Merck to Present New Findings from Chronic Hepatitis C Clinical Development Programs at The International Liver CongressTM 2016

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced the planned presentations of data from the company’s broad chronic hepatitis C virus (HCV) clinical development programs at the upcoming International Liver Congress™ 2016. Clinical data from trials evaluating ZEPATIER™ (elbasvir and grazoprevir) 50mg/100mg tablets will be featured, including the Phase 3 C-EDGE Head-to-Head trial comparing ZEPATIER to a regimen of sofosbuvir with peginterferon alfa and ribavirin (RBV), and the Phase 3 C-EDGE IBLD and C-EDGE CO-STAR studies evaluating ZEPATIER in underserved patients with historically difficult-to-treat conditions. In addition, data from trials evaluating Merck’s chronic HCV candidates MK-3682B (grazoprevir/MK-8408¹/MK-3682²) and MK-8408 monotherapy will be presented. ZEPATIER – Merck’s once-daily, fixed-dose combination tablet indicated with or without RBV for the treatment of chronic HCV genotype (GT) 1 or GT4 infection in adults – was approved by the U.S. Food and Drug Administration (FDA) on Jan. 28, 2016. The International Liver Congress™ 2016 is scheduled to take place at the Fira Barcelona Gran Via, Barcelona, Spain from April 13-17, 2016.

“We continue to build on the data that supported the recent U.S. FDA approval of ZEPATIER with additional studies that provide clinical evidence about ZEPATIER in multiple patient populations,” said Dr. Eliav Barr, vice president, infectious diseases, Merck Research Laboratories. “Merck remains committed to the fight against chronic hepatitis C through our ongoing clinical programs exploring diverse patient groups and areas of unmet need.”
At The International Liver Congress™ 2016, key data presentations will include:

• New data from the Phase 3 C-EDGE clinical trial program, evaluating ZEPATIER (elbasvir and grazoprevir) (with or without RBV), across multiple HCV genotypes (1, 4 and 6) and diverse patient populations, including those who are historically difficult-to-treat, over a 12-week treatment duration.

Thursday, April 14:

• C-EDGE Head-to-Head (H2H): Efficacy and Safety of Elbasvir and Grazoprevir Compared With Sofosbuvir/Pegylated Interferon/Ribavirin: A Phase 3 Randomized Controlled Trial (Oral presentation, Abstract #PS002, 4:15 p.m.-4:30 p.m. CEST)

• C-EDGE CO-STAR: Favorable Impact of Elbasvir and Grazoprevir on Health-Related Quality of Life in Treatment-Naïve HCV-Infected Persons Who Inject Drugs Receiving Opioid Agonist Therapy (Poster presentation, Abstract #THU-225, 8:00 a.m.-6:00 p.m. CEST)