OLYSIO™ (simeprevir): Quick Facts -- What You Need to Know

November 24, 2013
By Patricia Emory

OLYSIO™ (simeprevir) was approved in the United States November 22, 2013 by the FDA for the treatment of hepatitis C patients in conjunction with pegylated interferon and ribavirin in adult patients (treatment-naive and treatment-experienced) with genotype 1 including those with compensated cirrhosis.

OLYSIO™ (simeprevir) is a “2nd generation”  NS3/4A protease inhibitor which acts by blocking the protease enzyme that enables the virus to replicate.

Dosing and Duration of treatment

Dosing: Fixed dose of 150mg once a day

Duration of Treatment:

Treatment-naïve and prior-relapsers: 12 weeks of Simeprevir in combination with 24 weeks of pegylated interferon and ribavirin

Partial and null-responders: 12 weeks of Simeprevir in combination with 48 weeks of pegylated interferon and ribavirin

Adverse Effects

The most common adverse effects of Simeprevir are rash and sensitivity to sunlight (most common in the first 4 weeks of treatment) as well as those associated with pegylated interferon and ribavirin.

Q80K polymorphism

Q80K polymorphism is found in 56.7% of genotype 1a patients in the US. The Q80K polymorphism  greatly reduces treatment response. It is suggested that all patients being considered for treatment using Simeprevir be screened for the Q80K polymorphism.

Financial Assistance

According to the OLYSIO™ website:

“Information on financial assistance through OLYSIO^™ Support will be available soon. In the meantime, please call1-800-JANSSEN (1-800-526-7736) for information.”

Further Information

OLYSIO™ (simeprevir) website 

OLYSIO™ (simeprevir) Receives FDA Approval for Combination Treatment of Chronic Hepatitis C – Janssen Press Release

FDA approves new treatment for hepatitis C virus – FDA Press Release

FDA Antiviral Drugs Advisory Committee Meeting Briefing Document

Novel Patient Stratification Biomarkers for Liver Cancer

Proteome Sciences plc
(“Proteome Sciences” or the “Company”)
Novel Patient Stratification Biomarkers for Liver Cancer

20th November, 2013. Proteome Sciences is pleased to announce the discovery and validation
of novel protein biomarkers for patient stratification in liver cancer using proprietary proteomics workflows. Details are published today in the journal EuPA Open Proteomics: “Protein expression profiles of chemo-resistant mixed phenotype liver tumors using laser microdissection
and LC–MS/MS proteomics”
(http://www.sciencedirect.com/science/article/pii/S221296851300007X).
 
The study was performed in partnership with Professor Nigel Heaton and his team at Kings
College Hospital NHS Foundation Trust and used PS Biomarker Services™ leading edge
proteomic workflows.

Effective treatment of hepatocellular carcinoma (HCC) and cholangiocarcinoma (CC) remains
one of the toughest challenges for doctors, with a five year survival rate of only 13%, barely  \improved since the 1970’s. Prior to the discovery of these biomarkers, definition of the sub-types
of liver cancer which require different treatment options, has been extremely difficult.

After completing the analysis of 2,864 proteins, a panel of differentially expressed biomarkers  was identified and patents were filed prior to publication to cover these novel stratification  markers.

Commenting on the EuPA publication Professor Nigel Heaton, Director of the King’s Liver
Transplant Centre said:-

“The biomarkers published in EuPA Open Proteomics represent a major step towards improving
the outcomes in the treatment of liver cancer. We have been waiting for over 30 years for better
treatment options in liver cancer and a large part of the challenge has been the lack of effective
biomarkers to differentiate hepatocellular carcinoma and cholangiocarcinoma. Proteome  Sciences’ proprietary workflows for FFPE tissue for the first time provided a highly effective  way of identifying biomarkers for liver cancer and we need to accelerate further validation  before moving to widespread clinical adoption.”

Dr. Ian Pike, Chief Operating Officer of Proteome Sciences added:-

“Stratified medicine is a key component of the global response to major healthcare challenges
that urgently requires new biomarkers to guide early diagnosis and treatment selection. The
results from this study show the value of Proteome Sciences' proteomics technologies in  discovering and validating biomarkers for stratified medicine in liver cancer. We have additional
studies ongoing where our SysQuant® technology is defining high content cell signalling
pathway maps in pancreatic and liver cancers that will guide optimal drug selection and should
considerably improve and deliver better patient outcomes.”
 
