FDA Approves Mavyret for Hepatitis C
FRIDAY, Aug. 4, 2017 -- Mavyret (glecaprevir and pibrentasvir) has been approved by the U.S. Food and Drug Administration to treat adults with certain types of chronic hepatitis C virus (HCV).
The combination drug is the first approved therapy for hepatitis C to require as few as eight weeks of treatment, the FDA said in a news release. Other therapies require treatment of 12 weeks or longer.
Mavyret was evaluated in clinical studies of some 2,300 adults with all six HCV genotypes. At least 92 percent of patients who took the drug had no HCV detected in the blood 12 weeks after completing treatment, the FDA said.
The most common side effects of the drug included headache, fatigue, and nausea. The drug shouldn't be taken by patients with cirrhosis, or by those taking the antiviral drugs atazanavir and rifampin. Patients who are simultaneously infected with hepatitis B virus should be monitored carefully while taking Mavyret, the agency added.
Approval for Mavyret was given to AbbVie Inc., based in Chicago.
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Posted: August 2017