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]

BERLIN, March 31, 2011 /PRNewswire/ -- 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 http://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

SOURCE Janssen