AbbVie Inc. (ABBV) said Tuesday that Health Canada has approved a label change for Maviret (glecaprevir/pibrentasvir tablets) to include Treatment-Naïve Genotype 3 patients with compensated cirrhosis.
With this change, the recommended treatment duration for all individuals with chronic hepatitis C virus or HCV infection who are treatment naïve, genotypes 1-6 with or without compensated cirrhosis is eight weeks. Maviret is the only eight-week oral treatment approved for all HCV Genotypes.
"AbbVie is committed to eliminating hepatitis C by 2030 and sees this objective as a national public priority. Through meaningful partnerships, we are working to find sustainable solutions that allow more patients to be screened, linked to care, and treated sooner," said Denis Hello, Vice-President and General Manager AbbVie Canada.
Health Canada first approved Maviret in August 2017. Maviret is a once-daily ribavirin-free treatment for adults and adolescent patients aged 12 to 18 years with chronic hepatitis C virus infection across all major HCV genotypes (GT1-6). It is an 8-week, pan-genotypic treatment for patients without cirrhosis and who are new to treatment.
Abbvie noted that Maviret's efficacy and safety were evaluated in nine phase II and III clinical trials, in over 2,300 patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection and with compensated liver disease, with or without cirrhosis.
While an estimated 250,000 people in Canada live with chronic hepatitis C, as many as 44 percent are not aware that they have it. Left undiagnosed and untreated, chronic hepatitis C can lead to cirrhosis, liver cancer or liver failure. Currently, hepatitis C is the leading indication for liver transplant in Canada.
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