Combination therapy with interferon-α plus N-acetyl cysteine for chronic hepatitis C: A placebo controlled double-blind multicentre study

  1. P.R. Grant1,
  2. A. Black2,
  3. N. Garcia3,
  4. J. Prieto3,
  5. J.A. Garson1,*

Article first published online: 10 JUL 2000

DOI: 10.1002/1096-9071(200008)61:4<439::AID-JMV5>3.0.CO;2-L

Issue

Journal of Medical Virology

Journal of Medical Virology

Volume 61, Issue 4, pages 439–442, August 2000

Additional Information

How to Cite

Grant, P., Black, A., Garcia, N., Prieto, J. and Garson, J. (2000), Combination therapy with interferon-α plus N-acetyl cysteine for chronic hepatitis C: A placebo controlled double-blind multicentre study. Journal of Medical Virology, 61: 439–442. doi: 10.1002/1096-9071(200008)61:4<439::AID-JMV5>3.0.CO;2-L

Author Information

  1. 1

    Department of Virology, Royal Free and University College Medical School, London, United Kingdom

  2. 2

    Hepatitis Development Group, Glaxo Wellcome Research and Development, Middlesex, United Kingdom

  3. 3

    Servicio Medecina Interna, Clinica Universita De Navarra, Navarra, Spain

*Department of Virology, Royal Free and University College Medical School, Windeyer Building, 46, Cleveland Street, London W1P 6DB, UK

Publication History

  1. Issue published online: 10 JUL 2000
  2. Article first published online: 10 JUL 2000
  3. Manuscript Accepted: 8 NOV 1999

Funded by

  • GlaxoWellcome Research and Development Ltd

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Keywords:

  • hepatitis C virus;
  • treatment;
  • interferon;
  • N-acetyl cysteine;
  • clinical trial

Abstract

A small pilot study in patients with chronic hepatitis C (HCV) infection suggested that antiviral treatment with interferon (IFN) plus N-acetyl cysteine (NAC) was more effective than treatment with interferon alone [Beloqui et al. (1993) Journal of Interferon Research 13:279–282]. An attempt was made to confirm this by performing a placebo-controlled double-blind study at 8 medical centres in Spain and Italy. One-hundred forty-seven patients with chronic HCV infection were investigated, 73 received 3MU IFN-α thrice weekly plus NAC 1800 mg daily and 74 received IFN alone. Treatment was continued for 6 months and patients were followed up for a further 6 months. Amongst patients receiving IFN plus NAC, sustained virological responses were observed in 5.5%, transient responses in 26% and non-response in 68.5%. The figures for patients receiving IFN only were 4.1%, 24.3% and 71.6% respectively. Sustained virological response was significantly associated with non-type 1 genotypes (P = 0.045) and with low pre-treatment viraemia levels (P = 0.034). Biochemical response (serum ALT concentrations) correlated with virological outcome in 97% (n = 139) of cases. Patients who experienced a sustained virological response also showed reduction in the Knodell histological activity index. It is concluded that patients with chronic HCV infection are very unlikely to benefit from the addition of N-acetyl cysteine to conventional therapy with interferon-α. J. Med. Virol. 61:439–442, 2000. © 2000 Wiley-Liss, Inc.

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