FDA Approves Hepatitis C Drug

FDA said the safety and efficacy of Mavyret were evaluated during clinical trials enrolling approximately 2,300 adults with HCV infection without cirrhosis or with mild cirrhosis, and the trials demonstrated that 92-100 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.

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.

CDC has estimated 2.7 million to 3.9 million people in the United States have chronic HCV. There are at least six distinct HCV genotypes, or strains, which are genetically distinct groups of the virus. About 75 percent of Americans with HCV have genotype 1; 20-25 percent have genotypes 2 or 3; and a small number of patients are infected with genotypes 4, 5, or 6.

FDA said the safety and efficacy of Mavyret were evaluated during clinical trials enrolling approximately 2,300 adults with HCV infection without cirrhosis or with mild cirrhosis, and the trials demonstrated that 92-100 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 their infection had been cured. The most common adverse reactions in patients taking Mavyret were headache, fatigue, and nausea.

FDA granted approval of Mavyret to AbbVie Inc. and granted the application Priority Review and Breakthrough Therapy designations.

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