CHMP Supports MAVIRET Approval for Acute Hepatitis C

AbbVie announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) 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 three years and older, potentially expanding access to earlier treatment for a disease that often remains undiagnosed in its initial stages.

If approved by the European Commission, which is expected to make a final decision in the third quarter of 2026, MAVIRET would become indicated in the European Union for both acute and chronic hepatitis C infection. The therapy is already approved in Europe for chronic HCV infection and is widely used as an oral pangenotypic direct-acting antiviral (DAA) treatment targeting all major hepatitis C genotypes.

The CHMP recommendation marks an important regulatory step in efforts to improve early intervention for hepatitis C, a blood-borne viral infection that can silently progress to severe liver complications when left untreated. Acute HCV infection is frequently asymptomatic, meaning many individuals remain unaware they have contracted the virus until it develops into chronic liver disease, cirrhosis, or other serious complications.

Public health experts increasingly emphasize early diagnosis and treatment as central to global hepatitis elimination strategies. Current international guidance supports treating nearly all individuals diagnosed with HCV infection, regardless of whether the infection is acute or chronic, to reduce disease burden and prevent onward transmission.

AbbVie said the positive CHMP opinion aligns with evolving clinical recommendations supporting timely treatment initiation. The company highlighted the potential role of earlier intervention in reducing transmission risk, improving patient outcomes, and helping countries move closer to global hepatitis elimination targets.

Primal Kaur, senior vice president of global development for immunology, neuroscience, eye care, and specialty at AbbVie, described the recommendation as an important milestone toward enabling earlier treatment at a stage when hepatitis C frequently goes undetected.

The regulatory recommendation is supported by results from the Phase 3 M20-350 study, a multicenter, prospective, single-arm trial evaluating an eight-week course of MAVIRET in adults with acute HCV infection.

According to trial findings, MAVIRET demonstrated a 96% cure rate, measured by sustained virologic response at 12 weeks after treatment completion (SVR12), a widely accepted benchmark indicating successful viral clearance. The treatment’s safety profile was generally consistent with prior studies of the therapy, with the most frequently reported side effects including fatigue, diarrhea, headache, and asthenia.

Experts in liver disease said earlier access to treatment could simplify clinical management and reduce the risk of patients falling out of care after diagnosis.

Prof. Christoph Sarrazin, chief physician at St. Josef’s Hospital Wiesbaden in Germany, head of the Wiesbaden Liver Center, and board member of the German Liver Foundation, said acute HCV is often detected incidentally during routine testing or medical evaluations, creating challenges in ensuring patients receive timely therapy before being lost to follow-up. He noted that a treatment specifically indicated for acute infection could help streamline care pathways and accelerate treatment initiation.

The newly released 2026 World Health Organization Global Hepatitis Report has underscored persistent challenges in hepatitis diagnosis and treatment worldwide, warning that testing and treatment rates remain below global targets and emphasizing the need for improved linkage to care.

MAVIRET is already approved for acute and chronic hepatitis C infection in several markets, including Canada, Australia, the United States, Saudi Arabia, New Zealand, Taiwan, and Argentina. AbbVie said it continues to work with regulatory authorities globally to expand access to the therapy for people living with acute HCV infection.

If approved in Europe, MAVIRET could provide physicians with a broader treatment option to address hepatitis C earlier, potentially improving outcomes while supporting wider public health efforts to eliminate the disease.