NCT02702739

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Azienda Ospedaliera San Camillo Forlanini · Academic / Other
• Sex: All
• Age: 18 Years – 82 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Liver Cirrhosis

Interventions

Type	Name	Description
DRUG	Sofosbuvir 400mg/day/Simeprevir 150mg/day /Ribavirin 800mg/day for 12 weeks	Sofosbuvir 400 mg/day/Simeprevir 150 mg/day /Ribavirin 800/day for 12 weeks

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-12-01
• Completion: 2016-02-01
• First posted: 2016-03-09
• Last updated: 2016-03-09

Locations

1 site across 1 country: Italy