Giuseppe Cabibbo1, Ciro Celsa1, Vincenza Calvaruso1, Salvatore Petta1, Irene Cacciola2, Maria Rita Cannavò3, Salvatore Madonia4, Margherita Rossi1, Bianca Magro1, Francesca Rini1, Marco Distefano5, Licia Larocca6, Tullio Prestileo7, Giuseppe Malizia8, Gaetano Bertino9, Francesco Benanti10, Anna Licata11, Ignazio Scalisi12, Giovanni Mazzola13, Maria Antonietta Di Rosolini14, Giuseppe Alaimo15, Alfonso Averna16, Fabio Cartabellotta17, Nicola Alessi1, Salvatore Guastella1, Maurizio Russello3, Gaetano Scifo5, Giovanni Squadrito2, Giovanni Raimondo2, Franco Trevisani18, Antonio Craxì1, Vito Di Marco1, Calogero Cammà19. 1. Section of Gastroenterology and Hepatology, Dipartimento di Promozione della Salute, Materno Infantile, Medicina Interna e Specialistica di Eccellenza (PROMISE), University of Palermo, Italy. 2. UOC Epatologia Clinica e Biomolecolare; AOUP G. Martino, Dipartimento di Medicina Interna e Sperimentale, University of Messina, Italy. 3. UOS Epatologia, ARNAS Garibaldi-Nesima, Catania, Italy. 4. UOC Medicina Interna, AO Villa Sofia-Cervello, Palermo, Italy. 5. UOC Malattie Infettive, Ospedale Umberto I, Siracusa, Italy. 6. UOC Malattie Infettive, AOUP G. Rodolico, Catania, Italy. 7. UOC Malattie Infettive, ARNAS Civico-Di Cristina-Benefratelli, Palermo, Italy. 8. UOC Gastroenterologia, AO Villa Sofia-Cervello, Palermo, Italy. 9. UOC Medicina Interna, AOUP G. Rodolico, Catania, Italy. 10. UOC Malattie Infettive, ARNAS Garibaldi-Nesima, Catania, Italy. 11. UOC Medicina Interna, AOUP Paolo Giaccone, Palermo, Italy. 12. UOC Medicina Interna, Ospedale di Mazzara del Vallo, ASP, Trapani, Italy. 13. UOC Malattie Infettive, Azienda Ospedaliera Universitaria Paolo Giaccone, Palermo, Italy. 14. UOC Malattie Infettive, Ospedale di Modica; ASP Ragusa, Italy. 15. UOC Medicina Interna, Ospedale di Agrigento, ASP Agrigento, Italy. 16. UOC Malattie Infettive, Ospedale di Caltanissetta, ASP Caltanissetta, Italy. 17. UOC Medicina Interna, Ospedale Buccheri La Ferla, Palermo, Italy. 18. Semeiotica Medica, Dipartimento di Scienze Mediche e Chirurgiche, Alma Mater Studiorum - University of Bologna, Italy. 19. Section of Gastroenterology and Hepatology, Dipartimento di Promozione della Salute, Materno Infantile, Medicina Interna e Specialistica di Eccellenza (PROMISE), University of Palermo, Italy. Electronic address: calogero.camma@unipa.it.
