EU Approves AbbVie’s Maviret for Acute Hepatitis C Treatment

By expanding the label for glecaprevir/pibrentasvir, regulators have positioned the drug as the only therapy in the European Union approved for both acute and chronic infections. Clinical leaders suggest this approval addresses a critical gap in the care pathway, as delayed intervention is historically linked to higher risks of liver cancer and disease progression. Data from the Phase 3 M20-350 study underscored the efficacy of the eight-week regimen, with 96.2% of patients in the intent-to-treat population achieving a sustained virological response 12 weeks after therapy. Researchers observed no on-treatment virologic failures during the trial, and the reported adverse events, including fatigue and headache, remained mild or moderate in severity. This regulatory milestone provides clinicians with a standardized tool to interrupt transmission chains and mitigate long-term health complications. AbbVie intends to leverage this approval to streamline access across the region, aligning with broader public health objectives to eliminate the virus as a significant health threat.