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
Abstract
BACKGROUND

The efficacy and safety profile of tenofovir amibufenamide (TMF) in chronic hepatitis B (CHB) patients is not well-established.

AIM

To compare the efficacy and safety of TMF and tenofovir alafenamide (TAF) over a 48-wk period in patients with CHB.

METHODS

A total of 215 subjects meeting the inclusion criteria were enrolled and divided into two groups: TMF group (n = 106) and the TAF group (n = 109). The study included a comparison of virological response (VR): Undetectable hepatitis B virus DNA levels, alanine transaminase (ALT) normalization rates, renal function parameters, and blood lipid profiles.

RESULTS

At 24 and 48 wk, VR rates for the TMF group were 53.57% and 78.57%, respectively, compared with 48.31% and 78.65% for the TAF group (P > 0.05). The VR rates were also similar in both groups among patients with low-level viremia, both hepatitis B e antigen (HBeAg)-positive and HBeAg-negative subgroups. The TMF cohort showed ALT normalization and renal safety profiles similar to the TAF group. There was a notable increase in total cholesterol levels in the TAF group (P = 0.045), which was not observed in the TMF group (P > 0.05). In patients with liver cirrhosis, both groups exhibited comparable VR and ALT normalization rates and renal safety profiles. However, the fibrosis 4 score at 48 wk showed a significant reduction in the TAF group as compared to the TMF group within the liver cirrhosis subgroup.

CONCLUSION

Our study found TMF is as effective as TAF in treating CHB and has a comparable safety profile. However, TAF may be associated with worsening lipid profiles.

Keywords: Alanine transaminase normalization; Chronic hepatitis B; Renal safety; Virological response; Blood lipid; Tenofovir

Core Tip: This is a retrospective study to compare the efficacy and safety of tenofovir amibufenamide (TMF) and tenofovir alafenamide (TAF) for 48 wk in patients with chronic hepatitis B (CHB). Our study found that TMF is as effective as TAF in treating CHB and has comparable safety profiles. In addition, TAF may cause deterioration of lipid profiles. These results suggest that TMF may be a viable alternative to TAF for CHB treatment.