- Ends -

For further information please contact:
Proteome Sciences plc
Christopher Pearce, Chief Executive Officer
Dr. Ian Pike, Chief Operating Officer Tel: +44 (0)1932 865065
James Malthouse, Finance Director
 
Nominated Adviser
Cenkos
Stephen Keys/Camilla Hume Tel: +44 (0)20 7397 8900
 
Public Relations
IKON Associates
Adrian Shaw
Tel: +44 (0)1483 271291

Notes to Editors:

About Proteome Sciences

Proteome Sciences is a global leader in applied proteomics and peptidomics offering high sensitivity, proprietary technologies for protein and peptide biomarker discovery, validation and assay development. Its PS Biomarker Services™ uses isobaric and isotopic Tandem Mass Tag® (TMT®) workflows developed on the latest Orbitrap® Velos Pro and TSQ Vantage mass spectrometers to deliver rapid, robust and reproducible biomarker assay development for customers in the pharmaceutical, diagnostic and biotechnology sectors. Services are provided from its ISO 9001: 2008 accredited facilities in Frankfurt, Germany. By combining Selected Reaction Monitoring (SRM) and TMT® workflows highly multiplexed assays can be developed rapidly and are suitable for screening hundreds of candidate biomarkers in larger validation studies and can be transferred for immunoassay development. The Company’s own research has discovered a large number of novel protein biomarkers in key human diseases and is focused mainly in neurological/neurodegenerative conditions and in cancer. It has discovered and patented blood biomarkers, including Alzheimer’s disease, stroke, brain damage and lung cancer for diagnostic and treatment applications that are available for license or are already outlicensed. Proteome Sciences, based in Cobham, UK, with facilities in London and Frankfurt, delivers outsourced proteomics services and proprietary biomarkers/biomarker assays to pharmaceutical, biotechnology and diagnostics companies.

Visit: http://www.proteomics.com

Source

Serum nitrotyrosine and psychometric tests as indicators of impaired fitness to drive in cirrhotic patients with minimal hepatic encephalopathy

Liver International

Volume 33, Issue 10, pages 1478–1489, November 2013

Cirrhosis and Liver Failure

Vicente Felipo¹, Amparo Urios², Pedro Valero³, Mar Sánchez³, Miguel A. Serra⁴,  Ignacio Pareja³, Felicidad Rodríguez⁴,  Carla Gimenez-Garzó¹, Jaime Sanmartín³,  Carmina Montoliu^2,*

Article first published online: 29 MAY 2013

DOI: 10.1111/liv.12206

© 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd

Keywords: 3-nitrotyrosine;  fitness to drive;  minimal hepatic encephalopathy;  psychometric tests

Abstract

Background & Aims

Cirrhotic patients with minimal hepatic encephalopathy (MHE) show impaired driving ability and increased vehicle accidents. The neurological deficits contributing to impair driving and the underlying mechanisms are poorly understood. Early detection of driving impairment would help to reduce traffic accidents in MHE patients. It would be therefore useful to have psychometric or biochemical parameters reflecting driving impairment. The aims of this work were as follows: (i) to shed light on the neurological deficits contributing to impair driving; (ii) to assess whether some psychometric test or biochemical parameter is a good indicator of driving impairment.

Methods

We assessed in 22 controls, 36 cirrhotic patients without and 15 with MHE, driving performance using a driving simulator (SIMUVEG) and Driver Test. MHE was diagnosed using the psychometric hepatic encephalopathy score (PHES). Psychometric tests assessing different neurological functions (mental processing speed, attention, visuo-spatial and bimanual coordination) were performed. Blood ammonia and parameters related with nitric oxide-cGMP metabolism, IL-6, IL-18 and 3-nitrotyrosine were measured.

Results

Patients with MHE showed impaired driving ability correlating with MHE grade, with impaired vehicle lateral control in spite of reduced driving speed. Patients with MHE show psychomotor slowing, longer reaction times, impaired bimanual and visuo-spatial coordination and concentrated attention and slowed speed of anticipation and increased blood ammonia, cGMP, IL-6, IL-18 and 3-nitrotyrosine.

Conclusions

Impaired mental processing speed, attention and alterations in visuo-spatial and motor coordination seem main contributors to impaired driving ability in patients with MHE. Increased serum 3-nitrotyrosine is associated with impaired driving ability.

Source

Prescription Assistance for OLYSIO™ (Simeprevir): Coming soon!

Coming Soon:

Information on financial assistance through OLYSIO™ Support will be available soon. In the meantime, please call 1-800-JANSSEN (1-800-526-7736) for information.

Source