Introduction:The use of direct-acting antivirals (DAAs) has drastically changed the management of HCV-infected patients by achieving a 95–98% sustained virologic response (SVR) and reducing morbidity and mortality in this population. However, despite their effectiveness, controversy exists concerning the occurrence of oncologic events following DAA therapy.Aims and Methods:A retrospective analysis was conducted on data from the Swiss Hepatitis C Cohort Study, a prospective cohort involving patients with positive HCV viremia upon inclusion, enrolled in various Swiss centers from September 2000 to November 2021. To examine potential differences in the risk of intrahepatic tumor (IHT) occurrence and death among patients treated with direct-acting antivirals (DAAs), untreated patients, and those receiving interferon (IFN)-based therapy, a semiparametric competing risk proportional hazards regression model was used.Results:Among 4082 patients (63.1% male, median age 45 years; genotype 1: 54.1%; cirrhosis: 16.1%), 1026 received exclusive treatment with IFN-based regimens, and 1180 were treated solely with DAAs. Over a median follow-up of 7.8 years (range: 3.8–11.9), 179 patients (4.4%) developed intrahepatic tumors (IHT), and 168 (4.1%) experienced extrahepatic tumors (EHT). The 5-year cumulative incidence of IHT was 1.55% (95% CI 0.96–2.48) for IFN-based therapy, 4.27% (95% CI 2.93–6.2) for DAA and 0.89% (95% CI 0.4–1.99) for untreated patients. There was no statistically significant difference in the risk of developing IHT (HR = 1.34; 95% CI = [0.70; 2.58];p= 0.380) or death (HR = 0.66; 95% CI = [0.43; 1.03];p= 0.066) between patients treated with DAAs and those treated with IFN.Conclusions:The DAAs reduced the risk of death and were not associated with an increased risk of extrahepatic tumors (EHT). In the adjusted model, accounting for cirrhosis and high liver stiffness, the DAA treatment was associated with a higher risk of IHT occurrence compared with untreated patients, emphasizing the relevance of implementing standardized hepatocellular carcinoma (HCC) screening post-DAA treatment.
引言：直接抗病毒药物（DAAs）的应用通过实现95%-98%的持续病毒学应答（SVR），并降低HCV感染人群的发病率和死亡率，极大地改变了该群体的临床管理策略。然而，尽管其疗效显著，关于DAA治疗后肿瘤事件发生风险仍存在争议。 目的与方法：本研究对瑞士丙型肝炎队列研究的数据进行回顾性分析。该前瞻性队列纳入了2000年9月至2021年11月期间瑞士多家中心收治的、入组时HCV病毒血症阳性的患者。为探究接受直接抗病毒药物（DAAs）治疗、未接受治疗以及接受基于干扰素（IFN）治疗方案的患者在肝内肿瘤（IHT）发生风险和死亡风险方面的潜在差异，研究采用半参数竞争风险比例风险回归模型进行分析。 结果：在4082名患者中（男性占63.1%，中位年龄45岁；基因1型占54.1%；肝硬化占16.1%），1026例患者接受基于干扰素的治疗方案，1180例患者仅接受DAAs治疗。在中位7.8年（范围：3.8-11.9年）的随访期间，179例患者（4.4%）发生肝内肿瘤（IHT），168例患者（4.1%）发生肝外肿瘤（EHT）。基于干扰素治疗组的5年IHT累积发生率为1.55%（95% CI 0.96-2.48），DAA治疗组为4.27%（95% CI 2.93-6.2），未治疗组为0.89%（95% CI 0.4-1.99）。DAAs治疗组与干扰素治疗组在发生IHT风险（HR = 1.34；95% CI = [0.70; 2.58]；p = 0.380）或死亡风险（HR = 0.66；95% CI = [0.43; 1.03]；p = 0.066）方面均无统计学显著差异。 结论：DAAs降低了死亡风险，且未增加肝外肿瘤（EHT）发生风险。在调整肝硬化及高肝脏硬度等因素的模型中，与未治疗患者相比，DAA治疗与更高的IHT发生风险相关，这强调了在DAA治疗后实施标准化肝细胞癌（HCC）筛查的重要性。
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