AbbVie Gets FDA Nod for Hepatitis C Drug
The US Food and Drug Administration (FDA) has approved AbbVie’s Viekira Pak, an all-oral, interferon-free treatment, with or without ribavirin (RBV), for the treatment of patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated cirrhosis.
Viekira Pak contains three distinct mechanisms of action: an NS5A inhibitor, an NS3/4A protease inhibitor, and a non-nucleoside NS5B polymerase inhibitor, which work together to attack the virus at three separate stages of the disease lifecycle to inhibit it from reproducing. It consists of the fixed-dose combination of ombitasvir 25 mg (an NS5A inhibitor), paritaprevir 150 mg (an NS3/4A protease inhibitor), and ritonavir 100 mg (an approved HIV-1 protease inhibitor), dosed once daily with a meal, and dasabuvir 250 mg (a non-nucleoside NS5B palm polymerase inhibitor), dosed twice daily with a meal. Viekira Pak was granted priority review and designated as a breakthrough therapy by the FDA, a status given to medicines or regimens that may offer substantial improvement over available therapies
Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals for HCV protease inhibitors and regimens that include protease inhibitors. Paritaprevir is being investigated by AbbVie for use in combination with AbbVie’s other investigational medicines for the treatment of hepatitis C.