The US Food and Drug Administration (FDA) has just approved AbbVie’s Mavyret (glecaprevir/pibrentasvir), the first treatment for hepatitis C to show a 98 percent cure rate in as little as eight weeks. The drug has been approved to treat hepatitis C virus (HCV) infection in patients with one of six major genotypes, including those with mild liver cirrhosis.
“With Mavyret, physicians and patients now have a treatment option that is highly effective and has the potential to cure the majority of HCV patients in as short as 8 weeks, regardless of genotype,” said Dr. Michael Severino, executive vice president, research and development and chief scientific officer, AbbVie. “The approval of Mavyret demonstrates AbbVie’s commitment to advancing science to help address unmet needs by delivering a new cure for patients who historically had limited treatment options, including those with genotype 3 HCV, individuals with [chronic kidney disease] CKD and certain [direct-acting antiviral] DAA failure patients.
According to AbbVie, as many as 95 percent of US patients with hepatitis C could be eligible for treatment with their newly-approved therapy. The list price for Mavyret, without taking insurance coverage into account, has been set at $26,400 for an eight week course.
It’s estimated that 3.4 million people in the US currently suffer from a chronic hepatitis C virus infection. The active ingredients in Mavyret are designed to block the virus’ ability to replicate.
“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 compensated cirrhosis,” said Dr. Fred Poordad, vice president, academic and clinical affairs, Texas Liver Institute and professor of medicine, University of Texas Health, San Antonio. “This approval helps achieve physicians’ goals of delivering effective options for a broad range of patients.”
Like Gilead’s Vosevi, Mavyret could offer a secondary treatment option for patients who have previously been unresponsive to other DAA drugs. But with a shorter treatment period and a lower list price, Mavyret could be a strong competitor against all of Gilead’s hepatitis C therapies.