AbbVie announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of MAVIRET (glecaprevir/pibrentasvir), an oral pangenotypic Direct-Acting Antiviral (DAA) therapy for the treatment of acute hepatitis C infection (HCV) in adults and children aged 3 years and older. The final European Commission (EC) decision is expected in the third quarter of 2026. If approved, MAVIRET would be indicated for both acute and chronic hepatitis C (HCV) infection in the European Union (EU).

Primal Kaur, MD, Senior Vice President, Global Development of Immunology, Neuroscience, Eye Care and Specialty, AbbVie, said, "The CHMP positive opinion for MAVIRET in acute hepatitis C represents an important step toward enabling earlier treatment, at a stage when the disease is often asymptomatic and may go undiagnosed. This milestone aligns with global clinical guidance supporting treatment of suitable people with acute or chronic HCV infection. It also has the potential to help address unmet need, reduce the risk of onward transmission, and support global HCV elimination efforts."

HCV is a serious blood-borne virus that can progress to chronic liver disease when left untreated. Acute HCV infection is frequently asymptomatic, and many individuals remain unaware of their infection until it has progressed to a later stage. Global clinical guidance supports treatment of nearly all people with HCV infection, reflecting the importance of early diagnosis and timely initiation of therapy. The newly released 2026 WHO Global Hepatitis Report further underscores this need, highlighting that diagnosis and treatment coverage remain far below global targets and reinforcing the importance of earlier testing and rapid linkage to care.

The positive opinion is supported by data from the Phase 3, multicenter, single-arm prospective M20-350 study evaluating the safety and efficacy of MAVIRET eight-week treatment in adults with acute HCV infection. In the study, MAVIRET demonstrated a 96 percent cure rate, as measured by Sustained Virologic Response at 12 weeks after treatment (SVR12), with a safety profile generally consistent with prior experience; the most common Adverse Events (AEs) were fatigue, diarrhea, headache and asthenia.

Prof. Christoph Sarrazin, Chief Physician, St. Josef's Hospital Wiesbaden, Germany; Head of the Wiesbaden Liver Center; and Board Member, German Liver Foundation, said, "In clinical practice, acute HCV can be challenging to manage, as it is often identified incidentally and patients may be lost to follow-up before treatment is initiated. This treatment option could help streamline care pathways and support timely initiation of therapy once infection is confirmed, an important step for both individual patient outcomes and broader public health efforts."