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Medivir Announces an Interferon-Free Phase II Combination Trial With TMC435 and daclatasvir to Commence Shortly
Date:6/28/2012

STOCKHOLM, Sweden, June 29, 2012 /PRNewswire/ --

  • The phase II interferon-free combination study with TMC435 and daclatasvir will evaluate treatment-naïve or previous null responder patients with HCV genotype 1a and 1b
  • The study will include approx. 180 patients and will evaluate a combination of TMC435 and daclatasvir, with or without Ribavirin, in four different cohorts for 12 or 24 weeks of treatment

Medivir AB (OMX:MVIR), the research-based pharmaceutical company focused on the development of high-value treatments for infectious diseases, announces that a phase II combination study with the investigational compound TMC435 and Bristol-Myers Squibb's investigational compound daclatasvir will start in July. This study is part of the clinical collaboration agreement between Janssen R&D Ireland and Bristol-Myers Squibb Company (NYSE: BMY) announced on 2 December 2011 and on 18 April 2012.

TMC435 and daclatasvir (BMS-790052)

TMC435, a once daily potent NS3/4A protease inhibitor (PI) in phase III clinical development for the treatment of chronic genotype-1 hepatitis C virus (HCV) infection, will be investigated in an interferon free  phase II trial in combination with Bristol-Myers Squibb´s investigational NS5A replication complex inhibitor, daclatasvir (BMS-790052), also in phase III development.

The purpose of this study is to assess the efficacy and safety of TMC435 and daclatasvir in combination with or without Ribavirin in chronic genotype-1 hepatitis C infected patients who are treatment-naive or null responders to previous Peginterferon alfa/Ribavirin therapy.

Study design

In this open label phase II study the potential to achieve sustained viral response (SVR), 12 (SVR12) and 24 (SVR24) weeks post treatment in treatment-naïve and
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SOURCE Medivir
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