MAVIRET Approval Signals Major Shift in Canada's Hepatitis C Strategy

MONTREAL, QC – January 06, 2026 – Health Canada has approved a treatment that experts believe could significantly accelerate the nation's effort to eliminate hepatitis C, providing a powerful new tool to stop the virus in its earliest stages. AbbVie’s MAVIRET is now the first and only oral, eight-week treatment authorized for acute hepatitis C virus (HCV) infection, a move that enables doctors to treat the disease immediately upon diagnosis rather than waiting for it to become a chronic, lifelong condition.

The approval, granted through Health Canada's Priority Review process, extends to adults and children as young as three. It marks a pivotal shift towards a "treatment-as-prevention" strategy, a cornerstone of the World Health Organization's (WHO) goal to eliminate HCV as a public health threat by 2030. With over 214,000 Canadians living with hepatitis C and thousands of new infections annually, the ability to cure the virus before it takes permanent hold is being hailed as a public health game-changer.

A New Frontline Defense Against Transmission

Hepatitis C is a viral infection of the liver. While some individuals can clear the virus on their own, for most, an acute infection—the first six months after exposure—transitions into a chronic illness that can lead to severe liver damage, cirrhosis, and cancer. The challenge has been that acute HCV is often asymptomatic, allowing it to spread silently. In 2021 alone, Canada saw an estimated 8,212 new HCV infections.

The approval of MAVIRET (glecaprevir/pibrentasvir) for acute cases directly targets this cycle of transmission. By offering a highly effective cure in just eight weeks, the treatment can prevent an individual's infection from becoming chronic and simultaneously stop them from passing the virus to others.

"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," stated Dr. Brian Conway, Medical Director of the Vancouver Infectious Diseases Centre. "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."

This preventative approach is particularly vital for populations disproportionately affected by HCV, including people who inject drugs (PWID), who account for a majority of new infections. Providing a simple, short-duration cure at the point of diagnosis can dramatically reduce the virus's prevalence within these communities.

Reshaping the Treatment Landscape

Prior to this approval, the management of acute HCV in Canada was often a waiting game. Physicians would monitor patients to see if they would be among the roughly one in four who spontaneously clear the virus. This approach, however, carried the risk of patients being lost to follow-up and subsequently developing chronic disease.

MAVIRET's profile as a pan-genotypic, all-oral, eight-week regimen fundamentally alters this landscape. Its "pan-genotypic" nature means it is effective against all major strains of the hepatitis C virus, eliminating the need for complex and time-consuming genotype testing before starting treatment. This simplification removes a significant barrier, allowing healthcare providers in diverse settings—from specialist clinics to community health centers—to initiate care quickly and decisively.

The treatment's short, eight-week duration is a major advantage for improving patient adherence compared to longer regimens. The therapy combines two direct-acting antivirals, glecaprevir and pibrentasvir, into a once-daily dose of three tablets. The approval also covers its use in patients with specific challenges, including those with compensated cirrhosis and individuals with severe chronic kidney disease, making it a versatile option across a wide spectrum of patients. The Phase 3 study underpinning the approval found the treatment to be highly efficacious, with the most common side effects being mild, including diarrhea, fatigue, and nasopharyngitis.

The Race to 2030 and Lingering Hurdles

With the WHO's 2030 elimination deadline looming, the new indication for MAVIRET is a welcome development for public health advocates. Canada has endorsed the global strategy but has been criticized for lacking a coordinated national action plan to meet the targets, which include an 80% reduction in new infections and a 65% reduction in HCV-related deaths.

"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. "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."

Despite the promise of advanced treatments like MAVIRET, significant systemic barriers remain. An estimated 41.5% of Canadians with chronic HCV are unaware of their infection, creating a large, undiagnosed reservoir of the virus. Reaching these individuals, particularly those in marginalized communities who may face stigma or have limited access to healthcare, is a critical challenge. Experts emphasize that the availability of a powerful drug is not enough; it must be integrated into a broader strategy that includes expanded testing, robust harm reduction programs, and dedicated efforts to link people to care.

The next step will be for provincial and territorial drug plans to review and list MAVIRET for acute HCV. While direct-acting antivirals for chronic HCV are widely funded across Canada, securing broad and unrestricted public coverage for this new indication will be crucial to realizing its full public health potential. The high upfront cost of these therapies is often offset by the long-term savings from preventing liver transplants and cancer treatment, an economic argument that is even stronger when preventing the disease from ever becoming chronic. This new approval equips Canada with a vital instrument, but its effectiveness will ultimately depend on a concerted, nationwide effort to deploy it where it is needed most.