Antioxidant drugs combined with alpha-interferon in chronic hepatitis C not responsive to alpha-interferon alone: a randomized, multicentre study

Objective After non-response to the initial course of therapy, retreatment with alpha-interferon is not effective, The aim of this study was to ascert ain whether the administration of N-acetyl cysteine and vitamin E could inc rease the response rate to retreatment with alpha-interferon. Design Prospective, multicentre clinical trial, Setting Twelve hospitals in Lombardy, Italy. Participants 120 consecutive patients affected by biopsy-proven chronic hep atitis C who had been non-responders to a previous course of alpha-interfer on, administered at the dosage of 3-6 million units (MU) three times a week (tiw) for 6 months, Interventions The patients were randomly assigned to one of two groups of t reatment: group A, natural interferon-alpha N3, 6 or 9 MU tiw, when the bod y weight was < 60 kg or greater than or equal to 60 kg, respectively; group B, the same dosage of natural interferon-alpha N3 in association with oral administration of N-acetyl cysteine 1200 mg/day and vitamin E 600 mg/day, The period of treatment was 6 months in both groups, Results Neither end-therapy biochemical response nor sustained biochemical response rates were improved by the combination treatment, and in no case w as clearance of the virus from serum observed, Conclusions In this randomized study carried out on 120 patients with chron ic hepatitis C not responsive to alpha-interferon, oral supplementation wit h N-acetyl cysteine and vitamin E did not improve the poor efficacy of retr eatment with a-interferon alone, Eur J Gastroenterol Hepatol 11:1203-1207 ( C) 1999 Lippincott Williams & Wilkins.