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AbbVie Announces Positive CHMP Opinion for MAVIRET® (glecaprevir/pibrentasvir) for the Treatment of Acute Hepatitis C Infection
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May 22, 2026
• The positive opinion is supported by data from the Phase 3 M20-350 study evaluating the safety and efficacy of MAVIRET® in adults with acute hepatitis C virus (HCV) infection.
• MAVIRET is a direct-acting antiviral (DAA) treatment currently approved in the European Union for chronic HCV infection in adults and children aged 3 years and older.
• Acute HCV infection is often asymptomatic, highlighting the importance of early diagnosis and treatment to help reduce transmission, long-term liver-related complications, and support HCV elimination efforts.
NORTH CHICAGO, Ill., May 22, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today 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 3 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.
"The CHMP positive opinion for MAVIRET in acute hepatitis C represents an important step toward enabling earlier treatment, at a stage when the disease is often asymptomatic and may go undiagnosed," said Primal Kaur, M.D., senior vice president, global development of immunology, neuroscience, eye care and specialty at AbbVie. "This milestone aligns with global clinical guidance supporting treatment of suitable people with acute or chronic HCV infection. It also has the potential to help address unmet need, reduce the risk of onward transmission, and support global HCV elimination efforts."
The positive opinion is supported by data from the Phase 3, multicenter, single-arm prospective M20-350 study evaluating the safety and efficacy of MAVIRET eight-week treatment in adults with acute HCV infection.4 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, diarrhea, headache and asthenia.4
"In clinical practice, acute HCV can be challenging to manage, as it is often identified incidentally and patients may be lost to follow-up before treatment is initiated," said Prof. Christoph Sarrazin, chief physician at St. Josef's Hospital Wiesbaden, Germany; head of the Wiesbaden Liver Center; and board member of the German Liver Foundation. "This treatment option could help streamline care pathways and support timely initiation of therapy once infection is confirmed, an important step for both individual patient outcomes and broader public health efforts."
About the Phase 3 M20-350 Study4
The multicenter, 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 MAVIRET once 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 diarrhea (2%). No on-treatment virologic failures or post-treatment relapses were observed, and post-treatment reinfection occurred in 0.7% of patients.
https://www.prnewswire.com/news-releases/abbvie-announces-positive-chmp-opinion-for-maviret-glecaprevirpibrentasvir-for-the-treatment-of-acute-hepatitis-c-infection-302779052.html
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