Background

Purpose

The study compared the incidence and predictors of hepatocellular carcinoma (HCC) within and beyond year 5 of entecavir (ETV) therapy.

Methods

The study enrolled 1397 CHB patients who were naïve to nucleos(t)ide analogue (NA) treatment and had received ETV monotherapy for more than 12 months.

Results

The cumulative incidences of HCC at 3, 5, and 10 years of ETV treatment were 4%, 9.1%, and 15.8%, respectively. In the entire cohort, the annual incidence rates of HCC were 2.28% within the first 5 years and 1.34% within 5–10 years of therapy. The incidences of HCC did not differ significantly within and beyond 5 years of ETV therapy (p = 0.53), including patients with cirrhosis (p = 0.85) and without cirrhosis (p = 0.47). At year 5 of treatment, the multivariate analysis showed that the fibrosis-4 (FIB-4) index and alpha-fetoprotein (AFP) levels were independent risk factors for HCC development beyond year 5. The 10-year cumulative incidences of HCC beyond year 5 in the high-risk group (FIB-4 > 2.20 and AFP > 3.21 ng/mL) and low-risk group (FIB-4 ≤ 2.20 and AFP ≤ 3.21 ng/mL) were 48.7% and 0%, respectively. APA-B score at 12 months and year 5 had a higher C-index for the prediction of HCC beyond year 5 than the PAGE-B at baseline and year 5 (p = 0.003 and p = 0.039, respectively)

Conclusions

The HCC incidence tended to decrease but did not change significantly within and beyond 5 years of ETV therapy. The FIB-4 index and AFP levels at year 5 were predictive of HCC development beyond year 5 of ETV therapy.

中文翻译：

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恩替卡韦治疗5年后慢性乙型肝炎患者肝细胞癌的发病率和预测因素。

背景

目的

该研究比较了恩替卡韦（ETV）治疗5年内及以后的肝细胞癌（HCC）的发生率和预测指标。

方法

该研究招募了1397名未接受过核苷酸类似物（NA）治疗且接受过ETV单药治疗超过12个月的CHB患者。

结果

ETV治疗3年，5年和10年时HCC的累积发生率分别为4％，9.1％和15.8％。在整个队列中，HCC的年发病率在治疗的前5年为2.28％，在5-10年内为1.34％。在ETV治疗的5年内及以后，肝癌的发生率无显着差异（p  = 0.53），包括肝硬化（p  = 0.85）和无肝硬化（p = 0.47）。在治疗的第5年，多变量分析显示，纤维化4（FIB-4）指数和甲胎蛋白（AFP）水平是第5年以后肝癌发展的独立危险因素。第10年以后HCC的10年累积发生率高危组（FIB-4> 2.20和AFP> 3.21 ng / mL）和低危组（FIB-4≤2.20和AFP≤3.21 ng / mL）中的5分别为48.7％和0％。在第5年以后的12个月和第5年，APA-B评分的C指数高于在基线和第5年时的PAGE-B的C指数（分别为p  = 0.003和p  = 0.039）

结论

在ETV治疗5年内及以后，HCC发生率趋于下降，但没有明显变化。第5年的FIB-4指数和AFP水平可预测ETV治疗5年后的肝癌发展。