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Randomized comparison of 12 or 24 weeks of peginterferon alpha-2a and ribavirin in chronic hepatitis C virus genotype 2/3 infection.

Journal article
Authors Martin Lagging
Nina Langeland
Court Pedersen
Martti Färkkilä
Mads Rauning Buhl
Kristine Mørch
Amar P Dhillon
Åsa Alsiö
Kristoffer Hellstrand
Johan Westin
Gunnar Norkrans
Published in Hepatology (Baltimore, Md.)
Volume 47
Issue 6
Pages 1837-45
ISSN 1527-3350
Publication year 2008
Published at Institute of Biomedicine, Department of Infectious Medicine
Pages 1837-45
Language en
Links dx.doi.org/10.1002/hep.22253
Keywords Adult, Antiviral Agents, administration & dosage, Drug Administration Schedule, Drug Therapy, Combination, Female, Genotype, Hepacivirus, genetics, Hepatitis C, Chronic, blood, drug therapy, Humans, Interferon Alfa-2a, administration & dosage, Male, Middle Aged, Polyethylene Glycols, administration & dosage, Predictive Value of Tests, RNA, Viral, blood, Ribavirin, administration & dosage, Sensitivity and Specificity, Treatment Outcome
Subject categories Microbiology in the medical area

Abstract

Previous trials investigating the efficacy of treatment durations shorter than the standard of 24 weeks for chronic hepatitis C virus (HCV) genotype 2/3 infections have yielded discordant results. The aims of this investigator-initiated phase III study were to compare the efficacy of 12 or 24 weeks of treatment and to identify patients suitable for short-term therapy. Three hundred eighty-two genotype 2/3-infected patients [intention-to-treat (ITT) population] at 31 centers in Denmark, Finland, Norway, and Sweden were randomized to 12 or 24 weeks of peginterferon alpha-2a (180 microg/week) plus ribavirin (800 mg/day). Twelve weeks of therapy was inferior to 24 weeks in the ITT population (sustained viral response [SVR] rates: 59% versus 78%, P < 0.0001) and in the subgroups of patients infected with genotype 2 (56% versus 82%, P = 0.006) or 3 (58% versus 78%, P = 0.0015). These differences were observed regardless of the fibrosis stage. Age and HCV-RNA levels on days 7 and 29 were independent predictors of SVR. Short-term treatment was useful in patients < 40 years old, especially if HCV-RNA was undetectable on day 29, and also in patients > or = 40 years old, provided that HCV-RNA was below 1000 IU/mL on day 7 in addition to being undetectable on day 29. If neither of these two criteria were met for patients > or = 40 years old, 24 weeks of therapy was superior (P < 0.0001). CONCLUSION: Peginterferon/ribavirin treatment for 12 weeks in HCV genotype 2/3 infection is overall inferior to 24 weeks of treatment but may be useful in some patients with a rapid initial clearance of virus.

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