Expanding the Pool in Lung Transplantation

Study Overview
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Brief Summary
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To perform a study (20 patients) utilizing Hepatitis C positive (HCV Ab+/NAT -) donor lungs for hepatitis C negative recipients with post-operative surveillance and treatment only if a recipient infection occurs.

Detailed Description
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The investigators are proposing a study of efficacy, in which positive donors will be used for HCV negative patients. Following lung transplantation patients will undergo HCV antibody, virus PCR, and liver function testing. Recipients whom test positive for HCV viremia for 2 consecutive tests at any point will complete 12 weeks of Sofosbuvir/velpatasvir therapy. This initial study would enroll 20 patients and utilize donors that are young, otherwise healthy whom are Hepatitis C antibody positive but Nucleic Acid Amplification Testing (NAT) negative (HCV Ab+/NAT-). The recipients would be limited to those patients who have previously consented to receive a high risk lung transplant, consented to participant in this study, and who are physiologically optimized for transplantation (e.g., low risk for lung transplantation).

Official Title
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Expanding the Pool in Lung Transplantation: The Use of Hepatitis C Positive Donor Lungs in Hepatitis C Negative Recipients

Conditions
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Hepatitis C, Lung Transplant

Intervention / Treatment
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* Drug: Epclusa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who sign the informed consent for this study Patients whom agree to receive a PHS high risk organ Patients listed for heart transplantation Age 18-65 Exclusion Criteria: Patients who do not sign informed consent for this study HIV Seropositivity HBV Seropositivity (HBcAb and/or HBsAg positive) Abnormal liver enzymes - 3 times the normal liver function values (Bilirubin, INR, AST, ALT) Acute or chronic renal insufficiency (creatinine clearance <50 ml/min) or history of dialysis Patients on ECMO Respiratory insufficiency requiring mechanical respiratory support (ventilator, BiPAP) Liver insufficiency Prior history of hepatitis C Allergy to Sofosbuvir/velpatasvir Pregnancy

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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No

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: Lung Transplant<br>Patients will be transplanted with HCV positive lung. Recipients whom test positive for HCV viremia for 2 consecutive tests at any point will complete 12 weeks of Epclusa (Sofosbuvir/velpatasvir). | Drug: Epclusa<br>* Patients testing positive for HCV viremia will receive 12 weeks of Epclusa.<br>* Other names: Sofosbuvir/velpatasvir;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCV Viremia | Incidence of HCV Viremia | at 2 years | 
| Seroconversion | Rate of HCV seroconversion | at 2 years | 
| Liver Function Testing | Assessment of Hepatic function | at 2 years | 
| Survival | Survival rates | at 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rejection | The incidence of rejection | at 2 years | 
| Waitlist | Time on waitlist will be assessed | at 2 years |