• Vincenza Calvaruso, Giuseppe Cabibbo, Irene Cacciola, Salvatore Petta, Salvatore Madonia, Alessandro Bellia, Fabio Tinè, Marco Distefano, Anna Licata, Lydia Giannitrapani, Tullio Prestileo, Giovanni Mazzola, Maria Antonietta Di Rosolini, Licia Larocca, Gaetano Bertino, Antonio Digiacomo, Francesco Benanti, Luigi Guarneri, Alfonso Averna, Carmelo Iacobello, Antonio Magro, Ignazio Scalisi, Fabio Cartabellotta, Francesca Savalli, Marco Barbara, Antonio Davì, Maurizio Russello, Gaetano Scifo, Giovanni Squadrito, Calogero Cammà, Giovanni Raimondo, Antonio Craxì, Vito Di Marco, and Rete Sicilia Selezione Terapia–HCV (RESIST-HCV).
• Sezione di Gastroenterologia e Epatologia, Dipartimento Biomedico di Medicina Interna e Specialistica (Di.Bi.M.I.S.), University of Palermo, Palermo, Italy.
• Gastroenterology. 2018 Aug 1; 155 (2): 411-421.e4.

Background & AimsStudies have produced conflicting results of the incidence of hepatocellular carcinoma (HCC) in patients with hepatitis C virus-associated cirrhosis treated with direct-acting antivirals (DAAs). Data from clinics are needed to accurately assess the occurrence rate of HCC in patients with cirrhosis in the real world.MethodsWe collected data from a large prospective study of 2,249 consecutive patients (mean age = 65.4 years, 56.9% male) with hepatitis C virus-associated cirrhosis (90.5% with Child-Pugh class A and 9.5% with Child-Pugh class B) treated with DAAs from March 2015 through July 2016 at 22 academic and community liver centers in Sicily, Italy. HCC occurrence was evaluated by Kaplan-Meier curves. Cox regression analysis was used to identify variables associated with HCC development.ResultsA sustained virologic response (SVR) was achieved by 2,140 patients (total = 95.2%; 95.9% with Child Pugh class A and 88.3% with Child Pugh class B; P < .001). Seventy-eight patients (3.5%) developed HCC during a mean follow-up of 14 months (range = 6-24 months). At 1 year after exposure to DAAs, HCC developed in 2.1% of patients with Child-Pugh class A with an SVR and 6.6% of patients with no SVR and in 7.8% of patients with Child-Pugh class B with an SVR and 12.4% of patients with no SVR (P < .001 by log-rank test). Albumin level below 3.5 g/dL (hazard ratio = 1.77, 95% confidence interval = 1.12-2.82, P = .015), platelet count below 120 × 109/L (hazard ratio = 3.89, 95% confidence interval = 2.11-7.15, P < .001), and absence of an SVR (hazard ratio = 3.40, 95% confidence interval = 1.89-6.12, P < .001) were independently associated increased risk for HCC. The mean interval from exposure to DAAs to an HCC diagnosis was 9.8 months (range = 2-22 months) and did not differ significantly between patients with (n = 64, 9.2 months) and without (n = 14, 12.0 months) an SVR (P = .11). A larger proportion of patients with an SVR had a single HCC lesion (78% vs 50% without an SVR; P = .009) or an HCC lesion smaller than 3 cm (58% vs 28% without an SVR; P = .07).ConclusionsIn an analysis of data from a large prospective study of patients with hepatitis C virus-associated compensated or decompensated cirrhosis, we found that the SVR to DAA treatment decreased the incidence of HCC over a mean follow-up of 14 months.Copyright © 2018 AGA Institute. Published by Elsevier Inc. All rights reserved.

33 keywords...

hide…