Study of Hepatitis Eradication Receiving Protease Inhibitor Administration

Summary

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.

Eligibility

Inclusion 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

Exclusion Criteria:

* 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

Conditions3

Locations1 site

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