The objective of this study was to compare the efficacy of anti-hepatitis C virus (anti-HCV) treatment schedules on the basis of an early virological response (EVR), defined as undetectable serum HCV-RNA (< 50 IU/ ml) after a 12-week induction course of peginterferon alpha-2a (PEG-IFN) 180 mcg/week. Methods A total of 210 interferon-naive patients (69% male; median age, 42 years) with histologically proven chronic hepatitis C infection (genotype 1: 62%) received PEG-IFN 180 mcg/week for 12 weeks. Patients with EVR (58%) were randomized to continue PEG-IFN monotherapy (n=64) or to add ribavirin (RBV), 800 mg/day (n = 57), for 36 additional weeks. Patients without EVR (42%) were randomized to add RBV (n=42), or RBV plus amantadine, 200mg/day (n=47), for 36 additional weeks. Sustained virological response (SVR, undetectable HCV-RNA 24 weeks after treatment completion) was compared among treatment groups. Results Patients with EVR: SVR rate was 60.3% in the PEG-IFN group versus 672% in the PEG-IFN + RBV group (NS). In genotypes 2/3, SVR rates were 66.7 versus 73.1% (NS); in genotypes 1/4, SVR rates were 51.6 versus 61.3%, respectively (NS). Patients without EVR: SVR was 16.7% in the PEG-IFN + RBV group versus 31.9% in the triple therapy group (P=0.07). In patients with genotypes 1/4, SVR rates were 9.4 versus 29.7% (P=0.041). Conclusion In genotypes 1/4 patients without EVR, triple therapy results in higher SVR rates than standard dual therapy. This study confirms that addition of amantadine is beneficial in early-recognized 'difficult-to-treat' patients.
|Tipologia:||Articolo su rivista|
|Citazione:||Angelico, M., Koehler-Horst, B., Piccolo, P., Angelico, F., Gentile, S., Francioso, S., et al. (2008). Peginterferon alpha-2a and ribavirin versus peginterferon alpha-2a monotherapy in early virological responders and peginterferon alpha-2a and ribavirin versus peginterferon alpha-2a, ribavirin and amantadine triple therapy in early virological nonresponders: the SMIEC II trial in naive patients with chronic hepatitis C. EUROPEAN JOURNAL OF GASTROENTEROLOGY & HEPATOLOGY, 20(7), 680-687.|
|IF:||Con Impact Factor ISI|
|Settore Scientifico Disciplinare:||Settore MED/12 - Gastroenterologia|
|Revisione (peer review):||Sì, ma tipo non specificato|
|Digital Object Identifier (DOI):||10.1097/MEG.0b013e3282f5196c|
|Stato di pubblicazione:||Pubblicato|
|Data di pubblicazione:||2008|
|Titolo:||Peginterferon alpha-2a and ribavirin versus peginterferon alpha-2a monotherapy in early virological responders and peginterferon alpha-2a and ribavirin versus peginterferon alpha-2a, ribavirin and amantadine triple therapy in early virological nonresponders: the SMIEC II trial in naive patients with chronic hepatitis C|
|Autori interni:||ANGELICO, MARIO |
|Autori:||Angelico, M; Koehler-Horst, B; Piccolo, P; Angelico, F; Gentile, S; Francioso, S; Tarquini, P; Vecchia, RD; Ponti, L; Pilleri, G; Barlattani, A; Grieco, A; Soccorsi, F Guarascio P., Demelia L., Sorbello O., Rossi Z., Forlini G., Zaru S., Bandiera F.|
|Appare nelle tipologie:||01 - Articolo su rivista|
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