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Quick Response to Combination Therapy Signals Hope for HCV Patients

April 19, 2007

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An analysis of several recent clinical trials shows how important early responses to treatment are for clearing the Hepatitis C virus. Now doctors can tell earlier than ever, the chances patients can be cured. Find out just how soon doctors can now determine the success of treatment and what this means for newly diagnosed patients.

Treatment Optimisation With PEGASYS Plus COPEGUS Offers Patients With Hepatitis C an Excellent Chance for a Cure

www.presseportal.de

High Response Rates Confirmed in 'Real-Life' Study and Clinical
Trials

BASEL, Switzerland, April 13 /PRNewswire/

Patients with hepatitis C who respond quickly to treatment have an
excellent chance of being cured of the disease, according to data
presented today at the 42nd Annual Meeting of the European
Association for the Study of the Liver (EASL). Patients with genotype
1 hepatitis C (HCV) who clear the virus within a month of starting
treatment with PEGASYS (peginterferon alfa-2a (40KD)) plus COPEGUS
(ribavirin) have up to a 91% chance of achieving a sustained
virological response (SVR), considered a cure by researchers.

"Now we can tell earlier than ever - at just week 4 of treatment -
whether a patient has a good chance to be cured." said Professor
Patrick Marcellin, Hôpital Beaujon, Clichy, France. "Knowing their
virus levels in the first and third months of treatment helps
patients take ownership of beating the disease and helps motivate
them to stay on treatment. This information should be made available
for everyone starting therapy."

Early Response to Treatment Means Patients Have an Excellent
Chance for a Cure

An analysis of six different clinical trials highlights the value
of checking how well patients with genotype 1 HCV have responded to
treatment at weeks 4 and 12 of therapy(1). The results of the
analysis showed that of those patients treated with PEGASYS 180 mcg
weekly plus COPEGUS 1,000-1,200 mg daily:

- Up to one in five cleared the virus by week 4 of therapy
(called rapid viral response)

- 83-91% of patients with a rapid viral response went on to be
cured of their hepatitis C

- About 40% of patients who did not achieve a rapid viral response
managed to clear the virus by week 12 of therapy (called complete
early virological response); 65-67% of these patients were cured

Excellent Chance for a Cure for Rapid Viral Responders Confirmed
in 'Real-Life' Study

A large real-life study involving 4,377 patients conducted by the
Association of German Independent Gastroenterologists confirms that
these results can be replicated in clinical practice(2):

- One quarter of patients with 'difficult-to-cure' genotype 1
or 4 HCV who had their viral levels tested at week 4 of treatment
achieved a rapid viral response

- While the study is not yet complete, over 70% of those who have
finished their 6-month post-treatment follow-up period were cured

"These are really important results," said Dr Elmar Zehnter,
Gastroenterologist and Hepatologist, Dortmund, Germany, and
researcher in the study. "This study confirms that the high cure
rates reported for rapid viral responders in clinical trials
translate into clinical practice and are relevant to the patients we
see every day. At the moment, testing viral levels at 4 weeks of
treatment is not standard practice. Based on these results, however,
testing viral levels at 4 weeks of therapy should become a routine
test."

About Hepatitis C

Hepatitis C, the most common chronic blood-borne infection, is
transmitted primarily through blood or blood products. Hepatitis C
chronically infects 180 million people worldwide, which makes it more
than four times more prevalent than HIV(3,4). Alarmingly, many people
infected with hepatitis C don't even know they carry the virus. For
example, it is estimated that 80-90% of people with hepatitis C in
the UK are unaware that they are infected(5). Hepatitis C is a
leading cause of cirrhosis, liver cancer and liver failure, despite
the fact that many patients can be cured with treatments that are
available today.

About PEGASYS

PEGASYS, the market leader worldwide in hepatitis C therapy,
provides significant benefit over conventional interferon therapy in
HCV patients of all genotypes. The benefits of PEGASYS are derived
from its large 40 kilodalton (KD) branched-chain polyethylene glycol
(PEG) construction, which allows for sustained drug levels over the
course of a full week. PEGASYS also distributes more readily to the
liver (the primary site of infection) than conventional interferon.
PEGASYS is the only pegylated interferon available as a
ready-to-administer solution. Each weekly subcutaneous injection
contains 180 mcg of pegylated interferon alfa-2a (40KD), which is the
approved dose for all patients, regardless of body weight.

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 the world's biggest biotech
company and an innovator of products and services for the early
detection, prevention, diagnosis and treatment of diseases, the Group
contributes on a broad range of fronts to improving people's health
and quality of life. Roche is the world leader in in-vitro
diagnostics and drugs for cancer and transplantation, a market leader
in virology and active in other major therapeutic areas such as
autoimmune diseases, inflammation, metabolism and central nervous
system. In 2006 sales by the Pharmaceuticals Division totalled 33.3
billion Swiss francs, and the Diagnostics Division posted sales of
8.7 billion Swiss francs. Roche employs roughly 75,000 worldwide and
has R&D agreements and strategic alliances with numerous partners,
including majority ownership interests in Genentech and Chugai.
Additional information about the Roche Group is available on the
Internet at www.roche.com.

All trademarks used or mentioned in this release are protected by
law.

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References

1. Marcellin P, Hadziyannis S, Berg T, et al. Virological response
at 4 and 12 weeks predict high rates of sustained virological
response in genotype 1 patients treated with peginterferon alfa-2a
(40KD) plus ribavirin. In: 42nd Annual Meeting of the European
Association for the Study of the Liver; 2007 April 11-15; Barcelona,
Spain; 2007.

2. Zehnter E, Mauss S, Boeker K, et al. Potential relevance of
rapid viral response for SVR and optimisation of the treatment of
hepatitis C (CHC) with peginterferon alfa-2a (PEG) and ribavirin
(RBV). In: 42nd Annual Meeting of the European Association for the
Study of the Liver; 2007 April 11-15; Barcelona, Spain; 2007.

3. AIDS Epidemic Update. 2006. (Accessed February 27, 2007, at
http://www.who.int/hiv/mediacentre/2006_EpiUpdate_en.pdf.)

4. Initiative for Vaccine Research, Viral Cancers, Hepatitis C.
World Health Organization, 2006. (Accessed July 24, 2006, at http://w
ww.who.int/vaccine_research/diseases/viral_cancers/en/index2.html.)

5. The hepatitis C scandal. London: All-Party Parliamentary Group
on Hepatology; 2004.

ots Originaltext: Roche Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Contact: Janet Kettels, Roche, +1-862-596-9084; Natalie Henson, Axon
Communications, +44(0)20-843-99-406

Posted by Editors at April 19, 2007 9:25 AM