| Jul 25 2016, 17:37 ET | About: AbbVie Inc. (ABBV) | By: Douglas W. House, SA News Editor |
The FDA approves AbbVie's (NYSE:ABBV) VIEKIRA XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) extended-release tablets, a once-daily, extended-release co-formulation of the active ingredients in VIEKIRA PAK. The new product is indicated for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those patients with compensated cirrhosis (Child-Pugh A). It is used without ribavirin in genotype 1b patients and in combination with twice-daily ribavirin in genotype 1a patients.
The data supporting the application was generated in Phase 3 studies that showed a 100% cure rate in genotype 1b patients after 12 weeks of therapy without ribavirin and a 95% cure rate in genotype 1a patients when used with ribavirin for 12 or 24 weeks.
HCV-1 is the most prevalent form of HCV infection in the U.S., representing ~74% of cases. About 2.7M Americans are chronically infected with HCV.