单位：[1]Nanfang Hospital of Southern Medical University, Guangzhou, Guangdong, China[2]Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology, Wuhan, Hubei, China华中科技大学同济医学院附属同济医院[3]Beijing YouAn Hospital, Capital Medical University,Beijing, China[4]Shanghai Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China[5]Beijing 302Hospital, Beijing, China[6]The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China[7]Shanghai PublicHealth Clinical Center, Shanghai, China[8]West China Hospital, Sichuan University, Chengdu, Sichuan, China四川大学华西医院[9]The First AffiliatedHospital with Nanjing Medical University, Nanjing, Jiangsu, China[10]Hainan General Hospital, Haikou, Hainan, China[11]Nanjing No. 2 Hospital, Nanjing, Jiangsu, China[12]The 2nd Xiangya Hospital, Central South University, Changsha, Hunan,China[13]Gilead Sciences, Foster City, CA, USA[14]Liver Disease Center of Naval 905 Hospital, Shanghai, China[15]XiangyaHospital, Central South University, Changsha, Hunan, China[16]Beijing Friendship Hospital, Capital University, Beijing,China首都医科大学附属北京友谊医院[17]The Sixth People’s Hospital of Shenyang, Shenyang, Liaoning, China
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 China. We report 3-year results from two phase 3 studies with TAF in China (Clinicaltrials. gov: 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 analysis. Results: Of the 334 patients (180 HBeAg-positive and 154 HBeAg-negative) randomized and treated, baseline characteristics were similar between groups. The overall mean age was 38 years and 73% were male. The mean HBV DNA was 6.4 log(10) IU/mL. The median alanine aminotransferase was 88 U/L, and 37% had a history of antiviral use. At week 144, the proportion with HBV DNA <29 IU/mL was similar among the two groups, with TAF at 83% vs. TDF at 79%, and TAF at 93% vs. TDF at 92% for the HBeAg-positive and -negative patients, respectively. In each study, higher proportions of TAF than TDF patients showed normalized alanine aminotransferase (via the American Association for the Study of Liver Diseases and the China criteria) and showed loss of HBsAg; meanwhile, the HBeAg seroconversion rates were similar. Treatment was well-tolerated among the TAF patients, who showed a smaller median decline in creatinine clearance (-0.4 vs. -3.2 mL/min; p=0.014) and less percentage change in bone mineral density vs. TDF 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.
第一作者单位：[1]Nanfang Hospital of Southern Medical University, Guangzhou, Guangdong, China[*1]Nanfang Hospital of Southern Medical University, Guangzhou, Guangdong 510515, China
通讯作者：
通讯机构：[1]Nanfang Hospital of Southern Medical University, Guangzhou, Guangdong, China[2]Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology, Wuhan, Hubei, China[*1]Nanfang Hospital of Southern Medical University, Guangzhou, Guangdong 510515, China[*2]Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China
推荐引用方式(GB/T 7714)：
Hou Jinlin,Ning Qin,Duan Zhongping,et al.3-year Treatment of Tenofovir Alafenamide vs. Tenofovir Disoproxil Fumarate for Chronic HBV Infection in China[J].JOURNAL of CLINICAL and TRANSLATIONAL HEPATOLOGY.2021,9(3):324-334.doi:10.14218/JCTH.2020.00145.
APA：
Hou, Jinlin,Ning, Qin,Duan, Zhongping,Chen, You,Xie, Qing...&GS-US-320-0110 and GS-US-320-0108 China Investigators.(2021).3-year Treatment of Tenofovir Alafenamide vs. Tenofovir Disoproxil Fumarate for Chronic HBV Infection in China.JOURNAL of CLINICAL and TRANSLATIONAL HEPATOLOGY,9,(3)
MLA：
Hou, Jinlin,et al."3-year Treatment of Tenofovir Alafenamide vs. Tenofovir Disoproxil Fumarate for Chronic HBV Infection in China".JOURNAL of CLINICAL and TRANSLATIONAL HEPATOLOGY 9..3(2021):324-334
