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Incidence of Hepatocellular Carcinoma in Patients With HCV-Associated Cirrhosis Treated With Direct-Acting Antiviral Agents

  • Authors: Calvaruso, Vincenza; Cabibbo, Giuseppe; Cacciola, Irene; Petta, Salvatore; Madonia, Salvatore; Bellia, Alessandro; Tinè, Fabio; Distefano, Marco; Licata, Anna; Giannitrapani, Lydia; Prestileo, Tullio; Mazzola, Giovanni; Di Rosolini, Maria Antonietta; Larocca, Licia; Bertino, Gaetano; Digiacomo, Antonio; Benanti, Francesco; Guarneri, Luigi; Averna, Alfonso; Iacobello, Carmelo; Magro, Antonio; Scalisi, Ignazio; Cartabellotta, Fabio; Savalli, Francesca; Barbara, Marco; Davì, Antonio; Russello, Maurizio; Scifo, Gaetano; Squadrito, Giovanni; Cammà, Calogero; Raimondo, Giovanni; Craxì, Antonio; Di Marco, Vito; Di Marco, V.; Cammà, C.; Calvaruso, V.; Petta, S.; Cabbibbo, G.; Colletti, P.; Mazzola, G.; Cascio, A.; Montalto, G.; Licata, A.; Giannitrapani, L.; Prestileo, T.; Di Lorenzo, F.; Sanfilippo, A.; Ficalora, A.; Madonia, S.; Tinè, F.; Malizia, G.; Latteri, F.; Maida, M.; Cartabellotta, F.; Vassallo, R.; Cacciola, I.; Caccamo, G.; Maimone, S.; Saitta, C.; Squadrito, G.; Raimondo, G.; Mondello, L.; Smedile, A.; D'Andrea, S.; Bertino, G.; Ardiri, A.L.; Frazzetto, E.; Rigano, G.; Montineri, A.; Larocca, L.N.; Cacopardo, B.; Benanti, F.; Russello, M.; Benigno, R.; Bellia, A.; Iacobello, C.; Davì, A.; Di Rosolini, M.A.; Digiacomo, A.; Fuduli, G.; Scifo, G.; Distefano, M.; Portelli, V.; Savalli, F.; Scalici, I.; Gioia, G.; Magro, A.; Alaimo, G.; Alinovi, M.R.; Salvo, A.; Averna, A.; Lomonaco, F.; Guarneri, L.; Maffeo, F.; Falzone, E.; Pulvirenti, F.
  • Publication year: 2018
  • Type: Articolo in rivista (Articolo in rivista)
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Background & Aims: Studies 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. Methods: We 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. Results: A 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). Conclusions: In 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.