Officials with AbbVie this week announced its New Drug Application (NDA) has been accepted by the Food and Drug Administration (FDA) for a once-daily, fixed-dose formulation of the components of Viekira Pak.
A combination of ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets, Viekira Pak is an all-oral, interferon-free treatment approved with or without ribavirin (RBV) in the United States for patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including those with compensated cirrhosis. It is not for people with decompensated cirrhosis.
The proposed dosing for the fixed-dose formulation is three oral tablets once daily with a meal, with or without twice-daily RBV. The NDA filing is supported by data from two bioavailability studies. Currently, Viekira Pak is taken twice daily as three tablets in the morning and one tablet in the evening, taken with a meal.