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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Liver Cirrhosis

Intervention / Treatment
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* Drug: Sofosbuvir 400mg/day/Simeprevir 150mg/day /Ribavirin 800mg/day for 12 weeks


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 82 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I (<65 years)<br>Group I treated with Sofosbuvir 400mg/day/Simeprevir 150mg/day /Ribavirin 800mg/day for 12 weeks | Drug: Sofosbuvir 400mg/day/Simeprevir 150mg/day /Ribavirin 800mg/day for 12 weeks<br>* Sofosbuvir 400 mg/day/Simeprevir 150 mg/day /Ribavirin 800/day for 12 weeks<br>* Other names: Sovaldi Olysio Copegus;|
| Active Comparator: Group II (>65 years)<br>Group II treated with Sofosbuvir 400mg/day/Simeprevir 150mg/day /Ribavirin 800mg/day for 12 weeks | Drug: Sofosbuvir 400mg/day/Simeprevir 150mg/day /Ribavirin 800mg/day for 12 weeks<br>* Sofosbuvir 400 mg/day/Simeprevir 150 mg/day /Ribavirin 800/day for 12 weeks<br>* Other names: Sovaldi Olysio Copegus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained virological response week 12 after the end of treatment | to evaluate the efficacy in term of sustained virological response after 12 weeks from the end of treatment in the two Groups of patients | up 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events and severe adverse events during the treatment period | To report Adverse events and severe adverse events during the treatment period in the two Groups of patients | up 12 weeks |