Hepatitis C Positive Organ to Recipient Hepatitis C Negative Longitudinal Transplant Study

Study Overview
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Brief Summary
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Compare wait list mortality and time to liver, heart or kidney transplant for registrants listed to consider allografts from Hepatitis C Virus (HCV) Nucleic Amplification Testing (NAT)+ donors versus those who are not . The umbrella protocol has been set up to include heart and kidney transplant recipients.

Detailed Description
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The research project will take place within each transplant center and can be incorporated into routine pre- and post-transplant care (i.e., no extra visits are needed). Enrolling in this study will enable patients to accept offers of HCV NAT+ livers, in addition to the regular waitlist. All other transplant eligibility criteria have to be met per routine care. The multi-site project will establish a biorepository and prospective data collection with the goal of obtaining more generalizable results than single-center studies alone can. Patients who enroll in the study but receive an HCV- organ instead, will be (data collection only) as part of the study. Aims are to evaluate sustained virologic response (SVR) rates post-transplant with Direct Acting Anti-Viral (DAA) therapy, as well as long-term patient and graft outcomes. Evaluate the financial impact of timely transplant and DAA therapy compared to traditional wait time health care expenditure. Create a blood and tissue biorepository for future evaluation of HCV NAT+ allografts and their outcomes

Official Title
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Hepatitis C Positive Organ to Recipient Hepatitis C Negative Longitudinal Transplant Study (HERCULES)

Conditions
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Liver Transplant; Complications, Hepatitis C

Participation Criteria
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Eligibility Criteria
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Recipient Inclusion Criteria: Adult patients > or = 18 years of age Actively listed for Liver Transplant (LT) or Simultaneous Liver and Kidney (SLK) Current HCV NAT- status Review by multi-disciplinary transplant team that patient is appropriate for listing for HCV NAT+ liver offers Recipient Exclusion Criteria: Unwilling to consent to post transplant DAA therapy Hepatitis B Virus (HBV) viremia Donor Inclusion Criteria: HCV NAT+ Deceased Donor organs HBV cAb donors will be considered on a case by case basis based on specific recipient factors and plan for post-transplant prophylaxis Donor Exclusion Criteria: Bilirubin >3 Positive nucleotide testing for HBV Radiographic, laboratory or other clinical evidence of portal hypertension Fibrosis on pre-procurement liver biopsy fibrosis > F1 or fibroscan >7 (if both are done and discordant, use biopsy to determine eligibility

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients who received a HCV+ liver transplant<br>Patients on a wait list for a liver transplant who agree to receiving a hepatitis C+ virus positive tested liver transplant. | |
| Patients who received a HCV- liver transplant<br>Patients on a wait list for a liver transplant who agree to receiving a hepatitis C- virus positive tested liver transplant. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Transplant | Number of days between date of adding patient to the waitlist and transplant date comparing waitlist registrants listed to accept HCV NAT+ donor organs with those followed per standard of care (not accepting HCV NAT+ donor organs). | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wait list Mortality | Number of days between adding patient to the waitlist to death on the waitlist comparing waitlist registrants listed to accept HCV NAT+ donor organs with those followed per standard of care (not accepting HCV NAT+ donor organs). | 5 years |