Zdroj: |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) Agência para a Sociedade do Conhecimento (UMIC)-FCT-Sociedade da Informação instacron:RCAAP Ferenci, Peter; Asselah, Tarik; Foster, Graham R; Zeuzem, Stefan; Sarrazin, Christoph; Moreno, Christophe; Ouzan, Denis; Maevskaya, Marina; Calinas, Filipe; Morano, Luis E; Crespo, Javier; Dufour, Jean-François; Bourlière, Marc; Agarwal, Kosh; Forton, Daniel; Schuchmann, Marcus; Zehnter, Elmar; Nishiguchi, Shuhei; Omata, Masao; Kukolj, George; ... (2015). STARTVerso1: A randomized trial of faldaprevir plus pegylated interferon/ribavirin for chronic HCV genotype-1 infection. Journal of hepatology, 62(6), pp. 1246-1255. Elsevier 10.1016/j.jhep.2014.12.024 |
Popis: |
BACKGROUND & AIMS The efficacy and tolerability of faldaprevir, a potent hepatitis C virus (HCV) NS3/4A protease inhibitor, plus peginterferon and ribavirin was assessed in a double-blind, placebo-controlled phase 3 study of treatment-naïve patients with HCV genotype-1 infection. METHODS Patients were randomly assigned (1:2:2) to peginterferon/ribavirin plus: placebo (arm 1, n=132) for 24 weeks; faldaprevir (120 mg, once daily) for 12 or 24 weeks (arm 2, n=259); or faldaprevir (240 mg, once daily) for 12 weeks (arm 3, n=261). In arms 2 and 3, patients with early treatment success (HCV RNA |