Tags : Compensated Cirrhosis

Regulatory

AbbVie’s Maviret (glecaprevir/pibrentasvir) Receives EC’s Marketing Authorization as Eight-Week Regimen

Shots: The approval is based on P-IIIb EXPEDITION-8 study assessing Maviret in 343 treatment naïve chronic HCV patients with compensated cirrhosis across all major genotypes (GT1-6) for 8wks. The P-IIIb EXPEDITION-8 study results: GT1- 6 patients achieving SVR12 (97.7%); GT3 patients achieving SVR12 (95.2%); one case of virologic failure and no case of discontinuation was […]Read More

Regulatory

AbbVie’s Mavyret (glecaprevir/pibrentasvir) Receives FDA’s Approval for its Expanded Indication

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 […]Read More