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

Plain Language Summary

Simplified for easier understanding

This study tests whether taking antiviral medication before and after receiving a kidney transplant from a donor who had hepatitis C can prevent the recipient from getting hepatitis C, even if the recipient does not have the virus themselves. **You may be eligible if...** - You are 18 or older - You are waiting for a kidney transplant and meet your transplant center's standard requirements - You are able to understand and sign a consent form - You do not currently have hepatitis C (no active HCV infection) **You may NOT be eligible if...** - You currently have active hepatitis C (detectable HCV RNA) - You have cirrhosis or advanced liver scarring - Your liver enzyme levels (AST or ALT) are significantly elevated - You have HIV or active hepatitis B - You are pregnant or breastfeeding - You take medications that cannot safely be stopped or swapped out for this study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.