Merck & Co. Inc.MRK announced that results from the first phase III study (C-SURFER) on an investigational, once-daily, all-oral, ribavirin-free chronic hepatitis C virus (HCV) combination regimen of elbasvir and grazoprevir (50mg/100mg) were published in The Lancet.
The study was conducted on treatment-naive as well as treatment-experienced patients suffering from advanced chronic kidney disease (CKD) stages 4 or 5 and chronic HCV genotype 1 (GT1) infection. It included a small phase II pharmacokinetic assessment as well. Data from the study were already presented at The International Liver Congress in Apr 2015.
We note that Merck is developing elbasvir/grazoprevir for multiple HCV genotypes under a broad clinical program including studies on difficult-to-treat conditions like cirrhosis, advanced CKD, HIV/HCV co-infection, inherited blood disorders and those on opiate substitution therapy. Currently, the elbasvir/grazoprevir combination is under priority review with the FDA for the treatment of adults with chronic HCV GT1, 4 or 6 infections, with a response from the agency expected by Jan 28, 2016.
The combination regimen enjoys Breakthrough Therapy status in the U.S. for the treatment of chronic HCV GT1 infection with end-stage renal disease on hemodialysis and chronic HCV GT4 infection. Additionally, the elbasvir/grazoprevir combination is under review in the EU for the treatment of adults suffering from chronic HCV GT1, 3, 4 or 6 infections.
Merck's efforts to build its HCV portfolio are encouraging. However, we remind investors that competition in the HCV market is gradually intensifying. Gilead Sciences' GILD Sovaldi and Harvoni and AbbVie's ABBV Viekira Pak are already approved for the treatment of this disease.
Merck holds a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Amgen Inc. AMGN , carrying a Zacks Rank #1 (Strong Buy). AbbVie holds a Zacks Rank #2 (Buy).
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