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
Abstract
BACKGROUND

Entecavir (ETV) is a potent and safe antiviral agent for patients with chronic hepatitis B (CHB); however, some patients may exhibit suboptimal response or resistance to ETV. Tenofovir alafenamide (TAF) is a novel tenofovir prodrug with improved pharmacokinetics and reduced renal and bone toxicity compared with tenofovir disoproxil fumarate.

AIM

To evaluate the efficacy and safety of switching from ETV to TAF in patients with CHB exhibiting suboptimal response to ETV.

METHODS

A total of 60 patients with CHB who had been treated with ETV for at least 12 mo and had persistent or recurrent viremia [Hepatitis B virus (HBV) DNA ≥ 20 IU/mL] or partial virologic response (HBV DNA < 20 IU/mL, but detectable) were enrolled in the study. The patients were randomly assigned to either continue ETV (0.5 mg) daily or switch to TAF (25 mg) daily for 48 wk. The primary endpoint was the proportion of patients who achieved a virologic response (HBV DNA level < 20 IU/mL) at week 48. Secondary endpoints included changes in serum alanine aminotransferase (ALT), hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), and anti-HBe levels, and renal and bone safety parameters.

RESULTS

At week 48, the proportion of patients who achieved a virologic response was significantly higher in the TAF group than in the ETV group (93.3% vs 66.7%, P = 0.012). The mean reduction in HBV DNA from baseline was also significantly greater in the TAF group than in the ETV group (-3.8 vs -2.4 Log10 IU/mL, P < 0.001). The rates of ALT normalization, HBeAg loss, HBeAg seroconversion, and HBsAg loss were not found to significantly differ between the two groups. None of the patients developed genotypic resistance to ETV or TAF. Both drugs were well tolerated, with no serious adverse events or discontinuations caused by adverse events. No significant changes were observed in the estimated glomerular filtration rate, serum creatinine level, or urine protein-to-creatinine ratio in either group. The TAF group had a significantly lower decrease in bone mineral density at the lumbar spine and hip than the ETV group (-0.8% vs -2.1%, P = 0.004; -0.6% vs -1.8%, P = 0.007, respectively).

CONCLUSION

Switching from ETV to TAF is effective and safe for patients with CHB exhibiting a suboptimal response to ETV and may prevent further viral resistance and reduce renal and bone toxicity.

Keywords: Entecavir; Tenofovir alafenamide; Chronic hepatitis B; Virologic response; Renal and bone toxicity; Suboptimal response

Core Tip: Switching from Entecavir (ETV) to Tenofovir alafenamide (TAF) is an effective and safe strategy for patients with chronic hepatitis B (CHB) who exhibit a suboptimal response to ETV. This switch improves virologic response rates and reduces the risk of viral resistance. TAF also demonstrates reduced renal and bone toxicity compared to Tenofovir disoproxil fumarate. This finding highlights the potential benefits of switching to TAF in managing CHB patients with suboptimal response to ETV, providing improved treatment outcomes and minimizing long-term safety concerns.