Prospective, Open-label, Single Arm Pilot Study Evaluating the Effect on Virological Response of the Switch From Tacrolimus to Cyclosporin Associated With a Peginterferon Alfa-2a / Ribavirin Bitherapy, in Non-responder or With Recurrent VHC+ Disease Liver Transplanted Patients.
In France, 50% of hepatitis C virus carriers develop chronic clinical hepatitis, which may
lead to cirrhosis and liver transplantation. Transplant infection by hepatitis C virus is
constant after transplantation. A main factor determining the severity of recurrent
hepatitis C after transplantation may be immunosuppression. Thus optimization of
immunosuppressive regimens might be a key aspect to improve the prognosis of chronic
hepatitis C in transplanted patients. The two most frequently used immunosuppressive drugs
are cyclosporin and tacrolimus. However, it has been shown that virus replication could be
inhibited by cyclosporin, through the blockade of cyclophilins, decreasing hepatitis C viral
load and improving liver function. These effects were not found with tacrolimus.
The aim of our study is to assess the efficacy on C virological response of the switch from
tacrolimus to cyclosporin associated with a peginterferon alfa-2a / ribavirin bitherapy, in
non-responder or with a recurrent VHC+ disease liver transplanted patients.
Patients will receive a 19 month cyclosporin treatment, associated during 12 months with a
peginterferon alfa-2a / ribavirin bitherapy. Efficacy will be assessed by the percentage of
patients with a negative qualitative PCR after 19 months of cyclosporin treatment.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Prolonged virological response
Percentage of patients with a negative qualitative PCR, 19 months after the initiation of cyclosporin treatment.
Yvon Calmus, MD, PhD
Hôpital Cochin, Paris
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)