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Leucocyte Interferon-alpha for Patients with Chronic Hepatitis C Intolerant to Other alpha-Interferons

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Abstract

Background

Alpha-interferon (α-IFN) is the treatment of choice for chronic hepatitis C but most patients experience adverse effects which sometimes lead to the suspension of therapy. Recently, higher doses of α-IFN or prolonged therapy have increased the number of cases of intolerance.

Study Design

In this open study we evaluated the efficacy and safety of leucocyte interferon-alpha (IFNα) [6MU three times a week] in 43 patients with chronic hepatitis C who had been intolerant to previous treatment courses with recombinant or lymphoblastoid IFNα. All patients were treated for 6 months and followed-up for an additional 6 months.

End of treatment responders were patients in whom hepatitis C virus (HCV)-RNA had been eradicated from the blood by the end of treatment, sustained responders were those patients who maintained negative HCV-RNA at the end of follow-up, and the remaining patients were considered non-responders. Adverse effects were monitored by interviews, laboratory and clinical examinations.

Results

Five patients (11.6%) discontinued the treatment, four due to the reappearance of previous adverse effects, and one due to an ex novo adverse effect. In six patients the dose had to be halved. At the end of treatment 11 patients (25.6%) had negative serum HCV-RNA. After discontinuation of therapy, disease flared in four patients, thus seven patients were sustained responders.

Conclusions

This study shows that leucocyte IFNα at a dose of 6MU three times a week is well tolerated in patients previously intolerant to recombinant or lymphoblastoid IFNα, allowing a high percentage of them to complete a course of treatment in terms of duration and dose.

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Acknowledgements

This study was in part supported by a grant from MURST (Ministero dell’Università e della Ricerca Scientifica e Tecnologica) in 1999. The authors declare that no relationship, funding or interests of any kind exists between themselves and the company that produces the interferon used in this study.

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Authors and Affiliations

  1. Dipartimento di Medicina Clinica e delle Patologie Emergenti, Servizio di Prevenzione e Cura delle Malattie Epato-biliari e Cattedra di Medicina Interna, Università di Palermo, Via del Vespro 141, Palermo, 90127, Italy

    Silvio Tripi, Maurizio Soresi, Giuseppa Di Gaetano, Antonio Carroccio, Lydia Giannitrapani, Onofrio Vuturo, Gaetana Di Giovanni &  Giuseppe Montalto

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  1. Silvio Tripi
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  2. Maurizio Soresi
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  3. Giuseppa Di Gaetano
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  4. Antonio Carroccio
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  5. Lydia Giannitrapani
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  6. Onofrio Vuturo
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  7. Gaetana Di Giovanni
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  8. Giuseppe Montalto
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Correspondence to Giuseppe Montalto.

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Tripi, S., Soresi, M., Di Gaetano, G. et al. Leucocyte Interferon-alpha for Patients with Chronic Hepatitis C Intolerant to Other alpha-Interferons. BioDrugs 17, 201–205 (2003). https://doi.org/10.2165/00063030-200317030-00006

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  • DOI: https://doi.org/10.2165/00063030-200317030-00006

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