AbbVie Announces Positive CHMP Opinion for MAVIRET® for the Treatment of Acute Hepatitis C Infection

• The positive opinion is supported by data from the Phase 3 M20-350 study evaluating the safety and efficacy of MAVIRET^® in adults with acute hepatitis C virus (HCV) infection.
• MAVIRET is a direct-acting antiviral (DAA) treatment currently approved in the European Union for chronic HCV infection in adults and children aged 3 years and older.
• Acute HCV infection is often asymptomatic, highlighting the importance of early diagnosis and treatment to help reduce transmission, long-term liver-related complications, and support HCV elimination efforts.

AbbVie (NYSE: ABBV) today announced thAbbVie.com%257C75c16df710a64168a35108deaf67e4c9%257C6f4d03de95514ba1a25bdce6f5ab7ace%257C0%257C0%257C639141057970707467%257CUnknown%257CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%253D%253D%257C0%257C%257C%257C%26sdata%3Du29oEw9EOgucjXe4U1rP7YMePSiJ7zKMnqebt0fQTbk%253D%26reserved%3D0&a=at+" target="_blank" rel="nofollow">at the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of MAVIRET® (glecaprevirpibrentasvir), an oral pangenotypic direct-acting antiviral (DAA) therapy for the treatment of acute hepatitis C infection (HCV) in adults and children aged 3 years and older. The final European Commission decision is expected in the third quarter of 2026. If approved, MAVIRET would be indicated for both acute and chronic hepatitis C (HCV) infection in the European Union.

"The CHMP positive opinion for MAVIRET in acute hepatitis C represents an important step toward enabling earlier treatment, at a stage when the disease is often asymptomatic and may go undiagnosed," said Primal Kaur, M.D., senior vice president, global development of immunology, neuroscience, eye care and specialty at AbbVie. "This milestone aligns with global clinical guidance supporting treatment of suitable people with acute or chronic HCV infection. It also has the potential to help address unmet need, reduce the risk of onward transmission, and support global HCV elimination efforts."

HCV is a serious blood-borne virus that can progress to chronic liver disease when left untreated.¹ Acute HCV infection is frequently asymptomatic, and many individuals remain unaware of their infection until it has progressed to a later stage.¹ Global clinical guidance supports treatment of nearly all people with HCV infection, reflecting the importance of early diagnosis and timely initiation of therapy.² The newly released 2026 WHO Global Hepatitis Report further underscores this need, highlighting that diagnosis and treatment coverage remain far below global targets and reinforcing the importance of earlier testing and rapid linkage to care.³

The positive opinion is supported by data from the Phase 3, multicenter, single-arm prospective M20-350 study evaluating the safety and efficacy of MAVIRET eight-week treatment in adults with acute HCV infection.⁴ In the study, MAVIRET demonstrated a 96% cure rate, as measured by sustained virologic response at 12 weeks after treatment (SVR₁₂), with a safety profile generally consistent with prior experience; the most common adverse events were fatigue, diarrhea, headache and asthenia.⁴

"In clinical practice, acute HCV can be challenging to manage, as it is often identified incidentally and patients may be lost to follow-up before treatment is initiated," said Prof. Christoph Sarrazin, chief physician at St. Josef's Hospital Wiesbaden, Germany; head of the Wiesbaden Liver Center; and board member of the German Liver Foundation. "This treatment option could help streamline care pathways and support timely initiation of therapy once infection is confirmed, an important step for both individual patient outcomes and broader public health efforts."

AbbVie continues to collaborate with global regulatory authorities to support access to MAVIRET for people living with acute HCV infection. MAVIRET is approved in Canada, Australia, the United States (as MAVYRET^®), Saudi Arabia, New Zealand, Taiwan, and Argentina for the treatment of acute and chronic HCV infection in adults and children aged 3 years and older.

About the Phase 3 M20-350 Study⁴
The multicenter, single-arm prospective Phase 3 M20-350 clinical trial was designed to evaluate the safety and efficacy of MAVIRET (glecaprevir/pibrentasvir) eight-week treatment in adults and adolescent participants aged 12 years and older with acute HCV infection. The study enrolled 286 treatment-naïve adult patients with acute HCV infection across 70 locations globally. Patients received oral tablets of MAVIRET once daily for eight weeks and were followed for 12 weeks after the end of treatment. The primary endpoint was the percentage of patients with sustained virological response 12 weeks post-treatment (SVR₁₂) in the intent-to-treat population (ITT). The study met its primary endpoint, with 96.2% of patients in the ITT population achieving SVR₁₂ (p<0.0001). The key secondary endpoint was also met with 100% of patients in the modified ITT-Virologic Failure population achieving SVR₁₂ (p<0.0001).

