Watertown, MA— The U.S. Food and Drug Administration (FDA) has approved an expanded indication for MAVYRET® (glecaprevir/pibrentasvir), making it the first and only direct-acting antiviral therapy authorized to treat acute hepatitis C virus (HCV) infection. The update allows healthcare providers to initiate treatment immediately upon diagnosis, potentially accelerating efforts to eliminate the disease.
MAVYRET, developed by AbbVie and featuring glecaprevir—a molecule discovered by Enanta Pharmaceuticals—can now be prescribed as an eight-week oral treatment for adults and children as young as three with acute or chronic HCV who do not have cirrhosis or have compensated cirrhosis. Clinical trials showed the drug achieved a 96% cure rate in acute HCV cases, with most adverse effects reported as mild or moderate.
“This milestone represents a significant step in the fight against HCV,” said Dr. Jay R. Luly, President and CEO of Enanta Pharmaceuticals. “With the ability to treat patients earlier in the disease course, we can reduce transmission and prevent the progression to chronic liver conditions such as cirrhosis or liver cancer. We’re proud that our discovery of glecaprevir has played a role in a treatment that continues to impact patients globally.”
The approval is based on data from a Phase 3 multicenter trial, which demonstrated MAVYRET’s strong efficacy and favorable safety profile in treating acute HCV. The most common side effects included fatigue, weakness, headache, and diarrhea.
MAVYRET was previously approved for chronic HCV and has already been used to treat over one million patients worldwide. With this new indication, experts believe the therapy could significantly improve early intervention and limit the long-term burden of the disease.
The FDA had granted Breakthrough Therapy Designation to MAVYRET for acute HCV, underscoring its potential to offer a meaningful improvement over existing treatments. This recognition helped expedite the drug’s development and review.
HCV is a highly contagious blood-borne virus that can lead to serious liver complications if left untreated. While acute infections may resolve on their own, many evolve into chronic cases, contributing to ongoing transmission and disease burden. Current global health guidelines recommend treatment for nearly all individuals diagnosed with HCV—whether acute or chronic—to curb the spread.
Despite global elimination goals set by the World Health Organization for 2030, most high-income countries, including the U.S., are projected to miss that target by decades. Public health leaders hope expanded access to short-course, effective therapies like MAVYRET will help close that gap.
MAVYRET is marketed by AbbVie and co-developed with Enanta Pharmaceuticals.
