Pre-Transplant Treatment to Prevent Recurrence of Hepatitis C After Liver Transplantation
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Recurrence
Intervention: LADR Treatment
Intervention description: PEG-Intron (peginterferon alfa-2b (PEGIFN)) Redipen; Rebetol (ribavirin (RBV) United States Pharmacopeia (USP)) Capsules:
Treatment was initiated with PEGIFN 0.75 µg/kg/week and RBV 600 mg/day. Dose escalations were performed at weeks 1 (PEGIFN 1.5 µg/kg/week and RBV 800 mg/day), 2 (RBV 1.0 g/day), and 3 (RBV 1.2 g/day for patients who weighed more then 75 kg) based upon patient tolerance and weekly blood counts. Once a patient reached the target RBV dose of 1-1.2 g/day (approximately 10.6 to 13.2 mg/kg/day), no further increases in RBV dose were made. Subsequent doses of PEGIFN and RBV were adjusted based upon adverse events, patient tolerability, and blood counts. If the highest tolerated dose of PEGIFN was <0.5 ug/kg, PEGIFN was permanently discontinued.
Intervention MeSH terms: Peginterferon alfa-2b
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis C; Ribavirin; PegInterferon alfa2b

Summary:

      The purpose of this study is to learn if pre-liver transplant treatment, using peginterferon
      plus ribavirin, will clear hepatitis C virus (HCV) RNA from the blood in HCV-infected
      recipients and reduce the risk of recurrent HCV and allograft hepatitis following liver
      transplant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult (18 or older)

          -  LDLT candidate

          -  HCV RNA positive

          -  Expected time on treatment is at least 12 weeks

          -  Candidates for DDLT who are listed for transplantation and meet UNOS criteria for MELD
             upgrade for HCC

        Exclusion Criteria:

          -  Severe cytopenia (polymorphonuclear (PMN) leukocytes < 750, OR hemoglobin [Hgb] < 10
             g/dL, OR platelet count < 35,000/mm3)

          -  Uncontrolled depression or psychiatric disease characterized by current symptoms of
             major depression or other psychiatric disease or increase in medication for major
             depression or other psychiatric disease within the past three months.

          -  Uncontrolled cardiopulmonary disease characterized by myocardial infarction, coronary
             artery bypass graft surgery, Percutaneous coronary intervention, or unstable angina
             within the past three months.

          -  Uncontrolled autoimmune disease characterized by current symptoms of autoimmune
             disease or increase in medications within the last three months.

          -  Autoimmune hepatitis

          -  Active substance abuse within 6 months of initiation of treatment

          -  Known intolerance or serious adverse event during prior therapy with interferon or
             ribavirin

          -  Prior nonresponse after at least 24 weeks of full dose treatment with peginterferon
             plus ribavirin

          -  Laboratory Model for End-Stage Liver Disease (MELD) score >20. Patients with
             laboratory MELD score 21-25 may be enrolled if deemed appropriate by the site
             investigator

          -  Serum creatinine >2.2 mg/dL