The European Commission has approved AbbVie's MAVIRET (glecaprevir/pibrentasvir) for the treatment of acute hepatitis C virus (HCV) infection in adults and children aged three years and older, making it the first and only therapy in the European Union approved for both acute and chronic HCV infection.

The approval marks an important step in efforts to improve early diagnosis and treatment of hepatitis C, a highly infectious blood-borne disease that often remains undetected due to the absence of symptoms in many patients. Early treatment is considered critical to preventing disease progression and reducing transmission.

"More than 12 million people in Europe live with hepatitis C, underscoring the need for earlier treatment," said Roopal Thakkar, Executive Vice President, Research and Development, and Chief Scientific Officer at AbbVie. 

"Today's European Commission approval of MAVIRET for acute hepatitis C infection enables earlier intervention, aiming to help more people access curative therapy at the time of diagnosis, while accelerating progress toward the goal of eliminating hepatitis C as a public health threat,” added Thakkar.

Although hepatitis C is curable, a significant number of people remain undiagnosed. If left untreated, the infection can lead to serious liver complications, including cirrhosis, liver cancer, and end-stage liver disease. Current clinical guidelines recommend treatment for nearly all individuals diagnosed with acute or chronic HCV infection.

According to Massimo Puoti, Director of the Infectious Diseases Department at Niguarda Hospital in Milan, Italy, delayed treatment remains a major challenge in HCV management.

"People living with HCV infection frequently face delayed treatment, leading to loss to care and onward transmission," Puoti said.

"With this approval, healthcare professionals across the European Union now have an approved treatment option to treat patients at the earliest stage of infection, supporting prompt intervention and helping to reduce transmission, disease progression, and long-term complications for people living with hepatitis C," he added.

The European Commission's decision was supported by results from the Phase 3 M20-350 clinical trial, a multicentre, prospective study evaluating the safety and efficacy of an eight-week MAVIRET treatment regimen in patients with acute HCV infection.

The study enrolled 286 treatment-naïve adult patients across 70 sites globally. Results showed that 96.2% of patients in the intent-to-treat population achieved sustained virological response 12 weeks after treatment (SVR12), the primary endpoint of the study. Among patients in the modified intent-to-treat virologic failure population, the SVR12 rate reached 100%.

Researchers reported no on-treatment virologic failures or post-treatment relapses, while post-treatment reinfection occurred in only 0.7% of patients.