AbbVie, a global biopharmaceutical company, announced that Health Canada has granted approval for MAVIRET (glecaprevir/pibrentasvir tablets), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6). MAVIRET is the only 8-week, pan-genotypic treatment for patients without cirrhosis and who are new to treatment, who make up a large portion of HCV patients in Canada.
“Despite recent advances in HCV treatment, physicians still face challenges treating patients with less common genotypes and those with other complicating health conditions,” said Dr. Morris Sherman, MD, FRCPC, Chairperson, Canadian Liver Foundation. “In order to eliminate hepatitis C in Canada, we need to identify all those living with the virus and have effective treatment options for everyone. This new therapy provides another tool for physicians to expand treatment to a greater number of patients while at the same time shortening the duration which may lead to cost savings for the health care system.”
MAVIRET is also approved for use in patients with specific treatment challenges, including those with compensated cirrhosis across all major genotypes, and those who previously had limited treatment options, such as patients with severe chronic kidney disease (CKD), those GT1 patients not previously cured with certain direct-acting antiviral (DAA) treatment, and those with GT3 chronic HCV infection. MAVIRET is the only pan-genotypic treatment approved for use in patients across all stages of CKD.
“With the approval of MAVIRET, we are proud to bring the hope of a new cure to people living with hepatitis C in Canada, reflecting AbbVie’s dedication to addressing critical unmet needs for patients,” said Stéphane Lassignardie, General Manager, AbbVie Canada. “MAVIRET is designed to deliver a virologic cure for most HCV patients including those with specific treatment challenges. AbbVie will continue to work with local health authorities and stakeholders across Canada to get our treatment to as many patients as possible.”
The efficacy and safety of MAVIRET was evaluated in nine Phase 2-3 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).
Approximately 300,000 Canadians are infected with hepatitis C. In 2012 alone, more than 10,000 new cases of hepatitis C were reported, but 40 percent of patients are estimated to be living unaware of their disease. GT1 is the most common genotype in Canada and GT3 is the most difficult to treat.3,5 Over time chronic hepatitis C can lead to chronic liver diseases, with a risk of developing cirrhosis of up to 30 percent within 20 years of infection. Additionally, HCV is common among people with severe CKD, and some of these patients previously did not have a DAA-based treatment option.
With 8 weeks of treatment, 97 percent (n= 639/657) of GT1-6 patients without cirrhosis and who were new to treatment achieved a virologic cure. These high cure rates were achieved in patients with varied patient and viral characteristics and including those with CKD. Additionally, 97.5 percent (n=274/281) of patients with compensated cirrhosis achieved a virologic cure with the recommended duration of treatment, including patients with CKD. In registrational studies for MAVIRET, less than 0.1 percent of patients permanently discontinued treatment due to adverse reactions. The most commonly reported adverse reactions (incidence greater than or equal to 10 percent) were headache and fatigue.
“In an extensive clinical trial program, patients achieved high cure rates with MAVIRET regardless of genotype, fibrosis score, viral load, and even in patients with resistant virus strains and those with chronic kidney disease,” said Dr. Magdy Elkhashab, Gastroenterologist/Hepatologist, Director of the Toronto Liver Centre. “In clinical practice, MAVIRET has the potential to simplify treatment decisions for physicians, offering, in one therapy, a cure for the majority of HCV patients and cutting out pre-testing before treatment initiation.”
MAVIRET combines two new, potent direct-acting antivirals that target and inhibit proteins essential for the replication of the hepatitis C virus.2 The presence of most genotypes or baseline mutations that are commonly associated with resistance have been shown to have no relevant impact on efficacy.
Filed Under: Drug Discovery