Merck announced its planned presentations of data from its broad clinical development programs for chronic hepatitis C virus (HCV), to be made at the International Liver Congress 2016 taking place in Barcelona, Spain, from April 13 to 17, 2016.
The presentations will include new data from three Phase 3 studies assessing the drug Zepatier, the C-EDGE Head-to-Head clinical trial comparing the compound to a regimen of sofosbuvir plus peginterferon alfa and ribavirin (RBV), and the C-EDGE IBLD and C-EDGE CO-STAR trials assessing the drug in patients with difficult-to-treat diseases. The studies in this program evaluated Zepatier, with or without RBV, across multiple HCV genotypes (1, 4 and 6) and patient groups over a 12-week treatment period. Additionally, results from trials assessing the company’s chronic HCV drug candidates, MK-3682B and MK-8408 monotherapy, will be presented.
Zepatier is a once-daily, fixed-dose combination tablet (50 mg or 100 mg) containing the NS5A inhibitor elbasvir and the NS3/4A protease inhibitor grazoprevir.
The U.S.Food and Drug Administration (FDA) approved Zepatier in January 2016 as a once-daily, fixed-dose combination tablet, with or without RBV, for the treatment of adult patients with chronic HCV genotype (GT) 1 or GT4 infection.
The FDA had previously granted two Breakthrough Therapy designations to Zepatier, for the treatment of chronic HCV GT1 infection in patients with end stage renal disease on hemodialysis, and for the treatment of patients with chronic HCV GT4 infection.
The presentations include:
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.)
- 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.)
- In a 5-Day Monotherapy Trial, MK-8408 Demonstrates Potent Antiviral Activity and Improved Resistance Profile in HCV Patients With Genotypes 1, 2, and 3 Infections (Poster presentation, Abstract #THU-222, 8:00 a.m.-6:00 p.m.)
Saturday, April 16:
- C-EDGE IBLD: Efficacy and Safety of Elbasvir/Grazoprevir (EBR/GZR) in Subjects With Chronic Hepatitis C Virus Infection and Inherited Blood Disorders (IBLD) (Poster presentation, Abstract #SAT-128, 8:00 a.m.-6:00 p.m.)
- C-EDGE TN: Final SVR24 Data From the Phase 3 C-EDGETreatment-Naïve (TN) Study of Elbasvir (EBR)/Grazoprevir (GZR) in Patients With Chronic HCV Genotype 1, 4 or 6 Infection (Poster presentation, Abstract #SAT-266, 8:00 a.m.-6:00 p.m.)
- C-EDGE CO-STAR: Risk of Reinfection Following Successful Therapy With Elbasvir and Grazoprevir in Persons Who Inject Drugs (PWID) Receiving Opioid Agonist Therapy (OAT) (Poster presentation, Abstract #SAT-163, 8:00 a.m.-6:00 p.m. CEST)
- High Efficacy of an 8-Week 3-Drug Regimen of Grazoprevir/MK-8408/MK-3682 in HCV Genotype 1, 2 and 3-Infected Patients: SVR24 Data From the Phase 2 C-CREST 1and 2 Studies (Poster presentation, Abstract #SAT-139, 8:00 a.m.-6:00 p.m.)
- Cost Effectiveness of Elbasvir (EBS, MK-8742)/Grazoprevir (GZR/MK-5172) Use in Treatment-Naïve and Treatment-Experienced Patients With Hepatitis C Virus (HCV) Genotype 1 Infection and Chronic Kidney Disease (CKD) in the United States (Poster presentation, Abstract #SAT-141, 8:00 a.m.-6:00 p.m. CEST)
“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,” Dr. Eliav Barr, vice president, infectious diseases, Merck Research Laboratories, said in a press release. “Merck remains committed to the fight against chronic hepatitis C through our ongoing clinical programs exploring diverse patient groups and areas of unmet need.”
A complete list of abstract titles to be presented is available at the congress’ website.