Pilot Study With Peginterferon, Ribavirin, and Boceprevir Prior to Transplantation to Clear Virus in Hepatitis C Genotype 1 Infected Individuals Undergoing Orthotopic Liver Transplantation
Condition: Liver Transplantation
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Currently, there is no treatment standard for use of anti-HCV (hepatitic C virus) medications
      for those preparing for a liver transplant. The purpose of this study is to determine whether
      those individuals who require liver transplantation for Hepatitis C, genotype I, who are
      undergoing liver transplantation may successfully get rid of their virus before the
      transplant by taking three medicines, peginterferon, ribavirin, and boceprevir, up until the
      time of the liver transplant surgery. If successful, the Hepatitis C virus will not re-infect
      the new liver that they receive and they will not require therapy for Hepatitis C after liver
      transplantation. This study involves the use of peginterferon alfa-2b, ribavirin, and
      boceprevir, all of which are approved for the treatment of genotype I Hepatitis C.

      Hypothesis: The addition of boceprevir to peginterferon alfa-2b and ribavirin in patients
      with Hepatitis C genotype 1 with or without hepatocellular carcinoma undergoing orthotopic
      liver transplantation will lead to rapid HCV RNA clearance of genotype I infected
      individuals. Transplantation with anhepatic boceprevir will prevent reinfection of the new
      transplanted graft and prevent graft infection posttransplantation.
    

Detailed description: 
      Subject Patient Inclusion Criteria: Men and women age 18 to 70 inclusive, patients with
      genotype I Hepatitis C who are listed for orthotopic liver transplantation (OLT) will be
      enrolled. Those with hepatocellular carcinoma with or without treatment of hepatoma may also
      be included. The MELD score for enrollment will be capped at 16. Patients must have medically
      controlled ascites and those who have moderate or poorly controlled ascites will be excluded.

      Treatment Plan: Fifteen patients with chronic genotype I Hepatitis C will be enrolled. All
      patients will begin with peginterferon and ribavirin for 4 weeks with the addition of
      boceprevir after Week 4 until orthotopic liver transplantation. The dose of interferon will
      be peginterferon 1.0 mcg/kg with weight-based ribavirin (600-1200 mg) with boceprevir 800 mg
      TID (three times per day) until OLT. All patients will be listed for orthotopic liver
      transplantation. HCV RNA will be measured monthly. When they are called in for transplant,
      they will take their last dose of ribavirin just prior to going to operating room. Patients
      will undergo orthotopic liver transplantation under standard protocol by Indiana University.
      They will receive by Dobhoff boceprevir 800 tid for 3 doses post transplantation. Virologic
      failure will be HCV RNA > 100 I.U. at Week 12.
    

Intervention name(s): boceprevir
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Liver Transplantation