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Eur J Gastroenterol Hepatol. 1999 Nov;11(11):1203-7.

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

Author information

  • 1Department of Hepatology, S. Giuseppe Hospital, Milano, Italy. g.ideo@oh-fbf.it

Abstract

OBJECTIVE:

After non-response to the initial course of therapy, retreatment with alpha-interferon is not effective. The aim of this study was to ascertain whether the administration of N-acetyl cysteine and vitamin E could increase 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 hepatitis C who had been non-responders to a previous course of alpha-interferon, 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 treatment: group A, natural interferon-alphaN3, 6 or 9 MU tiw, when the body weight was < 60 kg or > or = 60 kg, respectively; group B, the same dosage of natural interferon-alphaN3 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 was clearance of the virus from serum observed.

CONCLUSIONS:

In this randomized study carried out on 120 patients with chronic hepatitis C not responsive to alpha-interferon, oral supplementation with N-acetyl cysteine and vitamin E did not improve the poor efficacy of retreatment with alpha-interferon alone.

PMID:
10563527
[PubMed - indexed for MEDLINE]
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