Human leucocyte interferon‐α in chronic hepatitis C resistant to recombinant or lymphoblastoid interferon‐α: a randomized controlled trial

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Abstract
Patients with biopsy‐proven chronic hepatitis C, who failed to respond to a previous course of either recombinant (rIFN‐α) or lymphoblastoid (Ly IFN‐α) interferon‐α, were randomized to receive either leucocyte (Le) IFN‐α (patients) or a second course of the same IFN‐aL (controls), to compare the efficacy and safety of these treatment schedules. All patients received the same dose of IFN‐α as was used during their previous treatment (3 million units (MU) or 6 MU three times weekly) for 6 months. Patients with a normal alanine aminotransferase (ALT) value at month 6 were treated for a further 6 months. All patients were followed‐up for 12 months after treatment. A total of 69 patients were enrolled, 44 in the Le IFN‐α group and 25 in the control group. At the end of the treatment period, 13 of the 44 patients (29.5%) in the Le IFN‐α group had a biochemical response (normal ALT) and six of 44 (13.6%) patients had undetectable serum hepatitis C virus (HCV) RNA. At the end of the follow‐up period, 10 patients (22.7%) had normal ALT values and serum HCV RNA was undetectable in three (6.8%). None of the patients in the control group showed normal ALT values at any time. Genotype lb tended to be more frequent among non‐responders (61 vs 45%); basal γ‐glutamyl transpeptidase (γ‐GT) values were lower in responders than in non‐responders (33.3 ± 11.70 Ul‐1vs 58.4 ± 33.04; P= 0.01). Le IFN‐α was well tolerated by all patients. These results support the use of Le IFN‐α in patients with chronic hepatitis C who are non‐responders to a previous treatment with recombinant or lymphoblastoid IFN‐α.