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®).
Willing and capable of providing written informed consent
Age ≥ 18 years
Listed for isolated orthotopic heart transplant
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)
Listed for combined organ transplant
History of HCV viremia detectable by either HCV qualitative or quantitative PCR unless deemed cured (SVR-12),
Hepatitis B surface Ag positive(unless clinically determined to be previously negative and acutely positive due to vaccination with recombinant surface antigen) or detectable hepatitis B DNA,
Cirrhosis, as indicated by liver biopsy,
Single group
Epclusa
DrugIf and when these recipients develop confirmed viremia by HCV PCR, Epclusa® therapy will be administered for a 12-week course.
Sustained virologic response after 12 weeks of treatment
To evaluate the number of patients with sustained virologic response (SVR) 12 weeks after discontinuation of therapy.
1-year post-transplant survival
To evaluate the number of patients who survive 1-year post-transplant.
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