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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
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


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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