Lai RM, Lin S, Wang MM, Li N, Zhou JH, Lin XY, Chen TB, Zhu YY, Zheng Q. Tenofovir alafenamide significantly increased serum lipid levels compared with entecavir therapy in chronic hepatitis B virus patients. World J Hepatol 2023; 15(8): 964-972 [PMID: 37701915 DOI: 10.4254/wjh.v15.i8.964]
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03729887
Submitted on:
September 02, 2023, 02:24
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Reader Comments:
The prevalence of nonalcoholic fatty liver disease (NAFLD) in China has increased significantly in recent decades, leading to co-morbid chronic hepatitis B and NAFLD in some patients. Many HBV patients require long-term antiviral drugs such as Tenofovir alafenamide (TAF) and Entecavir (ETV), which are recommended as first-line agents in the HBV clinical practice guideline. It has been shown that TAF has a lipid-enhancing effect in HIV patients. But no studies comparing the effects of TAF and ETV on the lipid profiles of HBV patients. The aim of this article is to investigate the effect of TAF on lipid levels and the risk of developing NAFLD in patients with chronic hepatitis B, and to compare the changes in lipid levels before and after antiviral therapy with TAF or ETV.
In this study, 336 patients with chronic hepatitis B treated with ETV or TAF enrolled at the outpatient department of the Hepatology Research Institute of the First Affiliated Hospital of Fujian Medical University from January 2020 to January 2021. The baseline data of patients with CHB and the clinical characteristics, lipids, and metabolic factors before and approximately 1 year after TAF or ETV treatment were statistically analyzed using SPSS 23.0, and the effects of ETV and TAF on HDL, LDL, triglycerides, and total cholesterol (TCHO) were evaluated using propensity score-matched model.
Post-treatment TCHO levels were significantly higher in the TAF group than in the ETV group. In the propensity score-matched model, TCHO levels were significantly higher than baseline levels in patients in the TAF treatment group, whereas there was no difference in the ETV group. In logistic regression analysis, body mass index, gender, hypertension, baseline TCHO, and CK- MB levels were significantly associated with elevated TCHO levels. However, 1 year of TAF treatment did not increase the incidence of NAFLD. Therefore, in this study TCHO was higher in patients treated with TAF than in patients with chronic hepatitis B who received ETV; however, there was no increase in the incidence of NAFLD due to TAF-induced dyslipidemia.
The study was comprehensive. In addition to comparing the baseline data and clinical features of patients treated with TAF and ETV, this study compared changes in lipid profiles as well as whether NAFLD increased before and after TAF or ETV therapy. It assessed the impact and extent of TAF on achieving elevated lipid levels compared with ETV, and the correlation between BMI, gender, hypertension, baseline TCHO, CK-MB levels and elevated TCHO levels was summarized.
The research topic is new. In the context of increasing prevalence of NAFLD and 84 million people with HBV infection in China, as well as existing studies showing that TAF could increase lipid levels in patients with HIV, limited data t are available about the effect of TAF on metabolism-related complications in patients with CHB and that the effect of ETV on lipids has not yet been reported in post-marketing studies. Therefore, it is important to investigate whether TAF raises lipid levels and increases the prevalence of NAFLD in patients with chronic hepatitis B and to compare it with ETV.
The study was methodologically scientific. The study excluded patients with insufficient years of drug use, interference with other antiviral drugs or comorbidities associated with other liver-related diseases or heavy alcohol intake, and enrolled 336 chronic hepatitis B patients taking TAF or ETV in a single center. They were divided into the group receiving TAF and the group receiving ETV. And pre-treatment lipid profiles and repeat lipid assessments were performed 1 year after the initiation of antiviral therapy. Baseline information and data related to clinical characteristics, metabolic levels, and lipids were collected from enrolled patients before antiviral therapy and after 1 year of treatment. Statistical analysis was performed using SPSS 23.0. Normally distributed continuous variables were expressed as mean ± standard deviation, and Student's t-tests were performed for the different treatment groups to assess whether the differences were statistically significant. Categorical variables were described using frequencies and proportions, and the χ2 test was used to compare categorical variables. Paired t-tests and paired χ2 tests were used to assess differences in levels before and after treatment for the same treatment group. Differences in each lipid profile component between pre- and post-treatment were calculated, and propensity score matching models were used to assess the effect of treatment type (TAF vs ETV) on changes in lipid profile components. Finally, logistic regression analysis was used to estimate the odds ratio of associations between baseline factors and elevated TCHO levels.
The findings of this study are innovative. It found that chronic hepatitis B patients treated with TAF had higher elevations of TCHO than those treated with ETV. With fewer studies on the subject, these findings are intended to provide guidance for future treatment of patients with CHB combined with NAFLD.
Shortcomings: the study period is short, whether TAF and ETV can increase the prevalence of NAFLD in patients with chronic hepatitis B has not been effectively verified. This study is a single-center retrospective study, which is prone to retrospective bias and selection bias. Therefore, a large-sample multicenter prospective trial would be necessary to verify these findings.
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Reader's ID:
03723046
Submitted on:
September 01, 2023, 22:37
Reader Expertise:
Reader’s expertise on the topic of the manuscript
Conflicts-of-Interest Statement:
Does the reader have a conflict of interest?
Reader Comment Standards for Published Articles:
1 Title
Does the title reflect the main subject/hypothesis of the manuscript?
2 Abstract
Does the abstract summarize and reflect the work described in the manuscript?
3 Key Words
Do the key words reflect the focus of the manuscript?
4 Background
Does the manuscript adequately describe the background, present status and significance of the study?
5 Methods
Does the manuscript describe methods (e.g., experiments, data analysis, surveys, and clinical trials, etc.) in adequate detail?
6 Results
Are the research objectives achieved by the experiments used in this study?
Has the study made meaningful contributions towards research progress in this field?
7 Discussion
Does the manuscript interpret the findings adequately and appropriately, highlighting the key points concisely, clearly and logically?
Are the findings and their applicability/relevance to the literature stated in a clear and definite manner?
Is the Discussion accurate and does it discuss the paper’s scientific significance and/or relevance to clinical practice sufficiently?
8 Illustrations and Tables
Are the figures, diagrams and tables sufficient, good quality and appropriately illustrative of the paper contents?
Do figures require labeling with arrows, asterisks, etc., or better legends?
9 Biostatistics
Does the manuscript meet the requirements of biostatistics?
10 Units
Does the manuscript meet the requirements of use of SI units?
11 References
Does the manuscript appropriately cite the latest, important and authoritative references in the Introduction and Discussion sections?
Does the author self-cite, omit, incorrectly cite and/or over-cite references?
12 Quality of manuscript organization and presentation
Is the manuscript concisely and coherently organized and presented?
Are the style, language and grammar accurate and appropriate?
13 Ethics statements
For all manuscripts involving human studies and/or animal experiments, author(s) must submit the related formal ethics documents that were reviewed and approved by their local ethical review committee. Did the manuscript meet the requirements of ethics?
Scientific Quality:
The overall quality of the manuscript, based on the above-listed criteria, should be evaluated and classified according to the following five categories
Language Quality:
Language quality (style, grammar, and spelling) should be evaluated and classified according to the following five categories.
Reader Comments:
The results of this well designed trial demonstrated that there might be potential side effects of Tenofovir alafenamide as a leading killer targeting anti-hepatitis B virus. As known, Tenofovir alafenamide was developed initially for hepatitis C, however, data was not convincing. With the prevalence of COVID-19, increasing evidence showed the novel use of anti-virus medication might be of effect in areas otherwise, which seems helpful.
Reply from the Editorial Office:
Thank you very much for your comments.