Simeprevir/New Data Will Be Presented at Easl's International Liver Congress 2016

Medivir: New Data for Simeprevir Will Be Presented at Easl's International Liver Congress 2016
April 11, 2016 09:46 AM Eastern Daylight Time


STOCKHOLM--(BUSINESS WIRE)--Regulatory News:

Medivir (STO:MVIRB)

Medivir AB (Nasdaq Stockholm: MVIR) today informs that new clinical data for simeprevir, an NS3 / 4A protease inhibitor for the treatment of hepatitis C virus infection, will be presented by our partner Janssen Sciences Ireland UC (Janssen) in conjunction with The International Liver Congress ™ 2016 of the European Association for the Study of the Liver (EASL) in Barcelona, on 13-17 April. A total of nine presentations will be made, including one "late breaker" presentation. The presentations will cover the efficacy, safety and tolerability of simeprevir used as a component of various combination therapies in a number of different adult patient populations, and will be based on data from phase II and phase III studies and from on-going clinical use (so-called "real-world data").

Data presented at the International Liver Congress 2015 include:

Late-Breaking Poster Presentation

Simeprevir plus sofosbuvir for hepatitis C virus genotype 4 infection: a phase 3, open-label study.

· Abstract LBP516

· Lead Author: M. Buti; Hospital Vall d’Hebron and Centro Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas (CIBERehd), Barcelona, Spain

Poster Presentations

Pharmacokinetic interactions between simeprevir and ledipasvir in treatment-naïve hepatitis C virus genotype 1-infected patients without cirrhosis treated with a simeprevir/sofosbuvir/ledipasvir regimen

· Abstract SAT-264

· Lead Author: S. Bourgeois, Department of Internal Medicine, ZNA Ster, Antwerp

Deep sequencing results from the Phase 2 IMPACT study of simeprevir in combination with daclatasvir and sofosbuvir in treatment-naïve and -experienced patients with chronic hepatitis C virus genotype 1 or 4 infection and decompensated liver disease

· Abstract THU-215

· Lead Author: C. Sarrazin, Johann Wolfgang Goethe University Medical Center, Frankfurt am Main, Germany

Consistent simeprevir resistance profile in hepatitis C virus genotype 1-infected patients failing simeprevir interferon-free compared with interferon-containing regimens

· Abstract THU-214

· Lead Author: B. Fevery, Janssen Infectious Diseases BVBA, Beerse, Belgium

Effectiveness of simeprevir-containing regimens among patients with chronic hepatitis C virus in various US practice settings: The SONET study

· Abstract SAT-167

· Lead Author: I. Alam, Austin Hepatitis Center, Austin, TX, USA

Efficacy and safety of simeprevir and sofosbuvir with and without ribavirin for 12 weeks in subjects with recurrent genotype 1 hepatitis C post-orthotopic liver transplant: The GALAXY study

· Abstract FRI-457

· Lead Author: J.G. O'Leary, Baylor University Medical Center, Dallas, TX, USA

Efficacy and tolerability of simeprevir and daclatasvir for 12 or 24 weeks in HCV genotype 1b-infected treatment-naïve patients with advanced fibrosis or compensated cirrhosis

· Abstract SAT-130

· Lead Author: C. Hézode, Department of Hepatology and Gastroenterology, Hôpital Henri Mondor, Université Paris-Est, France

Effectiveness of simeprevir treatment for hepatitis C in real practice: preliminary results from the STIly Italian observational study

· Abstract SAT-162

· Lead Author: G.B. Gaeta, Seconda Universita di Napoli, Napoli, Italy

Safety of simeprevir-based treatment for hepatitis C in real practice: preliminary results from the STIly observational study

· Abstract SAT-212

· Lead Author: M. Colombo, Ospedale Maggiore Policlinico, Milano, Italy

Details of all presentations for The International Liver Congress ™ 2016 are available at the conference website: http://www.ilc-congress.eu