Use of Direct-acting Antiviral to Treat HCV Recurrence After Liver Transplantation (ANRSCO23CUPILT) Infection

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy, safety and tolerability of direct-acting antivirals therapy in liver transplanted patients who experienced HCV recurrence. This cohort is multicentric with constitution of biobank (plasma, serum) and the prospective collect of biological and clinical data's in the liver transplanted patients with recurrent HCV infection and treated with direct-acting anti-HCV agents.

Official Title
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Cohort of Liver Transplanted Patients With Hepatitis C Virus Recurrence and Treated With Direct-acting Antiviral Agents

Conditions
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HCV Recurrence, Liver Transplantation, Direct-acting Antiviral Agents

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years-old Liver transplanted patient Hepatitis C virus infection before transplantation HCV recurrence with a detectable HCV RNA before enrollment in cohort Use of at least one direct-acting antiviral agents with or without association with peginterferon and with or without association with ribavirin Treated by direct-acting antiviral agents or has been yet completed the treatment but still on follow up Affiliated to Health Insurance Written Signed consent form Exclusion Criteria: Pregnant or breast-feeding female

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of sustained virological response 12 weeks after discontinuation of direct-acting anti-HCV therapy in liver transplanted patients with HCV recurrence | Sustained virological response (SVR) at 12 weeks after the end of the treatment (SVR defined as undetectable HCV RNA measured by PCR en real time at 12 weeks after antiviral therapy discontinuation) | 12 weeks after discontinuation of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virological responses at 1,2,3,4,6,8,12,16, 20, 24, 36, 48 weeks during treatment and 4,12,24,48 weeks after treatment discontinuation | Detectability of HCV RNA according to real time PCR | Baseline, 1,2,3,4,6,8,12,16, 20, 24, 36, 48 weeks during treatement and 4,12,24,48 weeks after treatment discontinuation | 
| Tolerability of direct acting antiviral HCV agents | Clinical and laboratory parameters (hepatic, renal, hematological in particular) to assess safety and recording of adverse events | Baseline, 1,2,3,4,6,8,12,16, 20, 24, 36, 48 weeks during treatment and 4,12,24,48 weeks after treatment discontinuation | 
| Drug-drug interactions | Trough blood concentration of immunosuppressive drugs | Baseline, 1,2,4,12,16, 24, 48 weeks during treatement and 4weeks after treatment discontinuation | 
| To evaluate emergence of viral resistance to direct-acting antivirals agents |  | Baseline, 1,2,3,4,6,8,12,16, 20, 24, 36, 48 weeks during treatement and 4,12,24,48 weeks after treatment discontinuation | 
| To establish predictive factors of treatment failure and of emergence of viral resistance | The rate of anticipated antiviral treatment discontinuation because of intolerability or of severe adverse events | Baseline, 1,2,3,4,6,8,12,16, 20, 24, 36, 48 weeks during treatement and 4,12,24,48 weeks after treatment discontinuation | 
| Evaluate the incidence of graft loss and acute rejection | The rate of graft loss | Day 0, 1,2,3,4,6,8,12,16, 20, 24, 36, 48 weeks during treatement and 4,12,24,48 weeks after treatment discontinuation | 
| Impact on concomitant therapy on virological responses and safety |  | Baseline, 1,2,3,4,6,8,12,16, 20, 24, 36, 48 weeks during treatment and 4,12,24,48 weeks after treatment discontinuation |