The European Commission has approved AbbVie’s MAVIRET® for acute hepatitis C in patients aged ≥3 years with compensated liver disease, making it the only EU‑authorized therapy for both acute and chronic HCV. Approval was supported by Phase 3 data showing 96.2% SVR12.
Written By: Nalam Karthik, PharmD
Reviewed By: Pharmacally Editorial Team
The European Commission has approved MAVIRET® (glecaprevir/pibrentasvir) for the treatment of acute hepatitis C virus (HCV) infection in adults and children aged three years and older with compensated liver disease, including those with cirrhosis. The approval expands the label of the oral pangenotypic direct-acting antiviral (DAA) and establishes MAVIRET as the only therapy authorized in the European Union for both acute and chronic HCV infection.
The decision allows clinicians to initiate treatment as soon as acute infection is confirmed, potentially reducing delays in care, limiting onward transmission, and lowering the risk of long-term liver complications such as cirrhosis, liver failure, and hepatocellular carcinoma.
Scientific Context
HCV remains a major global public health challenge despite the availability of curative therapies. Many infected individuals remain undiagnosed because acute infection is frequently asymptomatic. Without treatment, chronic infection can progressively damage the liver and lead to severe complications, including end-stage liver disease and liver cancer.
MAVIRET combines two direct-acting antivirals with complementary mechanisms of action. Glecaprevir inhibits the HCV NS3/4A protease, while pibrentasvir targets the NS5A protein, disrupting viral replication across all major HCV genotypes. Its pangenotypic activity allows treatment without genotype-specific selection, simplifying clinical management.
Current treatment guidelines recommend therapy for nearly all individuals with acute or chronic HCV infection, reflecting growing efforts to eliminate hepatitis C as a public health threat.
Phase 3 Data
The approval was supported by results from the Phase 3 M20-350 study (NCT04903626), a multicenter, prospective, single-arm trial evaluating an eight-week MAVIRET regimen in treatment-naïve patients with acute HCV infection.
The study enrolled 286 adults and adolescents aged 12 years and older across 70 sites globally. Participants received oral MAVIRET once daily for eight weeks and were monitored 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 reaching SVR12.
Investigators reported no on-treatment virologic failures and no post-treatment relapses. Post-treatment reinfection occurred in only 0.7% of participants.
Safety
Safety findings were consistent with the established profile of MAVIRET in chronic HCV infection. No treatment-related serious adverse events or treatment discontinuations were observed. The most frequently reported adverse events were fatigue (3%), asthenia (2%), headache (2%), and diarrhea (2%), most of which were mild to moderate in severity.
Clinical Implications
AbbVie highlighted the approval as an important step toward earlier intervention and broader access to curative HCV therapy. Company leadership noted that enabling treatment at diagnosis could improve retention in care and support public health efforts to reduce transmission.
Clinical experts also emphasized that delayed treatment remains a persistent challenge in HCV management. An approved therapy for acute infection provides healthcare professionals with greater flexibility to intervene before patients are lost to follow-up or progress to advanced liver disease.
Regulatory Path Forward
MAVIRET is already approved for acute and chronic HCV infection in several countries, including the United States, Canada, Australia, New Zealand, Saudi Arabia, Taiwan, and Argentina. With the EU approval now secured, AbbVie continues to work with global regulators to expand access to early HCV treatment and support international hepatitis C elimination initiatives.
Reference
About the Writer
Nalam Karthik (LinkedIn) is a healthcare writer and PharmD graduate with interests in pharmacovigilance, drug safety, clinical data analysis, and quality assurance. He is passionate about translating clinical and pharmaceutical knowledge into accessible healthcare content while staying engaged with advancements in drug development and patient safety initiatives.