By VETTAPHARMA reporter – Derek Roche: The European Commission (EC) has approved AbbVie’s MAVIRET® (glecaprevir/pibrentasvir) for the treatment of acute hepatitis C virus 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 approved in the European Union for both acute and chronic hepatitis C virus infection, enabling clinicians to initiate treatment immediately after diagnosis and potentially reduce disease progression and transmission.
The expanded indication addresses an important gap in hepatitis C care, where delayed treatment frequently results in loss to follow-up, continued viral transmission, and progression to advanced liver disease. According to AbbVie, more than 12 million people in Europe are living with hepatitis C virus infection, while globally the disease causes more than 200,000 liver cancer-related deaths annually. People living with hepatitis C are up to 17 times more likely to develop liver cancer than unaffected individuals.
The approval was supported by the pivotal Phase 3 M20-350 study (NCT04903626), a multicenter, prospective, single-arm trial evaluating an eight-week oral MAVIRET regimen in treatment-naïve adults and adolescents with acute hepatitis C virus infection. The study enrolled 286 adult patients across 70 global sites. The primary endpoint was sustained virologic response 12 weeks after treatment (SVR12) in the intent-to-treat population. MAVIRET achieved the primary endpoint, with 96.2% of patients achieving SVR12 (p<0.0001). The key secondary endpoint was also met, with 100% of patients in the modified intent-to-treat virologic failure population achieving SVR12 (p<0.0001). No on-treatment virologic failures or post-treatment relapses were observed, while post-treatment reinfection occurred in 0.7% of patients.
The safety profile was consistent with previous experience in chronic hepatitis C virus infection. No treatment-related serious adverse events or treatment discontinuations were reported. The most common adverse reactions were fatigue (3%), asthenia (2%), headache (2%), and diarrhea (2%). The prescribing information recommends screening for hepatitis B virus before initiating treatment because of the risk of viral reactivation associated with direct-acting antiviral therapy.
MAVIRET is an oral, once-daily, ribavirin-free, pangenotypic direct-acting antiviral that combines glecaprevir, an NS3/4A protease inhibitor, with pibrentasvir, an NS5A inhibitor. The therapy is already approved in the United States, Canada, Australia, New Zealand, Saudi Arabia, Taiwan, and Argentina for both acute and chronic hepatitis C virus infection.
Quick FAQs
1. What Is MAVIRET?
MAVIRET® (glecaprevir/pibrentasvir) is an oral, once-daily, pangenotypic direct-acting antiviral approved for the treatment of acute and chronic hepatitis C virus infection.
2. What Happened?
The European Commission approved AbbVie’s MAVIRET for adults and children aged 3 years and older with acute hepatitis C virus infection, making it the only therapy approved in the European Union for both acute and chronic hepatitis C virus infection.
3. What Is The M20-350 Study?
M20-350 (NCT04903626) is a Phase 3, multicenter, prospective, single-arm study evaluating an eight-week MAVIRET regimen in 286 treatment-naïve adults with acute hepatitis C virus infection.
4. What Is Acute Hepatitis C Virus Infection?
Acute hepatitis C virus infection is the early stage of infection caused by the hepatitis C virus. Without treatment, it can progress to chronic liver disease, cirrhosis, liver failure, and liver cancer.
5. What Were The Key Results?
MAVIRET achieved a 96.2% sustained virologic response in the intent-to-treat population and 100% in the modified intent-to-treat virologic failure population, with no on-treatment virologic failures or post-treatment relapses observed.
6. Why Is This Important?
The approval enables treatment to begin immediately after diagnosis and establishes MAVIRET as the only therapy approved in the European Union for both acute and chronic hepatitis C virus infection, supporting earlier intervention and broader hepatitis C elimination efforts.
