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Randomized comparison of 12 or 24 weeks of peginterferon α‐2a and ribavirin in chronic hepatitis C virus genotype 2/3 infection
Author(s) -
Lagging Martin,
Langeland Nina,
Pedersen Court,
Färkkilä Martti,
Buhl Mads Rauning,
Mørch Kristine,
Dhillon Amar P.,
Alsiö Åsa,
Hellstrand Kristoffer,
Westin Johan,
Norkrans Gunnar
Publication year - 2008
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.22253
Subject(s) - ribavirin , genotype , medicine , virology , hepatitis c virus , chronic hepatitis , virus , randomized controlled trial , hepacivirus , gastroenterology , biology , gene , biochemistry
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 α‐2a (180 μg/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 ≥ 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 ≥ 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. (H EPATOLOGY 2008.)