The US Food and Drug Administration has approved Mavyret (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate-to-severe kidney disease and those who are on dialysis.
Mavyret is also approved for adult patients with HCV genotype 1 infection who have been previously treated with a regimen either containing an NS5A inhibitor, or an NS3/4A protease inhibitor, but not both.
Mavyret is the first treatment of eight weeks duration approved for all HCV genotypes 1-6 in adult patients without cirrhosis who have not been previously treated. Standard treatment length was previously 12 weeks or more.
‘This approval provides a shorter treatment duration for many patients, and also a treatment option for certain patients with genotype 1 infection, the most common HCV genotype in America, who were not successfully treated with other direct-acting antiviral treatments in the past,’ said Edward Cox, MD, Director of the Office of Antimicrobial Products in the FDA’s Centre for Drug Evaluation and Research.
