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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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."

"With this positive CHMP opinion, we will bring an eight-week treatment option for the many HCV patients with GT1b."

See Also:

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%).