NORTH CHICAGO, Ill., June 23, 2026
AbbVie announced that the European Commission has approved MAVIRET® (glecaprevir/pibrentasvir) for the treatment of acute hepatitis C virus (HCV) infection in adults and children aged 3 years and older with compensated liver disease, with or without cirrhosis. The approval makes MAVIRET the only therapy authorized in the European Union for both acute and chronic HCV infection, enabling healthcare professionals to begin treatment immediately after diagnosis rather than delaying care. Early intervention is expected to reduce disease progression, lower the risk of cirrhosis, liver failure, and liver cancer, while supporting broader public health efforts to eliminate hepatitis C. The expanded indication strengthens AbbVie’s leadership in antiviral therapies and provides clinicians with a simplified treatment option across the entire spectrum of HCV infection.
Phase 3 Trial Demonstrated High Cure Rates and Favorable Safety
The European Commission approval was supported by results from the global Phase 3 M20-350 clinical trial, which evaluated an eight-week, once-daily oral regimen of MAVIRET in 286 treatment-naïve adults with acute HCV infection across 70 clinical sites worldwide. The study successfully met its primary endpoint, with 96.2% of patients in the intent-to-treat population achieving Sustained Virological Response 12 weeks after treatment (SVR12), while 100% of patients in the modified ITT virologic failure population achieved SVR12. Investigators reported no on-treatment virologic failures or post-treatment relapses, with only 0.7% of patients experiencing reinfection after therapy. The overall safety profile remained consistent with previous studies in chronic HCV, with the most frequently reported adverse events including fatigue, headache, diarrhea, and asthenia, most of which were mild to moderate in severity.
Earlier Treatment May Reduce Disease Burden Across Europe
Hepatitis C virus remains a major global health challenge, with millions of people across Europe living with chronic infection, many of whom remain undiagnosed because symptoms often do not appear until advanced liver damage has occurred. Untreated HCV can progress to advanced fibrosis, cirrhosis, liver failure, and hepatocellular carcinoma, significantly increasing healthcare costs and mortality. Clinical guidelines now recommend treating nearly all patients diagnosed with either acute or chronic HCV infection, making rapid access to antiviral therapy increasingly important. By approving MAVIRET for acute infection, the European Commission enables clinicians to initiate curative treatment immediately after diagnosis, helping reduce viral transmission, minimize patient loss to follow-up, and improve long-term clinical outcomes through earlier intervention.
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AbbVie Strengthens Global Leadership in Hepatitis C Care
The latest approval further expands AbbVie’s global hepatitis C portfolio, with MAVIRET already approved for treating both acute and chronic HCV infection in several countries, including the United States, Canada, Australia, New Zealand, Saudi Arabia, Taiwan, and Argentina. The once-daily, ribavirin-free direct-acting antiviral (DAA) combines glecaprevir, an NS3/4A protease inhibitor, with pibrentasvir, an NS5A inhibitor, providing pangenotypic activity across all major HCV genotypes. By offering a single therapy suitable for both newly diagnosed and chronic patients, MAVIRET has the potential to simplify treatment pathways, improve healthcare efficiency, and accelerate progress toward the World Health Organization’s hepatitis C elimination goals. The approval reinforces AbbVie’s commitment to advancing innovative antiviral therapies that improve patient outcomes and support global efforts to reduce the burden of hepatitis C.
Source: AbbVie press release
