Health Canada expands Maviret use for acute hepatitis C in children, adults
Trial results show 8-week oral treatment clears virus in 96% of patients
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Health Canada has expanded its approval of Abbvie’s oral therapy Maviret (glecaprevir/pibrentasvir), making it the first eight-week, pan-genotypic treatment available for both acute and chronic hepatitis C in adults and children as young as 3.
The decision specifically targets acute hepatitis C infections in patients weighing at least 12 kg (about 26 lbs), offering a “treatment-as-prevention” strategy to stop the virus before it becomes a lifelong illness. This expansion, granted under a priority review, allows healthcare providers to treat all major strains of the virus in patients who have not yet developed severe liver scarring (cirrhosis) or have compensated cirrhosis, when the liver can still work despite cirrhosis.
“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,” Rami Fayed, vice president and general manager of Abbvie Canada, said in a company press release.
Expanding the reach of hepatitis C treatment
According to Abbvie, Maviret is the first and only treatment for acute and chronic hepatitis C that is taken orally over the course of eight weeks and is pan-genotypic, meaning it works equally well on all or most strains of the hepatitis C virus (HCV).
“Collaboration and prevention are essential in our fight against hepatitis C,” Fayed said. “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.”
The Canadian approval follows a similar expansion in the U.S. this past June. The therapy, which is sold in the U.S. under the brand name Mavyret, was also approved in 2017 for adults with chronic hepatitis C caused by any of the major HCV strains.
The hepatitis C virus, which infects the liver, is mainly spread by exposure to infected blood. When the virus first enters the body, it causes an acute infection, which is typically followed by a chronic or long-term infection in most cases. This chronic infection can set the stage for life-threatening complications such as liver failure and cancer.
Maviret is one of several direct-acting antivirals (DAAs), or therapies that stop the growth of the virus in the body, that are available for hepatitis C. It combines two DAA agents, glecaprevir and pibrentasvir, and is taken once daily in the form of three capsules.
“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 Brian Conway, MD, medical director of the Vancouver Infectious Diseases Centre and professor at Simon Fraser University, in Canada. “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.”
The therapy’s label expansions were based on data from a Phase 3 clinical trial, called M20-350 (NCT04903626), in which 286 adults with acute hepatitis C were given first-line treatment with Maviret.
Results showed 96.2% of participants were free from the virus three months after finishing the eight-week treatment course. Maviret was generally tolerated well, with the most common safety issues reported being diarrhea, fatigue, and the common cold.
“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.”
