Transplanting Hepatitis C Positive Organs

Brigham and Women's Hospital148 enrolled

Overview

This is an open-label, pilot safety and efficacy trial for adults who are active on the heart, lung, or kidney transplantation lists and are eligible to receive an organ from an increased risk donor who has evidence of active or prior hepatitis C infection (HCV).

This is an open label pilot study transplanting organs from Hepatitis C positive donors into HCV uninfected recipients at Brigham and Women's Hospital. Heart, lung and kidney transplant participants will be stratified into two different study arms depending on whether the donor of the organ was HCV nucleic acid amplifications technology (NAT) positive or negative. In the NAT positive arm, the recipients will receive a course of direct acting antivirals (DAA) to begin on the day of transplant. If the donor was HCV antibody (Ab) positive and NAT negative, the recipients will receive close monitoring with serial HCV viral loads (VL) and will only begin treatment with DAA if they develop HCV viremia.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

148

Conditions

Hepatitis C Awaiting Organ Transplant

Interventions

Sofosbuvir/velpatasvirDRUG

2 weeks of treatment beginning on the day of transplant

MonitoringOTHER

Close HCV viral load monitoring Will receive direct acting antiviral treatment with 6 weeks of sofosbuvir/velpatasvir if the recipient develops HCV viremia during the post-transplant HCV viral load testing

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men and women who are age ≥ 18 years * Active on either the cardiac, lung, or kidney transplant waiting list * Willing and able to provide written informed consent to receive organs from an increased risk donor with a known transmissible infection Exclusion Criteria: * Hepatitis B NAT or viral load positive * Evidence of cirrhosis or clinically significant liver disease

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

RECRUITING

Outcomes

Primary Outcomes

Graft survival

Functioning allograft not requiring mechanical support

Time frame: 6 months post-transplant

HCV status of the transplant recipient

Sustained virologic response (SVR) 12 weeks after HCV treatment completion in Arm A or at 6 months in Arm B (SVR defined as HCV RNA \< lower limit of quantification)

Time frame: 6 months post-transplant

Secondary Outcomes

Treatment related adverse events

Number of treatment related adverse events per patient using direct-acting antiviral HCV regimens in post transplant recipients

Time frame: 6 months post-transplant

Central Contacts

Ann Woolley, MD

CONTACT

617-732-5500 awoolley@bwh.harvard.edu

Data from ClinicalTrials.gov

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