Liver Cirrhosis
Conditions
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.
Interventions
DRUGSofosbuvir 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
Sponsors
Azienda Ospedaliera San Camillo Forlanini
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 82 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed