icon-folder.gif   Conference Reports for NATAP  
 
  38th Annual Meeting of the European Association for the Study of the Liver
 
Istanbul, Turkey. March 28-April 1, 2003
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EFFICACY OF PEGINTERFERON ALFA-2A (40KD) (PEGASYS) PLUS RIBAVIRIN FOR 24 WEEKS IN GENOTYPE 1 PATIENTS WITH CHRONIC HEPATITIS C FOLLOWED BY MONO OR COMBINATION THERAPY FOR 22 WEEKS: PRELIMINARY ANALYSIS OF AN OPEN, MULTICENTER, RANDOMIZED TRIAL
 
 
  J.P. Bronowicki*,1 D. Ouzan,2 T. Asselah,3 H. Desmorat,4 J.P. Zarski,5 J. Foucher,6 M. Bourliere,7 C. Renou,8 A. Tran,8 P. Melin,9 C. Hezode,10 M. Chevallier,11 M. Bouvier,10 J.M. Pawlotsky,10 I. Lonjon-Domanec,12 *Presenting Author 1Hosp Brabois, Nancy, 2Arnaud Tzanck Institute, St Laurent Du Var, 3Hosp Beaujon, Clichy, 4Clin Du Parc, Toulouse, 5Univ Hosp, Grenoble, 6Hosp Haut Leveque, Pessac, 7Hosp Saint Joseph, Marseille, 8Hosp Acad 2, Nice, 9Hosp Saint, Dizier, 10Hosp Henri Mondor, Creteil, 11Lab Meyrieux 12Roche, Neuilly France
 
Recent clinical studies have shown that patients infected with HCV genotype 1 derive significant benefit from combination therapy with Peginterferon plus ribavirin (RBV) given for 48 weeks. However, ribavirin may have severe side effects, that may lead to discontinuation.
 
Objective: The objective of this study was to determine if shorter RBV administration could improve tolerance without altering efficacy in patients infected with HCV genotype 1 who respond to combined therapy.
 
Methods: 524 naive patients with HCV genotype 1 chronic infection were included. They received Peginterferon alfa 2-a (40KD) 180g/week plus RBV (800mg/day) for 24 weeks. The virologic responders at week 24 were randomized at week 26 into: Group A Peginterferon alfa 2-a (40KD) plus ribavirin, or group B, Peginterferon alfa 2-a (40KD) alone for 22 additional weeks. Qualitative HCV-RNA detection was performed at weeks 30, 36, 42, 48, 52, 60 and 72 in each group.
 
Results of preliminary analysis: At week 24, 366 patients were negative by PCR which corresponds to a virologic response rate of 70%. Only age (<44vs>44 years), fibrosis (F1-2 vs F3-4) and male gender were independently predictive of response at week 24. At week 26, 360 patients were randomized. Currently, 234 patients have reached to week 48 and were tested for HCV RNA: 2.7% patients (3/ 111) relapsed during therapy in group A vs 11.4% (14/123) in group B.
 
Conclusions: the results of this preliminary analysis reveal a trend toward a higher rate of virological breakthrough in the peginterferon alfa 2-a monotherapy arm after week 24.