In a randomized, controlled trial, we sought to determine whether prophylaxis with interferon-α 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-α (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-α 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-α patients versus 3.5 for control patients, P=NS). Interferon-α, however, significantly delayed the timing of occurrence of HCV hepatitis; recurrent HCV hepatitis developed a median of 408 days after transplant in the interferon-α 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-α 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-α 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-α use was not associated with a higher incidence of rejection compared with the control patients.