CHMP recommends approval of change of indication for Maviret in chronic hepatitis C genotype 3.- AbbVie

AbbVie announced that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended a change to the marketing authorization 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 is currently 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. If approved by the European Commission (EC), Maviret will be the only 8-week treatment option for treatment-naïve chronic HCV patients, without cirrhosis or with compensated cirrhosis, regardless of genotype.The CHMP positive opinion is supported by data from the Phase IIIb EXPEDITION-8 study, which showed that with 8 weeks of Maviret, 97.7 percent (n=335/343) of GT1- 6 patients achieved a sustained virologic response 12 weeks after treatment (SVR12) (ITT). For patients with GT3, the SVR12 rate was 95.2% (n= 60/63) (ITT). To date, one virologic failure has been reported in these patients and no patients have discontinued treatment due to adverse events. Adverse events (frequency >5%) reported in the study include pruritus (8%), fatigue (9%), headache (8%) and nausea (6%). Six serious adverse events (2%) occurred during the study, none of which were deemed to be related to glecaprevir/pibrentasvir. No new safety signals were identified in this study. The Phase IIIb EXPEDITION-8 study evaluated the safety and efficacy of Maviret in treatment-naïve chronic HCV patients with compensated cirrhosis across all major genotypes (GT1-6). The results have been reported for GT1, 2, 3, 4, 5, and 6 (n=343) patients.