Merck Posts Phase 2 Data For Grazoprevir/Elbasvir In HCV

Merck announced that it presented results from the Phase 2 trial of combo therapy grazoprevir/elbasvir with or without ribavirin (RBV) in patients with Hepatitis C virus (HCV) genotype 1 infection.

Grazoprevir (MK-5172) is an investigational NS3/4A protease inhibitor while elbasvir (MK-8742) is a candidate NS5A inhibitor being developed by Merck as treatment for HCV. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to grazoprevir/elbasvir in October last year.

The parallel-group, randomized, double blind, dose response C-WORTHY study investigated grazoprevir/elbasvir with or without RBV in patients who had not undergone treatment as well as those who were previously treated with peg-interferon/ribavirin [PR]. Results show that the rate of sustained viral response 12 weeks following completion of therapy (SVR12) in previously treated patients was greater than or equal to 90 percent regardless of how long the treatment period is or if RBV was also administered. Treatment-naïve patients who were treated with grazoprevir/elbasvir also achieved high rates of SVR12.

The results of the study was published online in The Lancet and presented at the 65th American Association for the Study of Liver Diseases (AASLD) Annual Meeting, also called The Liver Meeting. Merck recently presented results from a separate study investigating grazoprevir/elbasvir in combination with Gilead’s Sovaldi as treatment for HCV, the results of which were also presented at The Liver Meeting.

Dr. Eliav Barr, VP of infectious diseases at Merck Research Laboratories, said, “Merck is committed to developing an efficacious, well-tolerated therapy suitable for a broad spectrum of patients with HCV. We are encouraged by the findings for grazoprevir/elbasvir in the C-WORTHy trial and look forward to advancing our broad Phase 3 program, which includes hard-to-cure patients that are of the highest need and least studied to date.”

The company is currently conducting the Phase 3 C-EDGE study assessing grazoprevir/elbasvir with or without RBV in various patients with chronic HCV. Results from the Phase 3 trial are expected in the first half of 2015.