Mavyret achieved a 96% cure rate in patients with acute hepatitis C following an 8-week oral treatment regimen.

The FDA has expanded the indication for glecaprevir/pibrentasvir (Mavyret) in its approval as the first and only oral, 8-week, pangenotypic regimen for both acute and chronic hepatitis C virus (HCV) infection in patients aged 3 years and older without cirrhosis or with compensated cirrhosis. This decision permits treatment at the time of diagnosis, which addresses a key gap in early management and aligns with international guidance that recommends treatment regardless of disease chronicity.

HCV remains a curable yet underdiagnosed viral infection. Acute infection is frequently asymptomatic, which can lead to delayed identification and increased risk of progression to cirrhosis, hepatocellular carcinoma, or other liver-related complications. The long-term economic impact of untreated HCV in the U.S. is estimated at approximately $120 billion through 2035. Early antiviral therapy may mitigate this burden.

FDA approval was supported by results from the phase 3, single-arm, multicenter M20-350 trial (NCT04903626), which enrolled 286 treatment-naïve adults with acute HCV. Participants received daily oral glecaprevir/pibrentasvir for 8 weeks. The primary endpoint—sustained virologic response at 12 weeks posttreatment—was achieved in 96% of participants. Adverse events–most commonly fatigue, asthenia, headache, and diarrhea–were predominantly mild or moderate.

The FDA previously granted Breakthrough Therapy Designation for this indication based on preliminary evidence that suggested improved outcomes relative to existing options. The updated label expands access to treatment and supports test-and-treat models that may facilitate progress toward HCV elimination goals that are set for 2030. Current projections suggest the U.S. and most high-income countries are unlikely to meet this target before 2050.

According to AbbVie, more than 1 million patients have been treated with glecaprevir/pibrentasvir to date. Broader implementation of simplified treatment pathways may further reduce HCV transmission and disease burden. Mavyret remains contraindicated in patients with moderate to severe hepatic impairment or in those receiving atazanavir or rifampin. Clinicians are advised to screen for hepatitis B virus reactivation risk prior to initiating therapy.

Source: AbbVie