AbbVie's Mavyret (glecaprevir/pibrentasvir) Receives FDA's Approval for its Expanded Indication in Treatment-Naïve Patients with Chronic Hepatitis C and Compensated Cirrhosis Across All Genot
Shots:
- The US FDA has granted approval to Mavyret for shortening the treatment duration from 12 to 8wks. in treatment-naïve- compensated cirrhotic- chronic hepatitis C (HCV) patients across all genotypes (GT1-6)
- The label expansion is based on P-IIIb EXPEDITION-8 study assessing Mavyret in treatment naïve- GT1-6 chronic HCV patients with compensated cirrhosis for 8wks.- resulted in achieving sustained virologic response 12 weeks (SVR12) in 98% patients
- Mavyret (qd) is a pan-genotypic- combination of glecaprevir (100mg) and pibrentasvir (40mg) and has received FDA’s approval as an 8-week- pan-genotypic treatment for the treatment-naïve HCV patients without cirrhosis in Aug’2017
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