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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.

Author(s): Nevens E, Van Vlierberghe H, D'Heygere E, Delwaide J, Adler M, Henrion J, Lenaerts A, Hendlisz A, Michielsen P, Bastens B, Brenard R, Laureys A, BERNAR-1 Study Group

Affiliation(s): Dienst Interne Geneeskunde Hepatologie,UZ Gasthuisberg KULeuven, Leuven, Belgium. frederik.nevens@uzleuven.be

Publication date & source: 2010-04, Acta Gastroenterol Belg., 73(2):223-8.

Publication type: Clinical Trial, Phase III; Multicenter Study; Randomized Controlled Trial

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.

Page last updated: 2010-10-05

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