A Pilot Study to Examine the Role of Nitazoxanide to Prevent Recurrence of Hepatitis C After Transplantation

Recurrence of Hepatitis C virus infection (HCV) is universal after orthotopic liver
transplantation (LTx) and is associated with allograft failure, death and need for
re-transplantation. Currently, there are no effective therapies to prevent HCV recurrence.
Nitazoxanide (NTZ), an oral thiazolide anti-infectious agent, was safe, well tolerated and
effective in achieving sustained viral response in patients with chronic HCV genotype 4.
Its role in the prevention of HCV recurrence after liver transplantation has not been
studied. The investigators propose to conduct an open label pilot study examining the role
of NTZ in the prevention of HCV re-infection in eight patients undergoing LTx. First time
transplant recipients for chronic HCV without history of renal failure or HIV/HBV
co-infection, will receive NTZ immediately prior to LTx and for 3 days thereafter. The
primary endpoint is the number of patients who remain HCV-RNA-negative at day 7 after LTx.
If at least one patient remains negative, the study will be determined to be positive.
Additionally, the investigators will examine the viral kinetics of HCV, tolerability and
safety of NTZ.