AbbVie announced that Health Canada has approved a change in the marketing authorization for MAVIRET® (glecaprevir/pibrentasvir) to include its use for the treatment in pediatric patients 3 to 12 years old, weighing at least 12kg to less than 45kg.1 MAVIRET is now approved as an 8-week, pan-genotypic (GT1-6) treatment for treatment-naïve, chronic HCV patients, without cirrhosis or with compensated cirrhosis in adults and children aged 3 years and older.
"There is an estimated 250,000 people living in Canada with chronic hepatitis C including young children who I have witnessed first-hand at SickKids in need of treatment options," said Dr. Simon Ling, MBChB, MRCP(UK), Division of Gastroenterology, Hepatology and Nutrition, SickKids Toronto. "The approval of MAVIRET® as a paediatric indication is a necessary step that will add a beneficial therapeutic option to treat HCV infection in children."
The label extension is supported by data from the phase 2/3, non-randomized, open-label, multicenter DORA Part 2 study evaluating the safety and efficacy of weight-based dosing of glecaprevir/pibrentasvir (G/P) granules for 8, 12 or 16 weeks in 80 children aged 3 years to less than 12 years with chronic HCV infection.1 Patients received a paediatric formulation of glecaprevir (GLE)/pibrentasvir (PIB), comprised of film-coated granules of GLE and PIB, in a sachet mixed together in a small amount of soft food for once-daily oral administration. The mixture of food and granules should be swallowed immediately; the granules should not be crushed or chewed.1
"With Canada's commitment to eliminating viral hepatitis as a public health threat by 2030, the approval of MAVIRET® for paediatric patients is a positive advancement in reaching our goals," said Jennifer van Gennip, Executive Director, Action Hepatitis Canada. "Now with access to treatment of viral hepatitis amongst children, one more barrier to elimination is removed."
In DORA Part 2, the overall SVR12 rate for the subjects who received the final recommended dose was 98.4% (61/62 )1. No subject taking the final recommended dose experienced virologic failure1. The adverse reactions observed in patients 3 less than 12 years of age were consistent with those observed in clinical trials of MAVIRET in adults with the exception of vomiting (occurring at approximately 8%), rash, and abdominal pain upper (each occurring at approximately 4%) which were observed more frequently than in adults.
"MAVIRET has had a significant impact on the lives of people affected by chronic HCV, and we are pleased that pediatric patients are now also able to benefit from this treatment option," said Tracey Ramsay, Vice-president and General Manager, AbbVie Canada. "We are committed to helping achieve the World Health Organization's 2030 goal of HCV elimination and we believe Health Canada's expanded approval for MAVIRET will help Canadians to get one step closer."
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!