AbbVie has received a positive opinion for a shorter, eight-week treatment of VIEKIRAX (ombitasvir / paritaprevir / ritonavir tablets) + EXVIERA (dasabuvir tablets) as an option for previously untreated adult patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) and minimal-to-moderate fibrosis.
The positive opinion was given by European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
VIEKIRAX + EXVIERA is currently approved in the European Union for use as a 12-week treatment for GT1b chronic HCV-infected patients without cirrhosis or with compensated cirrhosis.
AbbVie research and development executive vice president Michael Severino said: "AbbVie continuously strives to expand the utility of our HCV treatments, including investigating a shorter path to virologic cure for people living with HCV.
"With this positive CHMP opinion, we will bring an eight-week treatment option for the many HCV patients with GT1b."
The GT1b subtype accounts for 47% of the nine million people infected with chronic HCV across Europe.
The positive opinion follows data from the Phase IIIb multicentre, open-label, single-arm Garnet study.
Results showed that following treatment with VIEKIRAX + EXVIERA for eight weeks, 98% of previously untreated GT1b chronic HCV infected patients achieved sustained virologic response at 12 weeks post-treatment.
The commonly reported adverse events were headache (21%), fatigue (17%), nasopharyngitis (8%), pruritus (8%), nausea (6%) and asthenia (5%).