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

N/AUnknownNCT01944527

ANRS, Emerging Infectious Diseases699 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

699

Conditions

HCV Recurrence Liver Transplantation Direct-acting Antiviral Agents

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Outcomes

Primary Outcomes

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)

Time frame: 12 weeks after discontinuation of therapy

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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