AbbVie 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.

HCV is a highly infectious blood-borne disease affecting the liver. People recently infected, or those with acute HCV, may not have symptoms. If left untreated, HCV could lead to liver-related complications, such as cirrhosis or liver cancer. 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.

Current global clinical guidance calls for the universal treatment of nearly all people with acute or chronic HCV infection. Widespread implementation of these guidelines has the potential to substantially reduce the global spread of the disease. Additionally, the public health community has set a goal to eliminate HCV by 2030.

Nearly 80% of high-income countries, including the U.S., are not on track to achieve this goal until after 2050. 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.

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. The study results showed MAVYRET to be a highly efficacious treatment for people with acute HCV. The majority of the adverse events reported were mild or moderate in severity.

The most common adverse events were fatigue, asthenia, headache, and diarrhea.