DAA Treatment in Donor HCV-positive to Recipient HCV-negative Liver Transplant

Study Overview
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Brief Summary
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This is a single center study for the donation of Hepatitis C Virus (HCV)-positive livers to HCV negative recipient patients, with preemptive, interventional treatment to prevent HCV transmission upon transplantation.

Detailed Description
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Patients will be selected based on diminished likelihood of receiving a liver from the waitlist within a period during which they would be likely to succumb to severe comorbidities. This will be determined in part through use of a patient's Model of End Stage Liver Disease (MELD) score, listing status, and clinical judgment. To ensure maximal benefit for the recipient, only high quality donor livers will be accepted.

Official Title
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Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Liver Transplant

Conditions
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End Stage Liver Disease, Hepatitis C

Intervention / Treatment
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* Drug: Treatment with Direct Acting Antiviral tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recipient is Age ≥ 18 years Met Massachusetts General Hospital (MGH) transplant center criteria, listed for liver transplant HCV naïve Able to sign informed consent Exclusion Criteria: Pregnant or nursing (lactating) women Human immunodeficiency virus (HIV) positivity Need for dual organ transplant Any contra-indication to liver transplantation per center protocol

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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with Direct Acting Antiviral (DAA) Fixed Dose Combination<br>12 weeks of HCV treatment with medically appropriate direct acting antiviral | Drug: Treatment with Direct Acting Antiviral tablet<br>* HCV Treatment for 12 Weeks<br>* Other names: DAA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Undetectable Hepatitis C Virus (HCV) Viral RNA | Number of dosed subjects with negative HCV viral RNA at 12 weeks after the last dose of treatment. | 12 weeks post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment Emergent Adverse Events and Out of Range Lab Values | Safety and tolerability of direct acting antiviral therapy in the liver transplant patient will be monitored by quantifying the number of treatment related adverse events per patient and evaluating clinically significant out of range laboratory results as compared to baseline/pretreatment values per patient. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCV, Epclusa, ESLD