AbbVie Gains EU Approval for MAVIRET in Acute Hepatitis C Across Adults and Children

AbbVie's European Commission approval of MAVIRET (glecaprevir/pibrentasvir) for acute hepatitis C virus infection reshapes the EU labeling landscape for the pangenotypic direct-acting antiviral, extending its authorized indication beyond chronic HCV to cover acute infection in adults and children aged 3 years and older, a distinction that carries immediate implications for supply forecasting, distribution agreements, and pharmacovigilance obligations across EU member states.

MAVIRET is now the only treatment approved in the European Union for both acute and chronic HCV infection. The expanded label permits clinicians to initiate treatment at confirmed diagnosis rather than waiting for chronic-phase criteria to be met, a shift that compresses the treatment window and alters demand patterns manufacturers and distributors will need to model against existing capacity commitments.

The regulatory submission was supported by data from the Phase 3 M20-350 study, a multicenter, single-arm prospective trial evaluating an eight-week MAVIRET regimen in 286 treatment-naïve adults and adolescents aged 12 and older with acute HCV infection. The study demonstrated high efficacy; adverse events were predominantly mild to moderate, with fatigue, diarrhea, headache, and asthenia reported most frequently. The safety profile does not introduce new risk-management requirements beyond those already established for the chronic indication, though QA teams should confirm whether the expanded patient population triggers any post-authorization safety study obligations under EMA's pharmacovigilance framework.

For regulatory affairs leads, the approval adds to an existing multi-market authorization footprint that includes the United States, Canada, Australia, New Zealand, Saudi Arabia, Taiwan, and Argentina for both acute and chronic HCV. Aligning labeling, package inserts, and risk management plans across jurisdictions with differing acute-HCV approval timelines will require close coordination between regulatory operations and supply chain teams to avoid version-control gaps at the point of distribution.

The epidemiological context is material to demand planning: more than 12 million people in Europe live with hepatitis C, and current clinical guidance supports treating nearly all individuals with acute or chronic infection. Earlier intervention at the acute stage, if adopted broadly by EU prescribers, could accelerate volume uptake relative to projections built on chronic-only utilization data.

AbbVie has indicated it continues to engage global regulatory authorities on access for acute HCV, suggesting further label expansions in additional markets remain in scope.

The measurable near-term checkpoint is the rate of formulary inclusion and reimbursement decisions by EU national health authorities, which will determine how quickly the expanded indication translates into actual dispensing volume.

Source: AbbVie News Center via PR Newswire, 23 June 2026.