U.S. FDA Approves Expanded Indication for AbbVie's MAVYRET® (Glecaprevir/Pibrentasvir) as First and Only Treatment for People with Acute Hepatitis C Virus

Core Insights - AbbVie announced FDA approval for MAVYRET® (glecaprevir/pibrentasvir) to treat adults and pediatric patients aged three years and older with acute or chronic hepatitis C virus (HCV) infection, marking it as the first DAA therapy approved for eight-week treatment of acute HCV with a 96% cure rate [1][3][5] - The approval aligns with global clinical guidelines advocating for universal treatment of HCV, aiming to eliminate the disease by 2030, although many high-income countries, including the U.S., are not on track to meet this goal until after 2050 [1][4][5] - The Phase 3 M20-350 study demonstrated MAVYRET's efficacy and safety, enrolling 286 treatment-naïve adult patients, with the primary endpoint being the sustained virological response (SVR12) at 12 weeks post-treatment [2][4] Company Insights - AbbVie has treated over one million patients with HCV through MAVYRET, recognizing the ongoing need for effective treatment options for acute infections [1][3] - The FDA granted Breakthrough Therapy Designation for MAVYRET, expediting its development and review process due to its potential to significantly improve treatment outcomes compared to existing therapies [1][7] - The company emphasizes the importance of early treatment to prevent progression to chronic disease and associated complications, such as cirrhosis and liver cancer [1][3][4] Industry Insights - HCV is a highly infectious disease that can lead to severe liver-related complications if untreated, with the U.S. projected to incur approximately $120 billion in medical costs over the next decade due to chronic liver disease linked to untreated HCV [1][3] - Current public health goals aim for the elimination of HCV by 2030, with a focus on increasing testing and treatment accessibility [1][4][5] - The majority of adverse events reported in the MAVYRET study were mild to moderate, indicating a favorable safety profile for the treatment [2][4]