FDA accepts NDA for Viekira Pak (ombitasvir + paritaprevir + ritonavir + dasabuvir) in hepatitis C- Abbvie
AbbVie’s New Drug Application (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) for patients with hepatitis C. The proposed dosing for the fixed-dose formulation (dasabuvir, ombitasvir, paritaprevir, ritonavir tablets) is three oral tablets once daily with a meal, with or without twice-daily RBV, which may offer another important treatment option for people living with GT1 HCV.
The NDA filing is supported by data from two bioavailability studies. Currently, Viekira Pak is given twice daily as three tablets in the morning and one tablet in the evening, taken with a meal.
Comment: Viekirax Pak has joined Solvadi (sofosbuvir) and Harvoni (sofosbuvir + ledispavir) from Gilead as oral, revolutionary therapies in the treatment of chronic Hepatitis C, replacing the pegylated interferon injectable drugs that carried serious side effects. The new drugs carry impressive cure rates of 90% or more in patients after 8 weeks or 12 weeks of treatment contrasting with the 65%-70% cure rates with the pegylated interferons.
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