FDA Approves Hepatitis C Drug

“The U.S. Food and Drug Administration has approved Mavyret (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus 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.
According to the agency’s announcement, 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 the United States, who were not successfully treated with other direct-acting antiviral treatments in the past,” said Dr. Edward Cox, M.D., director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research.”
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