DAA Treatment in Donor HCV-positive to Recipient HCV-negative Heart Transplant

Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Heart Transplant

This is a proof of concept, single center study for the donation of HCV-positive hearts to HCV negative recipient patients, with preemptive, interventional treatment with 12 weeks of commercially available DAA therapy to prevent HCV transmission upon transplantation.

The goal of this study is to determine if preoperative dosing and sustained administration of pan-genotypic DAA therapy after cardiac transplantation prevents the transmission of hepatitis C virus (HCV) infection from an HCV-positive donor heart to an HCV naïve recipient.

Inclusion Criteria:

• Recipient is Age ≥ 18 years
• Serum ALT within normal limits with no history of liver disease
• Lack of sensitization (i.e. PRA < 20%) that would be expected to result in a high likelihood of needing aggressive immunosuppression to treat rejection

Exclusion Criteria:

• Sensitization (i.e. PRA >20%)
• Any liver disease in recipient
• Albumin < 3g/dl or platelet count < 75 x 103/mL
• Need for dual organ transplant