OREANDA-NEWS. Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the presentation of results from the initial phase (Part A) of the company’s C-CREST 1 and 2 Phase 2 clinical development program evaluating two investigational all-oral, triple-combination treatment regimens – a regimen of grazoprevir1, MK-36822 andelbasvir3; and a regimen of grazoprevir, MK-3682 and MK-84084 – in treatment-na?ve patients with chronic hepatitis C virus (HCV) genotypes (GT) 1, 2 or 3 infection. These data will be presented today during a late-breaking abstract session at The Liver Meeting® (Abstract #LB-15). Based on the results of this initial trial, Merck has initiated further study of grazoprevir (100mg), MK-3682 (450mg) and MK-8408 (60mg) in the second phase (Part B) of the C-CREST Phase 2 clinical development program.

“Merck’s chronic hepatitis C development program continues to focus on the goal of advancing a short-duration treatment regimen that offers high virologic cure rates across all viral genotypes,” said Dr. Roy Baynes, senior vice president and head of global clinical development, Merck Research Laboratories. “The strong results observed in this study support the further investigation of the novel triple-combination regimen of grazoprevir, MK-3682 and MK-8408 in patients with chronic hepatitis C.”

In these randomized, open-label clinical trials, C-CREST 1 evaluated treatment-naive, non-cirrhotic patients with chronic HCV GT1 or 2 infection and C-CREST 2 evaluated treatment-naive, non-cirrhotic patients with chronic HCV GT3 infection. The primary efficacy endpoint was sustained virologic response 12 weeks after the completion of treatment (SVR12, or virologic cure). All 240 enrolled patients completed eight weeks of treatment and reached follow-up 12 weeks after end of treatment. Treatment with grazoprevir (100mg), MK-3682 (450mg) and MK-8408 (60mg), without ribavirin (RBV), for eight weeks resulted in virologic cure rates of greater than 90 percent across chronic HCV patients with GT1, 2 or 3 infection, which supported the decision to advance this regimen into Part B of the C-CREST Phase 2 clinical trial program.

 

Summary of SVR12 Findings Following 8 Weeks of Treatment*: C-CREST 1 and 2 Part A
 
Population   N  

Grazoprevir
+ Elbasvir
+ MK-3682
300mg

  

Grazoprevir
+ Elbasvir
+ MK-3682
450mg

  

Grazoprevir
+ MK-8408
+ MK-3682
300mg

  

Grazoprevir
+ MK-8408
+ MK-3682
450mg
GT1   93   100% (23/23)   100% (23/23)   100% (24/24)   91% (21/23)
GT2   61   69% (11/16)   60% (9/15)   71% (10/14)   94% (15/16)
GT3   86   90% (19/21)   86% (19/22)   95% (20/21)   91% (20/22)

*Treatment-naive, non-cirrhotic patients
 

The most commonly reported adverse events across all regimens (greater than 10% incidence) were headache (23%), fatigue (20%) and nausea (13%). There were no drug-related serious adverse events and no discontinuations due to adverse events.