MAVIRET® receives Health Canada Approval for the Treatment of Acute Hepatitis C Virus

MAVIRET® receives Health Canada Approval for the Treatment of Acute Hepatitis C Virus

• MAVIRET is the first and only oral eight-week pan-genotypic treatment option approved for people with acute or chronic hepatitis C virus (HCV) in Canada
• MAVIRET received approval through Health Canada's Priority Review process, based on data from the Phase 3 M20-350 Studyestablishing it to be a highly efficacious treatment for people with acute hepatitis C.
• The approval supports global clinical guidelines to advance testing and treatment for people with HCV regardless of chronicity and supports the World Health Organization's goal to eliminate HCV by 2030.
• Universal treatment of people with acute or chronic HCV can significantly reduce the spread of the disease.¹

MONTREAL, Jan. 6, 2026 /CNW/ - AbbVie (NYSE: ABBV) announced today that Health Canada has approved MAVIRET (glecaprevir/pibrentasvir tablets) for the treatment of acute and chronic hepatitis C virus (HCV) infection in adults and pediatric patients 3 years of age and older and weighing ≥ 12 kg.² It is the first and only oral eight-week pan-genotypic treatment option approved in Canada.

Hepatitis C is a liver infection caused by the hepatitis C virus, impacting over 214,000 Canadians.³ Acute hepatitis C is a shorter-term illness that occurs within the first six months of exposure.⁴ If left untreated, it can lead to liver damage. Hepatitis C does not affect all people in Canada equally with different populations disproportionately affected.³

"Early detection and treatment of acute hepatitis C is critical to achieving the World Health Organization objective of eliminating HCV as a public health concern by 2030," says Dr. Brian Conway, Medical Director of the Vancouver Infectious Diseases Centre and Adjunct Professor in the Faculty of Health Sciences at Simon Fraser University. "Not only will it lead to the treatment of this potentially life-threatening infection at the earliest possible time, but it will also allow us to interrupt transmission networks that sustain the HCV pandemic in a more effective manner."

With this approval, Canadian healthcare providers are now empowered to start treatment for acute HCV as soon as the diagnosis is made.

"With five years left to reach the elimination of hepatitis C as a public health threat, we need every tool that reduces harm and increases access," says Jennifer van Gennip, Executive Director of Action Hepatitis Canada. "Being able to treat acute hepatitis C can help interrupt transmission and protect people and communities. Health Canada's approval is a positive step, and it underscores the continued need for prevention and timely linkage to equitable care if we're going to reach elimination by 2030."

The acute hepatitis C indication for MAVIRET was approved by Health Canada through the Priority Review pathway, based on data from the Phase 3, multicenter, single-arm prospective study evaluating the safety and efficacy of MAVIRET eight-week treatment in adults with acute hepatitis C infection.² The study results demonstrated MAVIRET to be a highly efficacious treatment for people with acute hepatitis C. The most reported adverse events were diarrhea, fatigue and nasopharyngitis.²

"This approval addresses an unmet need for patients living with acute hepatitis C, supporting the treatment-as-prevention approach to enhance hepatitis C care in Canada," says Rami Fayed, Vice President and General Manager of AbbVie Canada. "Collaboration and prevention are essential in our fight against hepatitis C. AbbVie remains committed in our efforts to help make hepatitis C elimination a reality through our work with healthcare partners, patient organisations and communities as we believe that we can only solve our greatest health challenges together. 

About the Phase 3 M20-350 Study²
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 patients 12 years or 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 Intention-to-Treat (ITT) population. Secondary endpoints included the percentage of patients achieving SVR12 in the Modified ITT-Virologic Failure (mITT-VF) population, and the percentage of patients with on-treatment virologic failure and post-treatment relapse in the ITT population.

About MAVIRET^® (glecaprevir/pibrentasvir tablets)
MAVIRET is approved by Health Canada for the treatment of acute and chronic hepatitis C virus (HCV) infection in adults and children 3 years and older across all major genotypes (GT1-6).

MAVIRET is a pan-genotypic, once-daily, ribavirin-free treatment that combines glecaprevir (100 mg), an NS3/4A protease inhibitor, and pibrentasvir (40 mg), an NS5A inhibitor, dosed once-daily as three oral tablets. The pediatric formulation consists of MAVIRET coated granules in sachet. Each sachet contains 50 mg of glecaprevir and 20 mg of pibrentasvir.

MAVIRET is an 8-week, pan-genotypic option for patients without cirrhosis and who are new to treatment. MAVIRET is also approved as a treatment for patients with specific treatment challenges, including those with compensated cirrhosis across all major genotypes, and those who previously had limited treatment options, such as patients with severe chronic kidney disease (CKD). MAVIRET is a pan-genotypic treatment approved for use in patients across all stages of CKD.

Please consult the MAVIRET product monograph for more information.

About AbbVie in Virology
A global leader in the fight to treat HCV, AbbVie is relentlessly pursuing breakthrough innovations in the treatment of viruses with difficult solutions such as hepatitis C. We've expanded hepatitis C treatment and resources through AbbVie's innovative partnerships to support Canada's HCV elimination goal by 2030. Since 2021, we have supported over 100 HCV micro-elimination projects in the community. AbbVie offers a cure for people infected by hepatitis C and focuses on diseases with high unmet need. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our virology medicines.

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.

For more information about AbbVie, please visit us at www.abbvie.ca.

Follow AbbVie Canada on Instagram or LinkedIn. For more information on AbbVie's complete Virology portfolio, please visit http://www.abbvie.ca/. 

SOURCE AbbVie Canada