One hundred and ninety-two weeks treatment of entecavir maleate for Chinese chronic hepatitis B predominantly genotyped B or C  

作　　者：Jing-Hang Xu Sa Wang Da-Zhi Zhang Yan-Yan Yu Chong-Wen Si Zheng Zeng Zhong-Nan Xu Jun Li Qing Mao Hong Tang Ji-Fang Sheng Xin-Yue Chen Qin Ning Guang-Feng Shi Qing Xie Xi-Quan Zhang Jun Dai 

机构地区：[1]Department of Infectious Diseases,Center for Liver Diseases,Peking University First Hospital,Beijing 100094,China [2]Clinical and Research Center of Infectious Diseases,Beijing Ditan Hospital,Capital Medical University,Beijing 100015,China [3]Department of Infectious Diseases,The Second Affiliated Hospital with Chongqing Medical University,Chongqing 400010,China [4]Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd,Nanjing 222006,Jiangsu Province,China [5]Department of Infectious Diseases,The First Affiliated Hospital with Nanjing Medical University,Nanjing 210029,Jiangsu Province,China [6]Department of Infectious Diseases,Southwest China Hospital,Chongqing 400038,China [7]Department of Infectious Diseases,West China Hospital,Chengdu 610041,Sichuan Province,China [8]Department of Infectious Diseases,The First Affiliated Hospital of Zhejiang University,Hangzhou 310010,Zhejiang Province,China [9]Department of International Medicine,Beijing Youan Hospital,Capital Medical University,Beijing 100069,China [10]Department and Institute of Infectious Diseases,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,Hubei Province,China [11]Department of Infectious Diseases,Huashan Hospital,Fudan University,Shanghai 200040,China [12]Department of Infectious Diseases,Ruijin Hospital,Jiaotong University School of Medicine,Shanghai 200025,China

出　　处：《World Journal of Clinical Cases》2022年第28期10085-10096,共12页世界临床病例杂志

摘　　要：BACKGROUND Entecavir(ETV)is a potent and selective nucleotide analog with significant activity against hepatitis B virus(HBV).ETV maleate is a derivative compound of ETV and was reported to have an efficacy and safety profile that is comparable to ETV(Baraclude)when used in Chinese patients with chronic hepatitis B(CHB)in phase III clinical trials(Clinical Trials.gov number,NCT-01926288)at weeks 48,96,and 144.AIM To investigate the antiviral potency and safety of ETV maleate at week 192 in Chinese CHB patients predominantly genotyped B or C.METHODS In this double-blind study,we randomly assigned patients to receive 0.5 mg/d ETV(Group A)or ETV maleate(Group B)(ratio,1:1),each with a placebo tablet for 48 wk.Then,all patients received open-label treatment with 0.5 mg/d ETV maleate starting at week 49.The primary efficacy endpoint was the reduction in HBV DNA levels from baseline.Secondary endpoints included the proportion of patients with undetectable HBV DNA(<20 IU/m L),serologic response,serum alanine aminotransferase(ALT)normalization and development of resistance mutations.RESULTS Two hundred eighteen patients who were hepatitis B e antigen(HBe Ag)positive and 57 who were HBe Ag negative were analyzed and predominantly presented with genotype B(49.82%)or C(48.73%).For the HBe Ag-positive CHB patients,the mean HBV DNA level decrease(6.61 Log10 IU/m L vs 6.69 Log10 IU/m L,P>0.05),viral suppression with HBV DNA<20 IU/m L(83.33%vs 79.17%,P>0.05)and HBe Ag seroconversion(28.77%vs 20.00%,P>0.05)occurred similarly between Groups A and B at week 192.However,there was a significant difference in the proportion of patients with normal ALT levels(91.14%vs 78.38%,P<0.05).For the HBe Ag-negative CHB patients,no significant difference was found between Groups A and B at week 192 in terms of reductions in HBV DNA levels from baseline(6.05 Log10 IU/m L vs 6.03 Log10 IU/m L,P>0.05),percentages of patients who achieved undetectable HBV DNA(100%vs 100%,P>0.05)and rates of ALT normalization(95.65%vs 100.00%,P>0.05).Safety and adve

关 键 词：Chronic hepatitis B Entecavir maleate Randomized controlled trial Treatment outcome MUTATION GENOTYPE 

分 类 号：R512.62[医药卫生—内科学]