Sustained Virological Response (SVR) to Antiviral Treatment of Liver Transplant Recipients With Recurrent Hepatitis C

Inclusion criteria:

* Liver transplantation performed at least 6 months and up to 5 years prior randomization and due to HCV cirrhosis, with or without pre-transplant hepatocellular carcinoma (HCC) within Milan or UCSF criteria
* Immunosuppresive regimen based on tacrolimus b.i.d.- (twice or once daily) for at least 6 months prior randomization
* Diagnosis of HCV genotypes 1 or 4 infection prior to transplantationconfirmed at screening
* Indication of treatment with Peg-IFN and ribavirin due to histological evidence of chronic HCV infection defined as a fibrosis stage equal or greater than 1 using the Ishak-Knodell scoring system (IK ≥1) in a liver biopsy performed at screening or up to 4 months prior to randomization.

Exclusion criteria:

* Serum creatinine \>150 μmol/L (1.6 7 mg/dL) or eGFR \< 50 ml/min (4-variable Modification of Diet in Renal Disease \[MDRD Cockcroft-Gault formula\])
* Multi-organ transplant recipients
* Recent episode of steroid-treated acute rejection (AR) within 3 months prior to randomization, or \>1 episode of steroid-treated AR in the last 6 months, or any number of steroid-resistant AR episodes in the last 6 months including evidence of chronic rejection or ductopenia
* Evidence of conditions that could cause graft dysfunction other than HCV infection
* Patients with signs of decompensated liver disease, defined as presence of ascites, variceal bleeding, encephalopathy or deteriorated hepatic synthetic function (albumin \<3.5g/dL or, total direct bilirubin \>1.5mg/dL or, INR \>1.5)
* Co-infection with HIV or Hepatitis B (defined as HBsAg-positive) at screening
* Use of mTOR inhibitors (everolimus or sirolimus) in the 6 months prior to screening
* Antiviral treatment for HCV administered at any time after liver transplantation
* Patients on daily doses of corticosteroids higher than 5 mg/day
* Patients with fibrosing cholestatic hepatitis
* Patients with current diagnosis of malignancies, including lymphoproliferative disorders
* Patients with platelet count \<70,000/mm3 or neutrophiles \<1,500/mm3
* History of HCC outside Milan criteria based on radiology or UCSF criteria based on analysis of the explant