Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver and Post-Kidney Transplant (PRO-ACT:)

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.