By Fineline Cube 
US-based AbbVie (NYSE: ABBV) announced that the US Food and Drug Administration (FDA) has approved a label extension for its Mavyret (glecaprevir/pibrentasvir), an oral pangenotypic direct-acting antiviral (DAA) therapy. The approval now includes treatment for acute hepatitis C virus (HCV) infection (genotypes 1-6) in adults and pediatric patients aged 3 years and older without cirrhosis or with compensated cirrhosis.
Expanded Indications
The expanded approval allows Mavyret to be used for both acute and chronic HCV in patients aged 3 years and older. Previously, the drug was approved for adults and children aged 3 and older with chronic HCV genotypes 1-6 without cirrhosis or with compensated cirrhosis. It was also approved for patients with HCV genotype 1 who had previously been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor.
Clinical Trial Results
The approval was supported by positive results from the M20-350 study, which evaluated the efficacy and safety of Mavyret in 286 newly diagnosed acute HCV patients. The results demonstrated that 96% of patients achieved sustained virological response (SVR12) 12 weeks post-treatment, with no cases of virological failure.-Fineline Info & Tech