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Title: Extended treatment with pegylated interferon alfa/ribavirin in patients with genotype 2/3 chronic hepatitis C who do not achieve a rapid virological response: final analysis of the randomised N-CORE trial
Authors: Shiffman, Mitchell L.
Cheinquer, Hugo
Berg, Christoph P.
Berg, Thomas
Figueiredo-Mendes, Claudio de
Dore, Gregory J.
Ferraz, Maria Lucia [UNIFESP]
Mendes-Correa, Maria Cassia
Lima, Maria Patelli
Parise, Edison R. [UNIFESP]
Perez Rios, Alma Minerva
Reuter, Tania
Sanyal, Arun J.
Shafran, Stephen D.
Hohmann, Marc
Tatsch, Fernando
Bakalos, George
Zeuzem, Stefan
Bon Secours Hlth Syst
Hosp Clin Porto Alegre
Med Univ Klin
Univ Klinikum Leipzig
Santa Casa Misericordia Rio de Janeiro
Univ New S Wales
St Vincents Hosp
Universidade Federal de São Paulo (UNIFESP)
Pontificia Univ Catolica Campinas
Ctr Invest Farmaceut Especializada
Univ Fed Espirito Santo
Virginia Commonwealth Univ
Univ Alberta
F Hoffmann La Roche Ltd
JW Goethe Univ Hosp
Keywords: Hepatitis C virus
Chronic hepatitis C
Genotype 2/3
Slow virological responders
Issue Date: 1-Oct-2014
Publisher: Springer
Citation: Hepatology International. New York: Springer, v. 8, n. 4, p. 517-526, 2014.
Abstract: Background and aims the combination of pegylated interferon alfa/ribavirin will likely remain the treatment of choice for HCV genotype 2/3 patients in financially constrained countries for the foreseeable future. Patients with poor on-treatment response may benefit from treatment extension. This study examined the effect of 48 versus 24 weeks of peginterferon alfa-2a/ribavirin on the sustained virological response (SVR) in patients with HCV genotype 2/3 who did not achieve rapid virological response (RVR).Methods N-CORE was a multicentre, randomised, phase III study. HCV genotype 2/3 patients receiving peginterferon alfa-2a/ribavirin without a rapid but with an early virological response were randomised at week 24 to stop treatment (Arm A) or continue to 48 weeks (Arm B). the primary efficacy endpoint was SVR.Results Two hundred thirty-five patients were enrolled. End of treatment response was similar in both treatment arms. SVR24 rates were not significantly greater in the extended treatment arm compared with the standard 24-week treatment in either the intention-to-treat or the per-protocol populations (61 vs. 52 %, p = 0.1934 and 63 vs. 52 %, p = 0.1461, respectively). Serious adverse events occurred more frequently in patients receiving extended treatment duration (12 %) versus 24-week therapy (4 %).Conclusions It is unclear whether the extension of peginterferon alfa-2a/ribavirin treatment may benefit HCV genotype 2/3 patients who do not achieve RVR. the study was stopped early because recruitment was slower than anticipated, and this may have limited the statistical impact of these findings.
ISSN: 1936-0533
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