Olysio simeprevir regulatory update

Members of the California Technology Assessment Forum (CTAF) said that there is adequate evidence to support the superiority of Sovaldi sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD, Foster City, Calif.) and Olysio simeprevir from Johnson & Johnson and Medivir to standard of care, but said the benefits do not justify the high cost of the HCV drugs.

Based on meta-analyses conducted by the not-for-profit Institute for Clinical and Economic Review (ICER), the CTAF panel said Sovaldi or Olysio plus peginterferon and ribavirin were superior to a firstgeneration protease inhibitor added to peginterferon and ribavirin in patients with HCV genotype 1 infection. The panel also said Sovaldi plus ribavirin was superior to peginterferon plus ribavirin alone in patients with HCV genotype 2 and genotype 3 infections. Sovaldi is a single isomer of a nucleotide analog HCV NS5B polymerase inhibitor. Olysio is an HCV NS3/4A protease inhibitor. ...