Sofosbuvir/Simeprevir Plus a Flat Dose of Ribavirin in Genotype 1 Elderly HCV Cirrhotic Patients (HCV)

Efficacy and Safety of Sofosbuvir/Simeprevir Plus a Flat Dose of Ribavirin in Genotype 1 Elderly Cirrhotic Patients: a Real Life Study

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 and Simeprevir (SOF/SMV) plus a flat dose of ribavirin (RBV) in elderly patients compared to younger patients.

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 and Simeprevir (SOF/SMV) plus a flat dose of ribavirin (RBV) in elderly patients (Group II) compared to younger patients (Group I) Multicenter, real world investigation study of once daily treatment with SOF 400 mg + SMV 150 mg with a flat dose of RBV 800 mg/day for a duration of 12 weeks in treatment naïve or experienced HCV genotype 1-infected patients with compensated cirrhosis.To evaluate efficacy, tollerability and safety of SOF/SMV/RBV in two different Group of patients.

to evaluate the efficacy in term of sustained virological response after 12 weeks from the end of treatment in the two Groups of patients

To report Adverse events and severe adverse events during the treatment period in the two Groups of patients

Inclusion Criteria: Naive or experienced patients with genotype 1 compensated cirrhosis Exclusion Criteria: HIV and hepatitis B infection, active hepatocellular carcinoma (HCC), decompensated cirrhosis, history of organ transplant, severe psychiatric disorders or treatment with drugs that showed an interaction with antiviral treatment.

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