By Fineline Cube 
AbbVie Inc. (NYSE: ABBV) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending approval of MAVIRET (glecaprevir/pibrentasvir) for the treatment of acute hepatitis C virus (HCV) infection in adults and children aged 3 years and older.
Regulatory Pathway & Timeline
| Parameter | Detail |
|---|---|
| Drug Name | MAVIRET (glecaprevir/pibrentasvir) |
| Indication | Acute hepatitis C infection (all genotypes) |
| Patient Population | Adults and children ≥3 years of age |
| Regulatory Body | European Medicines Agency (EMA) – CHMP |
| Current Status | Positive opinion adopted (May 22, 2026) |
| Expected Final Decision | European Commission approval expected Q3 2026 |
| Therapy Class | Oral pangenotypic direct-acting antiviral (DAA) |
Clinical Evidence from Phase 3 M20-350 Study
Efficacy Outcomes
- Study Design: Phase 3, multicenter, single-arm prospective trial
- Treatment Duration: 8-week regimen
- Primary Endpoint: Sustained virologic response at 12 weeks post-treatment (SVR12)
- Cure Rate: 96% SVR12 achieved in adult patients with acute HCV infection
- Genotype Coverage: Pangenotypic activity across all major HCV genotypes
Safety Profile
- Overall Safety: Generally consistent with previously established MAVIRET safety experience
- Most Common Adverse Events:
- Fatigue
- Diarrhea
- Headache
- Asthenia (weakness)
- Pediatric Data: Safety and efficacy extrapolated to children aged 3+ based on established pharmacokinetic and pharmacodynamic relationships
Strategic Significance & Market Impact
This regulatory milestone represents a significant expansion of MAVIRET’s therapeutic scope, extending from chronic to acute hepatitis C infection. Early intervention in acute HCV presents a critical opportunity to prevent disease progression to chronic infection, which occurs in approximately 75-85% of untreated cases.
The 96% cure rate with an abbreviated 8-week treatment course demonstrates exceptional efficacy in the acute setting, potentially offering healthcare systems substantial cost savings by preventing long-term complications including cirrhosis, liver failure, and hepatocellular carcinoma.
For AbbVie, this indication reinforces MAVIRET’s position as a comprehensive HCV solution across the disease spectrum and patient demographics. The pediatric approval component addresses an underserved population, as few antiviral therapies are approved for young children with HCV infection.
Global HCV Treatment Landscape
With an estimated 58 million people globally living with chronic HCV and approximately 1.5 million new infections annually, effective acute-phase interventions could significantly reduce the global disease burden. The WHO’s elimination targets for viral hepatitis by 2030 make early, highly effective treatments like MAVIRET strategically important public health tools.
AbbVie’s pangenotypic DAA therapy, already approved for chronic HCV in numerous markets worldwide, now positions itself as a potential first-line option for acute infection management across Europe pending final EC approval.
Forward-Looking Statements
This brief contains forward-looking statements regarding regulatory approvals, clinical development, and commercial expectations. Actual results may differ due to risks including final regulatory decisions, market competition, pricing negotiations, and evolving treatment guidelines.-Fineline Info & Tech