BioDrugs

, Volume 17, Issue 4, pp 281–286 | Cite as

Interferon-α (IFNα) Daily Dose Versus IFNα Plus Ribavirin for Treatment-Naive Chronic Hepatitis C Patients Infected by Genotype 1b

  • Gaetano Scotto
  • Fausto Campanozzi
  • Antonio D’Adduzio
  • Maria Grimaldi
  • Vincenzina Fazio
Original Research Article

Abstract

Introduction

Infection with hepatitis C virus genotype 1b (HCV1b) is known to be a predictive factor of poor response to both interferon-α (IFNα) alone and IFNα plus ribavirin combination therapy.

Study design, patients and methods

This randomised study evaluated the efficacy and safety of daily IFNα administration versus the combination of IFNα plus ribavirin in treatment-naive patients infected with chronic HCV1b. Sixty-two patients were randomised to receive either human leucocyte IFNα 6MU three times weekly for 12 months plus ribavirin 15 mg/kg/day for the first 6 months (group A: 29 patients), or human leucocyte IFNα 3MU daily for 12 months (group B: 33 patients). Response was evaluated by monitoring serum alanine aminotransferase (ALT) and HCV-RNA levels during treatment and follow-up (12 months).

Results and conclusion

Both treatment schedules were relatively well tolerated. Normal ALT levels and negative serum HCV-RNA were observed in 16 of 29 patients (55%) of group A and in 18 of 33 patients (54.5%) of group B at the end of treatment, as well as in 10 of 29 patients (34.5%) of group A and in 12 of 33 patients (36%) of group B at the end of the follow-up. There was no significant difference between the response rates obtained with the two regimens. In naive patients with chronic HCV1b infection, the efficacy of daily administration with IFNα is similar to that of IFNα plus ribavirin administered three times a week.

Keywords

Sustained Virological Response Sustained Virological Response Rate Fibrosis Score High Initial Dose Sustained Response Rate 

Notes

Acknowledgements

No sources of funding were used to assist in the preparation of this manuscript. The author appreciates the kind support of Dr M. Grimaldi from Alfa Wassermann S.p.A., in the planning of the study and in the execution of the relevant statistical analysis.

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Copyright information

© Adis Data Information BV 2003

Authors and Affiliations

  • Gaetano Scotto
    • 1
  • Fausto Campanozzi
    • 2
  • Antonio D’Adduzio
    • 3
  • Maria Grimaldi
    • 4
  • Vincenzina Fazio
    • 5
  1. 1.Department of Infectious DiseasesHepatology UnitFoggiaItaly
  2. 2.SERTTorremaggioreItaly
  3. 3.SERTLuceraItaly
  4. 4.Medical DepartmentBolognaItaly
  5. 5.II Laboratory, Infectious DiseasesFoggiaItaly

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