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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.
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Georges Philippe Pageaux, Professsor | HOSPITAL SAINT ELOI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Claire Fougerou | Rennes | 35033 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31384986 | Derived | 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. | |
| 28846559 |
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Serum and plasma
| 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 |
| Derived |
| 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. |
| 26044317 | Derived | 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. |