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Merck Recieves FDA approval of ZEPATIER (elbasvirand grazoprevir) for the treatment of chronic Hepatitis C Virus genotype 1 or 4 infection in adults following priority review; the new therapy will cost $54,600 for a 12-week regimen

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Merck’s broad clinical trial program supporting the efficacy of ZEPATIER included six studies in 1,373 patients with chronic HCV GT1 or GT4 infection. These studies assessed the rate of sustained virologic response 12 weeks after the completion of treatment with ZEPATIER (SVR12). The clinical development program for ZEPATIER enrolled diverse groups of HCV GT1- and GT4-infected patients, including treatment-naïve patients and those who had failed prior therapy with peginterferon alfa (PegIFN) and RBV, as well as patients suffering with meaningful co-morbidities and health complications, such as compensated cirrhosis and HIV-1 co-infection. GT1-infected patients with severe renal impairment on hemodialysis and those who previously failed therapy with PegIFN and RBV in combination with an HCV NS3/4A protease inhibitor (boceprevir, simeprevir or telaprevir) also were studied.
Clinical Data Clinical Studies Supporting Efficacy of ZEPATIER (elbasvir and grazoprevir):Clinical Trial(s) Population SVR12 (n/N)   TreatmentRegimen andDuration GT1 C-EDGE TN 
(double blind, placebo
controlled) TN +/- cirrhosis 95% (273/288)   ZEPATIER12 weeksC-EDGE CO-INFXN
(open-label, single arm) TN +/- cirrhosis + HIV-1
co-infection 95% (179/189)C-SURFER
(double blind, placebo
controlled) TN/TEa +/- cirrhosis +
severe renal impairment 94% (115/122)    C-EDGE TEd 
(open-label, comparative) TEb +/- cirrhosis +/- HIV-
1 co-infection 94% (90/96)  97% (93/96)   ZEPATIER12 weeks ZEPATIER+ RBV16 weeks C-SALVAGE 
(open-label, single arm) TEc +/- cirrhosis 96% (76/79)   ZEPATIER+ RBV
12 weeks GT4         C-SCAPE (open-label)C-EDGE TNC-EDGE CO-INFXN TN without cirrhosis
TN +/- cirrhosis
TN +/- cirrhosis + HIV-1
co-infection 97% (64/66)   ZEPATIER12 weeks C-EDGE TE TEb +/- cirrhosis 100% (8/8)   ZEPATIER+ RBV16 weeks
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Occurred on:
Jan 28, 2016
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Related Keywords Fda Approval, Zepatier, Elbasvirand Grazoprevir, Chronic Hepatitis C, Genotype 1 Or 4, Compensated Cirrhosis, Renal Impairment, Hiv-1/hcv Co-infection