Retrospective Study
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Dec 6, 2023; 11(34): 8139-8146
Published online Dec 6, 2023. doi: 10.12998/wjcc.v11.i34.8139
Efficacy and safety of tenofovir alafenamide in patients with chronic hepatitis B exhibiting suboptimal response to entecavir
Gui-Cai Yuan, Ai-Zhen Chen, Wei-Xin Wang, Xu-Lan Yi, Long Tu, Fang Peng, Zhi-Hong Qiu
Gui-Cai Yuan, Ai-Zhen Chen, Wei-Xin Wang, Xu-Lan Yi, Long Tu, Fang Peng, Zhi-Hong Qiu, Department of Infectious Diseases, Yichun University Second Affiliated Hospital, Yichun 336000, Jiangxi Province, China
Author contributions: Yuan GC, Chen AZ, and Qiu ZH jointly proposed the concept of this study; Wang WX and Yi XL contributed to data collection; Tu L and Peng F contributed to formal analysis; Yuan GC, Qiu ZH, and Chen AZ participated in the research; Qiu ZH and Yuan GC have contributed to these methods; Chen AZ guided research; Yuan GC and Qiu ZH validated this study; Tu L and Peng F contributed to the visualization of this study; Chen AZ and Yuan GC drafted the first draft; All authors jointly reviewed and edited the manuscript.
Supported by Study on the efficacy and safety of tenofovir alafenamide in treating chronic hepatitis B patients with poor entecavir response, No. SKJP22020201008.
Institutional review board statement: This study has been reviewed and approved by the Ethics Committee of the Second Affiliated Hospital of Yichun University.
Informed consent statement: This study has obtained the consent and signature of the patient or guardian.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: No data 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: Ai-Zhen Chen, Nurse, Department of Infectious Diseases, Yichun University Second Affiliated Hospital, No. 809 Yuanshan Middle Road, Yichun 336000, Jiangxi Province, China. caz996642292@163.com
Received: November 10, 2023
Peer-review started: November 10, 2023
First decision: November 22, 2023
Revised: November 23, 2023
Accepted: November 28, 2023
Article in press: November 28, 2023
Published online: December 6, 2023
Processing time: 26 Days and 4.1 Hours
ARTICLE HIGHLIGHTS
Research background

Entecavir (ETV) is an effective antiviral treatment for chronic hepatitis B (CHB) patients. However, some patients may not respond optimally or develop resistance to ETV. Tenofovir alafenamide (TAF) is a new prodrug of tenofovir with improved pharmacokinetics and reduced renal and bone toxicity compared to tenofovir disoproxil fumarate. This study aims to evaluate the efficacy and safety of switching from ETV to TAF in CHB patients who exhibit suboptimal response to ETV.

Research motivation

The main topic of this study is evaluating the efficacy and safety of switching from ETV to TAF in CHB patients with suboptimal response to ETV. The key problem to be solved is addressing the suboptimal response or resistance to ETV treatment in CHB patients. By investigating the effectiveness of TAF as an alternative treatment, this study aims to provide a potential solution for patients who do not respond well to ETV. Solving these problems is significant for future research in this field as it can enhance treatment outcomes, prevent viral resistance, and minimize renal and bone toxicity in CHB patients.

Research objectives

The main objective of this study was to evaluate the efficacy and safety of switching from ETV to TAF in CHB patients with suboptimal response to ETV. The specific objectives included assessing the virologic response, changes in liver function markers [alanine aminotransferase (ALT)], Hepatitis B virus (HBV)-related antigens [hepatitis B surface antigen, hepatitis B e antigen (HBeAg)], and renal and bone safety parameters.

Research methods

Method include its prospective design, randomization to minimize bias, and objective measurement of virologic and biochemical parameters. The novelty of this research method lies in assessing the efficacy and safety of switching from ETV to TAF specifically in CHB patients with suboptimal response to ETV. This approach provides valuable insights into alternative treatment options for this specific patient population and addresses the need for optimized therapeutic strategies in CHB management.

Research results

Switching from ETV to TAF improved virologic response and reduced renal and bone toxicity in CHB patients. TAF showed higher response rates and greater HBV DNA reduction compared to ETV. Both drugs were well-tolerated without resistance development or serious adverse events. TAF had a favorable safety profile regarding renal and bone parameters, with lower bone mineral density decline. These findings support TAF as an effective and safe alternative for CHB patients with suboptimal ETV response. Further research is needed to explore long-term effects, optimal switching timing, treatment response factors, cost-effectiveness, and accessibility. Addressing these gaps will enhance CHB management and patient care.

Research conclusions

Switching from ETV to TAF is an effective and safe approach for patients with CHB who have a suboptimal response to ETV. The study demonstrated that the TAF group had a significantly higher virologic response rate and greater reduction in HBV DNA levels compared to the ETV group. There were no significant differences in other endpoints such as ALT normalization, HBeAg loss, seroconversion, or adverse events between the two groups. TAF also exhibited favorable renal and bone safety profiles. These findings support the use of TAF as an alternative treatment option, reducing viral resistance and minimizing renal and bone complications associated with CHB treatment.

Research perspectives

Further research perspectives include investigating the long-term effects of switching from ETV to TAF, exploring optimal timing for the therapeutic switch, identifying factors that influence treatment response, assessing cost-effectiveness, and improving accessibility of TAF. Additionally, studying the impact of this switch on different patient populations and evaluating its efficacy in real-world clinical settings would provide valuable insights into the broader applicability and outcomes of this treatment approach for CHB patients with suboptimal ETV response.