AbbVie seeks EU approval to expand MAVIRET use for acute Hepatitis C treatment

USA—AbbVie has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has approved MAVIRET® (glecaprevir/pibrentasvir) as a treatment for acute hepatitis C virus (HCV) infection in adults and children three years of age and older.

The European Commission is expected to make a final decision during the third quarter of 2026.

If approved, MAVIRET would become one of the few therapies in the European Union indicated for both acute and chronic HCV infection.

The oral pangenotypic direct-acting antiviral (DAA) therapy is designed to treat all major hepatitis C virus strains and has already received approval in several countries, including the United States, Canada, Australia, Saudi Arabia, New Zealand, Taiwan, and Argentina.

Focus on earlier treatment

Primal Kaur, M.D., senior vice president of global development for immunology, neuroscience, eye care and specialty at AbbVie, said the CHMP’s positive opinion marks an important step toward expanding access to treatment earlier in the disease course, particularly when patients may not show symptoms and often remain undiagnosed.

She explained that the development aligns with global clinical guidance supporting the treatment of eligible patients with either acute or chronic HCV infection as early as possible.

According to Kaur, earlier treatment could help reduce ongoing transmission, address unmet medical needs, and strengthen international efforts to eliminate hepatitis.

Hepatitis C remains a major global public health challenge because many people do not realize they are infected until liver damage has already progressed.

The recently released 2026 World Health Organization Global Hepatitis Report showed that diagnosis and treatment rates continue to lag behind global targets, increasing the need for faster testing and quicker access to care.

Phase 3 trial results support recommendation

The CHMP recommendation is supported by findings from the Phase 3 multicenter M20-350 study, which evaluated the safety and effectiveness of an eight-week MAVIRET treatment course in adults with acute HCV infection.

In the trial, MAVIRET achieved a 96% cure rate, measured by sustained virologic response at 12 weeks after treatment (SVR12).

Researchers reported that the therapy’s safety profile remained consistent with previous studies, with fatigue, diarrhea, headache, and asthenia listed among the most commonly reported side effects.

Prof. Christoph Sarrazin, chief physician at St. Josef’s Hospital Wiesbaden and head of the Wiesbaden Liver Center in Germany, said acute HCV infection can be difficult to manage in routine clinical practice because it is often detected incidentally and many patients fail to return for treatment after diagnosis.

He noted that a simplified treatment option, such as MAVIRET, could help clinicians initiate therapy more quickly once infection is confirmed, while also improving patient outcomes and supporting broader public health initiatives to reduce hepatitis C transmission.

In recent weeks, AbbVie has also expanded its infectious disease and immunology pipeline through ongoing regulatory submissions and clinical research programs aimed at improving access to therapies for chronic and difficult-to-treat conditions.