Title
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A randomized, open-label, multicenter study evaluating the efficacy of peginterferon alfa-2a versus interferon alfa-2a, in combination with ribavirin, in naive and relapsed chronic hepatitis C patients
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Author
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Abstract
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Background/Aims : A large multicenter trial to compare the efficacy of peginterferon alfa-2a with interferon alfa-2a, in combination with ribavirin, in chronic hepatitis C patients. Efficacy data for prior relapsers are reported because treatment recommendations for this patient population are not well defined. Patients and methods : This study was a multicenter, prospective, randomized clinical trial. The primary efficacy endpoint was sustained virologic response in naive patients (n = 348) and relapsers (n = 95). Results : Sustained virologic response rates were similar in naive patients and relapsers, both for non-pegylated and pegylated interferon (respectively 27 and 26% and 54 and 43%). Pegylated interferon given for 48 weeks did not improved the relapse rate : 15.9 and 27.3% for non-pegylated and 16.7 and 30.4% for pegylated interferon, naive vs relapsers respectively. Stepwise logistic regression analysis revealed a significant association between slow response (detectable HCV RNA at week 12 and undetectable at week 24) and relapse in patients with an end-of-treatment response (55% versus 13% respectively; p = 0.02; odds ratio = 6.07). Conclusions : This trial confirms the value of using peginterferon alfa-2a in both naive and relapsed patients and provides support for a more tailored approach to treatment for relapsers and particulary for patients with a slow viral response. (Acta gastroenterol. belg., 2010, 73, 223-228). |
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Language
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English
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Source (journal)
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Acta gastro-enterologica belgica. - Bruxelles, 1946 - 1995
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Publication
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Bruxelles
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Acta Medica belgica
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2010
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ISSN
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0001-5644
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Volume/pages
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73
:2
(2010)
, p. 223-228
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ISI
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000280316400003
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