Acetylcysteine therapy for chronic hepatitis C: are its effects synergistic with interferon alpha? A pilot study

This trial reports the 6-month results of a pilot study using lymphoblastoid interferon alpha (IFNalpha) and acetylcysteine (N-acetylcysteine) separately and in combination in patients with chronic hepatitis C, genotype 1b, who were nonresponders to previous treatment with recombinant IFNalpha alone.

21 patients were randomly divided into three groups of seven each. Group A was treated with lymphoblastoid IFNalpha 6MU three times a week for 6 months; group B received the same schedule of lymphoblastoid IFNalpha 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.

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.

Acetylcysteine alone had no effect on hepatic cytolysis and viral replication; lymphoblastoid IFNalpha showed a modest, but better, response than recombinant IFNalpha, and the combination therapy, although in a limited number of patients, appeared to be more efficient than lymphoblastoid IFNalpha alone.