EU CHMP recommends approval of Viekirax (ombitasvir/paritaprevir/ritonavir) + Exviera (dasabuvir) for eight week treatment of genotype 1b patients with chronic HCV infection- Abbvie

Enanta Pharmaceuticals announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for an eight-week treatment regimen of AbbVie’s Viekirax (ombitasvir/paritaprevir/ritonavir tablets) + Exviera (dasabuvir tablets) as an option for previously untreated adult patients with genotype 1b (GT1b) chronic HCV infection and minimal to moderate fibrosis.

The CHMP positive opinion is supported by data from the dedicated Phase IIIb GARNET study. Results showed that with eight weeks of treatment with Viekirax + Exviera , 98 percent (n= 160/163) of previously untreated GT1b chronic HCV infected patients without cirrhosis achieved sustained virologic response at 12 weeks post-treatment (SVR12). The most commonly reported adverse events, occurring at rates equal to or greater than 5 percent, were headache (21 percent), fatigue (17 percent), nasopharyngitis (8 percent), pruritus (8 percent), nausea (6 percent) and asthenia (5 percent).

Comment: Viekirax + Exviera is approved in the European Union for the treatment of genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including patients with compensated cirrhosis. Viekirax is approved in the European Union for the treatment of genotype 4 (GT4) chronic HCV infection.