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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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Journal of Clinical and Translational Hepatology 2024年第5期12卷 469-480页

作者： Jinlin Hou Qin Ning Zhongping Duan Yu Chen Qing Xie Lunli Zhang Shanming Wu Hong Tang Jun Li Feng Lin Yongfeng Yang Guozhong Gong Yanwen Luo Shelley Xie Hongyuan Wang Roberto Mateo Tahmineh Yazdi Frida Abramov Leland JYee John Flaherty Chengwei Chen Yan Huang Mingxiang Zhang Jidong Jia Nanfang Hospital Southern Medical UniversityGuangzhouGuangdongChina Tongji Hospital Tongji Medical CollegeHuazhong University of Science and TechnologyWuhanHubeiChina Beijing YouAn Hospital Capital Medical UniversityBeijingChina Shanghai Ruijin Hospital Shanghai Jiao Tong University School of MedicineShanghaiChina The First Affiliated Hospital of Nanchang University NanchangJiangxiChina Shanghai Public Health Clinical Center ShanghaiChina West China Hospital Sichuan UniversityChengduSichuanChina The First Affiliated Hospital of Nanjing Medical University NanjingJiangsuChina Hainan General Hospital HaikouHainanChina The Second Hospital of Nanjing Affiliated to Nanjing University of Chinese MedicineNanjingJiangsuChina The Second Xiangya Hospital Central South UniversityChangshaHunanChina Gilead Sciences ShanghaiChina Gilead Sciences Foster CityCAUSA The People’s Liberation Army No.85 Hospital ShanghaiChina Xiangya Hospital Central South UniversityChangshaHunanChina The Sixth People’s Hospital of Shenyang ShenyangLiaoningChina Beijing Friendship Hospital Capital Medical UniversityBeijingChina

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 *** this study,we aimed to report the 5-year results from 2 years into the open-label TAF treatment ***:All participants completing the 144-week double-blind treatment were eligible to receive open-label TAF 25 mg once daily up to week *** analysis of viral suppression(hepatitis B virus DNAsafety outcomes at year 5(week 240)was ***: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 *** 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 *** frequencies of adverse events and laboratory abnormalities were low and similar between *** 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 ***: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 *** effects on bone and renal parameters were sustained with TAF treatment alone and were observed following the switch from TDF to TAF.

关键词： Chronic hepatitis B Antiviral therapy bone safety Renal safety Tenofovir alafenamide Tenofovir disoproxil fumarate Chinese

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3-year Treatment of Tenofovir Alafenamide *** Disoproxil Fumarate for Chronic HBV Infection in China

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Journal of Clinical and Translational Hepatology 2021年第3期9卷 324-334页

作者： Jinlin Hou Qin Ning Zhongping Duan You Chen Qing Xie Fu-Sheng Wang Lunli Zhang Shanming Wu Hong Tang Jun Li Feng Lin Yongfeng Yang Guozhong Gong John FFlaherty Anuj Gaggar Shuyuan Mo Cong Cheng Gregory Camus Chengwei Chen Yan Huang Jidong Jia Mingxiang Zhang GS-US-320-0110 and GS-US-320-0108 China Investigators Nanfang Hospital of Southern Medical University GuangzhouGuangdongChina Tongji Hospital Tongji Medical CollegeHuazhong University of Science and TechnologyWuhanHubeiChina Beijing YouAn Hospital Capital Medical UniversityBeijingChina Shanghai Ruijin Hospital Shanghai Jiao Tong University School of MedicineShanghaiChina Beijing 302 Hospital BeijingChina The First Affiliated Hospital of Nanchang University NanchangJiangxiChina Shanghai Public Health Clinical Center ShanghaiChina West China Hospital Sichuan UniversityChengduSichuanChina The First Affiliated Hospital with Nanjing Medical University NanjingJiangsuChina Hainan General Hospital HaikouHainanChina Nanjing No.2 Hospital NanjingJiangsuChina The 2nd Xiangya Hospital Central South UniversityChangshaHunanChina Gilead Sciences Foster CityCAUSA Liver Disease Center of Naval 905 Hospital ShanghaiChina Xiangya Hospital Central South UniversityChangshaHunanChina Beijing Friendship Hospital Capital UniversityBeijingChina The Sixth People’s Hospital of Shenyang ShenyangLiaoningChina 不详

Background and Aims:Tenofovir alafenamide(TAF)has similar efficacy to tenofovir disoproxil fumarate(TDF)but with improved renal and bone safety in chronic hepatitis B patients studied outside of *** report 3-year results from two phase 3 studies with TAF in China(***:NCT02836249 and NCT02836236).Methods:Chinese hepatitis B e antigen(HBeAg)-positive and-negative chronic hepatitis B patients with viremia and elevated alanine aminotransferase were randomized 2:1 to TAF or TDF treatment groups and treated in a double-blind fashion for 144 weeks(3 years).Efficacy responses were assessed by individual study while safety was assessed by a pooled ***:Of the 334 patients(180 HBeAg-positive and 154 HBeAg-negative)randomized and treated,baseline characteristics were similar between *** overall mean age was 38 years and 73%were *** mean HBV DNA was 6.4 log10 IU/*** median alanine aminotransferase was 88 U/L,and 37%had a history of antiviral *** week 144,the proportion with HBV DNAbone mineral density *** at hip(−0.95%vs.−1.93%)and spine(+0.35%vs.−1.40%).Conclusions:In chronic hepatitis B patients from China,TAF treatment provided efficacy similar to TDF but with better renal and bone safety at 3 years.

关键词： Chronic hepatitis B virus Antiviral therapy bone safety Renal safety

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