Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors

In this study, individuals without hepatitis C infection who are on the kidney transplant
waitlist will receive a kidney from a deceased donor with hepatitis C infection and will be
treated for hepatitis C at the same time. Treatment will include glecaprevir 300 mg /
pibrentasvir 120 mg (G-P) administered on-call to the operating room for the renal transplant
procedure and continued for 4 weeks post-renal transplant. The participant will continue to
be tested for Hepatitis C for 12 weeks post-treatment.

The primary hypothesis is that prophylactic treatment with glecaprevir/pibrentasvir before
and after transplant will prevent the establishment of HCV infection in the recipients of
kidneys from HCV-infected deceased donors. Based on the success of preliminary studies, the
objective of the study is to evaluate the safety and efficacy of 4 weeks of G-P as
prophylaxis for HCV D+/R- kidney transplant.

Recipient Inclusion Criteria

- Participants ≥ 40 years old

- On the deceased donor kidney waitlist at Johns Hopkins Hospital

- Awaiting a first kidney transplant

- No available living kidney donors

- On hemodialysis or peritoneal dialysis or stage 5 chronic kidney disease defined as a
glomerular filtration rate <15 ml/min for ≥ past 90 days

- HCV-uninfected (by both antibody and RNA PCR) and without any behavioral risk factors
for contracting HCV other than being on hemodialysis

- Calculated panel reactive anti-human leukocyte antigen antibody (cPRA) below 50%

Recipient Exclusion Criteria

- Plan to receive a multi-organ transplant

- Plan to receive a dual kidney transplant (including en bloc)

- Prior solid organ transplant

- Participating in another study that involves an intervention or investigational
product

- Plan to receive a blood type incompatible kidney

- History of human immunodeficiency (HIV), hepatitis C (HCV), or active hepatitis B
(HBV) infection, defined as being on active antiviral treatment for HBV, detectable
hepatitis B surface Ag or detectable hepatitis B DNA

- Unable to safely substitute or discontinue a medication that is contraindicated with
the study medication

- Psychiatric or physical illness that in the opinion of the investigator would make it
unsafe to proceed with transplantation or interfere with the ability of the subject to
participate in the study