RecruitingNot ApplicableNCT05653232

Prophylaxis With Direct-acting Antivirals for Kidney Transplantation From HCV-Infected Donors to Uninfected Recipients

Prophylaxis With Direct-acting Antivirals for Kidney Transplantation From Hepatitis C Virus-Infected Donors to Uninfected Recipients: a Randomized Controlled Trial

Sponsor

Johns Hopkins University

Enrollment

120 participants

Start Date

Apr 19, 2023

Study Type

INTERVENTIONAL

Conditions

HCV

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

Participant meets the standard criteria for KT at local center.
Participant is able to understand and provide informed consent.
Participant is ≥ 18 years old.

Exclusion Criteria7

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.
Participant is unable to safely substitute or discontinue a medication that is contraindicated with the study medication.
Past or current medical problems, which may pose additional risks from participation in the study, interfere with the participant's ability to comply with study, or impact the quality of the data obtained from the study.
Participant is pregnant or breastfeeding.

Interventions

OTHERProphylaxis (P2W)

For 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).

OTHERTransmit and Treat (T&T)

For 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.