The overall safety profile observed in the M20-350 study was similar to that observed in patients with chronic HCV infection. No serious adverse reactions or adverse reactions leading to treatment discontinuation were observed among patients with acute HCV infection. The most commonly reported adverse reactions were fatigue (3%), asthenia (2%), headache (2%), and diarrhea (2%). No on-treatment virologic failures or post-treatment relapses were observed, and post-treatment reinfection occurred in 0.7% of patients.

More information on the study can be found at www.clinicaltrials.gov (NCT04903626).

About MAVIRET® (glecaprevir/pibrentasvir)
MAVIRET® (glecaprevir/pibrentasvir) is an oral, pangenotypic, once-daily, ribavirin-free direct-acting antiviral treatment for chronic hepatitis C virus (HCV) infection. MAVIRET combines glecaprevir, an NS3/4A protease inhibitor, and pibrentasvir, an NS5A inhibitor, and is administered once daily with food.

In the European Union, MAVIRET is approved for the treatment of chronic HCV infection in adults and children aged 3 years and older. In adults and adolescents aged 12 years and older, or children weighing at least 45 kg, the recommended dose is three 100 mg/40 mg tablets once daily with food. In children aged 3 years to less than 12 years and weighing 12 kg to less than 45 kg, MAVIRET is available as coated granules in sachets, with dosing based on body weight.

MAVIRET is approved for use in patients with chronic HCV infection with compensated liver disease, including those with compensated cirrhosis, and in patients with severe renal impairment, including those on dialysis, according to the approved EU label.

Important EU Safety Information:

CONTRAINDICATIONS:
MAVIRET is contraindicated in patients with severe hepatic impairment (Child-Pugh C). Concomitant use with atazanavir-containing products, atorvastatin, simvastatin, dabigatran etexilate, ethinyl oestradiol-containing products, strong P-gp and CYP3A inducers (e.g., rifampicin, carbamazepine, St. John's wort [Hypericum perforatum], phenobarbital, phenytoin, and primidone).

SPECIAL WARNINGS AND PRECAUTIONS FOR USE:
Hepatitis B virus reactivation
Cases of hepatitis B virus (HBV) reactivation, some of them fatal, have been reported during or after treatment with direct-acting antiviral agents. HBV screening should be performed in all patients before initiation of treatment. HBV/HCV co-infected patients are at risk of HBV reactivation, and should, therefore, be monitored and managed according to current clinical guidelines.
Hepatic impairment
MAVIRET is not recommended in patients with moderate hepatic impairment (Child-Pugh B).
Patients who failed a prior regimen containing an NS5A and/or an NS3/4A inhibitor
MAVIRET is not recommended for the re-treatment of patients with prior exposure to NS3/4A and/or NS5A inhibitors.
Use in diabetic patients
Diabetics may experience improved glucose control and potential symptomatic hypoglycaemia after initiating HCV direct acting antiviral treatment. Glucose levels should be closely monitored, particularly within the first 3 months of treatment.

ADVERSE REACTIONS
Most common (≥10%) adverse reactions for MAVIRET were headache and fatigue.

This is not a complete summary of all safety information. See MAVIRET full summary of product characteristics (SmPC) at www.ema.europa.eu.
Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVie in Hepatitis C
At AbbVie, our mission begins with putting patients at the center of everything we do. We engage with those affected by hepatitis C (HCV) to understand their needs and work alongside partners and healthcare professionals worldwide to advance solutions and accelerate the elimination of HCV. By raising the standard of care and focusing on closing gaps in the care cascade, we aim for a remarkable impact on patients and transformative change in communities. Every step today brings us closer to global HCV elimination. For more information, visit www.abbvie.com.

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @AbbVie on LinkedIn, Facebook, Instagram, X, and YouTube.

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. 

Contact(s):

Global Media:
Amber Landis
+1 (231) 557-6596
amber.landis@abbvie.com

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