Hepatocellular Carcinoma Risk in Chronic Hepatitis B Patients Treated With Tenofovir Alafenamide or Tenofovir Disoproxil Fumarate

IF 5.2 2区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Liver International Pub Date : 2025-09-25 DOI:10.1111/liv.70357

Jiwon Yang, Jihye Lim, Ye-Jee Kim, Hwa Jung Kim, Jonggi Choi

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Abstract

Background and Aims

In phase 3 trials, tenofovir alafenamide (TAF) showed antiviral efficacy comparable to that of tenofovir disoproxil fumarate (TDF) for chronic hepatitis B (CHB), with an improved safety profile. This study aimed to compare the clinical efficacy of TAF and TDF in terms of the risk of hepatocellular carcinoma (HCC).

Methods

We conducted a nationwide historical population cohort study on treatment-naïve adult patients with CHB receiving TAF (n = 29 309) or TDF (n = 58 046) as first-line therapy from 2017 to 2022 using data from the Korean National Health Insurance Service database. Cumulative HCC incidence and associated risk factors were estimated using competing risk factors. Propensity score (PS)-matched analysis was used to minimise the confounding effects.

Results

A total of 54 185 patients were included in the study, with 20 994 in the TAF group and 33 191 in the TDF group. The annual incidence of HCC was significantly lower in the TAF group (7.5/1000 patient-years [PYs]) than in the TDF group (10.3/1000 PYs; subdistribution hazard ratio [SHR], 0.74; p < 0.001). After PS matching, TAF continued to exhibit a protective effect against HCC (7.5/1000 PYs vs. 9.9/1000 PYs; p < 0.001). Multivariable analysis with Fine–Gray proportional subdistribution hazards model identified TAF as significantly associated with a reduced HCC incidence (SHR: 0.76; p < 0.001). Subgroup analysis confirmed the hepatoprotective effect of TAF against HCC even in patients with cirrhosis (SHR: 0.78; p = 0.003).

Conclusion

This study showed that TAF had a hepatoprotective effect against HCC in patients with CHB, providing valuable guidance for clinicians in selecting the appropriate initial treatment for these patients.

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替诺福韦阿拉那胺或富马酸替诺福韦二氧吡酯治疗慢性乙型肝炎患者的肝细胞癌风险

背景和目的：在3期临床试验中，替诺福韦-丙烯酰胺（TAF）治疗慢性乙型肝炎（CHB）的抗病毒疗效与富马酸替诺福韦-二氧吡酯（TDF）相当，且安全性更高。本研究旨在比较TAF和TDF在肝细胞癌（HCC）风险方面的临床疗效。方法：我们使用韩国国民健康保险服务数据库的数据，对2017年至2022年接受TAF （n = 29 309）或TDF （n = 58 046）作为一线治疗的treatment-naïve成年CHB患者进行了全国历史人群队列研究。累积HCC发病率和相关危险因素使用竞争危险因素估计。倾向评分（PS）匹配分析用于最小化混杂效应。结果：共纳入54 185例患者，其中TAF组20 994例，TDF组33 191例。TAF组HCC年发病率（7.5/1000患者-年[PYs]）明显低于TDF组（10.3/1000患者-年[PYs]），亚分布风险比[SHR]， 0.74； p结论：本研究显示TAF对CHB患者HCC具有肝保护作用，为临床医生选择合适的初始治疗方案提供了有价值的指导。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Liver International 医学-胃肠肝病学

CiteScore

13.90

自引率

4.50%

发文量

348

审稿时长

2 months

期刊介绍： Liver International promotes all aspects of the science of hepatology from basic research to applied clinical studies. Providing an international forum for the publication of high-quality original research in hepatology, it is an essential resource for everyone working on normal and abnormal structure and function in the liver and its constituent cells, including clinicians and basic scientists involved in the multi-disciplinary field of hepatology. The journal welcomes articles from all fields of hepatology, which may be published as original articles, brief definitive reports, reviews, mini-reviews, images in hepatology and letters to the Editor.