Mavyret: Acute HCV Treatment Approval
- the Food and Drug Governance has approved a label expansion for Mavyret (glecaprevir/pibrentasvir) to include the treatment of acute hepatitis C virus, according to AbbVie, the manufacturer.
- Mavyret, an oral pangenotypic antiviral therapy, was initially approved for chronic hepatitis C virus in 2017.
- The approval was supported by phase 3 clinical trial results, which showed the primary endpoint was the percentage of patients with sustained virological response 12 weeks after treatment.
The FDA has broadened the scope of Mavyret to now treat acute hepatitis C, marking a significant stride in immediate viral management. This pivotal label expansion offers an eight-week therapy, perhaps impacting the global initiative to eradicate hepatitis C by 2030. Clinical trials showed a high percentage of patients achieving a sustained virological response after treatment with the oral pangenotypic antiviral therapy.Approved initially for chronic HCV in 2017, Mavyret has already helped over a million patients. This news, first reported by News Directory 3, underscores the importance of quick intervention in managing acute hepatitis C.Discover what’s next in early treatment strategies and the ongoing pursuit of a world without hepatitis C.
FDA expands Mavyret label for acute hepatitis C
Updated June 13, 2025
the Food and Drug Governance has approved a label expansion for Mavyret (glecaprevir/pibrentasvir) to include the treatment of acute hepatitis C virus, according to AbbVie, the manufacturer.
The FDA approved an expanded label for Mavyret to treat acute hepatitis C.
Mavyret, an oral pangenotypic antiviral therapy, was initially approved for chronic hepatitis C virus in 2017. The treatment course is eight weeks. The FDA previously granted Mavyret breakthrough therapy designation for acute hepatitis C.
The approval was supported by phase 3 clinical trial results, which showed the primary endpoint was the percentage of patients with sustained virological response 12 weeks after treatment.
Most adverse events reported were mild or moderate.
“Mavyret has treated more than 1 million patients with hepatitis C virus, but we recognize that a significant need remains for patients with acute infection,” Roopal Thakkar, MD, executive vice president for research and advancement and chief scientific officer at AbbVie, said. “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.”
What’s next
The expanded approval of Mavyret is expected to facilitate earlier treatment for individuals with acute hepatitis C,perhaps contributing to global efforts to eliminate the virus by 2030.