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

Toulouse University Hospital

Status: Completed

Conditions: Chronic Kidney Diseases; Hepatitis C

Treatments: Drug: Elbasvir and Grazoprevir

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03145623

RC31/17/0096

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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:

  1. Treatment-naïve: Naïve to all anti-HCV treatment
  2. Prior interferon or pegylated interferon + ribavirin treatment failure (null responders, partial responders, relapsers)
  3. Prior Interferon (IFN) or pegylated (PEG)-IFN + ribavirin + telaprevir or boceprevir or simeprevir treatment failures
  4. Prior sofosbuvir based therapy failures
  5. 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