Direct-acting Antiviral Agents, HCV Recurrence, Liver Transplantation
Conditions
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.
Interventions
None listed
Sponsors
ANRS, Emerging Infectious Diseases
Study design
Observational model
COHORT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 | — |
| 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 |
| 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 |
| 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 | — |
| 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 |
Countries
France
Outcome results
None listed