Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment

Study Overview
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Brief Summary
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The purpose of this study is to evaluate whether treatment with Epclusa (sofosbuvir/velpatasvir) after lung transplantation in individuals with chronic hepatitis C infection is feasible, safe and effective at curing HCV.

Official Title
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Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment: A Pilot Feasibility and Efficacy Study

Conditions
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Hepatitis C, Chronic, Lung Transplant

Intervention / Treatment
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* Drug: Epclusa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HCV RNA >= 10^3 IU/ml at screening Chronic HCV infection, defined as positive HCV antibody and/or HCV RNA more than 6 months prior to screening HCV Genotype 1, 2, 3, 4, 5 or 6 Otherwise eligible for lung transplant at study site Exclusion Criteria: Age <18 Treatment with any of the following agents: Amiodarone. Subjects previously treated with amiodarone must have stopped the amiodarone at least 60 days prior to day 1 SOF/VEL Carbamazepine, phenytoin, phenobarbital, oxcarbazepine Rifabutin, rifampin or rifapentine HIV regimens containing tenofovir or tipranavir/ritonavir St John's wort PPIs, including: Omeprazole, pantoprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole Modafinil Have any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with subject treatment, assessment or compliance Hepatitis B surface antigen positive History of hepatic encephalopathy or variceal hemorrhage Abnormal hematological and biochemical parameters, including: Hemoglobin <8g/dL Platelets <= 50,000/mm^3 ALT (alanine aminotransferase), AST (aspartase aminotransferase) or alkaline phosphatase >=10 times ULN Total bilirubin >3mg/dL Severe renal impairment, ie creatinine clearance (CrCl) <30mL/min Pregnant women or women planning to become pregnant Women or are breastfeeding Active or recent history (<=1 year) of drug or alcohol abuse

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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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Epclusa<br>Epclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food. | Drug: Epclusa<br>* Patients will be treated with this drug for 12 weeks post lung transplant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Sustained Virologic Response 12 Weeks (SVR 12) in Those Treated With EPCLUSA. | Sustained Virologic Response 12 weeks (SVR 12) in those treated with EPCLUSA. | 12 weeks | 
| Number of Patients That Reported an Adverse Event Resulting in Discontinuation of EPCLUSA | Adverse events resulting in discontinuation of EPCLUSA | 1 year | 
| Number of Patients Eligible for EPCLUSA Treatment | Eligibility for EPCLUSA treatment within 12 months of lung transplant | within 12 months of lung transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Serum HCV RNA Levels | Serum HCV RNA levels at 12-, 24-, and 48-weeks after initiation of EPCLUSA | 12, 24, and 48 weeks after initiation of EPCLUSA | 
| Number of Participants With Adverse Events Requiring Temporary Interruption of EPCLUSA Therapy | Adverse events requiring temporary interruption in EPCLUSA therapy | 1 year | 
| Patient Survival | 90-day post transplant patient survival | 90 days post-transplant | 
| Patient Survival | 1 year post transplant patient survival | 1 year post-tranplant | 
| Patient Survival | 90-day post transplant patient survival in recipients of HCV NAT positive donor organ | 90 days post-transplant | 
| Patient Survival | 1 year post transplant patient survival in recipients of HCV NAT positive donor organ | 1 year post-transplant |