Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan.
J Gastrointestin Liver Dis. 2019 Mar;28(1):63-71. doi: 10.15403/jgld.2014.1121.281.hpc.
Direct-acting antiviral agents (DAAs) and the risk of hepatocellular carcinoma (HCC) is controversially reported in the literature. The primary endpoints of this study were to clarify the cumulative incidence and recurrence rate of HCC after DAA treatment. The secondary endpoints were to identify the factors associated with the occurrence or recurrence of HCC after DAAs treatment.
Of 234 HCV patients, 211 with no history of HCC (no-HCC-history group) and 23 with previous treated HCC history (HCC-history group) were treated with DAAs and followed for more than 24 weeks to determine the incidence of HCC. Platelet count, albumin, α-fetoprotein (AFP) level, L3%, the FIB-4 index and APRI scores were analyzed as possible factors associated with HCC occurrence and recurrence. An intergroup comparison was made of the cumulative incidence of HCC. Cox proportional hazards regression was used to determine associations between blood test values and risk of HCC.
The median observation period was 21 months. Cumulative incidence of HCC was higher in the HCC-history group than in the no-HCC-history group (p < 0.0001, 19.0 and 0.52 per 100 patient-years, respectively). Univariate analysis revealed platelet count, albumin, α-fetoprotein (AFP) level, AFP-L3%, and FIB-4 index and APRI scores at the end of DAA treatment as being significantly associated with occurrence/recurrence of HCC. Multivariate analysis revealed that AFP levels before and after the administration of DAAs and AFP-L3% after DAA were independently associated with the occurrence/recurrence of HCC (p = 0.045, 0.043, 0.005, respectively).
The HCC occurrence rate after DAA treatment was very low, and the recurrence rate lower than that in previous interferon reports. The AFP level and AFP-L3% were identified as important factors in predicting occurrence/recurrence of HCC. Careful observation is needed when increased levels of AFP or AFP-L3% after DAAs treatment are observed.
直接作用抗病毒药物（DAA）与肝细胞癌（HCC）的风险在文献中存在争议。本研究的主要终点是阐明 DAA 治疗后 HCC 的累积发生率和复发率。次要终点是确定 DAA 治疗后 HCC 发生或复发的相关因素。
在 234 例 HCV 患者中，211 例无 HCC 病史（无 HCC 病史组）和 23 例既往治疗 HCC 病史（HCC 病史组）接受 DAA 治疗并随访超过 24 周，以确定 HCC 的发生率。分析血小板计数、白蛋白、α-胎蛋白（AFP）水平、L3%、FIB-4 指数和 APRI 评分作为与 HCC 发生和复发相关的可能因素。比较 HCC 累积发生率的组间差异。采用 Cox 比例风险回归分析确定血液检测值与 HCC 风险之间的关系。
中位观察期为 21 个月。HCC 病史组 HCC 的累积发生率高于无 HCC 病史组（p<0.0001，分别为 19.0 和 0.52/100 患者年）。单因素分析显示，DAA 治疗结束时的血小板计数、白蛋白、α-胎蛋白（AFP）水平、AFP-L3%以及 FIB-4 指数和 APRI 评分与 HCC 的发生/复发显著相关。多因素分析显示，DAA 治疗前后 AFP 水平和 AFP-L3%与 HCC 的发生/复发独立相关（p=0.045、0.043、0.005）。
DAA 治疗后 HCC 的发生率非常低，复发率低于既往干扰素报告。AFP 水平和 AFP-L3%是预测 HCC 发生/复发的重要因素。当 DAA 治疗后 AFP 或 AFP-L3%水平升高时，需要密切观察。
