US-based pharmaceutical company AbbVie Inc. (NYSE: ABBV) said on Tuesday that Health Canada has approved MAVIRET (glecaprevir/pibrentasvir) for the treatment of acute and chronic hepatitis C virus infection in adults and paediatric patients aged three years and older and weighing at least 12 kg.
The oral therapy is the first and only eight-week, pan-genotypic hepatitis C treatment approved in Canada.
The approval was granted under Health Canada's Priority Review pathway, supported by data from the Phase 3 M20-350 study, which showed MAVIRET to be highly efficacious in adults with acute hepatitis C. Commonly reported adverse events included diarrhoea, fatigue and nasopharyngitis.
Health authorities said the decision supports global clinical guidelines that recommend treatment regardless of disease chronicity and aligns with the World Health Organisation's goal to eliminate hepatitis C as a public health threat by 2030. Universal treatment of acute and chronic infection is expected to significantly reduce transmission.
With the approval, Canadian healthcare providers can begin treatment immediately after diagnosis, addressing an unmet need in acute hepatitis C and supporting a treatment-as-prevention approach.
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