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PubMed · 16082736

International, multicenter, randomized, controlled study comparing dynamically individualized versus standard treatment in patients with chronic hepatitis C.

Stefan Zeuzem·Jean-Michel Pawlotsky·Esther Lukasiewicz·Michael von Wagner·Ioannis Goulis·Yoav Lurie·Elia Gianfranco·Jan-Maarten Vrolijk·Juan I Esteban·Christophe Hezode·Martin Lagging·Francesco Negro·Alexandre Soulier·Elke Verheij-Hart·Bettina Hansen·Ronen Tal·Carlo Ferrari·Solko W Schalm·Avidan U Neumann·DITTO-HCV Study Group
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Abstract

BACKGROUND/AIMS: The aim of this study was to increase virologic response rates by individualized treatment according to the early virologic response. METHODS: Serum HCV-RNA was frequently quantified in patients with chronic hepatitis C (n=270) treated with peginterferon alfa-2a (180 microg/week) and ribavirin (1000-1200 mg/day). After 6 weeks patients were classified as rapid (RVR), slow (SPR), flat (FPR), or null responders (NUR) and randomized within each viral kinetic class to continue therapy either with an individualized or standard regimen. Individualized therapy comprised peginterferon monotherapy (48 weeks) or shorter combination therapy (24 weeks) for RVR, triple therapy with histamine (1 mg/day) (48 weeks) or prolonged combination therapy (72 weeks) for SPR, triple therapy for FPR, and high-dose peginterferon (360 microg/week) plus ribavirin for NUR patients. RESULTS: Patients were categorized as RVR (n=171), SPR (n=65), FPR (n=10), or NUR (n=22). Overall end-of-treatment and sustained virologic response rates were 77 and 60% in the individualized and 77 and 66% in the standard treatment arm, respectively. Histamine in addition to peginterferon and ribavirin and high-dose peginterferon plus ribavirin did not improve virologic response rates in patients with FPR and NUR, respectively. CONCLUSIONS: An improvement in virologic efficacy was not achieved with the available individualized treatment options.

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AdultAntiviral AgentsDose-Response Relationship, DrugDrug CarriersDrug Therapy, CombinationFemaleFollow-Up StudiesHepacivirusHepatitis C, ChronicHumansInterferon alpha-2Interferon-alphaInternational CooperationMaleMiddle AgedPolyethylene GlycolsRNA, ViralRecombinant ProteinsRetrospective StudiesRibavirinSafetyTreatment OutcomeViral LoadClinical TrialClinical Trial, Phase IIIJournal ArticleMulticenter StudyRandomized Controlled TrialResearch Support, Non-U.S. Gov't

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Stefan Zeuzem, Jean-Michel Pawlotsky, Esther Lukasiewicz, Michael von Wagner, Ioannis Goulis, Yoav Lurie, Elia Gianfranco, Jan-Maarten Vrolijk, Juan I Esteban, Christophe Hezode, Martin Lagging, Francesco Negro, Alexandre Soulier, Elke Verheij-Hart, Bettina Hansen, Ronen Tal, Carlo Ferrari, Solko W Schalm, Avidan U Neumann, DITTO-HCV Study Group. 2005. International, multicenter, randomized, controlled study comparing dynamically individualized versus standard treatment in patients with chronic hepatitis C.. https://doi.org/10.1016/j.jhep.2005.05.016

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