AbbVie has moved a step closer to expanding the reach of its blockbuster hepatitis C therapy, with European regulators backing the use of MAVIRET for acute HCV infections in adults and children as young as three.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval of the oral antiviral treatment.
This, paving the way for a final decision from the European Commission expected in the third quarter of 2026. If cleared, MAVIRET would become one of the few therapies in the European Union approved to treat both acute and chronic hepatitis C infections.
The recommendation comes as global health authorities intensify efforts to eliminate hepatitis C, a blood-borne virus that often goes undetected until it causes severe liver damage. Acute infections are frequently asymptomatic, leaving many patients untreated during the earliest stages of the disease.
"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," said Primal Kaur, senior vice president, global development of immunology, neuroscience, eye care and specialty at AbbVie.
"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."
The regulator’s backing was driven by Phase 3 trial data showing MAVIRET achieved a 96% cure rate after an eight-week treatment course in adults with acute HCV infection. Researchers said the therapy’s safety profile remained consistent with earlier studies, with fatigue, diarrhea, headache and asthenia among the most commonly reported side effects.
The push for earlier intervention has gained urgency following the release of the 2026 WHO Global Hepatitis Report, which warned that testing and treatment rates remain far below international targets despite the availability of highly effective antiviral therapies.
"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," said Prof. Christoph Sarrazin, chief physician at St. Josef's Hospital Wiesbaden, Germany.
"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."
