QUICKly Eradicate Hepatitis C in Patients Undergoing REnal Transplant With 4 Weeks of Glecaprevir/Pibrentasvir

Study Overview
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Brief Summary
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This is a single center study characterizing the experience of administration of 4 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 the administration of glecaprevir and pibrentasvir (G/P) for 4 weeks beginning in the immediate peri-transplant period prevents establishment of HCV infection in HCV negative recipients receiving transplanted kidneys from HCV RNA positive donors.

Official Title
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QUICKly Eradicate Hepatitis C in Patients Undergoing REnal Transplant With 4 Weeks of Glecaprevir/Pibrentasvir

Conditions
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Kidney Failure, Hepatitis C, Kidney Disease, Chronic

Intervention / Treatment
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* Drug: Glecaprevir and Pibrentasvir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (Recipient) Met MGH Transplant Center criteria and already listed for kidney transplant with stage 5 CKD / ESRD (eGFR <15 ml/min/1.73m2 or on renal replacement therapy) 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 Inclusion Criteria (Deceased Donor) Detectable HCV NAT test KDPI score is less than ≤ 0.850 Traditional Donor Selection Criteria Met - acceptable for transplantation per usual evaluation Exclusion Criteria (Recipient) Pregnant or nursing (lactating) women HBV positivity (Ag or DNA) Any contra-indication to kidney transplantation per MGH transplant center protocol Any signs or symptoms of clinically significant chronic liver disease per transplant center physician Inability to discontinue any medication with a known drug-drug interaction as listed in the G/P package insert Exclusion Criteria (Deceased Donor) 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: Treatment
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>4 week treatment period with glecaprevir and pibrentasvir (G/P) within 24 hours of transplant | Drug: Glecaprevir and Pibrentasvir<br>* 4 weeks of treatment starting within 24 hrs of kidney transplant<br>* Other names: Mavyret;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SVR12 | Sustained virologic response 12 weeks after completing G/P | 12 weeks post-treatment (16 weeks post-transplant) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Serious and non-serious adverse events attributed to study drug and/or HCV-viremia | 1 Year Study Period | 
| HCV RNA Viral Load | Assessment of HCV RNA viral load at on-treatment visits | Weeks 2 and 4 of Treatment | 
| Allograft Function | Post-transplant allograft function measured by mean eGFR over study period | 1 Year Study Period | 
| Rate of Death, Graft Failure, Acute Allograft Rejection, Delayed graft function, ALT elevation | The rate of clinical safety outcomes: death, graft failure, acute allograft rejection, delayed graft functions, ALT elevations > 5x ULN | 1 Year Study Period | 

 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