The NDA submission was based on data from two bioavailability studies. The existing dosing for Viekira Pak is twice daily, three tablets in the morning and one in the evening taken with a meal.
The proposed new dosing is three tablets once daily with a meal, with or without twice daily ribavirin (RBV).
Viekira Pak is an all-oral, interferon-free treatment approved with or without RBV in the US for patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including compensated cirrhosis.
It features the fixed-dose combination of ombitasvir 25mg (an NS5A inhibitor), paritaprevir 150mg (an NS3/4A protease inhibitor), ritonavir 100mg (an HIV-1 protease inhibitor), and dasabuvir 250mg (a non-nucleoside NS5B palm polymerase inhibitor).
AbbVie executive vice president, research and development and chief scientific officer Michael Severino said: "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.
"This milestone further underscores AbbVie’s commitment to offer people living with hepatitis C optimized treatment options."
AbbVie said Viekira Pak is taken for 12 weeks, while GT1a patients with cirrhosis should take it for 24 weeks.
RBV should be co-administered in GT1a patients, and those who have cirrhosis or undergone a liver transplant.
Image: AbbVie’s NDA for a once-daily formulation of Viekira Pak was based on data from two bioavailability studies. Photo: courtesy of Michelle Meiklejohn/FreeDigitalPhotos.net.