Merck to present VICTRELIS phase III study data against HCV at EASL annual meeting

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that several new data analyses from Phase III studies of VICTRELIS (boceprevir), its investigational oral hepatitis C protease inhibitor, will be presented at The International Liver CongressTM / 46th European Association for the Study of the Liver (EASL) annual meeting. The meeting will be held from March 30 - April 3 in Berlin. In total, more than 20 abstracts highlighting Merck medicines and investigational therapies for chronic hepatitis C virus (HCV) infection will be presented, including 3 oral presentations and 17 posters for VICTRELIS.

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Presented for the first time will be final results from a Phase III study of VICTRELIS administered in combination with Pegasys® (peginterferon alfa-2a) and ribavirin in adult patients with chronic HCV genotype 1 infection who were non-responders or relapsers to previous pegylated interferon and ribavirin therapy.

The EASL presentations will also include new analyses of the pivotal Phase III data for VICTRELIS administered in combination with PEGINTRON® (peginterferon alfa-2b) and ribavirin from the HCV SPRINT-2 and HCV RESPOND-2 studies:

  • Response-guided therapy with VICTRELIS in combination with current standard therapy among patients with chronic HCV genotype 1, including special populations such as those with advanced fibrosis / cirrhosis;
  • Overall safety profile of VICTRELIS administered in combination with current standard therapy for chronic HCV; and
  • Potential predictive factors for chronic HCV treatment success, including response following 4 weeks of lead-in therapy and IL28B polymorphism.

The abstracts were published and can be accessed on the EASL website. For program information, please visit http://www2.kenes.com/liver-congress/Pages/Home.aspx.

VICTRELIS (Boceprevir) Oral Presentations

Parallel Session: HCV Therapy, Thursday, March 31, 17:00 - 19:00, Hall 1

Boceprevir in Addition to Standard of Care Enhanced SVR in Hepatitis C Virus (HCV) Genotype-1 with Advanced Fibrosis/Cirrhosis: Subgroup Analysis of SPRINT-2 and RESPOND-2 Studies; S. Bruno et al. 17:15 - 17:30 CET

Boceprevir Resistance-Associated Variants (RAVS) are Observed More Frequently in HCV (Gt1)-Infected Patients with Poor Response to Peginterferon Alfa-2b/Ribavirin; S. Zeuzem et al. 17:45 - 18:00 CET

IL28B Polymorphism Predicts Virologic Response in Patients with Hepatitis C Genotype 1 Treated with Boceprevir (BOC) Combination Therapy. F. Poordad et al. 18:30 - 18:45 CET

VICTRELIS (Boceprevir) Key Poster Presentations

High Sustained Virologic Response (SVR) Among Genotype 1 Previous Non-Responders and Relapsers to Peginterferon/Ribavirin When Re-Treated With Boceprevir Plus Peginterferon Alfa-2A/Ribavirin. S. Flamm et al. Late-Breaker Abstract 1366. Thursday, March 31.

Response-Guided Therapy with Boceprevir Plus Peginterferon Alfa-2b/Ribavirin Reduces Duration in Naive and Peginterferon Alfa-2b/Ribavirin Previous-Treatment-Failure Patients with HCV Genotype 1. M.P. Manns et al. Abstract 448. Thursday, March 31.

Overall Safety Profile of Boceprevir Plus Peginterferon Alfa-2b/Ribavirin. M.P. Manns et al. Abstract 449. Thursday, March 31.

Four-Week Therapy with Peginterferon Alfa-2b/Ribavirin Effectively Predicts Sustained Virologic Response in Treatment-Naïve and Previous-Treatment-Failure Patients with HCV-1 Treated with Boceprevir Plus Peginterferon Alfa-2b/Ribavirin. J.M. Viering et al. Abstract 481. Thursday, March 31.

Utility of Historical Data Compared to Lead-In Response in Predicting Sustained Virologic Response in Non-Responders and Relapsers to Peginterferon/Ribavirin When Re-Treated With Boceprevir+Peginterferon Alfa-2b/Ribavirin (P/R). R. Esteban et al. Abstract 418. Thursday, March 31.

Posted in: Drug Trial News | Disease/Infection News

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