AbbVie said that the U.S. Food and Drug Administration (FDA) has approved Mavyret to shorten the once-daily treatment duration from 12 to eight weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C patients across all genotypes.
|AbbVie's Hepatitis C treatment Maryvet|
The drug received regulatory approval in the U.S. as an eight-week, pan-genotypic treatment for treatment-naïve hepatitis C virus (HCV) patients without cirrhosis in August 2017.
"While more than 100,000 patients have been prescribed Mavyret for chronic HCV in the U.S., there are still a significant number of patients that need options," said Janet Hammond, vice president of AbbVie's general medicine and virology therapeutic division. "This approval provides more HCV patients with an option to treat their disease in as little as eight weeks."
The FDA granted the label expansion based on data from the phase 3b EXPEDITION-8 study, a single-arm, open-label study that evaluated the safety and efficacy of Mavyret in treatment-naïve adults with GT1-6 chronic hepatitis C and compensated cirrhosis.
In the study, an overall 98 percent of patients achieved a sustained virologic response after 12 weeks of treatment.
"With more than 2.3 million people in the United States still living with chronic HCV, access to shorter-term, eight-week treatment options can help us move closer to achieving the World Health Organization's goal of eliminating chronic hepatitis C by 2030," said Robert S. Brown, a Professor of medicine at Weill Cornell Medical College.
The EXPEDITION-8 trial reported a single relapse out of 336 patients treated, and no patients discontinued treatment due to adverse events. The adverse reactions reported in greater than or equal to 5 percent of compensated cirrhotic patients were fatigue (8 percent), pruritus (7 percent), and headache (6 percent).
The data from cohort one (GT1,2,4,5,6) was presented last year at the Liver Meeting 2018 organized by the American Association for the Study of Liver Diseases, and data from cohort two (GT3) will be presented at an upcoming medical meeting.
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