AbbVie’s MAVYRET® Becomes First FDA-Approved 8-Week Treatment For Acute Hepatitis C Virus

AbbVie announced that the U.S. FDA has approved a label expansion for MAVYRET® (glecaprevir/pibrentasvir), making it the first and only direct-acting antiviral (DAA) approved for the treatment of both acute and chronic hepatitis C virus (HCV) in patients aged three years and older. The eight-week oral regimen demonstrated a 96% cure rate in acute HCV, expanding treatment access to younger populations and newly infected individuals without cirrhosis or with compensated cirrhosis.

"The physical, emotional, and economic burden of a curable condition like hepatitis C is far too great in the United States and around the world. If treated early with safe and effective therapies, providers can cure virtually all patients with hepatitis C before it escalates to chronic disease and eventually cirrhosis or liver cancer. The public health community now has a good opportunity to cure nearly all persons to support eliminating the toll of this deadly virus. No one should die of hepatitis C," said John Ward, M.D., director, Coalition for Global Hepatitis Elimination. 

Acute HCV infections often go undetected due to a lack of symptoms, but can progress to serious liver complications such as cirrhosis or liver cancer if untreated. The U.S. faces a projected $120 billion in HCV-related healthcare costs through 2035. With the global public health goal of eliminating HCV by 2030 slipping out of reach for many high-income countries, including the U.S., MAVYRET’s new indication supports a major step forward in prevention and early intervention strategies.

"MAVYRET has treated more than one million patients with HCV, but we recognize that a significant need remains for patients with acute infection. The label expansion for MAVYRET, coupled with the implementation of test and treat models of care, serve as tools to support the public health community in treating more patients and bringing us closer to achieving the global 2030 elimination goal," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. 

The label expansion was backed by a Phase 3 multicenter study, which confirmed MAVYRET’s high efficacy and favorable safety profile in treating acute HCV. The FDA granted Breakthrough Therapy Designation to MAVYRET in this indication, underscoring its potential to significantly improve current HCV treatment paradigms with a shorter, more accessible regimen.