Patients living with genotype 1b (GT1b) chronic hepatitis C virus (HCV) and compensated cirrhosis (Child-Pugh A) may soon have a new therapy option with the U.S. Food and Drug Administration's (FDA) acceptance of a supplemental New Drug Application (sNDA) for AbbVie's Viekira Pak.
In addition to the sNDA, AbbVie, a global biopharmaceutical company, has been granted priority review of the Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin (RBV).
"We are pleased that the FDA has granted priority review for Viekira Pak without ribavirin as a therapy for treating GT1b chronic hepatitis C patients who have compensated cirrhosis," Dr. Michael Severino, chief scientific officer of AbbVie, said. "The filing of this sNDA further underscores AbbVie's commitment to patients living with chronic HCV infection."
Viekira Pak without RBV was the subject of AbbVie's recent TURQUOISE-III study, during which adult patients who either did not know they were receiving treatment or for whom other treatments had failed were treated with the drug for 12 weeks. The results showed that, post treatment, patients experienced 100 percent sustained virological response after 12 weeks.
