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

Korábbi kezelés

• Listed for combined organ transplant
• History of prior solid organ transplant
• Patients who have undergone or who will undergo immune desensitization therapy

Más betegség

• History of HIV infection

Laborértékek

• Any of the following liver disease states, including:
  • 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,
  • 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,
• 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

Egyéb

• Pregnant individuals
• Prospective-positive cross-match or predicted positive cross-match
• Patients unwilling to notify their sexual partner(s) of participation in this trial

• 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)