Viekira Pak regulatory update

The regimen includes ribavirin in patients with HCV genotype 1a infection and in patients with HCV genotype 1 infection who have cirrhosis or have received a liver transplant. Viekira Pak’s label recommends a 12-week course for HCV genotype 1a patients without cirrhosis and HCV genotype 1b patients with or without cirrhosis. HCV genotype 1a patients with cirrhosis are dosed for 24 weeks.

The paritaprevir component of Viekira Pak is an HCV NS3/4A protease inhibitor discovered under a 2006 deal with Enanta, which will receive a $75 million milestone payment as a result of the approval. Ombitasvir is an HCV NS5A protein inhibitor, dasabuvir is a non-nucleoside HCV NS5B polymerase inhibitor and Norvir is an HIV protease inhibitor. An MAA for Viekira Pak is under accelerated assessment in the EU, with a final decision expected this quarter (see BioCentury, Nov. 24, 2014). ...