Barriers to the treatment of deadly timebomb disease removed

• Wednesday, 23 August 2006

NICE approves PEGASYS® for treatment of mild hepatitis C

Welwyn Garden City, 23rd August 2006 – Today the National Institute for Health and Clinical Excellence (NICE) approved the use of Pegasys (pegylated interferon alpha 2a (40KD)) to treat hepatitis C1 before measurable damage occurs to a patient’s liver. The new guidance to treat patients with mild chronic hepatitis C means that hundreds of thousands of people in the UK with asymptomatic infection may experience an early cure and avoid the potential progression of the virus to liver cirrhosis, liver cancer or death. Significantly the new guidance removes the necessity to perform a liver biopsy before starting treatment, a procedure often cited by patients as a barrier to treatment.

Professor Graham Foster, professor of Hepatology at Queen Mary, University of London and a consultant hepatologist at Barts and the London NHS Trust in East London said, “The earlier a patient is treated the best chance we have of curing them of their disease. This new guidance means that more patients, regardless of where they live in the UK, can have an increased chance of avoiding serious liver damage.”

Charles Gore, from The Hepatitis C Trust added, “This is excellent news for our ongoing battle against hepatitis C. Many patients are deterred from treatment by the thought of a liver biopsy or instead are forced to endure a lengthy wait before a biopsy can be conducted. Now patients can be effectively treated while the damage caused by this virus is still limited.”

Pegasys combination therapy was recommended as first line treatment along with peginterferon alfa-2b combination therapy, within their respective licensed indications. Before today, people with hepatitis C had to wait until there was evidence of significant scarring (fibrosis) and/or significant inflammation of the liver, and undergo a liver biopsy, before they were able to get treatment on the NHS. Over 60% of those infected can be cured of this infectious disease, rising to over 80% of patients for some strains of the virus (genotype 2 and 3), but treating hepatitis C as early as possible provides the best chance of a cure. Pegasys is the only pegylated interferon approved to treat patients with normal “ALT” levels – a widely used marker to determine potential damage to the liver.

Once infected with the hepatitis C virus, untreated patients are sitting on a ticking timebomb, just waiting for the virus to slowly start to destroy their liver. The frightening fact is of the estimated 466,000 people infected with hepatitis C only 1 in 7 have been diagnosed with the disease,2 and only 1-2% of those infected have been treated with potentially curative drugs.3 However, the huge breakthrough for those that know they are infected is that they now have an increased chance to fight and beat this insidious disease, thanks to this new NICE guidance.

In making its decision, NICE reviewed the clinical effectiveness of Pegasys across three major clinical trials. The results of these trials showed that people with genotype 2 and 3 yielded sustained virological responses (indicative of a cure) rates of 72-84% after 24 weeks. In the most difficult to treat form of hepatitis C, genotype 1, trials showed that Pegasys plus ribavirin yielded a sustained virological response rate of 40-52% after 48 weeks of treatment. 1

Pegasys is the most commonly prescribed pegylated interferon for patients infected with hepatitis C worldwide. An extensive clinical study programme has demonstrated its tolerability and efficacy profile in the broadest range of patients including those with more difficult-to-treat disease.

Notes to Editors:

About Hepatitis C

Hepatitis C, one of the most common chronic blood-borne infections, is transmitted primarily through blood or blood products. Estimates of prevalence for hepatitis C in England and Wales vary considerably from 200,000 to 500,000. Hepatitis C chronically infects 170 million people worldwide, with an additional three to four million people newly infected each year. It is a leading cause of cirrhosis, liver cancer and liver failure. Genotype 2 and 3 hepatitis C is the most common in Europe, and patients with this type of hepatitis C typically have the best response to treatment.

About Roche in the UK

Roche aims to improve people's health and quality of life with innovative products and services for the early detection, prevention, diagnosis and treatment of disease. Part of one of the world’s leading healthcare groups, Roche in the UK employs nearly 2,000 people in pharmaceuticals and diagnostics. Globally, Roche is the leader in diagnostics and the leading supplier of medicines for cancer and transplantation.

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References:

1. NICE final guidance for Peginterferon alfa and ribavirin for the treatment of mild chronic hepatitis C. 23 August 2006.

2. All Party Parliamentary Group on Hepatology. The Hepatitis C Scandal, London. All Party Parliamentary Group on Hepatology, 2004.

3. Parkes J. Epidemology of Hepatitis C infection. Presentation at EASL, April 2005.

If you have any queries or would like to receive copies of the referenced papers above, please contact:-

Katy Davidson
WeberShandwick
T: 0207 067 0205
Email: kdavidson@webershandwick.com

Greg Page
Roche
T: 01707 367812
M: 07739 821088
Email : greg.page@roche.com

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