FDA

Mavyret now approved for the treatment of acute hepatitis C infection

June 19, 2025

FDA approved Mavyret (glecaprevir/pibrentasvir) for the treatment of adults and pediatric patients ≥3 years of age with acute or chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A).

Mavyret is also indicated for the treatment of adult and pediatric patients ≥3 years of age with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both.

Efficacy

The efficacy of Mavyret in subjects with documented acute HCV infection was evaluated in M20-350 (NCT04903626), a single-arm, open-label study of 286 adults who were treatment-naïve for the current infection and received Mavyret for 8 weeks. The overall rate of sustained virological response 12 weeks post treatment (SVR12) was 96%, with no patients experiencing virologic failure. Two patients who didn’t achieve SVR12 were likely reinfected with HCV based on having different HCV genotypes or subtype clades between baseline and follow-up periods.

Safety

The most commonly reported adverse reactions (≥10%) in patients receiving Mavyret are headache and fatigue.

Sources:

Mavyret (glecaprevir and pibrentasivir) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209394s019,215110s005lbl.pdf Revised June 2025. Accessed June 17, 2025.

US FDA approves expanded indication for AbbVie’s Mavyret® (glecaprevir/pibrentasvir) as first and only treatment for people with acute hepatitis C virus. [News release]. 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