Transplant of Redeemed Organs by Judicious Administration of New Direct-Acting Antivirals for Hepatitis-C Heart Recipients

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 immunity to hepatitis B (manifest as negative
qualitative or quantitative Hepatitis B surface Ab) will be encouraged to immediately begin a
non-infectious recombinant hepatitis B surface antigen vaccination series, combined with, or
in parallel to, an inactive hepatitis A vaccination at the treating clinician's discretion.

Enrolled recipients will be closely surveilled with serial HCV polymerase chain reaction
(PCR) as inpatients during the immediate post-OHT hospitalization and subsequently as
specified in the post-transplant period assessements. Donor serum will be collected at
transplant harvest and will be sent by the transplant center for HCV NAT and genotyping. If
and when these recipients develop confirmed viremia by HCV PCR, Epclusa® therapy will be
administered for a 12-week course. The study drug, Epclusa®, will be provided by Gilead
Sciences, Inc. Study drug, Epclusa®, comes in bottles that contain 28 tablets each. Serologic
data will also be collected. If an enrolled subject does not develop quantifiable viremia by
week 12, they will be followed by standard of care surveillance, with additional standard of
care surveillance per UNOS mandate for CDC-increased-risk donors and discontinued from study;
additional subjects may be enrolled at the Principal Consortium Investigator's discretion to
complete 20 Epclusa®-treated subjects according to the protocol.

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. History of HCV viremia detectable by either HCV qualitative or quantitative PCR
unless deemed cured (SVR-12),

2. Hepatitis B surface Ag positive or detectable hepatitis B DNA,

3. Cirrhosis, as indicated by liver biopsy,

4. Portal hypertension as indicated by a hepatic venous pressure gradient > 5 mm Hg
and/or the presence of esophageal varices e.) ALT and AST > 3x ULN unless
adjudicated to be from a non-hepatic cardiac or skeletal muscle source,

3. History of prior solid organ transplant

4. Pregnant individuals

5. History of HIV infection

6. History of severe renal disease currently requiring dialysis. Chronic kidney disease
with creatinine clearance <30 ml/min/1.73m2 (by MDRD method) at screening or on last
two consecutive measurements before acceptance of transplant organ offer

7. Ongoing chronic amiodarone use (must be off regularly scheduled amiodarone a minimum
of 28 days prior to enrollment), If amiodarone was acutely delivered, within 28 days
of enrollment with a maximal dose of 600 mg within 48 hour period, subject will not be
excluded.

8. Patients who have undergone or who will undergo immune desensitization therapy

9. Prospective-positive cross-match or predicted positive cross-match

10. Patients unwilling to notify their sexual partner(s) of participation in this trial