Adriano M Pellicelli1, Valeria Pace Palitti2, Pascal Vignally3, Francesca Ceccherini-Silberstein4, Massimo Siciliano5, Valerio Giannelli1, Alessandra Moretti6, Pierluigi Tarquini7, Gaetano Scifo8, Vincenzo Messina9, Antonio Ascione10, Antonio Izzi11, Massimo Marignani12, Cecilia D'Ambrosio1, Lucia Fondacaro1, Giuseppe M Ettorre13, Pasquale Ialongo14, Rodolfo Sacco15, Carlo F Perno4, Giorgio Barbarini16. 1. Liver Disease Unit, Department of Liver Transplantation, San Camillo Forlanini Hospital, Rome, Italy. 2. Hepatology Department of Medicine, ASL Pescara, Pescara, Italy. 3. Emergency Department, Galliera Hospital, Genoa, Italy. 4. Department of Experimental Medicine and Surgery, University of Tor Vergata, Rome, Italy. 5. Internal Medicine, Catholic University Policlinico Gemelli, Rome, Italy. 6. Gastroenterology, San Filippo Neri Hospital, Rome, Italy. 7. Infectious Disease, ASL Teramo, Teramo, Italy. 8. Infectious Disease, Umberto I Hospital, Siracusa, Italy. 9. Infectious Disease, Sant'Anna and San Sebastiano Hospital Caserta, Rome, Italy. 10. Center for Liver Disease, Fatebenefratelli Hospital, Napoli, Italy. 11. Infectious Disease, Cotugno Hospital, Napoli, Italy. 12. Digestive and Liver Disease Unit, Faculty Medicine and Psychology, S. Andrea Hospital, Sapienza University of Rome, Rome, Italy. 13. Division of General Surgery and Liver Transplantation, S. Camillo Forlanini Hospital, Rome, Italy. 14. Radiology, Camillo Forlanini Hospital, Rome, Italy. 15. Liver Unit, Azienda Universitaria Pisana, Pisa, Italy. 16. Infectious Disease, IRCCS San Matteo, Pavia, Italy.
Abstract
BACKGROUND & AIMS: The proportion of HCV-infected patients over age 65 years in Western countries is increasing. This growth and the advent of new antiviral therapy bring into the question the real-world efficacy and safety of the combination of sofosbuvir (SOF) and simeprevir (SMV) plus a flat dose of 800 mg/d ribavirin (RBV) in elderly patients with cirrhosis compared to younger patients. METHODS: Retrospective observational multicentre real-life investigation study of SOF/SMV/RBV for a duration of 12 weeks in HCV genotype 1-infected patients with cirrhosis. RESULTS: Of the 270 patients enrolled in this study, with compensated cirrhosis, 133 (49.2%) were ≥65 years of age. Sustained virological response at 12 weeks (SVR12) was achieved by 94.2% (129/137) of those aged <65 years and 97.7% (130/133) of those ≥65 years. Diabetes was the most common comorbidity in patients ≥65 years compared to younger patients (26.3% vs 12.4% P<.003). The most common adverse event (AE) in elderly patients was a grade 2 anaemia (35.3% vs 19.9% P<.004). CONCLUSIONS: Sofosbuvir/simeprevir plus a daily flat dose of RBV 800 mg for 12 weeks was highly effective and safe in genotype 1 elderly patients with compensated cirrhosis.
BACKGROUND & AIMS: The proportion of HCV-infectedpatients over age 65 years in Western countries is increasing. This growth and the advent of new antiviral therapy bring into the question the real-world efficacy and safety of the combination of sofosbuvir (SOF) and simeprevir (SMV) plus a flat dose of 800 mg/d ribavirin (RBV) in elderly patients with cirrhosis compared to younger patients. METHODS: Retrospective observational multicentre real-life investigation study of SOF/SMV/RBV for a duration of 12 weeks in HCV genotype 1-infectedpatients with cirrhosis. RESULTS: Of the 270 patients enrolled in this study, with compensated cirrhosis, 133 (49.2%) were ≥65 years of age. Sustained virological response at 12 weeks (SVR12) was achieved by 94.2% (129/137) of those aged <65 years and 97.7% (130/133) of those ≥65 years. Diabetes was the most common comorbidity in patients ≥65 years compared to younger patients (26.3% vs 12.4% P<.003). The most common adverse event (AE) in elderly patients was a grade 2 anaemia (35.3% vs 19.9% P<.004). CONCLUSIONS:Sofosbuvir/simeprevir plus a daily flat dose of RBV 800 mg for 12 weeks was highly effective and safe in genotype 1 elderly patients with compensated cirrhosis.
Authors: Giovanni Battista Gaeta; Alessio Aghemo; Barbara Menzaghi; Gianpiero D'Offizi; Alessia Giorgini; Hamid Hasson; Giuseppina Brancaccio; Maria Palma; Roberta Termini Journal: Medicine (Baltimore) Date: 2018-07 Impact factor: 1.889