Retrospective Efficacy and Safety Study With Elbasvir/Grazoprevir in HCV-infected Patients With Chronic Kidney Disease

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Hepatitis C, Chronic Kidney Diseases

Intervention / Treatment
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* Drug: Elbasvir and Grazoprevir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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: Treatment-naïve: Naïve to all anti-HCV treatment Prior interferon or pegylated interferon + ribavirin treatment failure (null responders, partial responders, relapsers) 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). Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Elbasvir and Grazoprevir|Elbasvir 50 mg and grazoprevir 100 mg during the French temporary authorization for use (ATU) program|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Elbasvir (EBR)/Grazoprevir (GZR) | Describe the real life efficacy (Sustained Virologic Response SVR 12) of EBR 50 mg/GZR 100 mg based therapy by assessment of the HCV RNA | 12 weeks after the end of all study therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety during treatment | Assessment of all Adverse Events and laboratory tests collected during treatment | during treatment |