FDA Approves Label Expansion For AbbVie's MAVYRET, Oral Pangenotypic Direct Acting Antiviral Therapy

• MAVYRET® (glecaprevir/pibrentasvir) is the first and only oral eight-week pangenotypic treatment option approved for people with acute or chronic hepatitis C virus (HCV)*
• With this approval, providers can now treat HCV patients immediately at the time of diagnosis
• HCV is a curable condition, but patients can often go undiagnosed.1 If left untreated, people with acute HCV could progress to chronic disease, including liver-related complications, such as cirrhosis or liver cancer1
• The approval supports global clinical guidelines to advance testing and treatment for people with HCV regardless of chronicity, and supports public health goals for disease elimination

NORTH CHICAGO, Ill., June 11, 2025 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved a label expansion for MAVYRET® (glecaprevir/pibrentasvir), an oral pangenotypic direct acting antiviral (DAA) therapy. It is now approved for the treatment of adults and pediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis. With this approval, MAVYRET is the first and only DAA therapy approved to treat patients with acute HCV in eight weeks with a 96% cure rate. 2,†

HCV is a highly infectious blood-borne disease affecting the liver.1 People recently infected, or those with acute HCV, may not have symptoms.1 If left untreated, HCV could lead to liver-related complications, such as cirrhosis or liver cancer.1 The United States is expected to incur ~$120 billion in total medical costs over the next 10 years through 2035 linked to chronic liver disease and other related conditions caused by untreated HCV.

The FDA granted Breakthrough Therapy Designation (BTD) for MAVYRET for the treatment of acute HCV. The BTD program is designed to expedite the development and review of medicines that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.7

The label expansion was supported by data from the Phase 3, multicenter, single-arm prospective study evaluating the safety and efficacy of MAVYRET eight-week treatment in adults with acute HCV infection.2 The study results showed MAVYRET to be a highly efficacious treatment for people with acute HCV.2 The majority of the adverse events reported were mild or moderate in severity.2 The most common adverse events were fatigue, asthenia, headache, and diarrhea.