FDA Approves Mavyret to Treat Adults with Chronic Hepatitis C

The U.S. Food and Drug Administration (FDA) has approved AbbieVie Inc.’s Mavyret (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis 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. It 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.

Approval was based on the safety and efficacy of clinical trials that enrolled approximately 2,300 adults with genotype 1, 2, 3, 4, 5 or 6 HCV infection without cirrhosis or with mild cirrhosis. Results of the trials demonstrated that between 92 percent and 100 percent of patients who received Mavyret for eight, 12 or 16 weeks duration had no virus detected in the blood 12 weeks after finishing treatment, suggesting patients’ infection had been cured. The most common adverse reactions were headache, fatigue and nausea. Mavyret is not recommended in patients with moderate cirrhosis and contraindicated in patients with severe cirrhosis or those taking the drugs atazanavir and rifampin.