Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver and Post-Kidney Transplant

Inclusion Criteria:

- Adult (≥ 18 year-old), wait-listed for primary kidney or liver transplant without a
potential suitable living donor or for simultaneous liver kidney transplant;

- HCV non-infected at the time of transplant. Subjects who were previously HCV infected
but who have had documented SVR12 are eligible to participate;

- Agree to use two methods of birth control during the study;

- Donor characteristics: serum HCV NAT-positive and negative for hepatitis B surface
antigen. For liver transplant: pre-donation liver biopsy with no fibrosis (F0) or
minimal fibrosis (F1). For kidney transplant: kidney donor profile index < 85%.

Exclusion Criteria:

- Donor and/or recipient HIV infection

- Subject pregnant or nursing

- Donor and/or recipient Hepatitis B surface antigen positive

- Kidney-pancreas transplant

- Single organ liver recipients who received hemodialysis for more than 7 days prior to
liver transplantation

- Kidney recipients: on dialysis for > 5 years at time of Screening; subjects sensitized
with panel reactive antibody > 80%; for single organ kidney transplant, subjects with
advanced liver fibrosis (Knodell stage 3) or cirrhosis

- Individuals being treated with and needing to continue rifabutin, rifampin,
carbamazepine, phenytoin, phenobarbital, oxcarbazepine, St. John's wort (Hypericum
perforatum), medium- or high-dose rosuvastatin or atorvastatin, or high-dose proton
pump inhibitors (See Concomitant Medications).

- Individuals treated with amiodarone within 42 days of organ transplant.