EASL-Simeprevir plus sofosbuvir with/without ribavirin data to be presented

New Simeprevir data will be presented at The International Liver Congress 2014 of the European Association for the Study of the Liver, (EASL)

Presentations Include late-breaking final results from the phase II COSMOS study

Stockholm, Sweden — Medivir AB (OMX: MVIR) today announces that new data from the clinical development program for simeprevir in the treatment of genotype 1 or genotype 4 chronic hepatitis C virus (HCV) in adult patients with compensated liver disease will be presented at The International Liver Congress of the European Association for the study of the Liver (EASL). The International Liver Congress 2014 will take place from April 9-13 in London, United Kingdom.

Eight oral and poster presentations spanning over the phase II and phase III development program for simeprevir in treatment combinations with and without ribavirin and interferon are planned. New analyses of data from the phase III QUEST-1, QUEST-2 and PROMISE clinical trials of simeprevir in combination with pegylated interferon and ribavirin, as well as final data from the phase II COSMOS study will be presented during the Congress.

The data to be presented at the International Liver Congress 2014 include:

Late-Breaking Presentations
Simeprevir plus sofosbuvir with/without ribavirin in HCV genotype 1 prior null-responder/treatment-naïve patients (COSMOS Study): primary endpoint (SVR12) results in patients with METAVIR F3-4 (Cohort 2)
- Lead Author: Eric Lawitz; The Texas Liver Institute, University of Texas Health Science Center, San Antonio, USA

Once-daily simeprevir (TMC435) with peginterferon/ribavirin in treatment-naïve or treatment-experienced chronic HCV genotype-4 infected patients: SVR12 results of a Phase 3 trial (RESTORE Study)
- Lead Author: Christopher Moreno; ULB Hôpital Erasme, Brussels, Belgium

Oral Presentations
Once-daily simeprevir (TMC435) plus sofosbuvir (GS-7977) with or without ribavirin in HCV genotype 1 prior null responders with METAVIR F0-2: COSMOS Study Cohort 1 subgroup analysis
- Lead Author: Mark Sulkowski; Johns Hopkins University School of Medicine, Baltimore, USA

Simeprevir with peginterferon/ribavirin for treatment of chronic HCV genotype 1 infection in European patients who relapsed after previous interferon-based therapy: the PROMISE trial
- Lead Author: Xavier Forns; Liver Unit, Hospital Clinic, Barcelona, Spain

Poster Presentations
Simeprevir (TMC435) with peginterferon/ribavirin for treatment of chronic HCV genotype 1 infection in treatment-naïve European patients in the QUEST-1 and QUEST-2 Phase 3 trials
- Lead Author: Graham R. Foster; Queen Mary’s, University of London, London, UK

Simeprevir reduces time with peginterferon/ribavirin-induced symptoms and quality-of-life impairments: 72-week results from three Phase 3 studies
- Lead Author: Jane Scott; Janssen

Virology analyses of simeprevir in Phase 2b and 3 studies
- Lead Author: Oliver Lenz; Janssen

Deep sequencing analyses of minority baseline polymorphisms and persistence of emerging mutations in HCV genotype 1-infected patients treated with simeprevir
- Lead Author: Bart Fevery; Janssen

Full session details and data presentation listings for The International Liver Congress 2014 can be found at

http://www.ilc-congress.eu.