Study of Hepatitis C Virus (HCV) Entry Inhibitor in Liver Transplant Recipients With HCV Infection

All subjects will receive 28 days of ITX 5061 beginning at the time of transplant.

Dosing of ITX 5061 is as follows:

Day of Transplant prior to surgery: ITX 5061 300 mg Day of Transplant following surgery: ITX
5061 300 mg Post-Operative Days 1-6: ITX 5061 300 mg Post-Operative Days 7-27: ITX 5061 150
mg

Subjects will be monitored for HCV RNA levels, HDL cholesterol and ITX 5061 drug
concentration levels.

A liver biopsy will be performed at 6 months post-transplant to assess for histological
signs of HCV recurrence.

Inclusion Criteria:

- Age 18-72

- Patients accepted onto waiting list for liver transplantation for HCV related liver
disease and receiving a deceased donor liver allograft

- HCV RNA (+) at time of listing for transplantation. All HCV genotypes will be
eligible

- Patients with HCC and those receiving hepatitis B core (+) donor livers will be
eligible

- Standard immunosuppression protocol with tacrolimus, corticosteroid taper, and
mycophenolate mofetil

Exclusion Criteria:

- Viral co-infection (HBV/HIV)

- Receipt of a HCV (+) donor allograft

- Patients undergoing retransplantation for recurrent HCV

- Multivisceral transplantation

- Patients receiving anti-viral therapy at the time of LT

- Live donor liver transplantation