New Related Protocol to be submitted

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)

Anticipate to share coded data with collaborators

Ancicipate data would be available to share by 6 months are the final patient visit.

Coded data would be shared with collaborators who have received IRB approval to use the data and have been approved by the PI for their collaboration.