New Data Shows 83% of Patients With Genotype 1 Hepatitis C, Who Have Previously Relapsed on Existing Standard of Care Treatments, Achieve a Cure With Investigational Agent Telaprevir[1]
By Janssen, PRNEWednesday, March 30, 2011
BERLIN, March 31, 2011 - Janssen Pharmaceutical Companies of Johnson & Johnson* is today
announcing, at the 46th Annual Meeting of the European Association for the
Study of the Liver (EASL), the results of the phase 3 REALIZE study with
telaprevir, a direct-acting antiviral agent, which involved patients with
genotype 1 hepatitis C who have previously failed to respond to currently
available treatments.
In the REALIZE study, 83% of patients taking telaprevir on top of
standard of care treatment achieved a cure. The current standard of care
treatment for hepatitis C, pegylated interferon-alfa and ribavirin, is
successful in only about 50% of patients with genotype 1, leaving the other
50% without a successful treatment outcome.[2]
"I welcome this exciting new data showing that a telaprevir combination
regimen may significantly improve cure rates for people who have failed
previous treatment. This applies to people with genotype 1 hepatitis C which,
up until now has been common and very difficult to treat," said Professor
Graham Foster, Professor of Hepatology, Queen Marys, University of London.
"The advent of a new standard of care provides fresh hope of a cure for
people living with hepatitis C and significant advancements in treatment such
as this will make a real difference in reducing the burden of hepatitis C."
Despite being a curable disease, hepatitis C is a silent killer - a
public health crisis that leads to significant morbidity and mortality and
burden to the NHS. In the UK, it is estimated that approximately 185,000
individuals are chronically infected with hepatitis C.[2] However, other
sources suggest a range of between 250,000 to 466,000 people.[3] Chronic
hepatitis C can result in serious long-term health problems - of those who
develop chronic hepatitis C an estimated 30% of people will develop cirrhosis
(deterioration of the liver), others will develop liver cancer, some of whom
may require liver transplantation.[4] Chronic hepatitis C is the most common
reason for liver transplants in Europe.[5]
* Telaprevir, a protease inhibitor, is a direct-acting antiviral agent
which was co-developed by Vertex Pharmaceuticals and Tibotec, an affiliate of
Janssen Pharmaceutical Companies of Johnson & Johnson, and the company
responsible for marketing telaprevir in Europe.
Notes to the Editor:
About the Hepatitis C Virus
- When people become infected with hepatitis C, there is no way to
predict whether or not they will go on to develop serious problems.
- Around 13,000 people are newly infected every year, but less than 5,000
are currently receiving treatment.[3]
- Sustained viral response (SVR), which means the virus remains
undetectable in patients' blood six months after completion of treatment. SVR
is the goal of hepatitis C treatment and is considered a cure.
About Janssen
Janssen Pharmaceutical Companies of Johnson & Johnson, is dedicated to
addressing and solving the most important unmet medical needs of our time,
including oncology (e.g. multiple myeloma and prostate cancer), immunology
(e.g. psoriasis), neuroscience (e.g. schizophrenia, dementia and pain),
infectious disease (e.g. HIV/AIDS, Hepatitis C and tuberculosis), and
cardiovascular and metabolic diseases (e.g. diabetes). Driven by our
commitment to patients, we develop sustainable, integrated healthcare
solutions by working side-by-side with healthcare stakeholders, based on
partnerships of trust and transparency.
More information can be found at www.janssen.co.uk
References:
1. Zeuzem S, Andreone P, Pol S et al. REALIZE trial final results:
telaprevir-based regimen for genotype 1 hepatitis C virus infection in
patients with prior null response, partial response or relapse to
peginterferon/ribavirin. Paper presented at: 46th annual meeting of the
European Association for the Study of the Liver (EASL); 2011.
2. Hepatitis C in the UK: Annual Report2009. London Health Protection
Agency, December 2009
3. In The Dark: An audit of hospital hepatitis C services across England.
The All-Party Parliamentary Hepatology Group, August 2010
4. TA200: Peginterferon alfa and ribavirin for the treatment of chronic
hepatitis C. Part review of NICE technology appraisal guidance 75 and 106.
Issued September 2010.
5. Lang K, Weiner DB. Immunotherapy for HCV infection: next steps. Expert
Rev Vaccines. 2008;7(7): 915-923
For more information contact Ronan Collins, Janssen, Mobile: +44(0)7876-257746 Simon Goldsborough, Munro & Forster, Mobile: +44(0)7973-272915
For more information contact: Ronan Collins, Janssen, Mobile: + 44(0)7876-257746; Simon Goldsborough, Munro & Forster, Mobile: +44(0)7973-272915
Tags: Berlin, Germany, Janssen, March 31