LIVE-C-Free: Early and Late Treatment of Hepatitis C With Sofosbuvir/Ledipasvir in Liver Transplant Recipients

Exclusion Criteria

• •1. Serious or active medical or psychiatric illness
• •2. History of significant or unstable cardiac disease
• •3. Stomach disorder that could interfere with the absorption of the study drug
• •4. Pregnant or nursing females or males with a pregnant female partner
• •5. Co-infected with Hepatits B (HBV) or HIV
• •6. Recipients of an allograft from a donor that was infected with HCV with an unknown genotype or non-genotype 1 or 4 unless the recipient is demonstrated to have only genotype 1 or 4 HCV replication post-transplant
• •7. Allergic to or intolerant of sofosbuvir, ledipasvir, or ribavirin
• •8. History of exposure to an Nonstructural protein (NS5A) inhibitor
• •9. Within 1 year of transplant AND history of Hepatocellular Carcinoma (HCC) with tumor burden outside of the Milan Criteria (See Appendix II) prior to transplant
• •10. Participated in a clinical study with an investigational drug or biologic within the last 30 days
• •11. Combined liver/kidney transplant
• •12. History of organ transplant other than liver
• •13. Childs Turcotte Pugh (CTP) B or C
• •14. Patients with fibrosing cholestatic hepatitis
• •15. Platelet count of ≤ 30 k/mm3
• •16. Hemoglobin \< 10g/dL
• •17. Total bilirubin \> 10mg/dL
• •18. Alanine aminotransferase (ALT),aspartate aminotransferase (AST), or alkaline phosphatase ≥ 10x upper limit normal
• •19. Serum sodium \< 125mmol/L
• •20. Current use of any of the Prohibited Interventions (Section 5.3.2) and un-willing to discontinue use, or use of amiodarone within 6 months of screening