AbbVie announced that the Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for Viekira XR (dasabuvir, ombitasvir, paritaprevir, ritonavir) extended-release tablets for the treatment of patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated cirrhosis (Child-Pugh A).
Viekira XR is the extended-release formulation of the active ingredients found in Viekira Pak, which was approved in December 2014. It combines three direct-acting antivirals: dasabuvir, an HCV RNA-dependent RNA polymerase inhibitor; ombitasvir, an HCV NS5A inhibitor, and paritaprevir, an HCV NS3/4A protease inhibitor. Ritonavir is a strong CYP3A inhibitor that increases peak and trough plasma drug concentrations of paritaprevir and overall drug exposure.
The FDA approval was based on seven Phase 3 clinical trials for Viekira Pak (n>2,300), which include data that showed 100% sustained virologic response 12 weeks following treatment (SVR12) in GT1b patients after 12 weeks of therapy without ribavirin, and 95% SVR12 in GT1a patients when given with ribavirin for 12 or 24 weeks of therapy. Data from two additional bioavailability studies comparing the formulations also supported the approval of Viekira XR.
Viekira XR will be available in 200mg/8.33mg/50mg/33.33mg strength tablets in a monthly carton containing 4 weekly cartons for a 28-day supply. Each weekly carton contains 7 daily dose packs and each daily dose pack contains 3 tablets.
For more information call (800) 633-9110 or visit AbbVie.com.