Hepatitis C Virus (HCV) Positive Liver Grafts in HCV Negative Recipients

Pilot Investigation Using HCV Positive Liver Grafts in HCV Negative or Previously Successfully Treated Recipients

To provide proof-of-concept data on the efficacy/safety of transplanting HCV positive donor grafts in HCV sero-negative liver recipients who are currently listed.

Inclusion Criteria:

• Male or female
• Age 18 and older
• Active on the transplant list
• Donor organ with Antibody and nucleic acid test (NAT) positive for HCV
• Graft with F2 fibrosis or less at time of explant
• HCV negative recipient; this includes patients who never had HCV and those with HCV previously eradicated with antiviral therapy. The latter is defined as those with undetectable HCV viral load at least 3 months since stopping therapy.
• Willing and able to provide written informed consent or for those subjects where hepatic encephalopathy affects their ability to provide initial or ongoing consent, has an appropriate and legally-authorized representative willing and able to provide consent on behalf of the subject

Exclusion Criteria:

• Participants co-infected with HIV
• Donor previously treated with a non-structural protein 5A (NS5a) containing regimen (if treatment history of donor known)
• Known allergies or hypersensitivity to direct acting antiviral drug (DAA) or ribavirin (RBV)
• Pregnancy and/or actively breastfeeding