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# FDA Priority Review for Viekira Pak sNDA
- URL: https://www.fdaweb.com/fda-priority-review-for-viekira-pak-snda/
- Published: 2016-01-07T12:00:00.000Z
- Updated: 2026-09-15T02:25:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134369

> FDA has granted a priority review for an AbbVie supplemental NDA for Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin (RBV) in patients with genotype 1b (GT1b) chronic hepatitis C virus and compensated cirrhosis (Child-Pugh A). The current dosing recommendation for patients with GT1b and compensated cirrhosis is to administer RBV with Viekira Pak for 12 weeks.  
>  
> The submission is supported with data from the company’s TURQUOISE-III study that evaluated the use of Viekira Pak without RBV for 12 weeks in GT1b patients with compensated cirrhosis (Child-Pugh A). “Results demonstrated 100%t (N=60/60) sustained virologic response at 12 weeks post-treatment,” the company says. No patients discontinued treatment due to adverse events, it says.