Ríos José, Sapena Víctor, Mariño Zoe, Bruix Jordi, Forns Xavier, Morros Rosa, Reig María, Torres Ferran, Pontes Caridad
Department of Clinical Pharmacology, Hospital Clinic and Medical Statistics Core Facility, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
Biostatistics Unit, Medical School, Universitat Autònoma de Barcelona, Campus, Cerdanyola, 08193, Barcelona, Spain.
Drugs Real World Outcomes. 2024 Sep;11(3):389-401. doi: 10.1007/s40801-024-00437-y. Epub 2024 Jun 14.
Direct-acting antivirals (DAAs) offer a high rate of hepatitis C virus (HCV) eradication. However, concerns on the risk of cancer after HCV eradication remain. Our study aimed at quantifying the incidence of cancer in patients treated with anti-HCV therapies in Catalonia (Spain) and their matched controls.
This was a population-based study using real-world data from the public healthcare system of Catalonia between 2012 and 2016. Propensity score matching was performed in patients with HCV infection treated with interferon-based therapy (IFN), sequential IFN and DAA (IFN+DAA), and DAA only (DAA) with concurrent controls. We estimated the annual incidence of overall cancer, hepatocellular carcinoma, and non-liver cancer of HCV-treated patients and their corresponding rate ratios.
The study included 11,656 HCV-treated patients and 49,545 controls. We found statistically significant increases in the rate of overall cancer for IFN+DAA-treated (rate ratio [RR] 1.77, 95% confidence interval [CI] 1.27-2.46) and DAA-treated patients (RR 1.90, 95% CI 1.66-2.19) and in the rate of HCC for IFN-treated (RR 1.50, 95% CI 1.02-2.22), IFN+DAA-treated (RR 3.89, 95% CI 2.26-6.69), and DAA-treated patients (RR 6.45, 95% CI 4.90-8.49) compared with their corresponding controls. Moreover, DAA-treated patients with cirrhosis showed an increased rate of overall cancer versus those without cirrhosis (RR 1.92, 95% CI 1.51-2.44).
Results showed that overall cancer and hepatocellular carcinoma incidence in Catalonia was significantly higher among HCV-treated patients compared with matched non-HCV-infected controls, and risks were higher in patients with cirrhosis. An increased awareness of the potential occurrence of uncommon malignant events and monitoring after HCV eradication therapy may benefit patients.
直接抗病毒药物（DAAs）对丙型肝炎病毒（HCV）的根除率很高。然而，HCV根除后癌症风险仍受关注。我们的研究旨在量化西班牙加泰罗尼亚接受抗HCV治疗的患者及其匹配对照中癌症的发病率。
这是一项基于人群的研究，使用了2012年至2016年加泰罗尼亚公共医疗系统的真实数据。对接受基于干扰素的治疗（IFN）、序贯IFN和DAA（IFN+DAA）以及仅接受DAA（DAA）治疗的HCV感染患者与同期对照进行倾向评分匹配。我们估计了接受HCV治疗患者的总体癌症、肝细胞癌和非肝癌的年发病率及其相应的率比。
该研究纳入了11,656例接受HCV治疗的患者和49,545例对照。我们发现，与相应对照相比，接受IFN+DAA治疗的患者（率比[RR]1.77，95%置信区间[CI]1.27 - 2.46）和接受DAA治疗的患者（RR 1.90，95% CI 1.66 - 2.19）的总体癌症发生率以及接受IFN治疗的患者（RR 1.50，95% CI 1.02 - 2.22）、接受IFN+DAA治疗的患者（RR 3.89，95% CI 2.26 - 6.69）和接受DAA治疗的患者（RR 6.45，95% CI 4.90 - 8.49）的肝细胞癌发生率有统计学显著增加。此外，与无肝硬化的DAA治疗患者相比，有肝硬化的DAA治疗患者的总体癌症发生率有所增加（RR 1.92，95% CI 1.51 - 2.44）。
结果表明，与匹配的未感染HCV的对照相比，加泰罗尼亚接受HCV治疗的患者中总体癌症和肝细胞癌的发病率显著更高，且肝硬化患者的风险更高。提高对罕见恶性事件潜在发生的认识以及在HCV根除治疗后进行监测可能对患者有益。
