FDA Approves Glecaprevir/Pibrentasvir (Mavyret) Label Expansion for Acute HCV

The US Food and Drug Administration has approved a label expansion for glecaprevir/pibrentasvir (Mavyret), an oral pangenotypic direct acting antiviral (DAA) therapy. With this decision, glecaprevir/pibrentasvir is now approved for the treatment of adults and pediatric patients ≥ 3 years of age with acute or chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis.1

Announced by AbbVie on June 11, 2025, the approval was supported by data from the phase 3, multicenter, single-arm prospective M20-350 study evaluating the safety and efficacy of glecaprevir/pibrentasvir 8-week treatment in adults with acute HCV infection. Of note, the decision makes glecaprevir/pibrentasvir the first and only DAA therapy approved to treat patients with acute HCV in 8 weeks with a 96% cure rate.1

"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," John Ward, MD, director of the Coalition for Global Hepatitis Elimination, said in a statement.1 "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."

Glecaprevir/pibrentasvir is a pan-genotypic, once-daily, ribavirin-free treatment that combines glecaprevir (100mg), an NS3/4A protease inhibitor, and pibrentasvir (40mg), an NS5A inhibitor, dosed once-daily as 3 oral tablets, taken with food. In 2017, it was granted FDA approval for the treatment of chronic HCV infection in treatment-naive adults across all major genotypes (GT1-6) without cirrhosis. The decision was based on data from 9 registrational studies in AbbVie's clinical development program, which evaluated > 2300 patients in 27 countries across all major HCV genotypes and special populations.2

In 2019, glecaprevir/pibrentasvir was approved to shorten the once-daily treatment duration from 12 to 8 weeks in treatment-naïve, compensated cirrhotic, HCV patients across all genotypes. The label expansion was based on data from the phase 3b EXPEDITION-8 study, a single-arm, open-label study evaluating the safety and efficacy of glecaprevir/pibrentasvir in treatment-naïve adults with GT1-6 chronic HCV and compensated cirrhosis. In the study, an overall 98% of patients achieved a sustained virologic response 12 weeks after treatment (SVR12).3

Most recently, the multicenter, single-arm prospective phase 3 M20-350 clinical trial was designed to evaluate the safety and efficacy of glecaprevir/pibrentasvir 8-week treatment in adults and pediatric patients with acute HCV infection. The study enrolled 286 treatment-naïve adult patients with acute HCV infection across 70 locations globally. Patients received oral tablets of glecaprevir/pibrentasvir once daily for 8 weeks and were followed for 12 weeks after the end of treatment.1

The trial’s primary endpoint was the percentage of patients with SVR12 in the Intention-to-Treat (ITT) population. Secondary endpoints included the percentage of patients achieving SVR12 in the Modified ITT-Virologic Failure (mITT-VF) population, and the percentage of patients with on-treatment virologic failure and post-treatment relapse in the ITT population.1

According to the release from AbbVie, study results showed glecaprevir/pibrentasvir to be a highly efficacious treatment for people with acute HCV. The majority of the adverse events reported were mild or moderate in severity, with the most common adverse events being fatigue, asthenia, headache, and diarrhea.1

“MAVYRET has treated more than one million patients with HCV, but we recognize that a significant need remains for patients with acute infection," Roopal Thakkar, MD, executive vice president of research and development and chief scientific officer at AbbVie, said in a statement.1 "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."

References

1. AbbVie. U.S. FDA Approves Expanded Indication for AbbVie's MAVYRET® (Glecaprevir/Pibrentasvir) as First and Only Treatment for People with Acute Hepatitis C Virus. 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. AbbVie. AbbVie Receives U.S. FDA Approval of MAVYRET™ (glecaprevir/pibrentasvir) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT 1-6) in as Short as 8 Weeks. August 3, 2017. Accessed June 12, 2025. https://news.abbvie.com/2017-08-03-AbbVie-Receives-U-S-FDA-Approval-of-MAVYRET-TM-glecaprevir-pibrentasvir-for-the-Treatment-of-Chronic-Hepatitis-C-in-All-Major-Genotypes-GT-1-6-in-as-Short-as-8-Weeks.

3. AbbVie. AbbVie Receives FDA Approval of MAVYRET® (glecaprevir/pibrentasvir) to Shorten Treatment Duration to Eight Weeks for Treatment-Naïve Patients with Chronic Hepatitis C and Compensated Cirrhosis Across All Genotypes. September 26, 2019. Accessed June 12, 2025. https://news.abbvie.com/2019-09-26-AbbVie-Receives-FDA-Approval-of-MAVYRET-R-glecaprevir-pibrentasvir-to-Shorten-Treatment-Duration-to-Eight-Weeks-for-Treatment-Naive-Patients-with-Chronic-Hepatitis-C-and-Compensated-Cirrhosis-Across-All-Genotypes.