This study is being done to find out the best time to start medication for Hepatitis C Virus (HCV) in HCV-negative recipients of HCV-positive (HCV D+/R-) kidney transplants. Participants will be randomized into one of two groups:
Arm 1 - Prophylaxis: This group will start the HCV medication before transplant and will take a shorter course of HCV medication for 2 weeks.
Arm 2 - Transmit and Treat: This group will start the HCV medication after transplant and will take the full course (12 weeks) of HCV medication.
Participant meets the standard criteria for KT at local center.
Participant is able to understand and provide informed consent.
Participant is ≥ 18 years old.
Participant has active HCV infection (detectable HCV RNA) at time of screening.
Participant has cirrhosis or advanced liver fibrosis.
Participant's aspartate aminotransferase (AST) or ALT > 2.5 times the upper limit of normal (ULN), within 60 days of screen.
Participant has human immunodeficiency virus infection (HIV), or active hepatitis B (HBV) infection.
Parallel
Prophylaxis (P2W)
Other interventionFor participants enrolled in P2W arm, the initial dose of SOF/VEL will be administered to the recipient when called to the operating room for transplant (typically 1-3 hours prior to the start of surgery). Post-transplant, SOF/VEL will be continued daily for 13 days post-KT (a total of 14 doses administered).
Transmit and Treat (T&T)
Other interventionFor participants enrolled in T\&T arm, SOF/VEL will begin between post-KT day 0 and post-KT day 14. Participants will be clinically-prescribed DAAs once viremia is detected, and participant's insurance will be petitioned to obtain treatment as soon as possible. If insurance-provided DAAs are approved before post-KT day 14, participant will begin 12 weeks of study-provided SOF/VEL on date of insurance-provided DAAs approval. If insurance-provided DAAs are not approved by post-KT day 14, study-provided SOF/VEL will begin on post-KT day 14 and continue for 12 weeks.
Composite event of HCV-related or HCV treatment-related death, fibrosing cholestatic hepatitis, or HCV relapse
Proportion of events in each arm.
Number of participants with liver injury
Measured with a longitudinal model of Alanine aminotransferase (ALT).
Participant survival
Time to event (death)
Graft survival
Time to event (graft loss)
HCV plasma RNA
Based on local testing
Graft rejection
Cumulative incidence of rejection
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
