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Abbvie recieves CHMP positive opinion for Viekirax + Exviera withthout Ribavirin in treating HCV in GT1B patients with compensated cirrhosis in Europe

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Additional Relevant Details The European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for the use of VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) without ribavirin (RBV) in chronic hepatitis C virus (HCV) infected genotype 1b (GT1b) patients with compensated cirrhosis (Child-Pugh A)."This positive CHMP opinion brings us one step closer to delivering a ribavirin-free treatment option for GT1b patients with compensated cirrhosis that has demonstrated high cure rates with no treatment discontinuations in our clinical trial," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "This milestone reinforces our continued commitment to provide additional treatment options for the HCV community, and we look forward to the final decision by the European Commission."
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Occurred on:
Feb 26, 2016
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Related Keywords Chmp, Viekirax, Exviera, Ribavirin, Hcv, Gtib, Compensated Cirrhosis