FDA Approves Glecaprevir/Pibrentasvir for Acute HCV
- The Food and Drug Management (FDA) has approved a label expansion for glecaprevir/pibrentasvir (Mavyret, AbbVie Inc.) to include the treatment of acute hepatitis C virus (HCV) infection in...
- Hepatitis C virus, a viral infection causing liver inflammation, can lead to severe liver damage, cirrhosis, and even liver cancer if untreated.
- Glecaprevir/pibrentasvir is a fixed-dose combination medication. Glecaprevir inhibits the HCV NS3/4A protease, preventing viral replication, while pibrentasvir inhibits HCV NS5A, also preventing viral replication and assembly.
The FDA has approved glecaprevir/pibrentasvir, also known as Mavyret, for treating acute hepatitis C (HCV) in adults and children aged 3 and older. This marks the first direct-acting antiviral (DAA) approved for acute HCV. The approval, based on Phase 3 clinical trial data, offers new hope in the fight against this viral infection, which can lead to severe liver damage.The medication, a fixed-dose combination, targets HCV, preventing viral replication. Results from the M20-350 trial demonstrated high efficacy. With this pivotal advancement, News Directory 3 can confirm that wider implementation of test and treat models could support the global 2030 hepatitis C elimination goal. discover what’s next for HCV treatment.
FDA Approves Glecaprevir/Pibrentasvir for Acute Hepatitis C Treatment
Updated June 11, 2025
The Food and Drug Management (FDA) has approved a label expansion for glecaprevir/pibrentasvir (Mavyret, AbbVie Inc.) to include the treatment of acute hepatitis C virus (HCV) infection in adults and children aged 3 years and older. This makes glecaprevir/pibrentasvir the first direct-acting antiviral (DAA) therapy approved for acute HCV, irrespective of cirrhosis status.
Hepatitis C virus, a viral infection causing liver inflammation, can lead to severe liver damage, cirrhosis, and even liver cancer if untreated. Many individuals with acute HCV infection are asymptomatic, but some may experience jaundice, fatigue, nausea, fever, and muscle aches.Chronic HCV, the long-term infection, frequently enough remains asymptomatic for years.The US Preventive Services Task Force recommends screening for HCV in all adults aged 18 to 79 because of the potential for long-term complications.
Glecaprevir/pibrentasvir is a fixed-dose combination medication. Glecaprevir inhibits the HCV NS3/4A protease, preventing viral replication, while pibrentasvir inhibits HCV NS5A, also preventing viral replication and assembly. The drug is now indicated for both acute and chronic HCV genotypes 1-6 in adults and children 3 years and older, with or without compensated cirrhosis, offering a notable advancement in hepatitis C virus treatment.
The FDA’s decision was supported by data from the Phase 3 M20-350 clinical trial (NCT04903626), a multicenter study evaluating the safety and efficacy of glecaprevir/pibrentasvir in individuals with acute HCV infection over an eight-week period.
The trial included 286 individuals with acute HCV from 70 locations globally. Participants received oral glecaprevir/pibrentasvir once daily for eight weeks and were monitored for 12 weeks post-treatment. The primary endpoint was the percentage of participants achieving a sustained virological response 12 weeks post-treatment (SVR12). Results showed high efficacy, with common adverse events including fatigue, asthenia, headache, and diarrhea.
“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,” said Dr. John Ward, director at the Coalition for Global Hepatitis Elimination. “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.”
What’s next
With this approval, wider implementation of test and treat models of care may help support the public health community in treating more patients, bringing the world closer to achieving the global 2030 hepatitis C virus elimination goal.