Journal of Clinical and Translational Hepatology

Journal of Clinical and Translational Hepatology

Wednesday, 08 / 04 / 2021

Articles

Abstract

ORIGINAL ARTICLE

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

Jinlin Hou1,*, Qin Ning2,*, Zhongping Duan3, You Chen3, Qing Xie4, Fu-Sheng Wang5, Lunli Zhang6, Shanming Wu7, Hong Tang8, Jun Li9, Feng Lin10, Yongfeng Yang11, Guozhong Gong12, John F. Flaherty13, Anuj Gaggar13, Shuyuan Mo13, Cong Cheng13, Gregory Camus13, Chengwei Chen14, Yan Huang15, Jidong Jia16, Mingxiang Zhang17 and GS-US-320-0110 and GS-US-320-0108 China Investigators

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
3  Beijing YouAn Hospital, Capital Medical University, Beijing, China
4  Shanghai Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
5  Beijing 302 Hospital, Beijing, China
6  The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
7  Shanghai Public Health Clinical Center, Shanghai, China
8  West China Hospital, Sichuan University, Chengdu, Sichuan, China
9  The First Affiliated Hospital 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  Xiangya Hospital, Central South University, Changsha, Hunan, China
16  Beijing Friendship Hospital, Capital University, Beijing, China
17  The Sixth People’s Hospital of Shenyang, Shenyang, Liaoning, China
*Correspondence to: Jinlin Hou, Nanfang Hospital of Southern Medical University, Guangzhou, Guangdong 510515, China. E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it. ; Ning Qin, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China. E-mail:This email address is being protected from spambots. You need JavaScript enabled to view it.

Journal of Clinical and Translational Hepatology 2021;9(3):324-334 DOI: 10.14218/JCTH.2020.00145
Received: December 1, 2020 Accepted: March 8, 2021 Published online: April 28, 2021

Abstract

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 log10 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.

Keywords

Chronic hepatitis B virus, Antiviral therapy, Bone safety, Renal safety

Journal of Clinical and Translational Hepatology 2021 vol. 9, 324-334  [ Html  ] [ PDF Full-text ]

© 2021 Authors. This is an Open Access article distributed under the terms of the  Creative Commons Attribution-Noncommercial 4.0 License(CC BY-NC 4.0), permitting all non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

 

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