Once-daily grazoprevir/elbasvir is effective in patients infected with chronic hepatitis C
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.
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THE PHASE 3 C-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
Stefan Zeuzem* 1, Reem Ghalib2, K. R. Reddy3, Paul J. Pockros4, Ziv B. Ari5, Yue Zhao6, Deborah Brown7, Mark DiNubile6, Michael Robertson6, Janice Wahl7, Eliav Barr6, Joan Butterton6
1Goethe University Hospital, Frankfurt, Germany, 2Texas Clinical Research Institute, Dallas, 3University of Pennsylvania, Philadelphia, 4Scripps Translational Science Institute, La Jolla, United States, 5Sheba Medical Center, Ramat Gan, Israel, 6Merck, 7Meck, Whitehouse Station, United States
Background and Aims: Safe, efficacious, and convenient antiviral regimens without interferon or ribavirin are being developed for chronic HCV infection. The C-EDGE TN study (P060) investigated the safety and efficacy of a once daily regimen of GZR (NS3/4A protease inhibitor) and EBR (NS5A inhibitor) for 12 weeks (wks) in TN patients (pts) with GT 1, 4, or 6 infection.
Methods: C-EDGE TN is an international, randomized, blinded, placebo-controlled, parallel-group trial of an oral fixed-dosed combination of GZR 100 mg/EBR 50 mg once daily in TN, HCV GT 1-, 4-, or 6-infected pts. Cirrhotic patients were eligible. Exclusion criteria included decompensated liver disease, HCC, HIV or HBV co-infection, platelets END