Merck & Co. Inc. (MRK, Financial) announced through Business Wire on Nov. 14 that the “results from three phase 2 clinical trials evaluating MK-3682B (MK3682/grazoprevir/ruzasvir1), the company’s investigational all-oral, triple-combination regimen" for the treatment of patients who are chronically infected with the hepatitis C virus, are ready to be presented at The Liver Meeting® 2016 Monday (C-CREST 1 & 2 Parts B and C) and Tuesday (C-SURGE).
Concerning the results of C-CREST 1 & 2, part B, the company will present the following findings:
- In the blood serum of approximately 95% of patients chronically infected with the hepatitis C virus, genotype 1, regardless of being cirrhotic and who have never undergone treatment for HCV, the RNA of the hepatitis C virus, “measured as HCV RNA less than 15 IU/mL,” was undetectable 12 weeks after the treatment of eight weeks with MK-3682B.
- In the blood serum of approximately 98.98% of patients chronically infected with the hepatitis C virus, genotype 1, regardless of being cirrhotic and who have never undergone treatment for HCV, the RNA of the hepatitis C virus, “measured as HCV RNA less than 15 IU/mL,” was undetectable 12 weeks after the treatment of 12 weeks with MK-3682B.
- In the blood serum of approximately 86% of patients chronically infected with the hepatitis C virus, genotype 2, regardless of being cirrhotic and who have never undergone treatment for HCV, the RNA of the hepatitis C virus, “measured as HCV RNA less than 15 IU/mL,” was undetectable 12 weeks after the treatment of eight weeks with MK-3682B alone or in combination with peginterferon/ribavirin (RBV).
- In the blood serum of approximately 97% of patients chronically infected with the hepatitis C virus, genotype 2, regardless of being cirrhotic and who have never undergone treatment for HCV, the RNA of the hepatitis C virus, “measured as HCV RNA less than 15 IU/mL,” was undetectable 12 weeks after the treatment of 16 weeks with MK-3682B alone or in combination with peginterferon/ribavirin (RBV).
- In the blood serum of approximately 95% of patients chronically infected with the hepatitis C virus, genotype 3, regardless of being cirrhotic and of whom 56% have never undergone treatment for HCV and 44% were HCV treatment experienced with RBV, the RNA of the hepatitis C virus, “measured as HCV RNA less than 15 IU/mL,” was undetectable 12 weeks after the treatment of eight weeks with MK-3682B alone or in combination with peginterferon/ribavirin (RBV).
- In the blood serum of approximately 97% of patients chronically infected with the hepatitis C virus, genotype 3, regardless of being cirrhotic and of whom 56% have never undergone treatment for HCV and 44% were HCV treatment experienced with RBV, the RNA of the hepatitis C virus, “measured as HCV RNA less than 15 IU/mL,” was undetectable 12 weeks after the treatment of 12 weeks with MK-3682B alone or in combination with peginterferon/ribavirin (RBV).
- In the blood serum of approximately 96% of patients chronically infected with the hepatitis C virus, genotype 3, regardless of being cirrhotic and of whom 56% have never undergone treatment for HCV and 44% were HCV treatment experienced with RBV, the RNA of the hepatitis C virus, “measured as HCV RNA less than 15 IU/mL,” was undetectable 12 weeks after the treatment of 16 weeks with MK-3682B alone or in combination with peginterferon/ribavirin (RBV).
Concerning the part C of C-CREST 1 & 2, the company says that it was “designed to evaluate retreatment with MK-3682B plus RBV for 16 weeks among patients who previously failed an investigational triple-therapy regimen (MK-3682/grazoprevir/ruzasvir or MK-3682/grazoprevir/elbasvir).”
In the blood serum of 23 out of 24 patients chronically infected with hepatitis virus C, genotypes 1 (two patients), 2 (14 patients) and 3 (eight patients), the RNA of the hepatitis virus C, “measured as HCV RNA less than 15 IU/mL,” was undetectable 12 weeks after the retreatment of 16 weeks with MK-3682B in combination with peginterferon/ribavirin (RBV).
The company adds that “one GT2 patient discontinued treatment after a single dose due to drug-related serious AEs.”
Concerning the C-SURGE, the company says that it is “an ongoing, open-label Phase 2 clinical trial designed to evaluate MK-3682B with or without RBV in chronic HCV GT1 patients who previously failed therapy with either ledipasvir/sofosbuvir (LDV/SOF) or ZEPATIER™ (elbasvir and grazoprevir).”
Merck says that this study “showed high rates of SVR12 and SVR8.” The company will present this part of results at the Liver Meeting® 2016 Nov. 15.
Approximately 3% of the world's population (150 million to 200 million people) have a liver pathology related to hepatitis C virus infection. Every year there are about 3.5 million new diagnoses of HCV infection. In the U.S., about 70% of hepatitis C infection cases are related to genotype 1. The World Health Organization (WHO) has implemented a classification that includes 11 HCV genotypes.
Few days ago, AbbVie Inc. (NYSE:ABBV) announced similar results of “its investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) across all major chronic hepatitis C virus (HCV) genotypes.”
Merck is trading at $63.79, down 0.25% from the previous trading day.
Disclosure: I have no positions in Merck.
Start a free seven-day trial of Premium Membership to GuruFocus.
