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

NARecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

April 19, 2023

Primary Completion Date

September 30, 2026

Study Completion Date

March 31, 2027

Conditions
HCV
Interventions
OTHER

Prophylaxis (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).

OTHER

Transmit 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.

Trial Locations (7)

10016

RECRUITING

NYU Langone Health, New York

10029

RECRUITING

Icahn School of Medicine at Mount Sinai, New York

21205

RECRUITING

Johns Hopkins University, Baltimore

23298

RECRUITING

Virginia Commonwealth University, Richmond

53792

RECRUITING

University of Wisconsin, Madison, Madison

84132

RECRUITING

University of Utah Medical Center, Salt Lake City

92037

RECRUITING

University of California San Diego, La Jolla

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

Johns Hopkins University

OTHER