EU approves AbbVie's Maviret for acute hepatitis C treatment

The European Commission has approved AbbVie's (NYSE: ABBV) Maviret (glecaprevir/pibrentasvir) for the treatment of acute hepatitis C virus (HCV) infection in adults and children aged 3 years and older, the company announced June 23.

Maviret was previously approved in the European Union for chronic HCV infection. With this new approval, AbbVie claims Maviret is the only treatment approved in the EU for both acute and chronic HCV infection in that age group.

The approval was based on data from the Phase 3 M20-350 study, a multicenter, single-arm prospective trial that enrolled 286 treatment-naïve adults with acute HCV infection across 70 locations globally. Patients received Maviret once daily for eight weeks. The study met its primary endpoint, with 96.2% of patients in the intent-to-treat population achieving sustained virological response 12 weeks post-treatment. The key secondary endpoint was also met, with 100% of patients in the modified intent-to-treat virologic failure population achieving the same response. No on-treatment virologic failures or post-treatment relapses were observed. Post-treatment reinfection occurred in 0.7% of patients.

The most commonly reported adverse reactions in the acute HCV study were fatigue, asthenia, headache, and diarrhea, each occurring in 2% to 3% of patients. No serious adverse reactions leading to treatment discontinuation judged as treatment-related were observed.

Maviret is also approved for acute and chronic HCV infection in the United States, Canada, Australia, New Zealand, Saudi Arabia, Taiwan, and Argentina.

"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," said Massimo Puoti, MD, director of the Infectious Diseases Department at Niguarda Hospital in Milan, Italy.

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