AbbVie has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Maviret(glecaprevir/pibrentasvir), an oral pangenotypic direct-acting antiviral (DAA) therapy for the treatment of acute hepatitis C infection (HCV) in adults and children aged three years and older.
The final European Commission decision is expected in the third quarter of 2026. If approved, Maviret would be indicated for both acute and chronic hepatitis C (HCV) infection in the European Union.
HCV is a serious blood-borne virus that can progress to chronic liver disease when left untreated. Acute HCV infection is frequently asymptomatic, and many individuals remain unaware of their infection until it has progressed to a later stage.
Global clinical guidance supports treatment of nearly all people with HCV infection, reflecting the importance of early diagnosis and timely initiation of therapy.The newly released 2026 WHO Global Hepatitis Report further underscores this need, highlighting that diagnosis and treatment coverage remain far below global targets and reinforcing the importance of earlier testing and rapid linkage to care.
The positive opinion is supported by data from the phase 3, multi-centre, single-arm prospective M20-350 study evaluating the safety and efficacy of Maviret eight-week treatment in adults with acute HCV infection.
In the study, Maviret demonstrated a 96% cure rate, as measured by sustained virologic response at 12 weeks after treatment (SVR12), with a safety profile generally consistent with prior experience; the most common adverse events were fatigue, diarrhoea, headache and asthenia.
AbbVie continues to collaborate with global regulatory authorities to support access to Maviret for people living with acute HCV infection. Maviret is approved in Canada, Australia, the United States (as Maviret), Saudi Arabia, New Zealand, Taiwan, and Argentina for the treatment of acute and chronic HCV infection in adults and children aged three years and older.
About the phase 3 M20-350 study
The multicentre, single-arm prospective phase 3 M20-350 clinical trial was designed to evaluate the safety and efficacy of Maviret(glecaprevir/pibrentasvir) eight-week treatment in adults and adolescent participants aged 12 years and older with acute HCV infection. The study enrolled 286 treatment-naïve adult patients with acute HCV infection across 70 locations globally.
Patients received oral tablets of Maviretonce daily for eight weeks and were followed for 12 weeks after the end of treatment. The primary endpoint was the percentage of patients with sustained virological response 12 weeks post-treatment (SVR12) in the intent-to-treat population (ITT).
The study met its primary endpoint, with 96.2% of patients in the ITT population achieving SVR12 (p<0.0001).
The key secondary endpoint was also met with 100% of patients in the modified ITT-Virologic Failure population achieving SVR12 (p<0.0001).
The overall safety profile observed in the M20-350 study was similar to that observed in patients with chronic HCV infection.
No serious adverse reactions or adverse reactions leading to treatment discontinuation were observed among patients with acute HCV infection.
The most commonly reported adverse reactions were fatigue (3%), asthenia (2%), headache (2%), and diarrhoea (2%). No on-treatment virologic failures or post-treatment relapses were observed, and post-treatment reinfection occurred in 0.7% of patients.
