HCV + to HCV - Kidney Transplant

Study Overview
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Brief Summary
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This is a single center study characterizing the experience of administration of 8 weeks of pan-genotypic DAA therapy in kidney transplantation to prevent the transmission of hepatitis C virus infection from an HCV-positive donor kidney to an HCV-negative recipient.

Detailed Description
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The goal of this study is to determine if 8 weeks of preemptive and sustained administration of pan-genotypic DAA therapy after kidney transplant prevents the transmission of hepatitis C virus (HCV) infection from an HCV-positive donor kidney to an HCV-naive recipient.

Official Title
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Hepatitis C Viral Kidneys Used for Non-Viremic Recipients

Conditions
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Kidney Failure, Hepatitis C

Intervention / Treatment
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* Drug: Direct Acting Antivirals


Participation Criteria
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Eligibility Criteria
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Recipient Inclusion Criteria: Met MGH transplant center criteria and already listed for kidney transplant Must agree to birth control. Women must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy and at least one barrier method No evidence of clinically significant liver disease at the time of transplant readiness as determined by the clinical team Able to sign informed consent Recipient Exclusion Criteria: Pregnant or nursing (lactating) women HBV positivity (Ag or DNA) Any contra-indication to kidney transplantation per center protocol Donor Inclusion Criteria Detectable HCV NAT test KDPI score is less than ≤ 0.850 Traditional Donor Selection Criteria Met - acceptable for transplantation per usual evaluation Donor Exclusion Criteria Confirmed HIV Confirmed HBV positive (surface antigen or HBV DNA positive) Any standard contra-indication to donation noted in donor (significant malignancy, unusual infection, kidney anatomical damage or significant pathology)

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 for HCV<br>8 weeks of treatment with HCV Direct Acting Antiviral tablet | Drug: Direct Acting Antivirals<br>* 8 weeks of DAA treatment<br>* Other names: Direct Acting Antiviral HCV Treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Undetectable HCV RNA | Negative HCV RNA 12 weeks after last dose of treatment | 12 weeks post-treatment | 
| Rate of Serious and non-serious adverse events | Determine safety of HCV+ to HCV- kidney transplantation by determining rate of adverse events related to HCV viremia or DAA treatment | 1 year post-transplant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney Transplant, Kidney Failure, HCV, Hepatitis C