Protocol transitioned to standard of care, no funding available to support research work

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

Anticipate to share coded data with collaborators

Anticipate data would be available to share within 6 months after the final patient completes the study.

Coded data would be shared with collaborators who have received IRB approval to use the data and have been approved by the PI for their collaboration.

Number of subjects initiating treatment with DAA

Adverse events were collected during the dosing period from date of first dose through date of last dose, an average of 12 weeks.

Adverse events were consider if related or possibly related to DAA treatment or receipt of an HCV viremic organ. Expected side effects and/or complications related to clinical transplantation were not captured or assessed.

Protocol was terminated prior to completion, primarily due to lack of resources (research staffing and funding) and clinical team moving HCV+ donor to HCV- recipient transplants to standard of care.