Results presented at The International Liver Congress 2015 show that a 12-week oral regimen of once-daily single tablet grazoprevir/elbasvir (GZR/EBR) is effective and well-tolerated in treatment-naive (TN) patients infected with chronic hepatitis C virus (HCV) genotypes (GT)-1, -4 or -6, including those with compensated cirrhosis.
Based on preliminary results from 316 GZR/EBR recipients in the immediate treatment arm, 299 patients (95%) achieved a sustained virologic response at 12 weeks (SVR12).
"These initial results show that once-daily grazoprevir/elbasvir offers significant advantages over older treatments, demonstrating the ideal combination of high efficacy with good tolerability and convenience in treatment-naive patients infected with chronic HCV," said Rajender Reddy, MD, FAASLD Professor of Medicine, Professor of Medicine in Surgery, Director of Hepatology, Medical Director of Liver Transplantation, University of Pennsylvania, USA.
Serious adverse events (AEs) occurred in 9 (3%) and 3 (3%) patients in the active (immediate treatment) and placebo (deferred treatment) arms, respectively.
"Newer antiviral regimens such as the combination of grazoprevir/elbasvir offer much hope to people living with hepatitis C. They have shown great efficacy and tolerability for the treatment of this chronic infection," said Dr Laurent Castera, Vice-Secretary, European Association for the Study of the Liver.
C-EDGE TN is an international, randomised, blinded, placebo-controlled, parallel-group trial of an oral fixed-dosed combination of GZR 100 mg/EBR 50 mg once-daily in TN patients infected with HCV GT-1, -4 or -6, including cirrhotic and non-cirrhotic patients.
Presenter: Stefan Zeuzem (Germany) Abstract G07: The Phase 3 edge treatment-naïve (TN) study of a 12-week oral regimen of grazoprevir (GZR, MK-5172)/elbasvir (ebr, mk-8742) in patients with chronic HCV genotype (gt) 1, 4, or 6 infection.