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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Efficacy of Elbasvir (EBR)/Grazoprevir (GZR)
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- Not provided
Outcomes
Primary Outcomes
Efficacy of Elbasvir (EBR)/Grazoprevir (GZR)
Time Frame: 12 weeks after the end of all study therapy
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
Secondary Outcomes
- Safety during treatment(during treatment)