DAA Treatment in Donor HCV-positive to Recipient HCV-negative Heart Transplant
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology, Hepatitis, Hepatitis |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/7/2019 |
| Start Date: | November 9, 2017 |
| End Date: | April 1, 2022 |
| Contact: | Raymond Chung, MD |
| Email: | RChung@partners.org |
| Phone: | 617-724-7562 |
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.
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.
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
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