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

Phase 4

Completed

• Conditions: Liver Cirrhosis
• Interventions: Drug: Sofosbuvir 400mg/day/Simeprevir 150mg/day /Ribavirin 800mg/day for 12 weeks

• Registration Number: NCT02702739
• Lead Sponsor: Azienda Ospedaliera San Camillo Forlanini

Brief 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.

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2015-12
• Study Completion: 2016-02
• Study First Submitted: 2016-02-23
• Status Verified: 2016-03
• Study First Submitted QC: 2016-03-08
• Last Update Submitted: 2016-03-08
• Study First Posted: 2016-03-09
• Last Update Posted: 2016-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II (>65 years)	Sofosbuvir 400mg/day/Simeprevir 150mg/day /Ribavirin 800mg/day for 12 weeks	Group II treated with Sofosbuvir 400mg/day/Simeprevir 150mg/day /Ribavirin 800mg/day for 12 weeks
Group I (<65 years)	Sofosbuvir 400mg/day/Simeprevir 150mg/day /Ribavirin 800mg/day for 12 weeks	Group I treated with Sofosbuvir 400mg/day/Simeprevir 150mg/day /Ribavirin 800mg/day for 12 weeks

Primary Outcome Measures

Name	Time	Method
Sustained virological response week 12 after the end of treatment	up 12 weeks	to evaluate the efficacy in term of sustained virological response after 12 weeks from the end of treatment in the two Groups of patients

Secondary Outcome Measures

Name	Time	Method
Adverse events and severe adverse events during the treatment period	up 12 weeks	To report Adverse events and severe adverse events during the treatment period in the two Groups of patients

Trial Locations

Locations (1)

AO San Camillo Forlanini; 🇮🇹 Rome, Italy