Merck's Victrelis approved for HCV

FDA approved an NDA from Merck & Co. Inc. (NYSE:MRK) for Victrelis boceprevir plus standard of care -- peginterferon alfa and ribavirin -- to treat chronic HCV in adults who are previously untreated or who have failed previous interferon and ribavirin therapy. Merck said it will begin shipping Victrelis to pharmacies within a week. The wholesale acquisition cost of Victrelis per week is $1,100. In April, FDA's Antiviral Drugs Advisory Committee unanimously backed approval of the HCV NS3/4A protease inhibitor based on Phase III data showing that Victrelis plus standard of care produced rates of sustained virologic response of 59-66% compared to 23-38% for standard of care alone.

Merck had proposed a treatment regimen of response guided therapy (RGT) in which treatment could be shortened from 48 weeks to 28-36 weeks depending on how quickly the patient achieved undetectable levels of HCV RNA. Victrelis' label states that response-guided therapy (RGT) is recommended for most patients, but longer dosing is recommended in targeted subgroups, including patients with cirrhosis (see BioCentury, May 2). ...