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
Core Tip

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.