New Pegasys Data Show Hepatitis B Patients Achieve Highly Positive Treatment Response That Comes as Close to a Cure as Possible

Basel, Switzerland (ots/PRNewswire) -

- No Nucleoside/Nucleotide Analogue Treatments Have Shown Similar
Results

New data revealed today show that a significant number of
patients with chronic hepatitis B virus infection who received
PEGASYS(R) (peginterferon alfa-2a) treatment achieved clearance of a
blood antigen known as hepatitis B s-antigen (HBsAg) (1). Clearance
of this marker is associated with favourable clinical outcomes, and
is as close to a cure as possible in this disease (1-4). HBsAg
clearance shows that an individual's own immune system is able to
control the infection. None of the nucleoside/nucleotide analogue
treatments for hepatitis B virus (HBV) have shown such a result.

The clinical improvements associated with s antigen clearance
include a decreased rate of cirrhosis, a markedly decreased rate of
liver cancer, and an increase in life expectancy (2-4).

These new data were presented at the European Association for the
Study of the Liver (EASL) congress today in Milan, Italy. The data
show that four years after the completion of a one-year treatment
course with Pegasys, 11% of patients achieved this positive outcome,
compared to only 2% of patients who received lamivudine, a
commonly-used treatment for HBV. The response of patients taking
lamivudine was similar to rates of spontaneous clearance of this
marker for HBV (0.1 percent to 0.8 percent per year) (5,6).

Remarkably, the number of patients achieving s-antigen clearance
increased each year even after Pegasys treatment was stopped, rising
from 3% at year one, 6% at year two, 8% at year three and finally, to
11% at year four. The long-term benefits of treatment with Pegasys
are thought to be due to the persistence of its immune
system-stimulating effects. Unlike nucleoside/nucleotide analogue
treatments for HBV, such as lamivudine, Pegasys works by fighting the
disease in two ways: by boosting the immune system and at the same
time, directly attacking the virus. Nucleoside/nucleotide analogues
have a direct antiviral effect only, so the disease tends to come
back in patients taking these medications when treatment has stopped
(7-9). Because of this risk, these types of medicines usually require
long-term or life-long treatment (7, 10, 11).

"These results with Pegasys in the treatment of HBV are
unprecedented, because they show for the first time that patients
treated with a pegylated interferon can achieve the best possible
outcome following a 1-year course of treatment - HBsAg clearance,"
said Dr Patrick Marcellin, Professor of Hepatology at the University
of Paris and Head of the Viral Hepatitis Research Unit in Hôpital
Beaujon, Clichy, France. "These data appear to offer real hope of
long-term freedom from this disease, and further bolster the case for
using Pegasys as a first line treatment in patients with e-antigen
negative chronic hepatitis B."

More About the Study

The data are from an international pivotal study of Pegasys which
enrolled followed 537 e antigen-negative hepatitis B patients from 54
centres. It compared the efficacy of 48 weeks treatment with Pegasys
180 mcg, Pegasys 180 mcg plus lamivudine 100 mg, or lamivudine 100 mg
alone. Initial results, published in the New England Journal of
Medicine, showed superior efficacy for Pegasys compared to lamivudine
-- as measured by HBV suppression and ALT normalization -- six months
after the end of treatment (12).

The results reported at EASL, at 4 years post-treatment, are
collected from centres which agreed to enter the long-term follow-up
portion of the study (315 patients from 42 centres in all three
arms). Data from both Pegasys treatment arms was combined for the
analysis of response. In addition to the superior rates of s-antigen
clearance among patients taking Pegasys, significantly more patients
maintained suppression of HBV below 400 copies/ml compared to
lamivudine (17% vs. 7%, respectively; p=0.042), and more patients had
normal ALT levels (27% vs. 18%, respectively).

Notes for Editors

About Chronic Hepatitis B

Chronic hepatitis B is a serious global healthcare problem that
affects more than 350 million people worldwide. It is one of the
principal causes of chronic liver disease, cirrhosis, and primary
liver cancer. Approximately one million people die from chronic
hepatitis B annually, making it the tenth leading cause of death
worldwide. For those chronically infected, the immediate aim of
treatment is remission of liver disease to prevent progression to
cirrhosis, liver failure, and primary liver cancer.

