Posted by Michael Wonder on 09 Mar 2020
European Commission grants AbbVie marketing authorisation shortening Maviret (glecaprevir/pibrentasvir) treatment duration to eight weeks for treatment naïve chronic HCV patients with genotype 3 and compensated cirrhosis
6 March 2020 - Maviret now available in the EU as an 8-week treatment option for treatment-naïve, chronic hepatitis C (HCV) patients without cirrhosis or with compensated cirrhosis, regardless of genotype.
AbbVie today announced that the European Commission has approved a change to the marketing authorisation for Maviret (glecaprevir/pibrentasvir) to shorten once-daily treatment duration from 12 to 8 weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients with genotype (GT) 3 infection. Maviret was already indicated as an 8-week, pan-genotypic (GT1-6), once-daily regimen for treatment naïve HCV patients without cirrhosis, and as an 8-week, once-daily regimen for treatment-naïve GT 1, 2, 4, 5 and 6 HCV patients with compensated cirrhosis.
The EC approval is supported by data from the Phase 3b EXPEDITION-8 study.
