Merck’s Investigational Chronic Hepatitis C Combination Therapy MK-5172/MK-8742 Demonstrates Antiviral Activity in Hard-to-Cure Patients with HCV Genotype 1 Infection

Merck has announced interim results from the ongoing C-WORTHy study, a multi-arm Phase II clinical trial evaluating the efficacy and safety of an all-oral, once-daily regimen combining MK-5172, an investigational hepatitis C virus (HCV) NS3/4A protease inhibitor, and MK-8742, an investigational HCV NS5A replication complex inhibitor, among patients with chronic HCV Genotype 1 infection (GT1). Interim analysis of hard-to-cure[1] patients administered MK-5172/MK-8742 with and without ribavirin (RBV) for 12 or 18 weeks showed sustained viral response[2] (SVR), 4 to 8 weeks after the completion of therapy (SVR4/8): 

• HCV GT1 infected, treatment-naïve cirrhotic patients, MK-5172/MK-8742 treated — 97% (28/29 and 29/30) for 12 and 18 weeks, and MK-5172/MK-8742 plus RBV — 90% (28/31) and 97% (30/31) for 12 and 18 weeks, respectively. 

• HCV GT1 infected prior-null responder patients (with or without cirrhosis), MK-5172/MK-8742 treated — 91% (30/33) and 97% (29/30) for 12 and 18 weeks, respectively, and MK-5172/MK-8742 plus RBV treated 94% (30/32) and 100% (32/32) for the 12 and 18 weeks, respectively.  

• Treatment-naïve, non-cirrhotic patients with HCV/HIV co-infection, MK-5172/MK-8742 treated for 12 weeks - 90 percent (26/29) and MK-5172/MK-8742 plus RBV for 12 weeks 97% (28/29).  

These data were presented at the 49th Annual Meeting of the European Association for the Study of the Liver (EASL), also known as The International Liver Congress 2014 in London, UK. 

“There is still a need for further options for the most difficult-to-cure patients, including those with cirrhosis and HCV/HIV co-infection,” said Dr Eric Lawitz, MD, vice president, Scientific and Research Development, The Texas Liver Institute, and clinical professor of medicine, University of Texas Health Science Center in San Antonio. “These findings provide additional clinical evidence regarding the potential of MK-5172/MK-8742 in treating a broad spectrum of HCV patients.” 

References

[1] Defined as treatment-naïve patients with liver cirrhosis, prior-null responder patients with and without cirrhosis and patients with HIV/HCV co-infection.
 
[2] Defined as HCV RNA below the limit of quantification or below the limit of detection at the last visit on record — 4, 8, 12, or 24 weeks after the completion of therapy.