HCV + to HCV - Kidney Transplant

Hepatitis C Viral Kidneys Used for Non-Viremic Recipients

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.

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.

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)