Posted by Michael Wonder on 03 Aug 2019
AbbVie's Maviret (glecaprevir/pibrentasvir) approved by European Commission to shorten treatment duration to eight weeks for treatment naïve patients with chronic hepatitis C and compensated cirrhosis
2 August 2019 - Maviret is now available as a shorter, 8-week, once-daily option for treatment-naïve, compensated cirrhotic, chronic hepatitis C patients with genotype 1, 2, 4, 5 and 6.
AbbVie today announced that the European Commission has granted 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)1, 2, 4, 5, and 6 infection. An analysis from the same clinical trial evaluating Maviret as an 8-week, once-daily treatment option for treatment-naïve, compensated cirrhotic, GT3 HCV patients is ongoing. Maviret is also currently approved as an 8-week, pan-genotypic (GT1-6) treatment for treatment-naïve patients without cirrhosis.
The marketing authorisation is supported by data from the ongoing Phase 3b EXPEDITION-8 study, which showed that with 8 weeks of Maviret 97.9% (n=274/280) of GT1, 2, 4, 5 and 6 patients achieved a sustained virologic response 12 weeks after treatment (SVR12) (ITT).
