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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
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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) 180µg/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.
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