CHMP recommends Viekirax and Exviera for HCV-AbbVie
The European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted positive opinions for AbbVie's all-oral, interferon-free treatment of Viekirax (ABT 450/r plus ABT 267 or paritaprevir/ombitasvir/ritonavir) + Exviera (ABT 333 or dasabuvir) with or without ribavirin (RBV) for patients with genotype 1 (GT1) and genotype 4 (GT4) chronic Hepatitis C virus (HCV) infection. The European Commission will review the opinions and make a final decision sometime in the first quarter of 2015.
The CHMP opinions are supported by a robust clinical development program consisting of six pivotal Phase III studies (SAPPHIRE-I, SAPPHIRE-II, PEARL-II, PEARL-III, PEARL-IV and TURQUOISE-II) including more than 2,300 GT1 patients in over 25 countries. In addition, the positive opinions were supported by a Phase II study, PEARL-I, in GT4 patients without cirrhosis, as well as preliminary data from the TURQUOISE-I study in GT1 HCV and HIV-1 co-infected patients and from the CORAL-I study in liver transplant recipients with recurrent GT1 HCV infection who were new to treatment after transplantation.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
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