AbbVie Gains Expanded Label on Hep C Drug

FDA has approved an AbbVie expanded label for Mavyret (glecaprevir/pibrentasvir) to include treating adults and pediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis. With this approval, the oral pangenotypic direct-acting antiviral therapy is the first therapy approved to treat patients with acute HCV in eight weeks with a 96% cure rate, the company says.

The label expansion was based on data from a Phase 3 study that showed Mavyret to be a highly efficacious treatment for people with acute HCV, AbbVie says. The majority of the adverse events reported were mild or moderate in severity, it says, adding that the most common were fatigue, asthenia, headache, and diarrhea.

Before today, Mavyret was approved for treating chronic Hepatitis C virus infection across all genotypes (1-6).