Clinical trial NCT01944527: Use of Direct-acting Antiviral to Treat HCV Recurrence After Liver Transplantation (ANRSCO23CUPILT) Infection
Official title: Cohort of Liver Transplanted Patients With Hepatitis C Virus Recurrence and Treated With Direct-acting Antiviral Agents
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HCV Recurrence
Liver Transplantation
Direct-acting Antiviral Agents
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2013-09-17
Enrollment: 699
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Liver transplant patients with recurrent hepatitis C virus infection treated with direct-acting antiviral agents and followed up in centers of transplantation of the university hospitals.

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.


Eligibility criteria: 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

Primary outcomes:
measure: The rate of sustained virological response 12 weeks after discontinuation of direct-acting anti-HCV therapy in liver transplanted patients with HCV recurrence
timeFrame: 12 weeks after discontinuation of therapy
Secondary outcomes:
measure: 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
timeFrame: 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
measure: Tolerability of direct acting antiviral HCV agents
timeFrame: 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
measure: Drug-drug interactions
timeFrame: Baseline, 1,2,4,12,16, 24, 48 weeks during treatement and 4weeks after treatment discontinuation
measure: To evaluate emergence of viral resistance to direct-acting antivirals agents
timeFrame: 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
measure: To establish predictive factors of treatment failure and of emergence of viral resistance
timeFrame: 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
measure: Evaluate the incidence of graft loss and acute rejection
timeFrame: 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
measure: Impact on concomitant therapy on virological responses and safety
timeFrame: 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
Other outcomes:
Locations:
city: Rennes
country: France
facility: Claire Fougerou
Study officials:
affiliation: HOSPITAL SAINT ELOI
name: Georges Philippe Pageaux, Professsor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barrail-Tran A, Goldwirt L, Gele T, Laforest C, Lavenu A, Danjou H, Radenne S, Leroy V, Houssel-Debry P, Duvoux C, Kamar N, De Ledinghen V, Canva V, Conti F, Durand F, D'Alteroche L, Botta-Fridlund D, Moreno C, Cagnot C, Samuel D, Fougerou-Leurent C, Pageaux GP, Duclos-Vallee JC, Taburet AM, Coilly A. Comparison of the effect of direct-acting antiviral with and without ribavirin on cyclosporine and tacrolimus clearance values: results from the ANRS CO23 CUPILT cohort. Eur J Clin Pharmacol. 2019 Nov;75(11):1555-1563. doi: 10.1007/s00228-019-02725-x. Epub 2019 Aug 5.
citation: Antonini TM, Coilly A, Rossignol E, Fougerou-Leurent C, Dumortier J, Leroy V, Veislinger A, Radenne S, Botta-Fridlund D, Durand F, Houssel-Debry P, Kamar N, Canva V, Perre P, De Ledinghen V, Rohel A, Diallo A, Taburet AM, Samuel D, Pageaux GP, Duclos-Vallee JC; ANRS C023 CUPILT study group. Sofosbuvir-Based Regimens in HIV/HCV Coinfected Patients After Liver Transplantation: Results From the ANRS CO23 CUPILT Study. Transplantation. 2018 Jan;102(1):119-126. doi: 10.1097/TP.0000000000001928.
citation: Leroy V, Dumortier J, Coilly A, Sebagh M, Fougerou-Leurent C, Radenne S, Botta D, Durand F, Silvain C, Lebray P, Houssel-Debry P, Kamar N, D'Alteroche L, Petrov-Sanchez V, Diallo A, Pageaux GP, Duclos-Vallee JC; Agence Nationale de Recherches sur le SIDA et les Hepatites Virales CO23 Compassionate Use of Protease Inhibitors in Viral C in Liver Transplantation Study Group. Efficacy of Sofosbuvir and Daclatasvir in Patients With Fibrosing Cholestatic Hepatitis C After Liver Transplantation. Clin Gastroenterol Hepatol. 2015 Nov;13(11):1993-2001.e1-2. doi: 10.1016/j.cgh.2015.05.030. Epub 2015 Jun 1.