Retrospective Cohort Study
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Hepatol. Aug 27, 2023; 15(8): 964-972
Published online Aug 27, 2023. doi: 10.4254/wjh.v15.i8.964
Tenofovir alafenamide significantly increased serum lipid levels compared with entecavir therapy in chronic hepatitis B virus patients
Rui-Min Lai, Shan Lin, Miao-Miao Wang, Na Li, Jia-Hui Zhou, Xiao-Yu Lin, Tian-Bin Chen, Yue-Yong Zhu, Qi Zheng
Rui-Min Lai, Shan Lin, Na Li, Jia-Hui Zhou, Xiao-Yu Lin, Yue-Yong Zhu, Qi Zheng, Department of Hepatology, Hepatology Research Institute, The First Affiliated Hospital, Fujian Medical University, Fujian Clinical Research Center for Hepatopathy and Intestinal Diseases, Fuzhou 350005, Fujian Province, China
Rui-Min Lai, Qi Zheng, Department of Hepatology, National Regional Medical Center, Binhai Campus of the First Affiliated Hospital, Fujian Medical University, Fuzhou 350212, Fujian Province, China
Miao-Miao Wang, Department of Endocrinology, The 910th Hospital of The Joint Service Support Force, Quanzhou 362000, Fujian Province, China
Tian-Bin Chen, Department of Laboratory Medicine, The First Affiliated Hospital, Fujian Medical University, Fuzhou 350005, Fujian Province, China
Author contributions: Lai RM and Lin S contributed equally to this work; Lai RM and Lin S conceived and designed the study; Chen TB and Zhou JH contributed to the data analysis and manuscript feedback; Li N and Wang MM collected clinical data of the patients; Lai RM and Zheng Q wrote the manuscript; All authors approved the final version of the manuscript.
Supported by Natural Science Foundation of Fujian Province, No. 2021J01123300.
Institutional review board statement: This retrospective study was approved by the ethics committee at the First Affiliated Hospital of Fujian Medical University, China.
Informed consent statement: Patients were not required to give informed consent to the study as the analysis used anonymous data that were obtained after each patient agreed to treatment by written consent.
Conflict-of-interest statement: All the authors declare that they have no conflicts of interest related to the manuscript.
Data sharing statement: The original anonymous dataset is available on request from the corresponding author at bei0825@163.com.
STROBE statement: The authors have read the STROBE Statement – checklist of items, and the manuscript was prepared and revised according to the STROBE Statement – checklist of items.
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: Qi Zheng, PhD, Chief Physician, Professor, Department of Hepatology, Hepatology Research Institute, The First Affiliated Hospital, Fujian Medical University, Fujian Clinical Research Center for Hepatopathy and Intestinal Diseases, No. 20 Chazhong Road, Taijiang District, Fuzhou 350005, Fujian Province, China. bei0825@163.com
Received: March 20, 2023
Peer-review started: March 20, 2023
First decision: May 18, 2023
Revised: May 26, 2023
Accepted: August 3, 2023
Article in press: August 3, 2023
Published online: August 27, 2023
Processing time: 154 Days and 16.1 Hours
ARTICLE HIGHLIGHTS
Research background

In recent decades, the prevalence of nonalcoholic fatty liver disease (NAFLD) has significantly increased in China, leading to the coexistence of NAFLD and chronic hepatitis B (CHB). Many patients require long-term anti-hepatitis B virus (HBV) therapy with potent oral drugs tenofovir alafenamide (TAF) and entecavir (ETV), which are recommended as first-line treatment in HBV clinical practice guidelines. However, no studies have compared the effects of TAF and ETV on lipid profiles in HBV-treated patients. Meanwhile, there are limited data on the effects of TAF on metabolism-related complications in real-world settings.

Research motivation

Many patients require long-term anti-HBV therapy with the potent oral drugs TAF and ETV, which are recommended as first-line treatment in HBV clinical practice guidelines. TAF has a serum lipid-raising effect in patients with HIV; however, its effect on serum lipids and NAFLD risk in patients with CHB is unclear.

Research objectives

This retrospective cohort study aimed to characterize the effect of TAF on serum lipid levels and NAFLD risk in patients with CHB, and we compared the pretreatment and post-treatment serum lipid profile changes after initiation of either TAF or ETV anti-viral therapy.

Research methods

The data including the clinical features, serum lipids, and metabolic factors of patients with CHB at baseline and approximately 1 year after TAF or ETV treatment were collected and analyzed. We used propensity score-matched models to assess the effects on high-density lipoprotein, low-density lipoprotein, triglycerides, and total cholesterol (TCHO).

Research results

Compared with the ETV group, the TAF group had significantly higher TCHO levels after treatment (4.67 ± 0.90 vs 4.36 ± 1.05, P=0.006). In a propensity score-matched model, TAF-treated patients had significantly increased TCHO levels compared to that at baseline (P = 0.019), while there was no difference for the ETV group. Body mass index, sex, hypertension, baseline TCHO, and creatine kinase-MB isoenzyme levels were significantly associated with elevated TCHO levels in logistic regression analysis. However, 1-year TAF treatment did not increase the incidence of NAFLD.

Research conclusions

Our study found that a greater increase in TCHO was observed in patients with CHB receiving TAF than in those receiving ETV; however, TAF-induced dyslipidemia did not increase the incidence of NAFLD.

Research perspectives

This was not a multicenter study, and most of patients with CHB in this study were Asians. Large-scale multicenter prospective studies should be conducted in the future to further evaluate the effects of CHB and anti-HBV therapies on the risk of dyslipidemia, NAFLD, cirrhosis, and hepatocellular carcinoma.