The U.S. Food and Drug Administration said it approved Mavyret (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus or 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. The FDA granted approval of Mavyret to AbbVie Inc.
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.
Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure.
Treatment duration with Mavyret differs depending on treatment history, viral genotype, and cirrhosis status.
The most common adverse reactions in patients taking Mavyret were headache, fatigue and nausea.
The FDA noted that Mavyret is not recommended in patients with moderate cirrhosis and contraindicated in patients with severe cirrhosis. It is also contraindicated in patients taking the drugs atazanavir and rifampin.
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