Transplantation Using Hepatitis C Positive Donors, A Safety Trial
Lung Transplant Infection, Heart Transplant Infection, Kidney Transplant Infection
About this trial
This is an interventional treatment trial for Lung Transplant Infection focused on measuring Organ Transplant, Hepatitis C Virus, Direct-Acting Antivirals (DAAs)
Eligibility Criteria
Donor Inclusion Criteria:
- Age <70
- NAT+ HCV donor
Donor Exclusion Criteria:
- HIV positive or HTLV 1/2 positive
- Hepatitis B surface Antigen positive
- Any medical issues in the donor that would normally clinically exclude the donor (e.g. history of cancer, evidence of organ dysfunction, etc)
- Age>70
Recipient Inclusion Criteria:
- Recipients listed for kidney, kidney-pancreas, pancreas transplant alone, heart, or lung transplant
- HCV NAT negative
- Provides written informed consent
Recipient Exclusion Criteria:
- Chronic liver disease with > stage 2 fibrosis
- Participating in another interventional clinical trial
- Recipient listed for liver transplant
- Known allergy or contraindication to Glecaprevir/Pibrentasvir or ezetimibe
Sites / Locations
- University Health Network Toronto General HospitalRecruiting
Arms of the Study
Arm 1
Experimental
Non Randomized Intervention
Intervention description: recipients on the wait-list for lung, heart, kidney, and/or pancreas transplants will all receive antiviral treatment in the form of 8 total doses of oral tablets. Lung recipients will also receive donor lungs that are treated with normothermic EVLP (details of both described below). Drug: All recipients will receive glecaprevir (300mg)/pibrentasvir (120mg) supplied as three tablets per dose 6-12 hours prior to transplant, and for 7 days post-transplant. Other Names: Maviret. Patients will also receive ezetimibe (10mg), supplied as one tablet per dose to be taken at the same time as Maviret tablets (6-12 hours prior to transplant in addition to 7 daily doses post-transplant). Ex Vivo Lung Perfusion (EVLP): Normothermic EVLP is a method of donor lung preservation, assessment, treatment, and repair of injured organs. This method allows donor lungs to be treated for at least 12h under protective physiological conditions. Other names: Normothermic EVLP.