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Intravenous immunoglobulin plus interferon-alpha in autoimmune hepatitis C.

Author(s): Malaguarnera M, Guccione N, Musumeci S, Brogna A, Motta M, Di Fazio I

Affiliation(s): Institute of Internal Medicine and Geriatrics, University of Catania, Italy. malaguar@mbox.unict.it

Publication date & source: 2004, BioDrugs., 18(1):63-70.

Publication type: Clinical Trial; Randomized Controlled Trial

BACKGROUND: Hepatitis C virus (HCV) may be associated with a variety of autoimmune phenomena causing a therapeutic dilemma for treatment with interferon-alpha (IFNalpha), which stimulates autoimmune symptoms, or with corticosteroids, which may lead to an increasing of viral load. To evaluate the possible role of intravenous immunoglobulins (IVIg) in the response of patients treated with IFNalpha, we administered IVIg plus IFNalpha and compared the results with a group of patients treated with IFNalpha alone. METHODS: Forty-two patients affected by chronic hepatitis C with probable autoimmune disease were eligible for this open-label, randomised study. All patients tested positively for anti-nuclear antibodies, anti-smooth muscle antibodies, anti-liver/kidney microsomal antibodies and anti-mitochondrial antibodies. Patients were randomly assigned to one of two groups: group A received IVIg at a dosage of 400 mg/kg each day for 5 days, and then 3 MUI of leucocyte IFNalpha three times a week, while group B received physiological solution followed by the administration of leucocyte IFNalpha three times a week at the same dosage for 6 months.Complete biochemical response was defined as a sustained normalisation of alanine aminotransferase levels, and complete virological response was defined as complete clearance of virus throughout the entire 6-month follow-up period. Immunological response was measured in terms of Autoimmune Hepatitis (AIH) score, while histological response was based on a reduction in histological activity index (HAI) score. RESULTS: Compared with patients receiving IFNalpha alone, a higher percentage of patients who received IFNalpha plus IVIg showed complete virological and histological responses (p = 0.04). More patients in the combination therapy group achieved biochemical and immunological responses, although the differences between the groups were not statistically significant at all time points. CONCLUSIONS: Exogenously added Ig might modulate the immune network at various points. We propose that the immunomodulating action of IVIg acts synergistically with IFNalpha, achieving a better response to IFN treatment in patients with chronic HCV associated with autoimmunity. Data obtained from this preliminary study indicate a positive prospective for the clinical use of gamma globulins in patients with a high probability of autoimmune disorders associated with HCV infection.

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