12:49am Wednesday 23 August 2017

FDA approves new treatment for hepatitis C

The United States Food and Drug Administration (FDA) has approved the antiviral drug Mavyret (glecaprevir and pibrentasvir) for the treatment of all genotypes of chronic hepatitis C (HCV).

Mavyret, which is manufactured by AbbieVie, Inc., is the first treatment with a duration of eight weeks for adult patients without cirrhosis who have not previously been treated.

“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 Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in an official press release.

Mavyret is approved to treat adults with chronic HCV, even those with mild liver disease (cirrhosis) and moderate to severe kidney disease, including patients on dialysis, the FDA said. The drug also is approved for adult patients with HCV genotype 1 infection who previously have been treated with an NS5A inhibitor or an NS3/4A protease inhibitor, but not both.

Hepatitis C is a viral infection that can cause severe inflammation of the liver, compromised liver function, and liver failure. As many as 3.9 million people in the U.S. suffer from chronic hepatitis C.

Testing for the new drug included 2,300 adult patients in 27 countries with all genotypes of hepatitis C. Results showed that between 92-100 percent of subjects who received Mavyret for eight, 12, or 16 weeks had no detectable virus in their blood. Treatment duration differences depended on viral genotype, treatment history, and whether or not the patient had cirrhosis.

“The clinical trial program for Mavyret resulted in high cure rates across a range of patient populations, from those who have never been treated and who do not have cirrhosis, all the way to patients with compensate cirrhosis,” said Fred Poordad, MD, vice president, academic and clinical affairs, Texas Liver Institute and professor medicine, University of Texas Health, San Antonio, in a company statement. “This approval helps achieve physician’s goals of delivering effective options for a broad range of patients.”

The FDA does not recommend Mavyret for people with moderate cirrhosis and says the drug is contraindicated in cases of severe cirrhosis.


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