EMA’s Committee for Medicinal Products for Human Use has issued a positive opinion endorsing MAVIRET as an oral pangenotypic therapy for acute hepatitis C infection in adults and children aged three and older. This recommendation positions MAVIRET for potential approval of both acute and chronic HCV indications pending a final European Commission decision in Q3 2026.

The multicenter, single-arm Phase 3 M20-350 trial enrolled 286 treatment-naïve adult patients with acute HCV infection to receive an eight-week MAVIRET regimen. Results demonstrated a 96.2% sustained virologic response at 12 weeks post-treatment (SVR12) and a safety profile consistent with known data, with no serious adverse reactions reported.

The final decision from the European Commission is expected by Q3 2026, after which MAVIRET could launch across the EU for both acute and chronic HCV. Approval would mark the first pangenotypic DAA indicated for acute infection, potentially streamlining treatment initiation and reducing undiagnosed cases.

Expanding MAVIRET’s label to acute HCV could enlarge the addressable patient population and support AbbVie’s HCV portfolio growth. Early treatment of often asymptomatic acute infection may reduce transmission rates, align with WHO elimination targets and bolster global market penetration.