Abstract
Objective: This trial reports the 6-month results of a pilot study using lymphoblastoid interferon alpha (IFNα) and acetylcysteine (N-acetylcysteine) separately and in combination in patients with chronic hepatitis C, genotype 1b, who were nonresponders to previous treatment with recombinant IFNα alone.
Patients and Methods: 21 patients were randomly divided into three groups of seven each. Group A was treated with lymphoblastoid IFNα 6MU three times a week for 6 months; group B received the same schedule of lymphoblastoid IFNα as group A plus acetylcysteine 1200 mg/day per os in two administrations, and group C received only acetylcysteine 1200 mg/day per os in two administrations.
Results: Mean serum alanine aminotransferase (ALT) levels at 6 months in groups A and B, but not in group C, were significantly lower than baseline values (p < 0.05 and p < 0.03, respectively). Two patients in group A (28.6%) and three in group B (42.9%), but none in group C, had normalised ALT levels at 6 months. During follow-up, levels flared in one group A and in one group B patient. Thus, at the end of follow-up one group A and two group B patients were sustained responders. At the end of therapy and follow-up, hepatitis C virus (HCV)-RNA was negative in one patient in group A and two patients in group B. As no serious adverse effects were observed, therapy was never interrupted or suspended.
Conclusion: Acetylcysteine alone had no effect on hepatic cytolysis and viral replication; lymphoblastoid IFNα showed a modest, but better, response than recombinant IFNα, and the combination therapy, although in a limited number of patients, appeared to be more efficient than lymphoblastoid IFNα alone.
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Tripi, S., Di Gaetano, G., Soresi, M. et al. Acetylcysteine Therapy for Chronic Hepatitis C. Clin. Drug Investig. 16, 297–302 (1998). https://doi.org/10.2165/00044011-199816040-00004
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DOI: https://doi.org/10.2165/00044011-199816040-00004