The Impact of Everolimus Based Immunosuppression in the Evolution of Hepatitis C Fibrosis After Liver Transplantation
Status:
Completed
Trial end date:
2016-08-01
Target enrollment:
Participant gender:
Summary
Background:
Hepatitis C recurrence, which invariably occurs in viremic liver transplant (LT) recipients,
associated with accelerated liver fibrosis leading to established graft cirrhosis in 40-20%
of patients in 5 years with another 5% experiencing an aggressive form with cirrhosis and
graft loss in 1 year. Since treatment after LT has a low efficacy, the overall survival of
HCV-infected LT recipients is shorter than that of uninfected LT patients.
New immunosuppressive agents such as mTOR inhibitors (Everolimus/Sirolimus) reduce the risk
of liver graft rejection, have antifibrotic properties and do not worsen HCV recurrence.
Moreover new directly-acting antiviral agents have increased efficacy of interferon-based
treatment but their use in LT recipients may be limited by side effects.
Hypothesis:
Use of individualized immunosuppressive regimen and early personalized anti-viral treatment
based on recipient and viral factors would improve outcome of HCV infected liver transplant
recipients.
Objectives:
1. To evaluate safety and efficacy of two steroid-free immunosuppressive regimens to reduce
hepatitis C recurrence associated to fibrosis progression (F≥2 under ISHAK score) at one
year post-transplant.
2. To identify viral and recipient factors associated with liver fibrosis progression using
ultra-deep pyrosequencing (UDPS).