EU CHMP issues positive opinion of Viekirax (ombitasvir/paritaprevir/ritonavir) + Exviera (dasabuvir) in hepatitis C virus infected genotype 1b patients with compensated cirrhosis- Abbvie

The European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for the use of Viekirax (ombitasvir/paritaprevir/ritonavir tablets) + Exviera (dasabuvir tablets), from Abbvie, without ribavirin (RBV) in chronic hepatitis C virus (HCV) infected genotype 1b (GT1b) patients with compensated cirrhosis (Child-Pugh A).

The CHMP opinion of the Type-II variation application for Viekirax + EXVIERA is supported by data from the Phase IIIb TURQUOISE-III study, which is part of AbbVie's larger clinical program investigating efficacy and safety in a broad range of GT1 patients. TURQUOISE-III is a dedicated Phase III study of Viekirax + EXVIERA without RBV for 12 weeks in GT1b patients with compensated cirrhosis. Results from the TURQUOISE-III study showed 100 percent (n=60/60) of GT1b chronic HCV infected patients with compensated cirrhosis (Child-Pugh A) achieved sustained virologic response at 12 weeks post-treatment (SVR12) with Viekirax + EXVIERA without RBV for 12 weeks. No patients discontinued treatment due to adverse events. The most commonly reported adverse events (>10 percent) were fatigue (22 percent), diarrhea (20 percent) and headache (18 percent).

On January 7, AbbVie announced that its supplemental New Drug Application (sNDA) for Viekirax Pak was accepted and granted priority review by the FDA.

Comment: Viekirax Pak has joined Solvadi (sofosbuvir) and Harvoni (sofosbuvir + ledispavir) from Gilead as oral, revolutionary therapies in the treatment of chronic Hepatitis C, replacing the pegylated interferon injectable drugs that carried serious side effects. The new drugs carry impressive cure rates of 90% or more in patients after 8 weeks or 12 weeks of treatment contrasting with the 65%-70% cure rates with the pegylated interferons.