Sovaldi sofosbuvir 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 and Olysio simeprevir from Johnson & Johnson (NYSE:JNJ, New Brunswick, N.J.) and partner Medivir AB (SSE:MVIR B, Huddinge, Sweden) 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. ...