· 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

Stockholm, Sweden – 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 null
responder patients infected with HCV genotype 1a and 1b will be
evaluated. Patients with advanced liver disease (F3/F4) will be allowed
up to approx. 35% of the total treated population.

Cohort one and
two will include patients with genotype 1b where TMC435 and daclatasvir
will be dosed with or without Ribavirin for 12 weeks with a 36 weeks
follow-up or for 24 weeks with a 24 weeks follow-up.

Cohort three
and four will include patients with genotype 1a where TMC435,
daclatasvir and Ribavirin will be dosed for 12 or 24 weeks with a 24
weeks post treatment follow-up.

For additional information from these recently updated studies, please see www.clinicaltrials.gov

For more information about Medivir, please contact:

Medivir Rein Piir, EVP Corporate Affairs & IR Mobile: +46 708 537 292
M:Communications medivir@mcomgroup.com
Europe: Mary-Jane Elliott, Amber Bielecka, Hollie Vile +44(0)20 7920 2330

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