Buonomo Antonio Riccardo, Scotto Riccardo, Coppola Carmine, Pinchera Biagio, Viceconte Giulio, Rapillo Costanza Maria, Staiano Laura, Saturnino Mariarosaria, Scarano Ferdinando, Portunato Federica, Pisaturo Mariantonietta, De Pascalis Stefania, Martini Salvatore, Tosone Grazia, Nappa Salvatore, Coppola Nicola, Gentile Ivan
Department of Clinical Medicine and Surgery - Section of Infectious Diseases, University of Naples Federico II.
Department of Internal Medicine - Unit of Hepatology and Interventional Ultrasonography. OORR Area Stabiese, Plesso Nuovo Gragnano, Naples.
Medicine (Baltimore). 2020 Feb;99(6):e18948. doi: 10.1097/MD.0000000000018948.
The effectiveness of direct-acting antivirals (DAAs) against hepatitis C virus (HCV) infection is ascertained. However, some authors raised the issue of an increased incidence of de novo hepatocellular carcinoma (HCC) in patients treated with DAAs. Aim of the study was to evaluate the rate of HCC occurrence in a real-life cohort of patients who received anti-HCV treatment with DAAs.A prospective multicentre study was conducted. All adult patients with HCV infection who received treatment between March 2015 and December 2017 in 4 hospital of Campania region (South Italy) with at least 6 months of follow-up were enrolled.A total of 323 patients were included in the study. Most patients had HCV genotype 1b (61.8%). The overall SVR12 rate was 95.5%. Median time of observation was 10 months. The incidence rate of HCC was 0.2 per 100 person-months (crude incidence rate 3.4%, 95 confidence interval: 1.5%-5.3%). The median time for HCC occurrence was 11 months. HCC occurrence rate was significantly higher among patients who did not achieve SVR12 compared with patients who did (28.6% vs 2.8%, P < 0.05). No patient with F0-F3 fibrosis developed HCC. Among patients with cirrhosis, at the multivariate time-to-event analysis, no covariates were independently associated with the risk of HCC occurrence.Treatment with DAAs did not increase the risk of HCC occurrence. Patients who achieved SVR12 had a lower rate of HCC occurrence. Further studies are needed to estimate the incidence and the risk for HCC in the long-term follow-up among patients undergoing treatment with DAAs.
已确定直接抗病毒药物（DAAs）对丙型肝炎病毒（HCV）感染的有效性。然而，一些作者提出了接受DAAs治疗的患者新发肝细胞癌（HCC）发病率增加的问题。本研究的目的是评估在接受DAAs抗HCV治疗的真实队列患者中HCC的发生几率。
进行了一项前瞻性多中心研究。纳入了2015年3月至2017年12月期间在坎帕尼亚地区（意大利南部）4家医院接受治疗且随访至少6个月的所有成年HCV感染患者。
共有323例患者纳入研究。大多数患者为HCV基因1b型（61.8%）。总体SVR12率为95.5%。中位观察时间为10个月。HCC的发病率为每100人月0.2例（粗发病率3.4%，95%置信区间：1.5%-5.3%）。HCC发生的中位时间为11个月。未达到SVR12的患者中HCC发生率显著高于达到SVR12的患者（28.6%对2.8%，P<0.05）。F0-F3纤维化患者中无HCC发生。在肝硬化患者中，多变量事件发生时间分析显示，无协变量与HCC发生风险独立相关。
DAAs治疗未增加HCC发生风险。达到SVR12的患者HCC发生率较低。需要进一步研究以评估接受DAAs治疗患者长期随访中HCC的发病率和风险。
