AbbVie’s NDA has been accepted by the FDA for a once-daily, fixed-dose formulation of the components of VIEKIRA PAK (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets). VIEKIRA PAK is an all-oral, interferon-free treatment approved with or without ribavirin (RBV) in the U.S. for genotype 1 (GT1) chronic hepatitis C virus (HCV) infection. This drug would compete with other, more convenient dosing regimens for HCV, including Gilead’s once-daily, single- Tablet regimen Harvoni.
The proposed dosing for the fixed-dose formulation (dasabuvir, ombitasvir, paritaprevir, ritonavir tablets) is three oral tablets once daily, 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.
"Nearly one year after the launch of VIEKIRA PAK, AbbVie is pleased to announce the acceptance of a New Drug Application for a once-daily formulation for the treatment of patients with chronic genotype 1 hepatitis C," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "This milestone further underscores AbbVie's commitment to offer people living with hepatitis C optimized treatment options."
The CDC estimates that in the U.S., approximately 2.7 million people are chronically infected with HCV. Genotype 1 is the most prevalent form, accounting for approximately 74% of all cases. There are six major HCV genotypes (GT1-6) for which there are no vaccines.
