Events Details
AbbVie Receives Positive CHMP Opinion for MAVIRET in Acute Hepatitis C Treatment
Monday, May 25, 2026
AbbVie announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending approval of MAVIRET for the treatment of acute hepatitis C virus (HCV) infection in adults and children aged three years and above.
Hepatitis C is a blood-borne viral infection that can progress to chronic liver disease if untreated. Acute infection is often asymptomatic, resulting in delayed diagnosis and treatment. Current global clinical guidance supports treatment for most individuals with HCV infection to reduce disease progression and transmission.
MAVIRET is a once-daily, ribavirin-free, direct-acting antiviral therapy combining glecaprevir, an NS3/4A protease inhibitor, and pibrentasvir, an NS5A inhibitor. In the European Union, it is currently approved for chronic HCV infection in adults and children aged three years and older, including patients with compensated liver disease and severe renal impairment.
The European Commission is expected to make a final decision during the third quarter of 2026. If approved, MAVIRET would become indicated for both acute and chronic HCV infection in the European Union.
The CHMP opinion is based on data from the Phase 3 M20-350 clinical study, which evaluated an eight-week treatment course of MAVIRET in adults with acute HCV infection. The study reported a 96.2 per cent sustained virologic response at 12 weeks after treatment completion (SVR12) in the intent-to-treat population. In the modified ITT-virologic failure population, all patients achieved SVR12.
The treatment showed a safety profile consistent with previous studies in chronic HCV infection. The most commonly reported adverse reactions included fatigue, asthenia, headache, and diarrhoea. No serious adverse reactions, treatment discontinuations, on-treatment virologic failures, or post-treatment relapses were reported.
The study enrolled 286 treatment-naïve adult patients across 70 global sites. Participants received oral MAVIRET tablets once daily for eight weeks and were monitored for 12 weeks following treatment completion.
The therapy is already approved for both acute and chronic HCV infection in several countries, including the United States, Canada, Australia, Saudi Arabia, New Zealand, Taiwan, and Argentina.
Source: abbvie.com
