The EMA’s CHMP has issued a positive opinion recommending AbbVie’s MAVIRET® for acute hepatitis C in adults and children aged ≥3 years, supported by Phase 3 trial data showing 96.2% SVR12. A European Commission decision is expected in Q3 2026.
Written By: Fariha Sameen, PharmD
Reviewed By: Pharmacally Editorial Team
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of MAVIRET for the treatment of acute hepatitis C virus (HCV) infection in adults and pediatric patients aged 3 years and older. A final decision from the European Commission is expected in the third quarter of 2026.
Expanded Use Beyond Chronic HCV
If approved, MAVIRET would expand its current European Union authorization for chronic HCV to include acute infection, positioning the regimen for use across the full spectrum of HCV disease.
The recommendation reflects increasing global emphasis on earlier diagnosis and rapid treatment initiation to reduce liver disease progression and limit viral transmission.
Public Health Context
HCV remains a major global health burden and often progresses silently during the acute phase. Many patients remain undiagnosed until advanced liver damage develops. International treatment guidelines now support therapy for nearly all individuals with confirmed HCV infection.
The 2026 WHO Global Hepatitis Report highlighted persistent gaps in diagnosis and treatment access worldwide, reinforcing the need for earlier testing and prompt linkage to care.
Mechanism of Action
MAVIRET combines glecaprevir, an NS3/4A protease inhibitor, with pibrentasvir, an NS5A inhibitor, creating a ribavirin-free, pangenotypic direct-acting antiviral regimen. The once-daily oral therapy is administered with food and is already approved for chronic HCV across multiple global markets.
Phase 3 M20-350 Trial Results
The CHMP recommendation was supported by data from the Phase 3 M20-350 study (NCT04903626), a multicenter, prospective, single-arm trial evaluating an eight-week MAVIRET regimen in treatment-naïve patients with acute HCV infection.
The study enrolled 286 adult patients across 70 global sites, while the broader protocol also included adolescent participants aged 12 years and older.
MAVIRET achieved a 96.2% sustained virologic response at 12 weeks post-treatment (SVR12) in the intent-to-treat population, meeting the primary endpoint with statistical significance (p<0.0001). In the modified intent-to-treat virologic failure population, SVR12 reached 100%.
Investigators reported no on-treatment virologic failures or post-treatment relapses.
Safety Profile
The safety profile remained consistent with previous chronic HCV studies. No serious adverse reactions or treatment discontinuations were reported.
The most common adverse events included fatigue, asthenia, headache, and diarrhea.
Global Regulatory Landscape
AbbVie continues to work with regulators worldwide to expand access to MAVIRET for acute HCV infection. The therapy already holds approvals for both acute and chronic HCV in countries including the United States, Canada, Australia, New Zealand, Saudi Arabia, Taiwan, and Argentina.
Reference
About the Writer
Fariha Sameen, PharmD (LinkedIn), is a clinical pharmacy professional with hands-on experience in patient counselling, medication review, therapeutic monitoring, and clinical documentation across multiple departments. She has experience identifying and assessing drug-related problems and supporting medication safety practices. Her interests include pharmacovigilance, ADR reporting, clinical research, and medical writing focused on clear, evidence-based communication.