S. FDA Expands Approval of AbbVie’s MAVYRET® for Treatment of Acute Hepatitis C
Thursday, June 12, 2025
AbbVie has received approval from the U.S. Food and Drug Administration (FDA) to expand the use of MAVYRET® (glecaprevir/pibrentasvir), its oral pangenotypic direct-acting antiviral (DAA), for treating adults and children aged three years and above with acute or chronic hepatitis C virus (HCV) infection. This approval applies to patients without cirrhosis or with compensated cirrhosis.
MAVYRET is now the first and only DAA approved for treating acute HCV in just eight weeks, demonstrating a 96% cure rate in clinical trials.
HCV is a blood-borne infection that affects the liver and often presents no symptoms in its early, or acute, stage. If left untreated, the disease can progress to serious complications such as cirrhosis or liver cancer. In the U.S. alone, untreated HCV could lead to approximately $120 billion in healthcare costs over the next decade due to liver-related conditions.
Global clinical guidelines recommend that nearly all individuals with either acute or chronic HCV infection should receive treatment. Broad adoption of these guidelines could play a key role in reducing transmission and disease burden worldwide. Public health authorities aim to eliminate HCV as a global health threat by 2030, although current projections suggest that most high-income countries, including the U.S., are not on track to meet this target until after 2050.
The latest FDA approval follows the granting of Breakthrough Therapy Designation for MAVYRET in acute HCV treatment. This designation is intended for therapies that show significant potential for improvement over existing treatments for serious conditions.
The label expansion is supported by results from the Phase 3 M20-350 trial, a global, multicentre, single-arm study involving 286 treatment-naïve adults with acute HCV. Participants received an eight-week course of MAVYRET and were monitored for 12 weeks post-treatment. The trial demonstrated high rates of sustained virological response (SVR12), with most side effects being mild to moderate. The most commonly reported side effects included fatigue, weakness, headache, and diarrhoea.
MAVYRET has already been used to treat over one million patients globally, and the expanded indication is expected to support wider access to early and effective treatment, contributing to broader efforts in HCV elimination.
Source: prnewswire.com
