Unable to meet enrollment goal prior to drug expiration

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.

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.

Inclusion Criteria (Recipient)

1. 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)
2. 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
3. No evidence of clinically significant liver disease at the time of transplant readiness as determined by the clinical team
4. Able to sign informed consent

Inclusion Criteria (Deceased Donor)

1. Detectable HCV NAT test
2. KDPI score is less than ≤ 0.850
3. Traditional Donor Selection Criteria Met - acceptable for transplantation per usual evaluation

Exclusion Criteria (Recipient)

1. Pregnant or nursing (lactating) women
2. HBV positivity (Ag or DNA)
3. Any contra-indication to kidney transplantation per MGH transplant center protocol
4. Any signs or symptoms of clinically significant chronic liver disease per transplant center physician
5. Inability to discontinue any medication with a known drug-drug interaction as listed in the G/P package insert

Exclusion Criteria (Deceased Donor)

1. Confirmed HIV
2. Confirmed HBV positive (surface antigen or HBV DNA positive)
3. Any standard contra-indication to donation noted in donor (significant malignancy, unusual infection, kidney anatomical damage or significant pathology)

Subjects receiving HCV RNA positive kidney transplant and initiating treatment with DAA

Adverse events were captured beginning at DAA administration (Day 1) until 1-year post kidney transplant with HCV RNA-positive organ.

For this protocol, Adverse events were defined as any untoward medical occurrence associated with administration of the DAA and/or receipt of an HCV RNA-positive kidney transplant.

The study was closed prior to completion and prior to achieving the target of 40 participants enrolled due to the expiration of the donated investigational product (Glecaprevir / Pibrentasvir). The final study enrollment of 2 participants provides insufficient data to support analysis of all defined secondary outcomes.