FDA expanded the approval of glecaprevir and pibrentasvir (Mavyret, AbbVie) tablets for certain chronic hepatitis C virus (HCV) patients.
Mavyret is 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. Standard treatment length for patients with compensated cirrhosis was previously 12 weeks or more, FDA said in a statement.
FDA expanded Mavyret for an 8-week duration for the treatment of adults and children ages 12 years and older or weighing at least 99 pounds who have genotype 1, 2, 3, 4, 5 or 6 infection and compensated cirrhosis and have not been previously treated for HCV (treatment-naïve).
“This approval provides a treatment duration of eight weeks for both pediatric and adult patients with compensated cirrhosis, regardless of HCV genotype; meaning that an eight-week treatment regimen is available for any treatment-naïve HCV patient, regardless of cirrhosis status or genotype,” said Jeffrey Murray, MD, deputy director of the Division of Antiviral Products in FDA’s Center for Drug Evaluation and Research, in the FDA 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, Murray added.
In August 2017, FDA cleared Mavyret as an 8-week, pan-genotypic treatment for treatment-naïve HCV patients without cirrhosis.
"While over 100,000 patients have been prescribed Mavyret for chronic HCV in the US, there are still a significant number of patients that need options," said Janet Hammond, MD, PhD, vice president, general medicine and virology therapeutic area of AbbVie, in a statement from the company. "This approval provides more HCV patients an option to treat their disease in as little as 8 weeks."
An estimated 2.7 to 3.9 million people in the US have chronic HCV, according to the CDC, and children born to HCV-positive mothers are at risk for HCV infection. Researchers estimate there are 23,000 to 46,000 children in the US with HCV infection.
The label expansion was based on data from the phase 3b EXPEDITION-8 study, which evaluated the safety and efficacy of MAVYRET in treatment-naïve adults with GT1-6 chronic HCV and compensated cirrhosis. In the study, an overall 98% of patients achieved a sustained virologic response 12 weeks after treatment, AbbVie said.
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