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Treatment of chronic he1patitis C genotype 1 with peginterferon-alpha2a (40 kDa) plus ribavirin under routine clinical practice in Spain: early prediction of sustained virological response rate.

Diago M, Olveira A, Solá R, Romero-Gómez M, Moreno-Otero R, Pérez R, Salmerón J, Enríquez J, Planas R, Gavilán JC, Del Olmo J, Uribarrena R, Sillero C, Benítez A, Sánchez-Galdón S, Dalmau B, Eraña L, Montoro M, Portu J, Garijo JM, Barniol R, Domínguez A, Rota R, Olcoz JL, Antón M, Pamplona X, Casanovas T, Jiménez E, Huarte M, Díaz F, Sánchez-Ruano J, Orive M, Muñoz-Sánchez M, Roset M

Hospital General de Valencia, Valencia, Spain. mdiagom@meditex.es

BACKGROUND: Sustained virological response rates of up to 52% have been obtained with peginterferon alpha2a (40 kDa) plus ribavirin in patients suffering from chronic hepatitis C genotype 1 in randomized-controlled trials. Aim: To assess early virological response and its clinical utility in predicting an sustained virological response in patients suffering from chronic hepatitis C genotype 1 in routine clinical practice in Spain. METHODS: Treatment-naïve patients received pegylated interferon alpha2a (40 kDa) 180 microg/week plus ribavirin 1000/1200 mg/day for 48 weeks, and were followed for a further 24 weeks. Overall, 475 patients received at least one dose of medication and were included in the efficacy population. RESULTS: The overall sustained virological response rate was 48%. Of those with week 12 virological data, 83% had an early virological response. The negative predictive value of an early virological response was 93%. CONCLUSION: If sustained virological response is the goal, a treatment-decision based on a 12-week evaluation during routine clinical practice is feasible.

Published 3 April 2007 in Aliment Pharmacol Ther, 25(8): 899-906.
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