单位：[1]State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Department of Hepatology Unit and Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China[2]3rd Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China中山大学附属第三医院[3]Ruijin Hospital Affiliated to Jiaotong University, School of Medicine, Shanghai, China[4]Huashan Hospital Affiliated to Fudan University, Shanghai, China[5]1st Affiliated Hospital of ZheJiang University, Hangzhou, China浙江大学医学院附属第一医院[6]Beijing Ditan Hospital, Capital Medical University, Beijing, China[7]Shanghai the 85th Hospital Affiliated to Nanjing Military, Shanghai, China[8]Southwest Hospital, Army Medical University, Chongqing, China[9]2nd Hospital of Nanjing, Nanjing, China[10]2nd Affiliated Hospital Chongqing Medical University, Chongqing, China[11]Xiangya Hospital Central-South University, Changsha, China[12]1st Affiliated Hospital of Jilin University, Changchun, China[13]Jinan Hospital for Infectious Disease, Jinan, China[14]Mengchao Hepatobiliary Hospital of Fujian Medical University, Fujian Sheng, China[15]West China Hospital, Sichuan University, Chengdu, China四川大学华西医院[16]Peking University People’s Hospital, Beijing, China[17]RenJi Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China[18]Beijing Friendship Hospital, Capital University, Beijing, China首都医科大学附属北京友谊医院[19]Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China华中科技大学同济医学院附属同济医院[20]Guangzhou Eighth Municipal People’s Hospital, Guangzhou, China[21]Shanghai Public Health Clinical Center, Shanghai, China[22]The First Affiliated Hospital with Nanjing Medical University, Nanjing, China江苏省人民医院[23]GlaxoSmithKline R&D Company Limited, Shanghai, China
Background and aim Long-term treatment with tenofovir disoproxil fumarate (TDF) has demonstrated suppression of viral replication outside of China. This study aims to assess efficacy, resistance and safety of TDF for up to 240 weeks in Chinese patients with chronic hepatitis B virus (HBV) infection. Methods Patients (HBeAg-positive or HBeAg-negative) who were randomised to receive TDF 300 mg or adefovir dipivoxil (ADV) 10 mg once daily in the 48-week double-blind phase (N = 498) were eligible to enter the open-label TDF phase (TDF-TDF and ADV-TDF groups) for additional 192 weeks. Results Overall, 457/512 (89.3%) randomised patients completed 240 weeks of treatment. Virological suppression was achieved in 84.5% and 87.9% in HBeAg-positive patients and 89.6% and 89.5% in HBeAg-negative patients in TDF-TDF and ADV-TDF groups, respectively, at week 240. The majority of patients from both groups had normalized alanine transaminase levels. More patients had HBeAg loss (41.7% vs. 36.4%) and HBeAg seroconversion (32.0% vs. 28.3%) in TDF-TDF than in ADV-TDF group, respectively. Only one HBeAg-positive patient in TDF-TDF group had HBsAg loss at week 240. No evidence of resistance to TDF was observed. The incidence of adverse events was similar in both groups (TDF-TDF, 56.4% vs. ADV-TDF, 51.6%). One patient had serum creatinine elevation >= 0.5mg/dL above baseline, and three patients had confirmed grade 3/4 phosphorus abnormalities (< 2mg/dL). Conclusion In Chinese patients with chronic HBV, long-term treatment with TDF showed sustained viral suppression without development of resistance up to 240 weeks. No new safety concerns were found with TDF in this patient population.
第一作者单位：[1]State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Department of Hepatology Unit and Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China
通讯作者：
推荐引用方式(GB/T 7714)：
Xieer Liang,Zhiliang Gao,Qing Xie,et al.Long-term efficacy and safety of tenofovir disoproxil fumarate in Chinese patients with chronic hepatitis B: 5-year results[J].HEPATOLOGY INTERNATIONAL.2019,13(3):260-269.doi:10.1007/s12072-019-09943-6.
APA：
Xieer Liang,Zhiliang Gao,Qing Xie,Jiming Zhang,Jifang Sheng...&Jinlin Hou.(2019).Long-term efficacy and safety of tenofovir disoproxil fumarate in Chinese patients with chronic hepatitis B: 5-year results.HEPATOLOGY INTERNATIONAL,13,(3)
MLA：
Xieer Liang,et al."Long-term efficacy and safety of tenofovir disoproxil fumarate in Chinese patients with chronic hepatitis B: 5-year results".HEPATOLOGY INTERNATIONAL 13..3(2019):260-269
医学