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Five-year Treatment with Tenofovir Alafenamide Achieves High Rates of Viral Suppression, Alanine Aminotransferase Normalization, and Favorable Bone and Renal Safety in Chinese Chronic Hepatitis B Patients

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单位: [1]Southern Med Univ, Nanfang Hosp, Guangzhou 510515, Guangdong, Peoples R China [2]Huazhong Univ Sci & Technol, Tongji Hosp, Tongji Med Coll, Wuhan 430030, Hubei, Peoples R China [3]Capital Med Univ, Beijing Youan Hosp, Beijing 100069, Peoples R China [4]Shanghai Jiao Tong Univ, Shanghai Ruijin Hosp, Sch Med, Shanghai, Peoples R China [5]Nanchang Univ, Dept Rheumatol, Affiliated Hosp 1, Nanchang, Jiangxi, Peoples R China [6]Shanghai Publ Hlth Clin Ctr, Shanghai, Peoples R China [7]Sichuan Univ, West China Hosp, Chengdu, Sichuan, Peoples R China [8]Nanjing Med Univ, Radiat Oncol, Affiliated Hosp 1, Nanjing, Jiangsu, Peoples R China [9]Hainan Gen Hosp, Haikou, Hainan, Peoples R China [10]Nanjing Univ Chinese Med, Hosp Nanjing 2, Nanjing, Jiangsu, Peoples R China [11]Cent South Univ, Xiangya Hosp 2, Changsha, Hunan, Peoples R China [12]Gilead Sci, Shanghai, Peoples R China [13]Gilead Sci, Foster City, CA USA [14]Peoples Liberat Army No 85 Hosp, Shanghai, Peoples R China [15]Cent South Univ, Xiangya Hosp, Changsha, Hunan, Peoples R China [16]Sixth Peoples Hosp Shenyang, Shenyang, Liaoning, Peoples R China [17]Capital Med Univ, Beijing Friendship Hosp, Beijing, Peoples R China
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关键词: Chronic hepatitis B Antiviral therapy Bone safety Renal safety Tenofovir alafenamide Tenofovir disoproxil fumarate Chinese

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Background and Aims: After 3 -years (144 week) of double-blind treatment in Chinese chronic hepatitis B patients in two ongoing phase 3 studies, tenofovir alafenamide (TAF) showed similar efficacy to tenofovir disoproxil fumarate (TDF), with improved renal and bone safety. In this study, we aimed to report the 5 -year results from 2 years into the open -label TAF treatment phase. Methods: All participants completing the 144 -week double-blind treatment were eligible to receive open -label TAF 25 mg once daily up to week 384. Serial analysis of viral suppression (hepatitis B virus DNA <2 9 IU/mL), alanine aminotransferase normalization, serological responses, and safety outcomes at year 5 (week 240) was performed. Results: The openlabel phase included 93% (311/334) of the enrolled participants, which included 212 who switched from double-blind TAF to open -label TAF (TAF-TAF) and 99 who switched from double-blind TDF to open -label TAF (TDF-TAF). Baseline characteristics were comparable. Week 240 viral suppression rates were similar between groups [93.4% vs. 93.9%; difference: -1.5%, (95% CI: -6.4 to -3.5), p=0.857]. Alanine aminotransferase normalization and serological response rates were higher in the TAF-TAF group than in the TDF-TAF group. The frequencies of adverse events and laboratory abnormalities were low and similar between groups. Both groups had similar small numerical declines from baseline in estimated glomerular filtration rate at year 5 (week 240, -2.85 mL/min vs. -3.29 mL/min, p=0.910). The greater declines in renal and bone parameters in the TDF-TAF group through week 144 improved after switching to TAF. Conclusions: The 5 -year TAF treatment efficacy was high and similar to that of 3 -year TDF followed by 2 -year TAF in Chinese chronic hepatitis B patients. Favorable effects on bone and renal parameters were sustained with TAF treatment alone and were observed following the switch from TDF to TAF.

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出版当年[2023]版:
大类 | 3 区 医学
小类 | 4 区 胃肠肝病学
最新[2025]版:
大类 | 3 区 医学
小类 | 3 区 胃肠肝病学
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出版当年[2022]版:
Q2 GASTROENTEROLOGY & HEPATOLOGY
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Q1 GASTROENTEROLOGY & HEPATOLOGY

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第一作者单位: [1]Southern Med Univ, Nanfang Hosp, Guangzhou 510515, Guangdong, Peoples R China [*1]Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong 510515, China
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通讯机构: [1]Southern Med Univ, Nanfang Hosp, Guangzhou 510515, Guangdong, Peoples R China [2]Huazhong Univ Sci & Technol, Tongji Hosp, Tongji Med Coll, Wuhan 430030, Hubei, Peoples R China [*1]Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong 510515, China [*2]Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China
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