AbbVie Announces Positive CHMP Opinion for MAVIRET (glecaprevir/pibrentasvir) for the Treatment of Acute Hepatitis C Infection

On 21 May 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Maviret. 

The CHMP adopted an extension to the existing indication as follows: Maviret is indicated for the treatment of acute and chronic hepatitis C virus (HCV) infection in adults and children aged 3 years and older 

The positive opinion is supported by data from the Phase 3 M20-350 study evaluating the safety and efficacy of MAVIRET in adults with acute hepatitis C virus (HCV) infection.

MAVIRET is a direct-acting antiviral (DAA) treatment currently approved in the European Union for chronic HCV infection in adults and children aged 3 years and older. Acute HCV infection is often asymptomatic, highlighting the importance of early diagnosis and treatment to help reduce transmission, long-term liver-related complications, and support HCV elimination efforts.