North Chicago, Illinois, USA – May 22, 2026
AbbVie announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of MAVIRET® (glecaprevir/pibrentasvir) for the treatment of acute hepatitis C virus (HCV) infection in adults and children aged three years and older. The recommendation represents a major advancement in hepatitis treatment strategy and could position MAVIRET as one of the first therapies in the European Union approved for both acute and chronic HCV infection. The final decision from the European Commission is expected during the third quarter of 2026.
The positive CHMP opinion was supported by findings from the global Phase III M20-350 clinical trial, where an eight-week MAVIRET treatment regimen achieved a 96% cure rate in patients with acute HCV infection. Researchers highlighted the importance of early diagnosis and rapid treatment initiation because acute hepatitis C often develops without symptoms, allowing infections to progress unnoticed and increasing risks of transmission and long-term liver complications.
Phase III Study Demonstrates High Cure Rates in Acute HCV
The multicenter Phase III M20-350 trial evaluated the safety and efficacy of an eight-week oral MAVIRET treatment course in treatment-naïve adults and adolescents with acute hepatitis C infection. The study enrolled 286 patients across 70 clinical locations worldwide and successfully met both primary and secondary efficacy endpoints. According to trial results, 96.2% of patients achieved sustained virologic response at 12 weeks post-treatment (SVR12), effectively demonstrating viral cure following therapy completion.
Researchers additionally reported that 100% of patients in the modified intent-to-treat virologic failure population achieved SVR12, reinforcing the therapy’s strong antiviral activity. No on-treatment virologic failures or post-treatment relapses were observed during the study period, while reinfection rates remained low at approximately 0.7%. Clinical investigators also confirmed that the overall safety profile observed during the trial was generally consistent with previous studies involving chronic HCV infection.
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The most commonly reported adverse events included fatigue, headache, diarrhea, and asthenia. Importantly, no serious adverse reactions or treatment discontinuations due to safety concerns were reported during the study. Experts believe simplified oral antiviral regimens with short treatment durations could significantly improve patient adherence and support broader hepatitis elimination strategies globally.
Early HCV Treatment Could Strengthen Global Elimination Efforts
Medical experts note that acute HCV infection remains difficult to diagnose because many patients remain asymptomatic during early disease stages. Without timely intervention, untreated acute infections can progress into chronic hepatitis C, eventually leading to liver fibrosis, cirrhosis, liver cancer, and liver failure. The World Health Organization continues prioritizing hepatitis elimination initiatives worldwide due to the significant long-term burden associated with chronic viral hepatitis infections.
AbbVie executives stated that earlier treatment initiation could help reduce transmission risk, improve patient outcomes, and simplify healthcare pathways by treating patients immediately after diagnosis rather than waiting for chronic infection development. Physicians involved in the study also highlighted that acute HCV patients are often lost to follow-up before treatment begins, making rapid treatment availability especially important in real-world healthcare settings.
MAVIRET is a once-daily oral direct-acting antiviral therapy combining glecaprevir, an NS3/4A protease inhibitor, and pibrentasvir, an NS5A inhibitor. The therapy is already approved in multiple global markets for chronic hepatitis C treatment and has become widely adopted due to its pan-genotypic activity, ribavirin-free regimen, and relatively short treatment duration.
AbbVie Expands Leadership in Viral Hepatitis Treatment
The positive CHMP opinion further strengthens AbbVie’s position in the global hepatitis C treatment market as healthcare systems continue expanding screening and treatment programs aimed at eliminating HCV infections. Analysts believe earlier intervention strategies supported by therapies such as MAVIRET may help healthcare providers reduce disease progression, lower long-term treatment costs, and improve public health outcomes worldwide.
The newly released 2026 WHO Global Hepatitis Report emphasized that global diagnosis and treatment coverage rates remain significantly below elimination targets, reinforcing the importance of earlier testing and rapid linkage to antiviral care. Industry experts believe approvals for acute HCV treatment could encourage broader screening initiatives and improve healthcare engagement among high-risk populations.
AbbVie confirmed that MAVIRET has already received approval for acute and chronic HCV treatment in several countries including the United States, Canada, Australia, New Zealand, Saudi Arabia, Taiwan, and Argentina. If formally approved by the European Commission later this year, MAVIRET could become one of the most comprehensive antiviral treatment options available for both acute and chronic hepatitis C management in Europe.
Source: AbbVie press release