Abstract
BACKGROUND & AIMS: The effectiveness of direct-acting antivirals (DAAs) against hepatitis C virus (HCV), following successful treatment of early hepatocellular carcinoma (HCC), has been studied extensively. However, the benefit in terms of overall survival (OS) remains to be conclusively demonstrated. The aim of this study was to assess the impact of DAAs on OS, HCC recurrence, and hepatic decompensation. METHODS: We prospectively enrolled 163 consecutive patients with HCV-related cirrhosis and a first diagnosis of early Barcelona Clinic Liver Cancer stage 0/A HCC, who had achieved a complete radiologic response after curative resection or ablation and were subsequently treated with DAAs. DAA-untreated patients from the ITA.LI.CA. cohort (n = 328) served as controls. After propensity score matching, outcomes of 102 DAA-treated (DAA group) and 102 DAA-untreated patients (No DAA group) were compared. RESULTS: In the DAA group, 7/102 patients (6.9%) died, HCC recurred in 28/102 patients (27.5%) and hepatic decompensation occurred in 6/102 patients (5.9%), after a mean follow-up of 21.4 months. OS was significantly higher in the DAA group compared to the No DAA group (hazard ratio [HR] 0.39; 95% CI0.17-0.91; p = 0.03). HCC recurrence was not significantly different between the DAA and No DAA groups (HR0.70; 95% CI0.44-1.13; p = 0.15). A significant reduction in the rate of hepatic decompensation was observed in the DAA group compared with the No DAA group (HR0.32; 95% CI0.13-0.84; p = 0.02). In the DAA group, sustained virologic response was a significant predictor of OS (HR 0.02; 95% CI 0.00-0.19; p <0.001), HCC recurrence (HR 0.25; 95% CI 0.11-0.57; p <0.001) and hepatic decompensation (HR 0.12; 95% CI 0.02-0.38; p = 0.02). CONCLUSIONS: In patients with HCV-related cirrhosis who had been successfully treated for early HCC, DAAs significantly improved OS compared with No DAA treatment. LAY SUMMARY: We aimed to determine whether direct-acting antivirals (DAAs) significantly improve overall survival in patients with hepatitis C virus-related compensated cirrhosis and a first diagnosis of hepatocellular carcinoma (HCC) which has been successfully treated with curative resection or ablation. Using propensity-score matched patients, we found that DAAs improved overall survival and reduced the risk of hepatic decompensation. However, the risk of HCC recurrence was not significantly reduced.
BACKGROUND & AIMS: The effectiveness of direct-acting antivirals (DAAs) against hepatitis C virus (HCV), following successful treatment of early hepatocellular carcinoma (HCC), has been studied extensively. However, the benefit in terms of overall survival (OS) remains to be conclusively demonstrated. The aim of this study was to assess the impact of DAAs on OS, HCC recurrence, and hepatic decompensation. METHODS: We prospectively enrolled 163 consecutive patients with HCV-related cirrhosis and a first diagnosis of early Barcelona Clinic Liver Cancer stage 0/A HCC, who had achieved a complete radiologic response after curative resection or ablation and were subsequently treated with DAAs. DAA-untreated patients from the ITA.LI.CA. cohort (n = 328) served as controls. After propensity score matching, outcomes of 102 DAA-treated (DAA group) and 102 DAA-untreated patients (No DAA group) were compared. RESULTS: In the DAA group, 7/102 patients (6.9%) died, HCC recurred in 28/102 patients (27.5%) and hepatic decompensation occurred in 6/102 patients (5.9%), after a mean follow-up of 21.4 months. OS was significantly higher in the DAA group compared to the No DAA group (hazard ratio [HR] 0.39; 95% CI0.17-0.91; p = 0.03). HCC recurrence was not significantly different between the DAA and No DAA groups (HR0.70; 95% CI0.44-1.13; p = 0.15). A significant reduction in the rate of hepatic decompensation was observed in the DAA group compared with the No DAA group (HR0.32; 95% CI0.13-0.84; p = 0.02). In the DAA group, sustained virologic response was a significant predictor of OS (HR 0.02; 95% CI 0.00-0.19; p <0.001), HCC recurrence (HR 0.25; 95% CI 0.11-0.57; p <0.001) and hepatic decompensation (HR 0.12; 95% CI 0.02-0.38; p = 0.02). CONCLUSIONS: In patients with HCV-related cirrhosis who had been successfully treated for early HCC, DAAs significantly improved OS compared with No DAA treatment. LAY SUMMARY: We aimed to determine whether direct-acting antivirals (DAAs) significantly improve overall survival in patients with hepatitis C virus-related compensated cirrhosis and a first diagnosis of hepatocellular carcinoma (HCC) which has been successfully treated with curative resection or ablation. Using propensity-score matched patients, we found that DAAs improved overall survival and reduced the risk of hepatic decompensation. However, the risk of HCC recurrence was not significantly reduced.
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