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

• Status: Recruiting
• Trial end date: 2021-02-28
• Target enrollment: 0
• Participant gender: All

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®).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor Research Institute
• Treatments: Sofosbuvir-velpatasvir drug combination

Criteria

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(unless clinically determined to be previously negative and acutely positive due to vaccination with recombinant surface antigen) 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. Patients who have undergone or who will undergo immune desensitization therapy

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

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