FDA Approves New Option for Hepatitis C Genotypes 1-6

The FDA has approved Mavyret (glecaprevir and pibrentasvir) for the treatment of 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 on dialysis. The drug is also approved for adults with HCV genotype 1 infection who have been treated with regimens containing either NS5A inhibitors or NS3/4A protease inhibitors, but not both.

Mavyret is the first treatment of 8-weeks duration approved for HCV genotypes 1-6 in adult patients without cirrhosis who have not been previously treated.
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The safety and efficacy of Mavyret was evaluated in clinical trials involving about 2300 adults with genotype 1, 2, 3, 4, 5, and 6 HCV infections without cirrhosis or with mild cirrhosis. Overall, 92% to 100% of patients who received Mavyret for 8, 12, or 16 weeks were free of detectable virus in the blood at 12 weeks following completion of treatment.

Treatment duration depends on treatment history, viral genotype, and cirrhosis status.

The most common adverse reactions observed in patients taking Mavyret were headache, fatigue, and nausea.

—Michael Potts

Reference:

FDA approves Mavyret for hepatitis C [press release]. August 3, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm570038.htm.