Phase IIIb EXPEDITION-8 study of Mavyret shows sustained response in hepatitis C.- AbbVie.
AbbVie announced new data for its pan-genotypic chronic hepatitis C virus (HCV) treatment, Mavyret (glecaprevir/pibrentasvir), in treatment-na�ve patients with compensated cirrhosis. Results from the Phase IIIb EXPEDITION-8 study showed that with 8 weeks of Mavyret, 100 percent (n=273/273) of genotype 1, 2, 4, 5 and 6 patients achieved a sustained virologic response 12 weeks after treatment (SVR12) per protocol analysis. To date, no virologic failures have been reported in cohort one of the study and no patients have discontinued treatment due to adverse events.1 Adverse events (more than 5%) reported of the study populations include pruritus (9.6%), fatigue (8.6%), headache (8.2%) and nausea (6.4%). Six serious adverse events (2%) have occurred during the study, none of which were deemed to be related to glecaprevir / pibrentasvir. No new safety signals were identified in this study.
This analysis is part of the ongoing Phase IIIb EXPEDITION-8 study evaluating the safety and efficacy of Mavyret in treatment-na�ve chronic HCV patients with compensated cirrhosis across all major genotypes (GT1-6). The study includes two cohorts; cohort one with genotype 1, 2, 4, 5, 6 chronic HCV-infected patients, and cohort two with genotype 3 (GT3) chronic HCV-infected patients. These data are being presented as a late-breaking, oral presentation at The Liver Meeting.