Phase 3 Study Demonstrated High Cure Rates and Favorable Safety
The approval was supported by results from the Phase 3 M20-350 trial, a multicenter, single-arm, prospective study evaluating an eight-week course of Maviret in adults and adolescents aged 12 years and older with acute HCV infection.
The study enrolled 286 treatment-naïve patients across 70 sites globally. Participants received Maviret once daily for eight weeks and were followed for 12 weeks after treatment completion. The trial met its primary endpoint, with 96.2% of patients in the intent-to-treat population achieving sustained virologic response 12 weeks after treatment (SVR12). The key secondary endpoint was also achieved, with 100% of patients in the modified intent-to-treat virologic failure population attaining SVR12.
Investigators reported no on-treatment virologic failures or post-treatment relapses, while post-treatment reinfection occurred in 0.7% of patients. The safety profile was consistent with previous studies in chronic HCV infection, with no treatment-related serious adverse events or treatment discontinuations observed. The most frequently reported adverse events included fatigue, asthenia, headache, and diarrhea.
What You Need to Know
MAVIRET is now the only therapy approved in the European Union for both acute and chronic hepatitis C virus infection.
The approval enables clinicians to begin treatment immediately after acute HCV diagnosis, potentially reducing transmission, loss to follow-up, and progression to cirrhosis or liver cancer.
In the M20-350 study, 96.2% of patients achieved sustained virologic response 12 weeks after treatment (SVR12), with no on-treatment virologic failures or post-treatment relapses observed.
According to Massimo Puoti, MD, director of the Infectious Diseases Department at Niguarda Hospital in Milan, Italy, the approval addresses a significant unmet need for patients diagnosed during the acute phase of infection.
"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," Puoti said.
The approval follows existing authorizations for acute and chronic HCV treatment in several countries, including the United States, Canada, Australia, New Zealand, Saudi Arabia, Taiwan, and Argentina, as AbbVie continues efforts to expand global access to the therapy.
About the Therapy
Maviret is an oral, pangenotypic, once-daily, ribavirin-free direct-acting antiviral treatment for acute and chronic HCV infection in adults and children 3 years and older. Maviret combines glecaprevir, an NS3/4A protease inhibitor, and pibrentasvir, an NS5A inhibitor, and is administered once daily with food.
