NEW DATA CALLS INTO QUESTION THE WATCH AND WAIT TREATMENT STRATEGY FOR HEPATITIS C -:- ITnews. Portale dell'ICT e dell'Economia Digitale

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[DUG]-The 'watch-and-wait' "strategy" is what my doctor/s feel towards MY case at this time, except I'm going to an Acupuncturist-/-Herbalist for 'treatment' right now,.... definitely I'll be showing/faxing this to my doctor/s most rapidly.[/DUG]

http://www.itnews.it/risorse/EuroNews,Zj0xMjAwNzA0

NEW DATA CALLS INTO QUESTION THE "WATCH AND WAIT" TREATMENT STRATEGY FOR HEPATITIS C

13-04-2005 06:07

BASEL, Switzerland, April 13 /PRNewswire/ --- New Results Show Treating Early With PEGASYS® Combination Therapy Significantly Increases Chance of Achieving a Cure

A study presented today at a major international medical meeting will sound a wake-up call for thousands of hepatitis C patients who are not currently receiving treatment for their disease.

New data demonstrate that patients with "normal" liver enzyme levels (alanine aminotransferase (ALT)) who are treated earlier, at a younger age, are much more likely to achieve a sustained virological response (indicative of a cure) than older patients.

These findings reinforce the growing body of evidence that the "watch-and-wait" treatment strategy for hepatitis C (HCV) patients may not be the most effective approach.

The study was presented at the 40th Annual Meeting of the European Association for the Study of the Liver (EASL) in Paris.

"Many hepatitis C sufferers with so called 'normal' ALT levels are not receiving treatment - either because they have been told they don't require therapy or because they're choosing to wait," said Professor Gane, from Auckland and Middlemore Hepatitis Clinics and the New Zealand Liver Transplant Unit, and lead author of the study.

"The results from our study confirm that not only do these patients benefit from PEGASYS combination therapy, they also experience better results when treated at an early age."

ALT is an enzyme used to estimate liver damage and, historically, hepatitis C patients with 'normal' ALT levels have not been treated due to the misconception that 'normal' levels indicated mild disease and that these patients were essentially 'healthy carriers' of hepatitis C.

However, the medical community is shifting its thinking as studies reveal that the vast majority of these patients actually have some degree of liver damage and suffer a reduced quality of life compared with uninfected persons.

The studies also reveal that these patients benefit from treatment with PEGASYS.[ii] At this time, PEGASYS in combination with ribavirin is the only treatment approved for these patients in Europe.

The Benefits of Treating Young:

Professor Gane's study examined how a patient's age affected their chance of achieving an SVR.

Investigators analysed patients aged forty and younger versus those aged over forty. Findings showed that patients treated at a younger age experienced significantly better results, regardless of genotype:

- 54% of genotype 1 patients aged forty or younger treated with 48 weeks of PEGASYS (180 mg/week) plus ribavirin (800 mg/day) achieved an SVR.

In contrast, only 34% of similarly-treated patients over forty achieved an SVR.

- 79% of patients forty or younger with genotype 2/3 HCV achieved an SVR following 24 weeks of the same PEGASYS combination therapy.

In comparison, 69% of patients over forty achieved an SVR with this treatment regimen.

"Age is one of the few treatment success factors that a patient has some control over," said Michel Bonjour,

President of SOS Hépatites-France and founding member of the European Liver Patients Association.

"Patients who choose to undergo therapy early increase their chance of curing themselves of this disease.

This especially holds true for those who take the initiative to educate themselves about hepatitis C, and are willing to take charge of their disease."

Today's findings regarding age are consistent with a study presented at the American

Association for the Study of Liver Diseases in 2003 which showed that patients with elevated ALT levels also benefit from treatment at a younger age.[iii]

Together, these studies show that age is a positive predictor of treatment success regardless of ALT levels.

Is High Patient Weight Really the Culprit?

In addition to learning more about how age affects a patient's chance of eradicating the hepatitis C virus, other factors influencing treatment success are also being carefully scrutinised.

Being overweight or obese has been shown in previous studies to reduce a patient's chance of achieving an SVR, irrespective of the pegylated interferon therapy used[iv],[v].

