLOGY
最新[2023]版：
Q2BIOTECHNOLOGY & APPLIED MICROBIOLOGYQ2MEDICINE, RESEARCH & EXPERIMENTAL
第一作者机构：[1]Liver Research Center, Beijing Friendship Hospital , Capital Medical University, Beijing Key Laboratory of Translational Medicine in Liver Cirrhosis, National Clinical Research Center of Digestive Diseases , Beijing , China.
共同第一作者：
通讯作者：
通讯机构：[1]Liver Research Center, Beijing Friendship Hospital , Capital Medical University, Beijing Key Laboratory of Translational Medicine in Liver Cirrhosis, National Clinical Research Center of Digestive Diseases , Beijing , China.[*1]Liver Center, Beijing Friendship Hospital, Capital Medical University, Beijing Key Laboratory of Translational Medicine in Liver Cirrhosis, National Clinical Research Center of Digestive Diseases, Beijing 100050, China
推荐引用方式(GB/T 7714)：
Wu Xiaoning,Shi Yiwen,Zhou Jialing,et al.Combination of entecavir with thymosin alpha-1 in HBV-related compensated cirrhosis: a prospective multicenter randomized open-label study.[J].EXPERT OPINION ON BIOLOGICAL THERAPY.2018,18:61-69.doi:10.1080/14712598.2018.1451511.
APA：
Wu Xiaoning,Shi Yiwen,Zhou Jialing,Sun Yameng,Piao Hongxin...&You Hong.(2018).Combination of entecavir with thymosin alpha-1 in HBV-related compensated cirrhosis: a prospective multicenter randomized open-label study..EXPERT OPINION ON BIOLOGICAL THERAPY,18,
MLA：
Wu Xiaoning,et al."Combination of entecavir with thymosin alpha-1 in HBV-related compensated cirrhosis: a prospective multicenter randomized open-label study.".EXPERT OPINION ON BIOLOGICAL THERAPY 18.(2018):61-69
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