Background and aims

Whether entecavir (ETV) or tenofovir alafenamide (TAF) is better at preventing hepatocellular carcinoma (HCC) development among patients with chronic hepatitis B (CHB) remains unclear. The present study was conducted to explore the ability of these two antivirals to prevent HCC.

Methods

From 2012 to 2019, treatment-naïve CHB patients undergoing ETV or TAF therapy were recruited at three academic teaching hospitals. The TAF group comprised patients starting TAF as first-line antiviral and those switching antivirals from tenofovir disoproxil fumarate to TAF. Patients with decompensated cirrhosis or HCC at enrollment were excluded from the analysis. Cumulative probabilities of HCC were assessed using the Kaplan–Meier method.

Results

In total, 1810 patients (1525 and 285 in ETV and TAF groups, respectively) were recruited. The annual HCC incidence was statistically not different between the ETV and TAF groups (1.67 vs. 1.19 per 100 person-years, respectively) with an adjusted hazard ratio (HR) of 0.681 (p = 0.255), as determined by multivariate analysis. Male, hypertension, liver cirrhosis, FIB-4 index, and albumin were independent prognostic factors for HCC development. Propensity score-matched and inverse probability of treatment weighting analyses yielded similar results, with non-statistically different HCC incidence between the ETV and TAF groups (1.07 vs. 1.19 per 100 person-years (HR = 0.973; p = 0.953) and 1.67 vs. 1.89 per 100 person-years, respectively (HR = 0.949; p = 0.743).

Conclusions

These findings suggest that ETV- and TAF-treated CHB patients have similar risk of developing HCC. Further studies with the larger sample size and longer follow-up are needed to validate these results.

中文翻译：

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替诺福韦艾拉酚胺与恩替卡韦对慢性乙型肝炎患者肝细胞癌风险的影响

背景和目标

恩替卡韦 (ETV) 或替诺福韦艾拉酚胺 (TAF) 在预防慢性乙型肝炎 (CHB) 患者发生肝细胞癌 (HCC) 方面是否更好仍不清楚。本研究旨在探讨这两种抗病毒药物预防 HCC 的能力。

方法

从 2012 年到 2019 年，在三个学术教学医院招募了接受 ETV 或 TAF 治疗的初治 CHB 患者。TAF 组包括开始使用 TAF 作为一线抗病毒药物的患者以及将抗病毒药物从富马酸替诺福韦二吡呋酯转为 TAF 的患者。入选时患有失代偿期肝硬化或 HCC 的患者被排除在分析之外。使用 Kaplan-Meier 方法评估 HCC 的累积概率。

结果

总共招募了 1810 名患者（ETV 和 TAF 组分别为 1525 和 285 名）。ETV 和 TAF 组之间的年度 HCC 发病率在统计学上没有差异（分别为每 100 人年 1.67 和 1.19），调整后的风险比 (HR) 为 0.681 ( p  = 0.255)，由多变量分析确定。男性、高血压、肝硬化、FIB-4 指数和白蛋白是 HCC 发展的独立预后因素。倾向评分匹配和治疗加权分析的逆概率产生了相似的结果，ETV 和 TAF 组之间的 HCC 发生率无统计学差异（每 100 人年 1.07 对 1.19（HR = 0.973；p  = 0.953）和 1.67 对. 1.89 每 100 人年（HR = 0.949；p  = 0.743）。

结论

这些发现表明接受 ETV 和 TAF 治疗的 CHB 患者发生 HCC 的风险相似。需要更大样本量和更长时间随访的进一步研究来验证这些结果。