Clinical Trials Study
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Jul 14, 2025; 31(26): 109285
Published online Jul 14, 2025. doi: 10.3748/wjg.v31.i26.109285
Tenofovir amibufenamide in chronic hepatitis B: Lipid changes and 144-week safety with tenofovir disoproxil fumarate-to-tenofovir amibufenamide switch
Zhi-Hao Zeng, Jin-Qing Liu, Min Zhang, Cai-Liang Qiu, Zhen-Yu Xu
Zhi-Hao Zeng, Min Zhang, Cai-Liang Qiu, Zhen-Yu Xu, Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha 410011, Hunan Province, China
Jin-Qing Liu, Department of Infectious Diseases, Xiangya Hospital of Central South University, Changsha 410011, Hunan Province, China
Co-first authors: Zhi-Hao Zeng and Jin-Qing Liu.
Co-corresponding authors: Cai-Liang Qiu and Zhen-Yu Xu.
Author contributions: Zeng ZH, Liu JQ collected data and drafted the manuscript; Qiu CL, Xu ZY contributed to completion statistics and edited the manuscript; Zhang M supervised the study, designed the study and revised the manuscript; All authors approved the final version of the manuscript.
Supported by The Scientific Research Program of Furong Laboratory, No. 2023SK2108; Clinical Medical Research Center for Viral Hepatitis of Hunan Province, No. 2023SK4009; Hunan Provincial Natural Science Foundation, No. 2023JJ60440; and Hunan Provincial Health Commission Research Program, No. 202303088786.
Institutional review board statement: The research was approved by the Ethics Committee of the Second Xiangya Hospital.
Clinical trial registration statement: This trial was registered at http://clinicaltrials.govas (No. NCT03903796).
Informed consent statement: All participants gave their verbal and written consent to participate and for the publication of this report.
Conflict-of-interest statement: The authors declare that they have no conflict of interest.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Data sharing statement: The data that support the findings of this study are available in https://clinicaltrials.gov/study/NCT03903796?term=NCT03903796&rank = 1.
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: Zhen-Yu Xu, PhD, Doctor, Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, No. 139 People’s Middle Road, Changsha 410011, Hunan Province, China. xuzhenyu@csu.edu.cn
Received: May 20, 2025
Revised: May 30, 2025
Accepted: June 23, 2025
Published online: July 14, 2025
Processing time: 65 Days and 22.2 Hours
Abstract
BACKGROUND

Tenofovir amibufenamide (TMF) has shown antiviral efficacy comparable to tenofovir disoproxil fumarate (TDF) in chronic hepatitis B (CHB), with improved renal and bone safety profiles. While TDF is recognized for its lipid-lowering properties, the long-term effects of TMF on lipid metabolism remain unclear.

AIM

To assess lipid changes and long-term safety of TMF in CHB, including outcomes after TDF-to-TMF switch over 144 weeks.

METHODS

This retrospective analysis utilized data from a phase III randomized, double-blind trial involving 53 patients with CHB treated with either TMF 25 mg (n = 39) or TDF 300 mg (n = 14) once daily for 96 weeks. Following this blinded phase, all participants entered an open-label extension in which they received TMF until week 144. This design enabled assessment of both the comparative effects of TMF and TDF and the impact of switching from TDF to TMF, thereby reflecting real-world treatment scenarios. Virological, biochemical and imaging evaluations were performed throughout the study.

RESULTS

At week 96, both groups achieved comparable virological suppression and maintained stable hepatic and renal function. However, total cholesterol and low-density lipoprotein cholesterol levels were significantly higher in the TMF group compared to the TDF group (P = 0.012 and P = 0.040, respectively). TDF was associated with a transient increase in serum phosphate (P = 0.030). After switching to TMF, lipid profiles in the former TDF group gradually aligned with those of the continuous TMF group by week 144, with no lipid abnormalities observed in either group.

CONCLUSION

TMF provides sustained antiviral efficacy and maintains a favourable long-term lipid and renal safety profile. These findings support TMF as a viable first-line therapy and a switch option for CHB management in clinical practice.

Keywords: Tenofovir amibufenamide; Hepatitis B virus; Lipid profile; Lipoprotein; Cholesterol

Core Tip: This 144-week dual-phase study investigated the long-term lipid and safety profile of tenofovir amibufenamide (TMF) in chronic hepatitis B patients. Through a randomized, double-blind comparison with tenofovir disoproxil fumarate (TDF) followed by a TDF-to-TMF switch, the trial revealed comparable antiviral efficacy, improved renal and bone safety, and a moderate elevation in lipid levels with TMF that stabilized after switch therapy. These findings support TMF as a viable first-line and sequential therapy option in real-world chronic hepatitis B management.