STARTVerso1: A Randomized Trial of Faldaprevir Plus Pegylated Interferon/Ribavirin for Chronic HCV Genotype-1 Infection

• Autor(a) principal: Ferenci, P
• Data de Publicação: 2015
• Outros Autores: Asselah, T, Foster, G, Zeuzem, S, Sarrazin, C, Moreno, C, Ouzan, D, Maevskaya, M, Calinas, F, Morano, L, Crespo, J, Dufour, JF, Bourlière, M, Agarwal, K, Forton, D, Schuchmann, M, Zehnter, E, Nishiguchi, S, Omata, M, Kukolj, G, Datsenko, Y, Garcia, M, Scherer, J, Quinson, AM, Stern, J
• Tipo de documento: Artigo
• Idioma: eng
• Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
• Texto Completo: http://hdl.handle.net/10400.17/2513
• topic: Adult; Antiviral Agents/administration & dosage; Double-Blind Method; Drug Therapy, Combination; Female; Genotype; Hepacivirus/classification; Hepatitis C, Chronic/virology; Humans; Interferon-alpha/administration & dosage; Male; Middle Aged; Oligopeptides/administration & dosage; Polyethylene Glycols/administration & dosage; RNA, Viral/blood; Recombinant Proteins/administration & dosage; Ribavirin/administration & dosage; Thiazoles/administration & dosage; CHLC GAS; Antiviral Agents/adverse effects; Hepacivirus/drug effects; Hepacivirus/genetics; Hepatitis C, Chronic/drug therapy; Interferon-alpha/adverse effects; Oligopeptides/adverse effects; Polyethylene Glycols/adverse effects; Recombinant Proteins/adverse effects; Ribavirin/adverse effects; Thiazoles/adverse effects

BACKGROUND & AIMS: The efficacy and tolerability of faldaprevir, a potent hepatitis C virus (HCV) NS3/4A protease inhibitor, plus peginterferon (PegIFN) and ribavirin (RBV) 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 PegIFN/RBV 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 <25 IU/ml at week 4 and undetectable at week 8) stopped all treatment at week 24. Other patients received PegIFN/RBV until week 48 unless they met futility criteria. The primary endpoint was sustained virologic response 12 weeks post-treatment (SVR12). RESULTS: SVR12 was achieved by 52%, 79%, and 80% of patients in arms 1, 2, and 3, respectively (estimated difference for arms 2 and 3 vs. arm 1: 27%, 95% confidence interval 17%-36%; and 29%, 95% confidence interval, 19%-38%, respectively; p < 0.0001 for both). Early treatment success was achieved by 87% (arm 2) and 89% (arm 3) of patients, of whom 86% and 89% achieved SVR12. Adverse event rates were similar among groups; few adverse events led to discontinuation of all regimen components. CONCLUSIONS: Faldaprevir plus PegIFN/RBV significantly increased SVR12, compared with PegIFN/RBV, in treatment-naïve patients with HCV genotype-1 infection. No differences were seen in responses of patients given faldaprevir once daily at 120 or 240 mg.