FDA Expands Indication for AbbVie’s Antiviral as First Treatment for People With Acute Hepatitis C

This week, the FDA approved a label expansion for glecaprevir/pibrentasvir (Mavyret), an oral pangenotypic direct acting antiviral (DAA) therapy. It is now approved for the treatment of adults and pediatric patients 3 years and older with acute or chronic hepatitis C (HCV) infection without cirrhosis or with compensated cirrhosis. With this approval, glecaprevir/pibrentasvir is 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, Coalition for Global Hepatitis Elimination, said in a statement. "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."¹

Phase 3 Data

The label expansion was supported by data from the phase 3, multicenter, single-arm prospective study evaluating the safety and efficacy of glecaprevir/pibrentasvir 8-week treatment in adults with acute HCV infection.The study results showed the antiviral to be a highly efficacious treatment for people with acute HCV.¹

The study enrolled 286 treatment-naïve adult patients with acute HCV infection across 70 locations globally. Patients received oral tablets once daily for 8 weeks and were followed for 12 weeks after the end of treatment. The primary endpoint 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 (mITT-VF) population, and the percentage of patients with on-treatment virologic failure and post-treatment relapse in the ITT population.

The majority of the adverse events reported were mild or moderate in severity.¹ The most common adverse events were fatigue, asthenia, headache, and diarrhea.¹

Screen and Treat

With this approval, providers can now treat HCV patients immediately at the time of diagnosis. American Association for the Study of Liver Diseases and Infectious Diseases Society of America (AASLD/IDSA) have partnered together to create a “screen and treat” algorithm. The algorithm provides guidance for clinicians to show them how to carry out this model and expedite the time needed to get tested and on HCV medication.

The strategy here is to get more people who are infected into the continuum of care right away to not only address their infection, but also prevent other infections.

What You Need to Know

The FDA has expanded the label for glecaprevir/pibrentasvir (Mavyret), making it the first and only direct-acting antiviral (DAA) therapy approved to treat both adults and children (ages 3 and older) with acute or chronic HCV.

The expansion enables immediate treatment at diagnosis and supports the development of “screen and treat” algorithms, aiming to simplify care pathways and reach vulnerable populations more effectively—minimizing loss to follow-up and enhancing public health efforts.

A Phase 3, multicenter study with 286 treatment-naïve adults confirmed the safety and high efficacy of an 8-week Mavyret regimen. Most adverse events were mild to moderate, supporting its usability in broader patient populations.

In a previous interview with Contagion, Andrew Aronsohn, MD, associate professor of Medicine, University of Chicago Medical Center, and one of the chairs of the AASLD/IDSA HCV panel, discussed the offered further insights into this treatment strategy.

“I think what's really important to think about when caring for people with hep C—both on an individual and a population basis—is that oftentimes, we're really focusing on helping very vulnerable populations,” said Aronsohn. “So these are folks that may be struggling with addiction; these are folks that may have difficulty with transportation or navigating huge health systems, or maybe undomiciled. Every time you set up another step for them to have to follow-up, you risking losing them to follow-up. There's a lot of data in HIV and even in hep C, that if you put this all into 1 visit and you can work on some education and actually give them medication in hand before they go out the door it is beneficial."

"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," Roopal Thakkar, MD, executive vice president, research and development, chief scientific officer, AbbVie, said in a statement.

For those interested in downloading the AASLD/IDSA algorithm, readers can go here.