Wednesday, April 5, 2017

Merck to Present New Data on (elbasvir and grazoprevir) and MK-3682B at International Liver Congress™ 2017

Merck to Present New Data on ZEPATIER® (elbasvir and grazoprevir) and Investigational Combination Therapy MK-3682B for the Treatment of Chronic Hepatitis C Infection at The International Liver Congress™ 2017

Merck (MRK), known as MSD outside of the United States and Canada, today announced that new data from the company’s chronic hepatitis C virus (HCV) clinical development programs as well as real-world studies on ZEPATIER® (elbasvir and grazoprevir) 50mg/100mg tablets will be presented at the upcoming International Liver Congress™ 2017. Seventeen scientific abstracts will be presented, including oral sessions featuring real-world data on chronic HCV-infected patients treated with ZEPATIER from the U.S. Department of Veterans Affairs Healthcare System and new results from the C-SURGE trial evaluating MK-3682B [uprifosbuvir (MK-3682)1/grazoprevir2/rusazvir3] in patients with chronic HCV infection who have previously failed a HCV direct-acting antiviral regimen. The International Liver Congress™ 2017 will take place in Amsterdam, Netherlands from April 19 – 23, 2017.

“We continue to generate new data on ZEPATIER while advancing our ongoing investigational program evaluating uprifosbuvir in combination with other assets, underscoring our continued commitment to chronic HCV research,” said Dr. Eliav Barr, senior vice president, global clinical development, infectious diseases and vaccines, Merck Research Laboratories. “Findings from both randomized clinical trials and real-world data analyses help us better understand the treatment of diverse patient types, including those who have been historically underserved or for whom unmet needs remain.”

In the United States, ZEPATIER is indicated for the treatment of chronic HCV genotype (GT) 1 or GT4 infection in adults. ZEPATIER is indicated for use with ribavirin (RBV) in certain patient populations. The U.S. Prescribing Information for ZEPATIER contains a Boxed Warning about the risk of hepatitis B virus (HBV) reactivation in patients co-infected with HCV and HBV.
Key presentations at The International Liver Congress™ 2017 will include:
ZEPATIER (elbasvir and grazoprevir)
Thursday, April 20
  • Real-World Use of Elbasvir/Grazoprevir and Outcomes in Patients With Chronic Hepatitis C: Retrospective Data Analyses From the TRIO Network (Poster presentation, Abstract THU-239, 8:00 a.m. – 6:00 p.m. CEST)
  • Prevention of Liver-Related Complications With Elbasvir/Grazoprevir in Hepatitis C Infected Patients who are Receiving Opioid Agonist Therapy (OAT) (Poster presentation, Abstract THU-246, 8:00 a.m. – 6:00 p.m. CEST)
  • Real-World Utilization of the New Fixed-Dose Combination Elbasvir/Grazoprevir in Adult Patients With Chronic Hepatitis C in Canada: Z-PROFILE Study (Poster presentation, Abstract THU-266, 8:00 a.m. – 6:00 p.m. CEST)
  • Clinically Meaningful Differences in Health-Related Quality of Life and Fatigue in Patients With Hepatitis C Virus (HCV) Infection Treated With Elbasvir/Grazoprevir (EBR/GZR) Compared to Sofosbuvir (SOF) With Pegylated Interferon and Ribavirin (PR) (Poster presentation, Abstract THU-245, 8:00 a.m. – 6:00 p.m. CEST)
  • Projected Long Term Impact of Elbasvir/Grazoprevir (EBR/GZR) Compared to Sofosbuvir Plus Pegylated Interferon/Ribavirin (SOF+PR) in Chronic Hepatitis C Virus Genotype 1 and 4 Patients in Italy: Translation of the C-EDGE Head-2-Head Study Findings (Poster presentation, Abstract THU-247, 8:00 a.m. – 6:00 p.m. CEST)
  • Safety and Efficacy of Elbasvir and Grazoprevir With or Without Ribavirin for the Treatment of Hepatitis C Virus Genotype 1: Results of the Hepatitis C Virus-TARGET Study (Poster presentation, Abstract THU-237, 8:00 a.m. – 6:00 p.m. CEST)
Friday, April 21
  • Real World Experience With Elbasvir/Grazoprevir in the Veterans Affairs Healthcare System (Oral presentation, Abstract PS-095, 4:00 – 4:15 p.m. CEST)
  • Efficacy and Safety of Elbasvir/Grazoprevir in Treatment-Na├»ve Patients With Chronic HCV GT 1, GT 4 and GT 6 Infection (C-CORAL): A Phase III Randomized Multinational Clinical Trial (Poster presentation, Abstract FRI-266, 8:00 a.m. – 6:00 p.m. CEST)
  • Elbasvir/Grazoprevir Plus Sofosbuvir in Treatment-Naive and Treatment-Experienced Cirrhotic Patients With Hepatitis C Virus Genotype 3 Infection Treated for 8, 12, or 16 weeks: Final Results of the C-ISLE Study (Poster presentation, Abstract FRI-213, 8:00 a.m. – 6:00 p.m. CEST)
  • Successful Treatment of Patients With HCV GT3 Infection and Cirrhosis with Elbasvir/Grazoprevir Plus Sofosbuvir Does Not Correct Insulin Resistance by 12 weeks Post-Treatment (Poster presentation, Abstract FRI-215, 8:00 a.m. – 6:00 p.m. CEST)
  • Impact of Elbasvir/Grazoprevir (EBR/GZR) on Health-Related Quality of Life (HRQOL) and Fatigue in Patients With Chronic Hepatitis C Virus (HCV) Infection and Inherited Blood Disorders (IBLD): Data From the C-EDGE IBLD Study (Poster presentation, Abstract FRI-251, 8:00 a.m. – 6:00 p.m. CEST)
Saturday, April 22
  • Elbasvir/Grazoprevir Effectiveness in Patients With Chronic Hepatitis C and Chronic Kidney Disease: Real-World Experience From the TRIO Network (Poster presentation, Abstract SAT-297, 8:00 a.m. – 6:00 p.m. CEST)
MK-3682B, INVESTIGATIONAL TRIPLE THERAPY
Thursday, April 20
  • Efficacy and Safety of the Fixed-Dose Combination Regimen of MK3 [MK-3682/Grazoprevir/Ruzasvir] With or Without Ribavirin in Non-Cirrhotic or Cirrhotic Patients With Chronic HCV GT1, 2, 3, 4 or 6 Infection (Parts A & B of C-CREST-1 & 2) (Poster presentation, Abstract THU-285, 8:00 a.m. – 6:00 p.m. CEST)
  • High Sustained Virologic Response Rates in Patients With Chronic HCV GT1, 2 or 3 Infection Following 16 Weeks of MK-3682/Grazoprevir/Ruzasvir Plus Ribavirin After Having Failed 8 Weeks of a Triplet Drug Regimen (Part C of C-CREST-1 & 2) (Poster presentation, Abstract THU-264, 8:00 a.m. – 6:00 p.m. CEST)
Saturday, April 22
  • Safety and Efficacy of the Fixed-Dose Combination Regimen of MK-3682/Grazoprevir/Ruzasvir in Cirrhotic or Non-Cirrhotic Patients With Chronic HCV GT1 Infection who Previously Failed a Direct-Acting Antiviral Regimen (C-SURGE) (Oral presentation, Abstract PS-159, 9:30 a.m. – 9:45 a.m. CEST)
For more information, including a complete list of abstract titles at the meeting, please visit: http://ilc-congress.eu/.

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