FDA Expands Use of Viekira Pak in HCV Patients

The approval for patients with genotype 1b (GT1b) chronic Hep C is based on a Phase 3b trial
The approval for patients with genotype 1b (GT1b) chronic Hep C is based on a Phase 3b trial

AbbVie announced that the Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the use of Viekira Pak (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets) without ribavirin in patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection and compensated cirrhosis (Child-Pugh A). 

The sNDA approval was supported by data from the Phase 3b, multicenter, open-label, single-arm TURQUOISE-III study that included chronic HCV GT1b patients with compensated cirrhosis treated with Viekira Pak without ribavirin for 12 weeks. Patients were either treatment-naive or treatment-experienced who had failed previous therapy with pegylated interferon and ribavirin. The primary endpoint was the rate of sustained virologic response 12 weeks post-treatment (SVR12).

RELATED: FDA Grants Priority Review to Expanded Viekira Pak Indication

The data showed all 60 patients achieved SVR12. There were no discontinuations due to adverse events and the most commonly reported events were fatigue (22%), diarrhea (20%) and headache (18%). 

Viekira Pak is now approved for use to treat chronic HCV GT1b infection without cirrhosis or with compensated cirrhosis, and to treat HCV GT1a infection without cirrhosis or with compensated cirrhosis in combination with ribavirin. It is available as a monthly carton providing a 28-day supply. Each monthly carton consists of 4 weekly cartons containing 7 daily dose packs each. 

For more information call (800) 633-9110 or visit Viekira.com.

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