The FDA has approved an expanded indication for AbbVie’s Mavyret (glecaprevir/pibrentasvir), making it the first and only direct-acting antiviral approved to treat both acute and chronic hepatitis C virus (HCV) infections in adults and children aged three years and older without cirrhosis or with compensated cirrhosis. The approval enables the use of an eight-week oral treatment regimen for acute HCV, supported by results from the Phase III M20-350 trial. Mavyret had previously been approved only for chronic HCV.¹

What Does the FDA’s Expanded Approval of Mavyret Mean for Hepatitis C Treatment?

"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 John Ward, MD, director, Coalition for Global Hepatitis Elimination, in a press release. "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."

Trial Design: Phase III M20-350

• The multicenter, single-arm prospective M20-350 trial evaluated the safety and efficacy of eight-week Mavyret in 286 treatment-naïve adult patients with acute HCV infection.
• After the treatment period ended, follow-up continued for an additional 12 weeks.
• The primary endpoint of the trial was the percentage of patients with sustained virological response 12 weeks post-treatment (SVR12) in the Intention-to-Treat (ITT) population.
• Secondary endpoints included the percentage of patients achieving SVR12 in the Modified ITT-Virologic Failure population, and the percentage of patients with on-treatment virologic failure and post-treatment relapse in the ITT population.

Trial Results: Efficacy and Safety Findings

• Results show that the eight-week Mavyret treatment demonstrated a 96% cure rate.
• Notably, no patients experienced virologic failure.
• Most adverse events (AEs) were reported to be mild to moderate in severity.
• The most common AEs included fatigue, asthenia, headache, and diarrhea.
• Other AEs that could result from Mavyret include worsening liver issues, liver failure, and death in patients with advanced liver issues.¹

Mavyret’s Regulatory History

The FDA first approved Mavyret in 2017 for the treatment of chronic HCV genotypes 1–6 without cirrhosis or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis.2 In 2019, approval was expanded to include all genotypes of HCV in children aged 12 to 17 years and to shorten the once-daily treatment duration from 12 to eight weeks in treatment-naïve, compensated cirrhotic HCV.^3,4

Hepatitis C Remains Underdiagnosed and Undertreated

According to the American Liver Foundation, approximately 2.7 million people in the United States are currently living with HCV. While patients with acute HCV usually have it for no more than six months, around 75% to 85% will go on to develop chronic HCV. Additionally, around 75% are unaware that they have HCV. Each year, approximately 17,000 new cases are diagnosed in the United States. Seventy-five percent of people with HCV were born between 1945 and 1965.⁵

Public Health Goal: Eliminate HCV by 2030

"Mavyret has treated more than one million patients with HCV, but we recognize that a significant need remains for patients with acute infection," said Roopal Thakkar, MD, EVP, research and development, chief scientific officer, AbbVie, in the press release. "The label expansion for Mavyyret, 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."

References

1. U.S. FDA Approves Expanded Indication for AbbVie's MAVYRET® (Glecaprevir/Pibrentasvir) as First and Only Treatment for People with Acute Hepatitis C Virus.AbbVie. June 11, 2025. Accessed June 12, 2025. https://news.abbvie.com/2025-06-11-U-S-FDA-Approves-Expanded-Indication-for-AbbVies-MAVYRET-R-Glecaprevir-Pibrentasvir-as-First-and-Only-Treatment-for-People-with-Acute-Hepatitis-C-Virus

2. FDA Approves Mavyret. Drugs.com. August 3, 2017. Accessed June 12, 2025. https://www.drugs.com/newdrugs/fda-approves-mavyret-glecaprevir-pibrentasvir-hepatitis-c-4569.html

3. FDA Approves Mavyret (glecaprevir and pibrentasvir) as First Treatment for All Genotypes of Hepatitis C in Pediatric Patients. Drugs.com. April 30, 2019. Accessed June 12, 2025. https://www.drugs.com/newdrugs/fda-approves-mavyret-glecaprevir-pibrentasvir-first-all-genotypes-hepatitis-c-pediatric-patients-4957.html