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

• Conditions: HCV Recurrence; Liver Transplantation; Direct-acting Antiviral Agents

• Registration Number: NCT01944527
• Lead Sponsor: ANRS, Emerging Infectious Diseases

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-13
• Study First Submitted QC: 2013-09-13
• Study First Posted: 2013-09-17
• Study Start: 2013-10
• Primary Completion: 2015-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-01
• Last Update Posted: 2016-02-02
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 699

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The rate of sustained virological response 12 weeks after discontinuation of direct-acting anti-HCV therapy in liver transplanted patients with HCV recurrence	12 weeks after discontinuation of therapy	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)

Secondary Outcome Measures

Name	Time	Method
Tolerability of direct acting antiviral HCV agents	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	Clinical and laboratory parameters (hepatic, renal, hematological in particular) to assess safety and recording of adverse events
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
Evaluate the incidence of graft loss and acute rejection	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	The rate of graft loss
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	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	Detectability of HCV RNA according to real time PCR
Drug-drug interactions	Baseline, 1,2,4,12,16, 24, 48 weeks during treatement and 4weeks after treatment discontinuation	Trough blood concentration of immunosuppressive drugs
To establish predictive factors of treatment failure and of emergence of viral resistance	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	The rate of anticipated antiviral treatment discontinuation because of intolerability or of severe adverse events
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

Trial Locations

Locations (1)

Claire Fougerou; 🇫🇷 Rennes, France