Direct-acting Antiviral Therapy to Prevent HCV Infection for HCV Positive Donor to HCV Negative Recipient Kidney Transplant

Study Overview
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Brief Summary
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Open label single center study for the donation of HCV positive kidneys to HCV negative recipients with interventional treatment to prevent HCV transmission upon transplantation.

Detailed Description
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The study objective is to determine if the administration of direct acting antivirals for 12-16 weeks after kidney transplantation prevents the spread of HCV infection from donor kidney with known HCV infection (all genotypes) to an HCV negative recipient as evidenced by a negative HCV viral RNA at 12 weeks post treatment.

Official Title
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Use of Direct-acting Antiviral Therapy to Prevent Spread of HCV Infection for Patients Receiving a HCV Positive Kidney Transplant as a HCV Negative Recipient

Conditions
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Renal Failure Chronic, Hepatitis C

Intervention / Treatment
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* Drug: Zepatier
* Drug: Zepatier plus Sofosbuvir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Donor meets MGH transplant center criteria and already listed for isolated kidney transplant No available living kidney donor Recipient has ≤ 730 days of accrued transplant waiting time Recipient chronic hemodialysis or peritoneal dialysis Recipient must agree to birth control. °.Weigh ≥ 50kg Serum ALT within normal limits Subject's Insurance company approves payment for DAA therapy post-kidney transplant Exclusion Criteria: AB Blood type HCV genotype 1 BMI > 35 Any liver disease in recipient Pregnant or nursing (lactating) women Known allergy or intolerance to tacrolimus that would require administration of cyclosporine Albumin < 3g/dl or Platelet count < 75 x 103/mL Positive crossmatch or positive donor specific antibodies HCV RNA positive Hepatitis B surface antigen positive Patients with primary focal segmental glomerulosclerosis (FSGS) Any contra-indication to kidney transplantation per our center protocol

Ages Eligible for Study
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Minimum Age: 40 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: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Based on the genotype and viral resistance testing of the donor, that will be determined within the first week, we will initiate a genotype specific regimen for HCV treatment as available by prescription
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HCV treatment - no viral resistance<br>Based on the genotype and negative viral resistance testing of the donor, (determined within the first week) we will initiate a genotype specific regimen of Zepatier | Drug: Zepatier<br>* Based on negative viral resistance testing of the donor treatment will be Zepatier<br>|
| Experimental: HCV treatment - viral resistance<br>Based on the genotype and positive viral resistance testing of the donor, (determined within the first week) we will initiate a genotype specific regimen of Zepatier plus Sofosbuvir | Drug: Zepatier plus Sofosbuvir<br>* Based on positive viral resistance testing of the donor treatment will be Zepatier with Sofosbuvir<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Undetectable HCV RNA | Negative HCV viral load 12 weeks after last dose of treatment | 12 weeks post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodialysis, renal failure, kidney transplant