Health Canada Approves MAVIRET as First Eight-Week Treatment for Acute Hepatitis C
核心洞察
Health Canada has approved MAVIRET (glecaprevir/pibrentasvir) as the first and only oral eight-week pan-genotypic treatment for acute hepatitis C virus infection in Canada.
The approval was granted through Priority Review based on Phase 3 M20-350 study data showing high efficacy in 286 treatment-naïve patients with acute HCV infection.
This milestone supports the World Health Organization's goal to eliminate hepatitis C by 2030 and enables immediate treatment upon diagnosis of acute infection.
AbbVie (搜索) announced 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 weighing ≥12 kg. The approval marks MAVIRET as the first and only oral eight-week pan-genotypic treatment option approved for people with acute or chronic hepatitis C virus in Canada.
The approval was granted through Health Canada's Priority Review process, based on data from the Phase 3 M20-350 Study demonstrating high efficacy for treating acute hepatitis C. This regulatory milestone supports global clinical guidelines to advance testing and treatment for people with HCV regardless of chronicity and aligns with the World Health Organization's goal to eliminate HCV by 2030.
Clinical Impact and Public Health Significance
Hepatitis C impacts over 214,000 Canadians, with acute hepatitis C representing a shorter-term illness that occurs within the first six months of exposure. If left untreated, acute infection can lead to liver damage. The disease does not affect all populations equally, with certain groups disproportionately affected.
"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," said 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 can now initiate treatment for acute HCV immediately upon diagnosis, supporting a treatment-as-prevention approach to enhance hepatitis C care.
Phase 3 Clinical Trial Results
The multicenter, single-arm prospective Phase 3 M20-350 clinical trial evaluated the safety and efficacy of MAVIRET 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 treatment completion. The primary endpoint measured the percentage of patients with sustained virological response 12 weeks post-treatment (SVR12) in the Intention-to-Treat population. Secondary endpoints included SVR12 rates in the Modified ITT-Virologic Failure population and rates of on-treatment virologic failure and post-treatment relapse.
The study results demonstrated MAVIRET to be a highly efficacious treatment for people with acute hepatitis C. The most commonly reported adverse events were diarrhea, fatigue and nasopharyngitis.
Drug Characteristics and Formulation
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 (搜索) inhibitor. The standard formulation is dosed as three oral tablets once daily. For pediatric patients, MAVIRET is available as coated granules in sachets, with each sachet containing 50 mg of glecaprevir and 20 mg of pibrentasvir.
The drug is approved for treatment across all major genotypes (GT1-6) and represents an 8-week pan-genotypic option for patients without cirrhosis who are new to treatment. MAVIRET is also approved for patients with specific treatment challenges, including those with compensated cirrhosis across all major genotypes and patients with severe chronic kidney disease, making it suitable for use across all stages of CKD.
Elimination Goals and Access
"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," said Jennifer van Gennip, Executive Director of Action Hepatitis Canada (搜索). "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."
Universal treatment of people with acute or chronic HCV can significantly reduce disease transmission. Since 2021, AbbVie (搜索) has supported over 100 HCV micro-elimination projects in the community as part of efforts to support Canada's HCV elimination goal by 2030.
"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," said Rami Fayed, Vice President and General Manager of AbbVie (搜索) 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."