Weekly pegylated interferon alpha-2b vs daily interferon a-2b versus standard regimen of interferon a-2b in the treatment of patients with chronic hepatitis C virus infection.


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Article: article from journal or magazin.
Weekly pegylated interferon alpha-2b vs daily interferon a-2b versus standard regimen of interferon a-2b in the treatment of patients with chronic hepatitis C virus infection.
Acta Gastro-enterologica Belgica
Horsmans Y., Colle I., Van Vlierberghe H., Langlet P., Adler M., Bourgeois N., Brenard R., Michielsen P., Goossens A., Bruckers L.
Working group(s)
Belgian Assocation for the Study of the Liver
Bastens B., Botembe N., Bourgeois S., Braxel Ch., Cabooter M., Caenepeel P., Callens J., Christiaens P., Collin JF., Coppens JP., Daenen G., DeGalocsy Ch., De Konink X., De Man M., De Reuck M., De Vaere S., De Wilde V., Deboever G., Deflandre J., Delatere M., Del Natale M., Deltenre P., Denié C., Denis P., Desmedt P., Elewaut A., Ferrante M., Fiasse M., Gehenot M., Golstein P., Gruselle P., Hassaini H., Hendrickx K., Henrion J., Jungers M., Lambrecht G., Lefèbvre V., Lenaerts A., Louis H., Marcelis L., Martinet JP., Mesureur T., Monsaert E., Mulkay JP., Nevens F., Noël P., Preux C., Reekmans A., Remery M., Reynaert H., Robaeys G., Rodenbach J., Saikali S., Sibile A., Sprengers D., Van der Meersch F., Van Hee W., Van Isveldt J., Van Roey G., Vandenbulcke JM., Vandenput F., Vandermeeren A., Wagner C., Wain E., Willocx R., Warzee P., Witterwulghe M.
0001-5644 (Print)
Publication state
Issued date
Publication types: Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled TrialPublication Status: ppublish
BACKGROUND AND STUDY AIMS: The combination of Pegylated (PEG)interferon alpha-2b and ribavirin is considered to be the standard treatment for naïve chronic hepatitis C patients. Study aims are to evaluate the differences between standard interferon and PEG-interferon by conducting a multi-centre, controlled randomized trial comparing 3 groups. Group A : daily interferon alfa-2b at a dose of 4 MIU + ribavirin, Group B : PEG-interferon alfa-2b at a dose of 100 mcg/week + ribavirin; Group C: interferon alfa-2b at a dose of 3 MIU TIW + ribavirin
PATIENTS AND METHODS: Multicentrer, open label study including naïve chronic Hepatitis C Virus patients randomised in three groups with a ratio of 2:2:1. Group A: daily interferon alpha-2b (4 MIU s.c. for patients > 65 kg or 0.06 MIU/kg < 65 kg) and ribavirin, group B: PEG-interferon alpha-2b (100 microg s.c. weekly for patients > 65 kg or 1.5 microg/kg weekly for patients < 65 kg) and ribavirin and group C (reference arm) : interferon alpha-2b (3MIU s.c. TWI) and ribavirin. The duration of the treatment was 48 weeks for all 3 groups, with a 6 month follow-up period. 336 patients were enrolled in the study and included in the intention-to-treat analysis; 78 never started treatment (35 in group A, 28 in group B and 15 in group C): 101 in group A, 98 in group B and 59 in group C.
RESULTS: Demographic data, PCR results and reasons for early withdrawal have been statistically analysed. At baseline, the 3 groups did not show any statistical difference regarding age, gender, race, genotypes and METAVIR score. At week 24 on treatment, HCV ribonucleic acid RNA was undetectable in 87% in group A, in 79% in group B and in 69% in group C. At the end of treatment, 73% 74% and 58% respectively, had a negative PCR result. At week 24 of follow-up, these results were 71%, 64% and 48%, respectively. When comparing the efficacy of the daily interferon (+ ribavirin) and the PEG-interferon (+ ribavirin) regimen, no statistical difference was found (p = 0.32). In group A, 38% of drop-outs were due to adverse events compared to 37% in group B and 58% in group C. No statistical differences were observed regarding safety.
CONCLUSION: Daily weight based interferon alpha-2b dosing and PEG interferon alpha-2b weighed based dosing once weekly both in combination with Ribavirin offer the same efficacy and safety rates.
Adolescent, Adult, Aged, Antiviral Agents/administration & dosage, Drug Combinations, Female, Hepatitis C, Chronic/drug therapy, Humans, Interferon-alpha/administration & dosage, Male, Middle Aged, Polyethylene Glycols, Recombinant Proteins, Ribavirin/administration & dosage
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Create date
06/12/2013 11:18
Last modification date
20/08/2019 15:43
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