Interferon-α (IFNα) Daily Dose Versus IFNα Plus Ribavirin for Treatment-Naive Chronic Hepatitis C Patients Infected by Genotype 1b
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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.
KeywordsSustained Virological Response Sustained Virological Response Rate Fibrosis Score High Initial Dose Sustained Response Rate
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.
- 6.Poynard T, Marcellin P, Lee SS, et al. Randomised trial of interferon alpha2b plus ribavirin for 48 weeks or for 24 weeks versus interferon alpha 2b plus placebo for 48 weeks for treatment of chronic infection with hepatitis C virus: International Hepatitis Interventional Therapy Group. Lancet 1998; 352: 1426–32PubMedCrossRefGoogle Scholar
- 16.Hadziyannis AS, Papaioannou C, Spanou F, et al. Long term efficacy of induction IFN therapy for 4 weeks followed by a standard tiw schedule in chronic hepatitis C [abstract]. Hepatology 1998; 28: 861AGoogle Scholar
- 23.Colombatto P, Oliveri F, Leandro G, et al. Platelet and white blood cell counts during therapy with different types of alpha interferon in patients with chronic viral hepatitis: Investigators of the Alpha Interferon Study Group of Piemonte, Italy. Ital J Gastroenterol Hepatol 1997; 29: 441–7PubMedGoogle Scholar
- 25.Proceedings of the European Association for the Study of the Liver International Consensus Conference on Hepatitis C: Paris, France, 26–27 Feb 1999. J Hepatol 1999; 31 Suppl. 1: 1-268Google Scholar