On January 7, 2015, AbbVie issued a press release that the FDA had granted Viekira Pak without ribavirin a priority review status for the treatment of hepatitis C genotype 1b in people with compensated cirrhosis. AbbVie did not provide details on an expected FDA approval date.
AbbVie submitted data to the FDA based on the Phase IIIb TURQUOISE-III study of 60 genotype 1b patients treated with Viekira Pak (ombitasvir, paritaprevir/ritonavir, dasabuvir) for a treatment duration of 12 weeks. The cure rates were 100% (60 of 60 pts). The most common side effects were fatigue, diarrhea, headache and joint pain.