New research presented at EASL shows that poorer treatment outcomes in heavy patients is a result of an array of other patient and disease characteristics.[vi]

"Our goal is to create an accurate profile of the kind of patient that doesn't respond well to treatment, which will then help us determine how we can modify treatment strategies and ultimately, cure more patients," said Professor Mark Swain, from the University of Calgary and lead investigator of the study.

"In this analysis, those with a high body weight were also more likely to be male, African American, and have cirrhosis.

These are all factors that can decrease a patient's chance of achieving a cure."

Professor Swain and other researchers reviewed data from two multinational trials examining the safety and efficacy of PEGASYS combination therapy for the treatment of hepatitis C.

Patients were divided into three groups: patients who weighed less than 65 kg; those weighing between 65 kg and 85 kg; and patients weighing more than 85 kg.

Each group was then analysed for additional factors that can influence response to therapy.

"Pointing the finger at a patient's weight as the culprit for poor response is too simplistic," said Professor Swain.

"These results show that finding the right treatment solution will require careful consideration and research."

PEGASYS - The Right Solution for More PatientsPEGASYS is the most frequently prescribed pegylated interferon for patients infected with hepatitis C. An extensive clinical study programme has demonstrated its safety and efficacy, particularly for those with difficult-to-treat disease. The benefits of PEGASYS are derived from its unique 40 kilodalton branched PEG molecule that is irreversibly bound to the interferon, and which provides sustained viral control for patients during the full once-weekly dosing interval.

In addition to becoming the first and only treatment approved for hepatitis C patients who are co-infected with HIV, PEGASYS is also the only approved medication in the EU for hepatitis C patients with 'normal' levels of alanine aminotransferases (ALT) - a patient population previously thought not to benefit from treatment.

PEGASYS monotherapy has been approved in 112 countries and PEGASYS combination therapy has been approved in 83 countries.

It has also been approved in the EU, Switzerland, Hong Kong, New Zealand, Taiwan and Thailand for the treatment of chronic hepatitis B, and is the first and only pegylated interferon with this indication.

Roche has recently completed enrolment for an important new study examining the effects of longer treatment duration and/or a high induction dose of PEGASYS in patients who were non-responsive to treatment with pegyinterferon alfa-2b.

This study is known as REPEAT - Retreatment with PegInteferon alfa2a in Patients not Responding to prior peginterferon alfa2b/ribavirin combination therapy.About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in Diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2004, sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R & D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai.All trademarks used or mentioned in this release are legally protected.Notes for the editor (recent PEGASYS announcements):US

approval for PEGASYS in HIV-HCV co-infected patients on February 25, 2005.EU approval for PEGASYS in HIV-HCV co-infected patients on February 3, 2005.EU approval for PEGASYS in HBV on February 25, 2005.Swiss approval for PEGASYS in HBV on December 22, 2004.EU approval for HCV patients with 'normal' ALT on November 11, 2004.Further information:About hepatitis C: http://www.health-kiosk.ch/start_hepaAbout Roche in virology: http://www.roche-hiv.comReferences: Gane, E, et al. Age and sustained virological response in patients with persistently `normal' ALT and chronic hepatitis C treated with peginterferon alfa-2a (40KD) plus ribavirin. Presented at 40th Annual Meeting of the European Association for the Study of the Liver, Paris, France, April 13-17, 2005.[ii] Zeuzem, S. et al. Peginterferon alfa-2a (40 kilodaltons) and ribavirin in patients with

chronic hepatitis C and normal aminotransferase levels. Gastroenterology. December 2004. 127(6):1724-1732.[iii] , G, et al. Treatment of Chronic Hepatitis C With Peginterferon Alfa-2a (40KD) (PEGASYS®) And Ribavirin (COPEGUS®): Patient Age Has a Marked Influence On The Individual Estimated Probability of Achieving A Sustained Virological Response. Presented at the American Association for the Study of Liver Diseases, 2003.[iv] Fried, MW et al. NEJM 2002:347;975-82[v] Manns, MP et al. Lancet, 2001; 358:958-65[vi] Swain, M, et al. Clustering of poor prognostic factors in patients with chronic hepatitis C. Presented at 40th Annual Meeting of the European Association for the Study of the Liver, Paris, France, April 13-17, 2005.Contact: Janet Kettels, Roche, +41-79-597-82-85; Joanne Galea, Axon Communications, +44(0)20-8822-6779 Copyright: 2005 PR Newswire Europe. All rights to PR Newswire Content are owned by PR Newswire

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