Retrospective Study
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Nov 28, 2023; 29(44): 5907-5918
Published online Nov 28, 2023. doi: 10.3748/wjg.v29.i44.5907
Tenofovir amibufenamide vs tenofovir alafenamide for treating chronic hepatitis B: A real-world study
Wen-Ting Peng, Chuan Jiang, Fei-Lan Yang, Nian-Qi Zhou, Ke-Yu Chen, Jin-Qing Liu, Shi-Fang Peng, Lei Fu
Wen-Ting Peng, Chuan Jiang, Fei-Lan Yang, Nian-Qi Zhou, Ke-Yu Chen, Jin-Qing Liu, Shi-Fang Peng, Lei Fu, Department of Infectious Diseases, Xiangya Hospital Central South University, Changsha 410008, Hunan Province, China
Author contributions: Fu L designed the research and supervised the study; Peng WT, Chen KY, Zhou NQ, and Yang FL collected the clinical data; Peng WT, Liu JQ, and Jiang C performed the experiments and wrote the manuscript; Peng SF assisted in experiments; all authors critically reviewed the final manuscript.
Supported by National Natural Science Foundation of China, No. 82170640, and No. 81974080; Natural Science Foundation of Hunan Province, No. 2022JJ30954.
Institutional review board statement: This study was reviewed and approved by the Ethics Committee of the Xiangya Hospital Central South University.
Informed consent statement: The study is a retrospective study that will maximize the protection of the rights and privacy of the study participants, and the content of the study and the results of the study do not involve personal privacy and commercial interests, exempt from informed consent.
Conflict-of-interest statement: We have no financial relationships to disclose.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Lei Fu, MD, PhD, Professor, Department of Infectious Diseases, Xiangya Hospital Central South University, No. 87 Xiangya Road, Changsha 410008, Hunan Province, China. fulei92@126.com
Received: September 2, 2023
Peer-review started: September 2, 2023
First decision: October 16, 2023
Revised: October 29, 2023
Accepted: November 14, 2023
Article in press: November 14, 2023
Published online: November 28, 2023
Processing time: 86 Days and 2.3 Hours
ARTICLE HIGHLIGHTS
Research background

Hepatitis B virus (HBV) infection may lead to cirrhosis and hepatocellular carcinoma, and the exploration of optimal antiviral drugs can improve patient prognosis.

Research motivation

Tenofovir amibufenamide (TMF) is a new antiviral drug with limited research on its safety and efficacy. Our research may provide new evidence for the treatment of patients with HBV infection.

Research objectives

To compare the efficacy and safety of TMF and tenofovir alafenamide (TAF) for 48 wk in patients with chronic hepatitis B (CHB). The primary outcome was the proportion of virological responses (VR) at 48 wk. Additional outcomes included the changes of renal function and lipid characteristic markers at weeks 24 and 48 compared to baseline.

Research methods

In this retrospective study, we enrolled a total of 587 patients who had been HBsAg positive for more than 6 mo. Of the enrolled patients, 215 were included in the final analysis and were divided into two groups based on their drug selection: The TMF group and the TAF group.

Research results

The VR rates of the TMF group and TAF group were comparable at 24 and 48 wk of treatment (P > 0.05). In patients with low-level viremia, hepatitis B e antigen (HBeAg) positive, and HBeAg negative, their VR rates are also similar. The alanine transaminase (ALT) normalization rate and renal safety of TMF are also comparable to those of TAF. However, total cholesterol levels increased in the TAF group (P = 0.045). In patients with liver cirrhosis, the renal safety, VR, and ALT normalization rate were comparable between the TMF group and the TAF group.

Research conclusions

TMF is as effective as TAF in treating CHB and has considerable safety. Moreover, TMF may have more advantages in lipid profile compared to TAF.

Research perspectives

The design and research of new nucleotide analogs should continue in the hope of achieving clinical cure of hepatitis B infection as soon as possible.