What is AbbVie (NYSE:ABBV) announcing about Maviret in Europe?

AbbVie reported that the EMA’s CHMP gave a positive opinion recommending approval of Maviret (glecaprevir/pibrentasvir) for treating acute hepatitis C in patients aged 3 years and older. If approved by the European Commission, this would expand Maviret’s EU label from chronic HCV to include acute infections.

What clinical data supports this recommendation?

The Phase 3 M20-350 trial evaluated 286 treatment-naïve patients with acute HCV on an eight-week regimen. The study achieved a 96.2% sustained virologic response at 12 weeks (SVR12), which is considered a virologic cure benchmark.

What is the safety profile of Maviret for acute HCV?

Maviret was generally well-tolerated in acute patients, consistent with chronic HCV trials. Common side effects included fatigue, asthenia, headache, and diarrhea, each affecting roughly 2–3% of participants.

How does this expansion fit into public health strategies?

Early intervention in acute HCV is critical because infections are often asymptomatic, leading to chronic progression and ongoing viral transmission. Expanding direct-acting antivirals to acute cases supports global viral elimination efforts.

Who can potentially benefit from this expanded indication?

Both adult and pediatric patients aged 3 years and older could receive treatment for acute HCV if the European Commission approves the expanded label.

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AbbVie secures positive EU panel backing to expand Maviret to acute Hepatitis C

Written by Heidi Cuthbert Published May. 22 2026Last Updated May. 22 2026

AbbVie (NYSE:ABBV) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Maviret (glecaprevir/pibrentasvir) for the treatment of acute hepatitis C virus (HCV) infection.

The recommendation covers both adult and pediatric patients aged 3 years and older.

If finalized by the European Commission, the decision will expand Maviret's existing European Union label—which is currently restricted to chronic HCV—to encompass both acute and chronic phases of the virus.

The regulatory milestone is supported by data from the open-label Phase 3 M20-350 clinical trial, which evaluated an eight-week treatment course of the oral, once-daily pangenotypic direct-acting antiviral therapy in 286 treatment-naïve patients.

The study met its primary efficacy endpoint, demonstrating a 96.2% sustained virologic response rate 12 weeks post-treatment (SVR12), which is considered the clinical benchmark for a virologic cure.

The safety profile observed in the acute patient population was generally consistent with historical data established across chronic HCV trials.

The most frequent adverse reactions reported during the study included fatigue, asthenia, headache, and diarrhea, each occurring in approximately 2% to 3% of participants.

Public health frameworks and global clinical guidance have increasingly shifted toward early intervention for HCV.

Acute infections are frequently asymptomatic, creating a diagnostic gap that often leads to chronic progression, long-term liver pathology, and ongoing viral transmission.

Expanding direct-acting antiviral treatments to the acute stage is viewed by clinicians as an important component of global viral elimination initiatives.

A final marketing authorization decision from the European Commission is expected in the third quarter of 2026.