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AbbVie Inc Completes Phase III Program of an All-Oral, Interferon-Free Therapy for the Treatment of Hepatitis C Genotype 1


Friday, 31 Jan 2014 07:39am EST 

AbbVie Inc:Says completion of its phase III clinical program and released results of four additional studies designed to assess AbbVie's investigational all-oral, interferon-free therapy with and without ribavirin (RBV) in patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection.Says these results described below confirm previously reported AbbVie data and further demonstrate high sustained virologic response rates 12 weeks post treatment (SVR12) and tolerability in these GT1 patients.Says the AbbVie investigational regimen consists of the fixed-dose combination of ABT-450/ritonavir (150/100mg) co-formulated with ABT-267 (25mg), dosed once daily, and ABT-333 (250mg) with or without ribavirin (weight-based), dosed twice daily.Says the combination of three different mechanisms of action interrupts the HCV replication process with the goal of optimizing SVR rates across different patient populations.Says in May of 2013, AbbVie's regimen with and without ribavirin for HCV GT1 was designated as aTherapy by the U.S. Food and Drug Administration (FDA).Says AbbVie is on track to begin major regulatory submissions early in the second quarter of 2014. AbbVie will disclose detailed study results at future scientific congresses and in publications. 

Company Quote

67.36
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21 Nov 2014