Summary

Health Canada has authorized MAVIRET® as the first 8-week oral treatment for acute Hepatitis C in adults and children, allowing for immediate care upon diagnosis. While the treatment costs approximately $14,000, it is widely covered by provincial health plans to support Canada’s goal of eliminating the virus by 2030.

Canada has taken a pivotal step toward its goal of eliminating hepatitis C as a public health threat. This week, Health Canada authorized MAVIRET®(glecaprevir/pibrentasvir) as the country’s first and only oral eight-week treatment option for both acute and chronic hepatitis C virus (HCV) in adults and children as young as three years old.

Interrupting the Chain of Infection

For years, the medical community focused primarily on treating “chronic” hepatitis C, the long-term version of the illness. However, acute hepatitis C occurs within the first six months of exposure. While some cases resolve on their own, many become chronic, leading to severe liver damage if left untreated.

The new authorization allows healthcare providers to start the 8-week MAVIRET regimen immediately upon diagnosis of an acute infection, rather than waiting to see if the virus becomes chronic. This “treatment-as-prevention” approach is designed to clear the virus earlier and, crucially, stop the spread of HCV within communities.

“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.

Coverage and Clinical Access

While the list price for an 8-week course of MAVIRET is approximately $14,000 USD, the vast majority of Canadians do not pay this out of pocket. As a public health priority, the treatment is widely covered by provincial and territorial health insurance plans under “Special Authorization” or “Limited Use” criteria.

Unlike many hospital-only treatments, MAVIRET is an oral medication taken at home once daily for 8 weeks. Because it is highly effective, curing over 95% of patients, it is now being integrated into standard care protocols across Canada to ensure rapid access following a positive test result.

Fast-Tracked for Public Health

Because of its potential to curb the spread of disease, MAVIRET received a Priority Review from Health Canada. The authorization was supported by the Phase 3 M20-350 study, which proved the eight-week treatment is highly effective for those with acute infections.

Key Details of the New Authorization:

  • Duration: A short, 8-week course for most patients.
  • Eligibility: Adults and pediatric patients (3+ years old, weighing at least 12 kg).
  • Safety: The most common side effects reported were fatigue, diarrhea, and nasopharyngitis (common cold symptoms).
  • Oral Administration: Taken once daily as three tablets for adults, or granules for younger children.

Closing the Gap to 2030

With only five years remaining to reach the World Health Organization’s 2030 elimination targets, advocates say this tool is arriving at a critical time. Currently, over 214,000 Canadians are living with hepatitis C, and many remain unaware of their status.

By removing the wait time between diagnosis and treatment, Canada moves one step closer to a future where hepatitis C is a memory rather than a public health crisis.

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