A Pilot Study to Examine the Role of Nitazoxanide to Prevent Recurrence of Hepatitis C After Transplantation
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.
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. We
 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, we will examine the
 viral kinetics of HCV, tolerability and safety of NTZ.
Inclusion Criteria:

 -  Adult male or female patients age 18-75

 -  HCV infection identified by positive, quantifiable HCV RNA prior to transplant

 Exclusion Criteria:

 -  Scheduled recipient of living donor transplantation

 -  History of chronic hepatitis B or HIV infection

 -  Transplantation for fulminant hepatic failure

 -  Estimated glomerular filtration rate <60ml/min

 -  Women who are pregnant or breast feeding and men or women that are sexually active but
 do not agree to use acceptable birth control