New Hepatitis C Treatment Gains FDA Approval

The FDA approves Mavyret as an 8-week treatment for all genotypes of HCV with compensated cirrhosis.

The US Food and Drug Administration (FDA) expanded the approval for glecaprevir and pibrentasvir (Mavyret) to treat the hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection and compensated cirrhosis.

The approval allows the treatment to be used for adults and children at least 12 years old or 99 pounds, who have not been previously treated for HCV.

The drug represents the first 8-week treatment approved for all treatment-naïve adult and certain pediatric patients with HCV genotypes 1-6 both without cirrhosis and with compensated cirrhosis. Previously standard treatment length for this patient population was 12 weeks or more.

"This approval provides a treatment duration of 8 weeks for both pediatric and adult patients with compensated cirrhosis regardless of HCV genotype; meaning that an 8-week treatment regimen is available for any treatment-naïve HCV patient, regardless of cirrhosis status or genotype," Jeffrey Murray, MD, deputy director of the Division of Antiviral Products in the FDA's Center for Drug Evaluation and Research, said in a statement. "Mavyret is a combination of direct-acting antiviral drugs that reduce the amount of HCV in the body to undetectable levels by preventing the virus from multiplying, and in most cases, curing HCV infection."

In clinical trials, investigators evaluated more than 2500 with HCV genotypes 1-6 infection who received the drug for 8,12, 16-weeks. The trials also included patients with HIV co-infection, kidney or liver transplant recipients and patients with advanced kidney disease, including those requiring hemodialysis.

The most common adverse reactions in patients taking Mavyret were headache and fatigue. Mavyret, developed by AbbVie, is contraindicated in patients with moderate or severe liver impairment (Child-Pugh B or C) or in those with any history of liver decompensation. It is also contraindicated in patients taking the drugs atazanavir and rifampin.

According to the US Centers for Disease Control and Prevention, an estimated 2.7-3.9 million people in the US have chronic HCV, and children born to HCV-positive mothers are at risk for HCV infection. Researchers estimate there are 23,000-46,000 children in the U.S. with HCV infection.