FDA approves sNDA for Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) in genotype 1b chronic hepatitis C virus infection and compensated cirrhosis (Child-Pugh A)- AbbVie

The FDA has approved a supplemental New Drug Application (sNDA) for the use of Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets), from AbbVie, without ribavirin (RBV) in patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection and compensated cirrhosis (Child-Pugh A). The application was previously granted priority review by the FDA, a designation given to investigational therapies that treat a serious condition and provide a significant improvement in safety or effectiveness.

The TURQUOISE-III study included in the sNDA evaluated the use of Viekira Pak without RBV for 12 weeks in GT1b patients with compensated cirrhosis (Child-Pugh A). Results demonstrated 100 percent (N=60/60) sustained virologic response at 12 weeks post-treatment (SVR12). Patients who achieve SVR12 are considered cured of HCV, as the virus is no longer detectable in the blood. No patients discontinued treatment due to adverse events. The most commonly-reported adverse events (at least 10 percent) were fatigue (22 percent), diarrhea (20 percent), headache (18 percent), arthralgia (10 percent), dizziness (10 percent), insomnia (10 percent) and pruritus (10 percent).

Comment: On February 26, AbbVie announced that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted a positive opinion for Viekirax (ombitasvir/ paritaprevir/ ritonavir tablets) + Exviera (dasabuvir tablets) and this RBV-free option is now approved for use for the treatment of chronic HCV infected GT1b patients with compensated cirrhosis (Child-Pugh A) in Europe.