Pegasys in Hepatitis B

Pegasys is the only pegylated interferon to be approved for the
treatment of chronic hepatitis B in over 60 countries. It is approved
in the EU, the US and the People's Republic of China, among others.

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, metabolic disorders and diseases
of the central nervous system. In 2007 sales by the Pharmaceuticals
Division totalled 36.8 billion Swiss francs, and the Diagnostics
Division posted sales of 9.3 billion Swiss francs. Roche has R&D
agreements and strategic alliances with numerous partners, including
majority ownership interests in Genentech and Chugai, and invested
over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group
employs about 79,000 people. Additional information is available on
the Internet at http://www.roche.com.

References:

1. Marcellin P, Piratvisuth T, Brunetto M, et al. Virological and
biochemical response in patients with HBeAg-negative chronic
hepatitis B treated with peginterferon alfa-2a (40KD) with or without
lamivudine: results of 4-year follow-up. Abstract presented at 43rd
Annual Meeting of the European Association for the Study of the Liver
(EASL); 26 April 2008; Milan, Italy.

2. Fattovich G, Giustina G, Sanchez-Tapias J, et al. Delayed
clearance of serum HBsAg in compensated cirrhosis B: relation to
interferon alpha therapy and disease prognosis. European Concerted
Action on Viral Hepatitis (EUROHEP). Am J Gastroenterol
1998;93:859-60.

3. Chen YC, Sheen IS, Chu CM, Liaw YF. Prognosis following
spontaneous HBsAg seroclearance in chronic hepatitis B patients with
or without concurrent infection. Gastroenterology 2002;123:1084-9.

4. Moucari R, Korevaar A, Asselah T, et al. High Rates of HBsAg
Seroconversion in Chronic Hepatitis B Patients Responding to
Interferon Therapy: a Long-term Follow-up Study. Abstract 991
presented at AASLD, Boston, USA 2-6 November 2007.

5. Wu TT, Hsu HC, Chen DS, et al. Clearance of hepatitis B
surface antigen (HBsAg) after surgical resection of hepatocellular
carcinoma. J Hepatol 1987;4:45-51.

6. Liaw Y-F, Pao C-C, Chu C-M, et al. Changes of serum hepatitis
B virus DNA in two types of clinical events preceding spontaneous
hepatitis B e antigen seroconversion in chronic type B hepatitis.
Hepatology 1987;7:1-3.

7. Song BC, Suh DJ, Lee HC, et al. Hepatitis B e antigen
seroconversion after lamivudine therapy is not durable in patients
with chronic hepatitis B in Korea. Hepatology 2000;32:803-6.

8. Chien RN, Yeh CT, Tsai SL, et al. Determinants for sustained
HBeAg response to lamivudine therapy. Hepatology 2003;38:1267-73.

9. Hadziyannis SJ, Tassopoulos NC, Heathcote EJ, et al. Long-term
therapy with adefovir dipivoxil for HBeAg-negative chronic hepatitis
B. N Engl J Med 2005;352(26):2673-81.

10. Leung NW, Lai CL, Chang TT, et al. Extended lamivudine
treatment in patients with chronic hepatitis B enhances hepatitis B e
antigen seroconversion rates: results after 3 years of therapy.
Hepatology 2001;33(6):1527-32.

11. Marcellin P, Chang TT, Lim SG, et al. Long-term efficacy and
safety of adefovir dipivoxil (ADV) 10 mg in HBeAg+ chronic hepatitis
B (CHB) patients: increasing serologic, virologic and biochemical
response over time. Hepatology 2004;40:655A.

12. Marcellin P, Lau GKK, Bonino F, et al. Peginterferon alfa-2a
alone, lamivudine alone, and the two in combination in patients with
HBeAg-negative chronic hepatitis B. New Engl J Med 2004; 351:
1206-17.

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

Contact:
Contact: Mike Nelson, Roche, +41-(79)-572-5165; Michelle Marchione,
Axon Communications, +44(0)208-439-9449