Hepatitis C, Liver Transplant; Complications
Conditions
Brief summary
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
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
Interventions
None listed
Sponsors
Yale University
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Recipient Inclusion Criteria: 1. Adult patients \> or = 18 years of age 2. Actively listed for Liver Transplant (LT) or Simultaneous Liver and Kidney (SLK) 3. Current HCV NAT- status 4. Review by multi-disciplinary transplant team that patient is appropriate for listing for HCV NAT+ liver offers Recipient
Exclusion criteria
1. Unwilling to consent to post transplant DAA therapy 2. Hepatitis B Virus (HBV) viremia Donor Inclusion Criteria: 1. HCV NAT+ 2. Deceased Donor organs 3. HBV cAb donors will be considered on a case by case basis based on specific recipient factors and plan for post-transplant prophylaxis Donor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Transplant | 5 years | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wait list Mortality | 5 years | 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). |
Countries
United States
Outcome results
None listed