Tenofovir disoproxil fumarate therapy in patients with chronic hepatitis B and advanced fibrosis or compensated cirrhosis  

作　　者：Huiying Rao Jia Shang Qing Xie Jianqi Lian Pujun Gao Junping Shi Xinyue Chen Jiefei Wang Min Xu Liaoyun Zhang Yingren Zhao QingMao Maorong Wang Wei Zhao Zong Zhang Jidong Jia Hong Tang Jiming Zhang Xin Zheng Chang Liu Lai Wei 

机构地区：[1]Peking University People's Hospital,Peking University Hepatology Institute,Beijing,China [2]Department of Infectious Diseases,Henan Provincial People's Hospital,Zhengzhou,Henan,China [3]Ruijin Hospital,Shanghai Jiaotong University School of Medicine,Department of Infectious Diseases,Shanghai,China [4]Department of Infectious Diseases,Tangdu Hospital,Fourth Military Medical University,Xi'an,Shaanxi,China [5]Jilin University First Hospital,The First Hospital of Jilin University,Changchun,China [6]Department of Liver Disease,The Affiliated Hospital of Hangzhou Normal University,Hangzhou,Zhejiang,China [7]First Department of Liver Disease Center,Beijing Youan Hospital,Capital Medical University,Beijing,China [8]Department of Severe Hepatology,Shanghai Public Health Clinical Centre,Fudan University,Shanghai,China [9]Department of Infectious Diseases,Guangzhou Eighth People's Hospital,Guangzhou Medical University,Guangzhou,China [10]Department Infectious Disease,First Hospital of Shanxi Medical University,Taiyuan,China [11]Department of Infectious Diseases and Hepatology,The First Affiliated Hospital of Xi'an Jiaotong University,Xi'an,Shaanxi,China [12]Department of Infectious Diseases,Southwest Hospital,Army Medical University,Chongqing,China [13]Liver Disease Center,General Hospital,Eastern Theater Command of PLA,Nanjing,China [14]Department of Liver Disease,The Second Hospital of Nanjing,Medical School,Southeast University,Nanjing,China [15]Shandong Public Health Clinical Centre,Shandong University,Jinan,China [16]Liver Research Centre,Beijing Friendship Hospital,Capital Medical University,Beijing,China [17]Department of Infectious Diseases,West China Hospital,Sichuan University,Chengdu,China [18]Department of Infectious Diseases,Huashan Hospital,Fudan University,Shanghai,China [19]Department of Infectious Disease,Institute of Infection and Immunology,Union Hospital,Tongji Medical College,HuaZhong University of Science and Technology,Wuhan,China [20]GlaxoSmithKline(China)R&D Company Limited,Shanghai,China [21]Hep

出　　处：《iLIVER》2022年第3期145-153,共9页国际肝胆健康（英文）

基　　金：supported by GlaxoSmithKline(China)R&D Company Limited.

摘　　要：Background and aims:Tenofovir disoproxil fumarate(TDF)is the first-line therapy for chronic hepatitis B.This interim analysis presents the efficacy and safety data for TDF at Week 144 in patients with chronic hepatitis B and advanced fibrosis or compensated cirrhosis from China.Methods:Patients were assessed for incidence of newly diagnosed hepatocellular carcinoma(HCC)and disease progression,liver stiffness measurement(LSM),virological suppression(serum hepatitis B virus DNA<20 IU/mL),alanine aminotransferase normalization,hepatitis B e antigen(HBeAg)loss and seroconversion,histological liver fibrosis score,and safety at Week 144.Results:Overall,197 patients were enrolled.At Week 144,the incidence of newly diagnosed HCC was observed in 2.1%patients,and the incidence of disease progression was observed in 3.6%patients.The mean(standard deviation)change in LSM from baseline was5.1(5.85)kPa.Serum hepatitis B virus DNA<20 IU/mL was observed in 94.1%patients,alanine aminotransferase normalization in 33.5%patients,HBeAg loss in 35.6%patients,and HBeAg seroconversion in 14.4%patients.Among patients with stage F3 or F4 fibrosis at baseline by LSM,38.3%patients regressed to stage F0/1,and 22.0%of patients regressed to stage F2 at Week 144.Overall,67.7%patients experienced≥1 adverse events,13.8%patients experienced TDF-related adverse events,and 16.4%patients experienced serious(none were TDF-related).Conclusions:At Week 144 of TDF treatment,low incidence of HCC and disease progression were reported.Virological suppression was observed in 94.1%patients,which was associated with fibrosis regression.No new safety events were identified.

关 键 词：Chronic hepatitis B Disease progression Hepatocellular carcinoma nucleos(t)ide analogs 

分 类 号：R512.62[医药卫生—内科学] R575.2[医药卫生—临床医学]