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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 naïve and relapsed chronic hepatitis C patients

par Nevens, Frederik;van Vlierberghe, Han;D'Heygere, François;Delwaide, Jean;Adler, Michael ;Henrion, Jean;Lenaerts, Anne;Hendlisz, Alain ;Michielsen, Peter;Bastens, Boris;Laureys, Annick;Brenard, B.
Référence Acta gastro-enterologica Belgica (Ed. multilingue), 73, 2, page (223-228)
Publication Publié, 2010-04

Article révisé par les pairs

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Résumé :

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 naïve patients (n = 348) and relapsers (n = 95).Results: Sustained virologic response rates were similar in naïve patients and relapsers, both for non-pegylated and pegylated interferon (respectively 27 and 26% and 54 and 43%). Psegylated 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, naïve 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 peginter- feron alfa-2a in both naïve 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 gastro enterol. belg., 2010, 73, 223-228).