INTERFERON-ALPHA FOR PROPHYLAXIS OF RECURRENT VIRAL-HEPATITIS-C IN LIVER-TRANSPLANT RECIPIENTS - A PROSPECTIVE, RANDOMIZED, CONTROLLED TRIAL

Background In a randomized, controlled trial, we sought to determine w hether prophylaxis with interferon-alpha for 6 months had an impact on rate, severity, and timing of onset of recurrent hepatitis C virus (H CV hepatitis in liver transplant recipients and to assess whether inte rferon use was associated with re jection in liver transplant recipien ts. Methods. Twenty-four consecutive liver transplant recipients with HCV were randomized after transplantation to receive either interferon alpha (3 million Il three times weekly) for 6 months or no prophylaxi s; median follow-up was 874 days. Results. Recurrent HCV hepatitis (hi stopathologically proven) developed in 50% (6 of 12) of the interferon -alpha patients versus 42% (5 of 12) of the control patients (P=NS). S everity of recurrence (as assessed by Knodell score on liver biopsies) also did not differ between the two groups (mean 4.0 for interferon-a lpha patients versus 3.5 for control patients, P=NS), Interferon alpha , however, significantly delayed the timing of occurrence of HCV hepat itis; recurrent HCV hepatitis developed a median of 408 days after tra nsplant in the interferon-alpha group versus 193 days in the control g roup (P=0.05). No difference in graft or patient survival was demonstr ated in the two groups. Rejection episodes, treated with corticosteroi ds, occurred in 50% (6 of 12) of patients in the interferon-alpha grou p versus 42% (5 of 12) in the control group (P=NS). Corticosteroid res istant rejection (requiring OKT3) occurred in only one study patient ( in the control group). Conclusions. Interferon-alpha in liver transpla nt recipients for 6 months delayed the occurrence of HCV hepatitis, bu t did not decrease the incidence nor the severity of HCV hepatitis aft er transplantation. Interferon-alpha use was not associated with a hig her incidence of rejection compared with the control patients.