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

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliera San Camillo Forlanini
• Treatments: Ribavirin; Simeprevir; Sofosbuvir

Criteria

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.