A Study of the Use of Hepatitis C Positive Donors for Hepatitis C Negative Lung Transplant Recipients With Post-transplant Treatment With Mavyret

Study Overview
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Brief Summary
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Patients who are Hepatitis C Negative (HCV negative) and are on the waiting list for a lung transplant at NYULH who consent to participate in this study will receive a lung transplant from a deceased donor that is HCV positive. Patients will initiate treatment for HCV with the pan-genotypic agent, Mavyret, on the day of surgery and will complete the full 8-week treatment course. Patients will be monitored post-transplant for the development of viremia, and for the time course of clearance of viremia among those who develop viremia.

Official Title
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A Single-center Pilot Study of the Use of Hepatitis C Positive Donors for Hepatitis C Negative Lung Transplant Recipients With Post-transplant Treatment With Mavyret

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: Mavyret


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recipient criteria: Listed for an isolated lung transplant at NYU Langone Health Between 18-70 years of age Able to travel to the NYU Langone Health for routine post-transplant visits and study visits for a minimum of 6 months after transplantation No active illicit substance abuse Weight at least 40kg Women of childbearing potential must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) after transplant due to the increased risk of birth defects and/or miscarriage Both men and women must agree to use at least one barrier method after transplant to prevent any secretion exchange Able and willing to provide informed consent Donor criteria: Detectable HCV RNA by nucleic acid test (NAT) or positive anti-HCV antibody Donor lung meets standard NYU Langone Health clinical criteria for procurement Exclusion Criteria: Recipient criteria: HIV positive HCV RNA positive or history of previously treated HCV Evidence of active hepatitis B infection or on active antiviral treatment for HBV Pregnant or nursing (lactating) women Use of strong CYP3A inducers Requires multi-organ transplant Donor criteria: Confirmed HIV positive Confirmed HBV positive (positive hepatitis B surface antigen, and/or detectable Hepatitis B virus DNA) Known previously failed treatment for HCV Donor age >60 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Post Lung Transplant Patients<br>The lung transplantation will be performed per standard of care techniques,and all post-transplant management of the transplanted organ, including immunosuppression, will be carried out per standard of care. | Drug: Mavyret<br>* Patients will be on 8 weeks of Mavyret<br>* Other names: glecaprevir;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Incidences of Viremia After Receiving a Lung Transplant From a Donor Who Tests Positive for Hepatitis C | Surveillance for the development of hepatitis C viremia post-transplant | 24 Months | 
| Number of Patients With Sustained Virologic Response After Treatment | HCV serologic testing to evaluate the presence of immunity to HCV or the evidence of prior infection with HCV. | 24 Months |