Retrospective Efficacy and Safety Study With Elbasvir/Grazoprevir in HCV-infected Patients With Chronic Kidney Disease
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Retrospective Efficacy and Safety Study With Elbasvir (EBR) 50 mg/Grazoprevir (GZR) 100 mg in Hepatitis C Virus (HCV)-infected Patients With Chronic Kidney Disease (CKD) Stage 4-5 During the French Temporary Authorization for Use (ATU) Program: Data From Real-life
Condition or disease
Hepatitis CChronic Kidney Diseases
Drug: Elbasvir and Grazoprevir
Primary objective : Retrospectively collect and describe the real life efficacy (SVR 12)* and safety data of EBR 50 mg/GZR 100 mg based therapy, 12 or 16 weeks dosed in HCV-infected patients with chronic kidney disease. These data are collected following French ATU allocation.
Retrospective Efficacy and Safety Study With Elbasvir 50 mg/Grazoprevir 100 mg in HCV-infected Patients With Chronic Kidney Disease Stage 4-5 During the French Temporary Authorization for Use (ATU) Program: Data From Real-life
Actual Study Start Date :
June 2, 2017
Actual Primary Completion Date :
December 31, 2017
Actual Study Completion Date :
December 31, 2017
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
CKD subjects with GT1 and GT4 HCV, compensated cirrhotic or non-cirrhotic (i.e all subjects with EBR 50 mg/GZR 100 mg based therapy in ATU allocation) will be included in this retrospective analysis
documented chronic (at least 6 months) HCV Genotype1 (GT1) and Genotype 4 (GT4) infection
Mono infected by HCV or co-infected by HCV and HIV
Have an HCV treatment status corresponding to one of the following:
Prior Interferon (IFN) or pegylated (PEG)-IFN + ribavirin + telaprevir or boceprevir or simeprevir treatment failures
Prior sofosbuvir based therapy failures
Pegylated interferon ribavirin intolerant
Have CKD defined as:
Subjects with glomerular filtration rate (GFR) ≤30 ml/min who are non-dialysis dependent (NDD) or have been on hemodialysis (HD) for at least 3 months (including subjects awaiting kidney transplant and subjects with failed kidney transplants no longer on immunosuppressant therapy).