Merck (MRK), known as MSD outside the U.S. and Canada, announced the first presentations of data from its ongoing C-EDGE pivotal Phase 3 clinical trial program evaluating the efficacy and safety of grazoprevir/elbasvir (100mg/50mg) in patients with or without cirrhosis infected with chronic hepatitis C virus (HCV) genotypes 1, 4 or 6 (GT1, 4 or 6) who received therapy for 12 weeks.
Patients in both the HCV infected and HIV/HCV co-infected trials treated for 12 weeks achieved rates of sustained virologic response 12 weeks after the completion of treatment (SVR12) of 95 percent (299/316 and 207/218, respectively).
In addition, HCV infected patients treated with or without ribavirin (RBV) for 12 weeks achieved SVR12 rates of 94 percent (98/104) and 92 percent (97/105), respectively, and those treated for 16 weeks achieved SVR12 rates of 97 percent (103/106) and 92 percent (97/105), respectively.
These data were presented at The International Liver Congress 2015 - the 50th annual congress of the European Association for the Study of the Liver. A paper detailing the findings of C-EDGE TN was published online in the Annals of Internal Medicine today.
Merck said it remains on track to submit New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) in the first half of 2015.
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