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JUNE 12, 2025

FDA Approves Expanded Indication for Mavyret for Acute HCV


Originally published by our sister publication Infectious Disease Special Edition

The FDA expanded the indication for glecaprevir-pibrentasvir (GLE/PIB; Mavyret, AbbVie) to treat adults and pediatric patients 36 months of age and older with acute or chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis. 

With this approval, GLE/PIB is the first and only direct-acting antiviral therapy approved to treat patients with acute HCV in eight weeks with a 96% cure