AbbVie receives FDA approval of Mavyret to shorten treatment duration to eight weeks for treatment-na�ve patients with chronic hepatitis C and compensated cirrhosis across all genotypes.

AbbVie announced that the FDA has granted approval of Mavyret (glecaprevir/pibrentasvir) to shorten the once-daily treatment duration from 12 to 8 weeks in treatment-na�ve, compensated cirrhotic, chronic hepatitis C (HCV) patients across all genotypes (GT1-6).

In August 2017, Mavyret received regulatory approval in the U.S. as an 8-week, pan-genotypic treatment for treatment-na�ve 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, M.D., Ph.D., vice president, general medicine and virology therapeutic area, AbbVie.

The label expansion was based on data from the Phase IIIb EXPEDITION-8 study, a single-arm, open-label study evaluating the safety and efficacy of Mavyret in treatment-na�ve adults with GT1-6 chronic HCV and compensated cirrhosis. In the study, an overall 98 percent (n=335/343) of patients achieved a sustained virologic response 12 weeks after treatment (SVR12). In EXPEDITION-8, a single relapse out of 336 patients treated was reported 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 (n=343) were fatigue (8%), pruritus (7%), and headache (6%). 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 (AASLD), and data from cohort two (GT3) will be presented at an upcoming medical meeting.