title: Interferon-alpha for prophylaxis of recurrent viral hepatitis C in liver transplant recipients: a prospective, randomized, controlled trial.
abstract: BACKGROUND
  In a randomized, controlled trial, we sought to determine whether prophylaxis with interferon-alpha for 6 months had an impact on rate, severity, and timing of onset of recurrent hepatitis C virus (HCV) hepatitis in liver transplant recipients and to assess whether interferon use was associated with rejection in liver transplant recipients.
  
  
  METHODS
  Twenty-four consecutive liver transplant recipients with HCV were randomized after transplantation to receive either interferon-alpha (3 million U three times weekly) for 6 months or no prophylaxis; median follow-up was 874 days.
  
  
  RESULTS
  Recurrent HCV hepatitis (histopathologically proven) developed in 50% (6 of 12) of the interferon-alpha patients versus 42% (5 of 12) of the control patients (P=NS). Severity of recurrence (as assessed by Knodell score on liver biopsies) also did not differ between the two groups (mean 4.0 for interferon-alpha patients versus 3.5 for control patients, P=NS). Interferon-alpha, however, significantly delayed the timing of occurrence of HCV hepatitis; recurrent HCV hepatitis developed a median of 408 days after transplant in the interferon-alpha group versus 193 days in the control group (P=0.05). No difference in graft or patient survival was demonstrated in the two groups. Rejection episodes, treated with corticosteroids, occurred in 50% (6 of 12) of patients in the interferon-alpha group versus 42% (5 of 12) in the control group (P=NS). Corticosteroid resistant rejection (requiring OKT3) occurred in only one study patient (in the control group).
  
  
  CONCLUSIONS
  Interferon-alpha in liver transplant recipients for 6 months delayed the occurrence of HCV hepatitis, but did not decrease the incidence nor the severity of HCV hepatitis after transplantation. Interferon-alpha use was not associated with a higher incidence of rejection compared with the control patients.
authors.affiliation: Veteran's Affairs Medical Center, Thomas E. Starzl Transplantation Institution, Pittsburgh, Pennsylvania 15240, USA.
authors.forename: N
authors.initials: N
authors.lastname: Singh
authors.forename: T
authors.initials: T
authors.lastname: Gayowski
authors.forename: C F
authors.initials: CF
authors.lastname: Wannstedt
authors.forename: A O
authors.initials: AO
authors.lastname: Shakil
authors.forename: M M
authors.initials: MM
authors.lastname: Wagener
authors.forename: J J
authors.initials: JJ
authors.lastname: Fung
authors.forename: I R
authors.initials: IR
authors.lastname: Marino
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D005260:Female; D006084:Graft Rejection; D006526:Hepatitis C / Q000517:prevention & control*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D016898:Interferon-alpha / Q000627:therapeutic use*; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D016853:Muromonab-CD3 / Q000627:therapeutic use; D012008:Recurrence
chemical_list: D000998:Antiviral Agents; D007166:Immunosuppressive Agents; D016898:Interferon-alpha; D016853:Muromonab-CD3