Study of Hepatitis Eradication Receiving Protease Inhibitor Administration

Description

This is a prospective, non-blinded cohort study that will assess the safety, tolerability, and antiviral efficacy of glecaprevir/pibrentasivir therapy given post-discharge to HCV-negative recipients of HCV infected donors. Patients who meet entry criteria will be enrolled while on the transplant waitlist. At the time of transplant, some donors will be HCV positive / NAT positive and some will not be infected. Enrolled patients who receive an HCV negative donor will serve as contemporaneous controls. All study subjects who receive an HCV positive organ will be confirmed to have acquired HCV infection and genotype will be assessed prior to treatment with therapy.

Conditions

Coronary Artery Disease, Morality

Study Overview

Study Details

Study overview

This is a prospective, non-blinded cohort study that will assess the safety, tolerability, and antiviral efficacy of glecaprevir/pibrentasivir therapy given post-discharge to HCV-negative recipients of HCV infected donors. Patients who meet entry criteria will be enrolled while on the transplant waitlist. At the time of transplant, some donors will be HCV positive / NAT positive and some will not be infected. Enrolled patients who receive an HCV negative donor will serve as contemporaneous controls. All study subjects who receive an HCV positive organ will be confirmed to have acquired HCV infection and genotype will be assessed prior to treatment with therapy.

The Study of Hepatitis Eradication Receiving Protease Inhibitor Administration

Study of Hepatitis Eradication Receiving Protease Inhibitor Administration

Condition
Coronary Artery Disease
Intervention / Treatment

-

Contacts and Locations

Norfolk

Sentara Norfolk General Hospital, Norfolk, Virginia, United States, 23507

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Subjects must meet all of the inclusion criteria specified below in order to be eligible for participation in this study
  • 1. Willing and capable of providing written informed consent
  • 2. Age ≥18 years
  • 3. On UNOS list as a candidate for heart transplant
  • * Subjects who meet any of the following exclusion criteria cannot be enrolled in this study.
  • 1. Individuals under 18 years of age
  • 2. History of advanced liver disease, including active hepatitis B or C, detectable hepatitis B surface Ag, hepatitis B DNA, HCV RNA, or cirrhosis
  • 3. Pregnant individuals
  • 4. HIV antibody positive

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sentara Norfolk General Hospital,

David Baran, MD, PRINCIPAL_INVESTIGATOR, Sentara Norfolk General Hospital

Study Record Dates

2024-12-31