AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for MAVYRET (glecaprevir/pibrentasvir) to include the treatment of acute hepatitis C virus (HCV) infection.

With this approval, MAVYRET becomes the first and only 8-week, oral, pangenotypic direct-acting antiviral (DAA) treatment option for both acute and chronic HCV infections in treatment-naïve patients without cirrhosis or with compensated cirrhosis. 

This expansion allows healthcare providers to initiate treatment immediately at the time of diagnosis, supporting public health efforts aimed at curbing disease progression and transmission. 

“Expanding treatment to include acute HCV helps close a critical gap in care,” said Dr. Roopal Thakkar, EVP and Chief Scientific Officer, AbbVie. “This approval enables immediate intervention and supports the global goal of hepatitis C elimination by 2030.” 

HCV is a highly infectious, curable liver disease, yet many individuals remain undiagnosed until complications develop. Without early treatment, acute HCV can progress to chronic infection, increasing risks of cirrhosis, liver failure, or cancer. U.S. healthcare costs associated with untreated HCV are projected to exceed $120 billion by 2035. 

“Early, accessible treatment can prevent serious outcomes and reduce the public health burden,” said Dr. John Ward, Director of the Coalition for Global Hepatitis Elimination. “With tools like MAVYRET and improved testing, we have an opportunity to eliminate hepatitis C as a public health threat.”