Transplant of Redeemed Organs by Judicious Administration of New Direct-Acting Antivirals for Hepatitis-C Heart Recipients
Baylor Research Institute
Summary
This phase II, multi-center, open-label study will evaluate the safety and efficacy of utilizing HCV-positive donors for heart transplant in HCV-negative recipients treated with sofosbuvir 400 mg / velpatasvir 100 mg (Epclusa®).
Description
utilizing HCV-positive donors (defined as HCV-NAT positive) for heart transplantation in HCV-negative recipients treated with Epclusa®. Subjects will be identified from the heart transplantation waitlist. Subjects who, according to the judgement of the Investigator, would have a net mortality benefit from cardiac transplantation irrespective of donor HCV status will be asked if they agree to receive a heart transplant from an HCV-positive donor. Subjects who sign consent and receive a heart transplant from an HCV-positive donor will be enrolled. Consented subjects who do not demonstrate immu…
Eligibility
- Age range
- 18–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Willing and capable of providing written informed consent 2. Age ≥ 18 years 3. Listed for isolated orthotopic heart transplant 4. HCV seronegative (or, if HCV seropositive, then subject must be PCR negative on at least 2 draws consistent with a spontaneously cleared or fully-treated and cleared prior infection; in this case last anti-HCV antiviral dose must be ≥12 weeks ago and 2 negative titers ≥12 weeks after completion of the antiviral regimen) Exclusion Criteria: 1. Listed for combined organ transplant 2. Any of the following liver disease states, including: 1…
Interventions
- DrugEpclusa
If and when these recipients develop confirmed viremia by HCV PCR, Epclusa® therapy will be administered for a 12-week course.
Locations (3)
- Cedars-Sinai Medical CenterLos Angeles, California
- Duke University Medical CenterDurham, North Carolina
- Baylor University Medical CenterDallas, Texas