Merck has released first presentations of data from C-EDGE phase III clinical trial of grazoprevir/elbasvir in patients with or without cirrhosis who are infected with chronic hepatitis C virus (HCV) genotypes 1, 4 or 6 (GT1, 4 or 6).
The report highlights that a once-daily combination of grazoprevir/elbasvir cured 95% of both the HCV infected, treatment-naive (C-EDGE TN), and HIV/HCV co-infected, treatment-naive (C-EDGE CO-INFXN) patients after 12 weeks of treatment.
Around 94% of HCV infected, treatment-experienced patients (C-EDGE TE) were cured when treated with ribavirin (RBV), while 92% of them were cured when treated without RBV for 12 weeks.
Those treated for 16 weeks achieved cure rates of 97% and 92% respectively.
University of Texas Health Science Center clinical professor Eric Lawitz said: “Patients with co-morbidities and varying treatment experiences represent important segments of the chronic hepatitis C population in need of additional innovative treatment options.
“These findings are important because they demonstrate that a single pill of grazoprevir/elbasvir taken once-daily achieved consistently high rates of SVR12 in the patient populations studied.”
Merck had announced to submit new drug application (NDA) to US Food and Drug Administration (FDA) in the first half of 2015.
C-EDGE is the phase III clinical development program for Merck’s investigational HCV treatment grazoprevir/elbasvir comprising five studies with more than 1,700 patients across more than 25 countries.