The Conversation (0)
- MAVIRET® (glecaprevir/pibrentasvir) is now approved in the European Union for the treatment of acute hepatitis C virus (HCV) infection with compensated liver disease (with or without cirrhosis) in adults and children aged 3 years and older.
- The approval gives clinicians an option to initiate treatment as soon as acute infection is confirmed, aiming to reduce delays in care and lower the risk of liver disease progression, cirrhosis and liver cancer.
- As the only treatment approved in the EU for both acute and chronic HCV infection, MAVIRET may help streamline care pathways and support broader efforts to advance HCV elimination goals.
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 Commission approved MAVIRET® (glecaprevirpibrentasvir), an oral pangenotypic direct-acting antiviral (DAA) therapy for the treatment of acute hepatitis C virus (HCV) infection in adults and children aged 3 years and older. With this approval, MAVIRET is now the only treatment approved in the European Union for both acute and chronic HCV infection.
"More than 12 million people in Europe live with hepatitis C, underscoring the need for earlier treatment," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "Today's European Commission approval of MAVIRET for acute hepatitis C infection enables earlier intervention, aiming to help more people access curative therapy at the time of diagnosis, while accelerating progress toward the goal of eliminating hepatitis C as a public health threat."
HCV is a highly infectious blood-borne disease that often goes undetected because people may not show symptoms.1 While HCV is curable, many people remain undiagnosed.1 If left untreated, HCV can progress to severe liver complications, including cirrhosis and end-stage liver disease.1 Current clinical guidance supports treating nearly all people with acute or chronic HCV infection.2
"People living with HCV infection frequently face delayed treatment, leading to loss to care and onward transmission," said Massimo Puoti, MD, director of the Infectious Diseases Department at Niguarda Hospital in Milan, Italy. "With this approval, healthcare professionals across the European Union now have an approved treatment option to treat patients at the earliest stage of infection, supporting prompt intervention and helping to reduce transmission, disease progression, and long-term complications for people living with hepatitis C."
Globally, HCV poses a substantial health and economic burden3, with over 200,000 deaths each year from liver cancer.1 People living with HCV are up to 17 times more likely to develop liver cancer than those unaffected.4
The approval was supported by data from the Phase 3, multicenter, single-arm prospective study evaluating the safety and efficacy of MAVIRET eight-week treatment regimen in patients with acute HCV infection.5 The study results showed MAVIRET to be a highly efficacious treatment for people with acute HCV.5 The majority of the adverse events reported were mild or moderate in severity.5 The most common adverse events were fatigue, diarrhea, headache, and asthenia.5
AbbVie continues to collaborate with global regulatory authorities to support access to MAVIRET for people living with acute HCV infection. MAVIRET is approved in the United States, Saudi Arabia, New Zealand, Canada, Taiwan, Australia 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 Study5
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). No on-treatment virologic failures or post-treatment relapses were observed, and post-treatment reinfection occurred in 0.7% of patients.
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 that were judged as treatment-related were observed among patients with acute HCV infection. The most commonly reported adverse reactions were fatigue (3%), asthenia (2%), headache (2%), and diarrhea (2%).
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 acute and chronic hepatitis C virus (HCV) infection in adults and children 3 years and older. 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 acute and chronic HCV infection in adults and children aged 3 years and older.
Important EU Safety Information:
CONTRAINDICATIONS:
MAVIRET is contraindicated in patients with severe hepatic impairment (Child-Pugh C). Concomitant use of MAVIRET is contraindicated 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
Patients with diabetes 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
In pooled Phase 2 and 3 clinical studies of adult subjects receiving MAVIRET with genotype 1, 2, 3, 4, 5 or 6 chronic HCV infection the most commonly reported adverse reactions were headache and fatigue.
In a Phase 3b clinical study of adult subjects receiving MAVIRET with genotype 1, 2, 3, or 4 acute HCV infection the most commonly reported adverse reactions were fatigue, asthenia, headache and diarrhoea.
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
Investors:
Liz Shea
liz.shea@abbvie.com
References
1 Hepatitis C. World Health Organization. Available at: https://www.who.int/news-room/fact-sheets/detail/hepatitis-c.
2 European Association for the Study of the Liver, et al. EASL recommendations on treatment of hepatitis C: Final update of the series. J Hepatol. 2020 Nov;73(5):1170-1218.
3 Cacoub P. Comment on Nuño Solinís R, et al. "Value of Treating All Stages of Chronic Hepatitis C: A Comprehensive Review of Clinical and Economic Evidence". Infect Dis Ther. 2017 Jun;6(2):297-301.
4 De Oliveria Andrade LJ., et al. Association between hepatitis C and hepatocellular carcinoma. J Glob Infect Dis. 2009 Jan;1(1):33-7.
5 MAVIRET® Summary of Product Characteristics. AbbVie; 2026.
View original content:https://www.prnewswire.com/news-releases/abbvie-announces-european-commission-approval-of-maviret-glecaprevirpibrentasvir-for-people-with-acute-hepatitis-c-virus-infection-302806984.html
SOURCE AbbVie
