Consensus interferon versus interferon-α 2b plus ribavirin in patients with relapsing HCV infection

Management of HCV infection and related liver disease with treatment currently available lead to a sustained virological response in 20% of patients using interferon (IFN)-alpha mono-therapy and approximately 40-45% in those on combination therapy with ribavirin. The aim of the present investigation was to compare the effect of consensus interferon alphacon-1 (C-IFN), and IFN-alpha 2b plus ribavirin, in patients relapsing after treatment with interferon alone. A total of 112 randomised patients with relapsing HCV infection (M/F = 53/59), were treated for 24 weeks with: (A) IFN-alpha 2b starting with 5/6 MU/day till negativity of HCV-RNA followed by 3 MU every other day, plus ribavirin 15 mg/kg/day (n = 34); (B) C-IFN 9 mug/day (n = 40); (C) ursodeoxycholic acid (UDCA; sodium salt) 450 mg/day (n = 37). At the end of treatment, patients were observed at follow-up for 24 weeks. Clearance of HCV-RNA was achieved by the end of treatment in 23 patients (68%) in Group A and 21 also showed a biochemical response with normal ALT; in Group B, 33 patients (82%) had both a virological and a biochemical response; in Group C, one patient cleared HCV-RNA. At the end of follow-up (sustained-response), 29% of patients in Group A (n = 10/34) had negative PCR (seven patients relapsed at the 4th week, six at the 12th); in Group B, a sustained response was achieved in 58% (p < 0.03; two patients relapsed at the 4th week, three at the 12th and five at the 24th). Major side effects comprised: neutropenia (n = 17) and decrease in Hb > 1.5 g/dl (n = 33) in Group A, recurrence of psoriasis in two patients in Group B and abdominal discomfort and diarrhoea in I I patients in Group C. Rapid clearance of circulating HCV-RNA was induced by C-IFN (66% at three weeks, 7 1% at six weeks): this was a good prognostic index both for end of treatment and sustained response. Treatment with C-IFN lead to a higher response rate compared to that of recombinant IFN-alpha 2b in association with ribavirin. The action of C-IFN is superior in the time taken to reach the maximal response rate during treatment and in the lower prevalence of relapse of the infection. (C) 2003 Elsevier B.V. All rights reserved.