Peginterferon Alfa-2a and Ribavirin for 24 Weeks in Hepatitis C Type 1 and 4 Patients With Rapid Virological Response
Background & Aims: This analysis reports the rate of sustained virological response (SVR) in patients infected with hepatitis C virus (HCV) genotype 1 or 4 who were assigned to 24 weeks of treatment with pegylated interferon (peginterferon) alfa-2a 180 μg/wk plus ribavirin 1000/1200 mg/day after achieving a rapid virological response (RVR; HCV RNA level <50 IU/mL) at week 4 in a prospective trial investigating response-guided therapy. Methods: Non-RVR patients with an early virological response were randomized to 48 or 72 weeks of therapy (this is a still-ongoing trial). Results: A total of 150 of 516 patients (29%) had an RVR, 143 of whom completed 24 weeks of treatment. Younger patients, leaner patients, and those with an HCV RNA level ≤400,000 IU/mL and HCV genotype 4 infection were more likely to achieve an RVR; however, among patients with an RVR, no baseline factor predicted SVR. The SVR rate was 80.4% (115/143; 95% confidence interval [CI], 72.9–86.6) in patients who completed 24 weeks of treatment. The SVR rate was 86.7% (26/30; 95% CI, 69.3%–96.2%) in patients infected with genotype 4 and 78.8% in those infected with genotype 1 (89/113; 95% CI, 70.1%–85.9%; intent to treat: 89/120; 74.2%; 65.4–81.7%). Treatment was well tolerated. Conclusions: This prospective study confirms that a 24-week regimen of peginterferon alfa-2a plus ribavirin 1000/1200 mg/day is appropriate in genotype 1 and 4 patients with a low baseline HCV RNA level who achieve an RVR by week 4 of therapy.
Abbreviations used in this paper: CI, confidence interval, EVR, early virological response, OR, odds ratio, PCR, polymerase chain reaction, peginterferon, pegylated interferon, RVR, rapid virological response
Supported by an unrestricted grant by Roche Austria. Roche Austria had no role in the study design; in the collection, analysis, and interpretation of data; and in the decision to submit the report for publication. The Main Association (Hauptverband) of the Austrian Health Insurers paid for the study medication.
P.F. serves on advisory boards and as a speaker and investigator for and has also received research grants from F. Hoffmann-La Roche. M.G., H.B., and P.S.-M. each serve as a speaker for F. Hoffmann-La Roche. K.L. is an employee of F. Hoffmann-La Roche. H.L., T.-M.S., A.M., R.S., M.B., B.B., C.D., E.F., and K.S. have no conflicts of interest to disclose.
Members of the Austrian Hepatitis Study Group—Graz: Bernhard Bauer, Nicole Hueter, Günther J. Krejs, Csilla Putz-Bankuti, Rudolf Stauber, Barbara Sutter, and Gernot Zollner; Innsbruck: Wolfgang Jessner, Karin Nachbaur, Bernhard Nilica, and Wolfgang Vogel; Krems: Hartwig Bognar; Linz: Franz Hackl, Rainer Hubmann, Andreas Maieron, Susanne Mild, Andreas Raml, and Sabine Metz; Ried: Björn Jagdt and Fritz Renner; Oberpullendorf: Felix Stockenhuber; Salzburg: Christian Datz, Hildegard Doppelmayr, and Michael Strasser; Vienna: Susanne Bach, Martin Bischof, Harald Brunner, Barbara Bognar, Ulrike Bergholz, Daniela Ferenci-Foerster, Peter Ferenci, Elisabeth Formann, Alfred Gangl, Michael Gschwantler, Calin Gurguta, Gerold Hartmann, Brigitte Hellmich, Harald Hofer, Hermann Laferl, Karin Mittischek, Christian Müller, Parnaz Ordubadi, Ali Reza Pourbyiabani, Markus Peck-Radosavljevic, Marianne Rosenbeiger, Kurt Schütze, Thomas-Matthias Scherzer, Katharina Staufer, Petra Steindl-Munda, Anika Stückler, and Christoph Wenisch; Villach: Rudolf Foditsch; Wels: Peter Knoflach and Bernhard Stadl.
PII: S0016-5085(08)00656-2
doi:10.1053/j.gastro.2008.04.015
© 2008 AGA Institute. Published by Elsevier Inc. All rights reserved.
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