By VETTAPHARMA reporter – Derek Roche: AbbVie’s MAVIRET (glecaprevir/pibrentasvir) received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on May 22, 2026, recommending approval for the treatment of acute hepatitis C virus (HCV) infection in adults and children aged 3 years and older. The CHMP opinion, if endorsed by the European Commission in the third quarter of 2026, would extend MAVIRET’s EU indication to include both acute and chronic HCV.
The recommendation rests on results from the single‑arm, multicenter Phase 3 M20‑350 study, which enrolled 286 treatment‑naïve adults across 70 global sites and evaluated an eight‑week MAVIRET regimen. The trial met its primary endpoint with a 96.2% sustained virologic response at 12 weeks post‑treatment (SVR12) in the intent‑to‑treat population; the modified ITT virologic‑failure population achieved 100% SVR12. No on‑treatment virologic failures or post‑treatment relapses were observed; post‑treatment reinfection occurred in 0.7% of participants.
Safety in the acute‑infection cohort mirrored the established chronic‑HCV profile. The most common adverse reactions were fatigue (3%), asthenia (2%), headache (2%), and diarrhea (2%). No serious adverse reactions or discontinuations due to adverse events were reported in the study population. Label cautions include contraindications in severe hepatic impairment (Child‑Pugh C) and warnings on hepatitis B reactivation, with guidance to screen and monitor HBV before and during therapy.
Clinically, the CHMP opinion supports earlier intervention for a frequently asymptomatic phase of HCV, aiming to reduce onward transmission and long‑term liver complications by enabling rapid linkage to care and an eight‑week oral regimen. For patients, the recommendation promises a short, ribavirin‑free, once‑daily option already approved in multiple jurisdictions, potentially simplifying care pathways and reducing loss to follow‑up.
Commercially, expanding MAVIRET into acute HCV broadens AbbVie’s addressable market and aligns with global elimination strategies; the product is already approved for acute and chronic HCV in several countries, and CHMP backing could accelerate EU uptake and reimbursement discussions. AbbVie signalled ongoing regulatory engagement to secure access across regions and highlighted the public‑health rationale for earlier diagnosis and treatment.
