Newly Published Study Shows That Re-Treatment With Pegasys(R) (Peginterferon Alfa-2a) Provides Hepatitis C Patients With a Second Chance for a Cure

Basel, Switzerland (ots/PRNewswire) - New data published
today in a major peer-reviewed journal, Annals of Internal Medicine,
show that re-treatment with Pegasys(R) (peginterferon alfa-2a) plus
Copegus(R) (ribavirin) provides previously-treated hepatitis C
patients a second chance for a cure. The study results demonstrated
that patients most likely to respond to re-treatment could be
identified after only 12 weeks, allowing patients and their doctors
to be confident early on about the likelihood of success.(1)

"While tremendous advances in hepatitis C treatment have cured
many hepatitis C patients, a significant proportion of patients do
not achieve success with their first treatment course. This is
leading to a large and growing population of patients who are in
urgent need of alternative treatment options," said Donald Jensen, US
principal investigator for REPEAT, and Professor of Medicine and
Director of the Center for Liver Diseases at the University of
Chicago Hospital in Chicago. "With 72 weeks of Pegasys and ribavirin
combination treatment as a new solution for those with the most
difficult-to-treat form of the virus, patients can now feel more
hopeful that they have the possibility to achieve a cure when
previous therapy has failed."

Pegasys (peginterferon alfa-2a) received European Commission
approval for the re-treatment of hepatitis C in December 2008, based
in part on results of the newly-published study. For patients with
genotype 1 virus who were initially treated with pegylated interferon
and ribavirin, it is recommended that they be retreated with
peginterferon alfa-2a for an extended period of 72 weeks.
Peginterferon alfa-2a is now the first and only pegylated interferon
to be approved anywhere for treatment of up to 72 weeks. For all
other previously-treated patients, the recommended treatment period
is 48 weeks.

The Need for Re-treatment Options

The standard of care for patients with chronic hepatitis C is the
combination of a pegylated interferon plus ribavirin. In hepatitis C,
sustained virologic response (SVR) to interferon-based treatment is
widely equated to cure(2) as it is associated with eradication of HCV
infection and improvement in liver disease. Approximately 50% of
patients with genotype 1, the most difficult to treat form of the
disease, and 20-30% of patients with genotypes 2 or 3 do not achieve
a cure after a first course of therapy.(1)

The REPEAT Study

Enrolling 950 patients from Europe, North America and Latin
America, the REPEAT (REtreatment with PEgasys in pATients Not
Responding to Peg-Intron Therapy) study was designed to explore
whether intensified treatment with a higher initial dose of Pegasys
(peginterferon alfa-2a) in combination with ribavirin, and/or longer
treatment duration, may increase treatment success rates in patients
who didn't respond to at least twelve weeks of PegIntron(TM)
(peginterferon alfa-2b) plus ribavirin and who didn't discontinue
treatment due to haematological adverse events.

The results demonstrated that while a fixed-dose induction did
not contribute to treatment success, patients receiving 72 weeks of
re-treatment with peginterferon alfa-2a doubled the chance of
achieving a cure compared with the previous standard of 48 weeks (16%
vs. 8%). Furthermore, the study showed that for the 17% of patients
who responded by week 12 (defined as HCV RNA levels of less than 50
IU/mL), 57% went on to achieve a cure after a 72-week treatment
course, compared with only 35% of patients who were re-treated for 48
weeks.

"It is a significant step forward that we now know patients who
have undetectable levels of hepatitis C at week 12 have a good
likelihood of achieving a cure with Pegasys and ribavirin. This
ability to predict success after just three months will give both
doctors and hepatitis C patients additional confidence when
considering whether to re-treat," said Professor Jensen.

Treatment with peginterferon alfa-2a plus ribavirin was well
tolerated in the study. The adverse event profile was similar to that
seen in patients treated for the first time. Further analyses of the
72-week treatment duration in REPEAT showed that it was associated
with a more favourable benefit:risk ratio than 48 weeks of
treatment.(3) The most common side effects of treatment were flu-like
symptoms, fatigue, depression and haematological abnormalities.

About hepatitis C

The hepatitis C virus (HCV) is transmitted primarily through
blood or blood products. HCV chronically affects 180 million people
worldwide, which makes it over four times more prevalent than
HIV.(4),(5) It is a leading cause of cirrhosis, liver cancer and
liver failure, despite the fact that many patients can be cured. In
Europe alone, HCV is estimated to cause more than 86,000 deaths every
year.(6)

A recent study examining the HCV-related burden of disease in 22
European countries estimated that 7.3-8.8 million people are infected
with HCV, representing 1.1-1.3% of the population.(6) The report also
found that no uniform HCV surveillance exists at the European level,
and that authorities need to work on an EU-wide, consistent
surveillance system for HCV.(6)

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in
research-focused healthcare with combined strengths in
pharmaceuticals and diagnostics. Roche is the world's largest biotech
company with truly differentiated medicines in oncology, virology,
inflammation, metabolism and CNS. Roche is also the world leader in
in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer
in diabetes management. Roche's personalised healthcare strategy aims
at providing medicines and diagnostic tools that enable tangible
improvements in the health, quality of life and survival of patients.

In 2008, Roche had over 80,000 employees worldwide and invested
almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6
billion Swiss francs. Genentech, United States, is a wholly owned
member of the Roche Group. Roche has a majority stake in Chugai
Pharmaceutical, Japan.

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

A copy of the Summary of Products Characteristics for
peginterferon alfa-2a can be accessed at
http://www.emc.medicines.org.uk

References

(1) Jenson DM, Marcellin P, Bradley F et al. Re-treatment of
chronic hepatitis C non-responders to peginterferon alfa-2b: a
randomized trial. Annals of Internal Medicine 2009;150(8):528-540.

(2) Swain M, Lai M, Shiffman M, Cooksley W et al. Sustained
virologic response (SVR) resulting from treatment with peginterferon
alfa-2a (40KD) (Pegasys(R)) alone or in combination with ribavirin
(Copegus(R)) is durable and constitutes a cure: an ongoing 5-year
follow-up. Abstract presented at Digestive Disease Week; 21 May 2007;
Los Angeles, California, USA.

(3) Marcellin P. et al. A 72-week treatment duration with
peginterferon alfa-2a (40KD) (PEGASYS(R)) plus ribavirin (COPEGUS(R))
has a favorable risk:benefit ratio in non-responders to pegylated
interferon alfa-2b (12KD) plus ribavirin: findings of the
multinational REPEAT study. Poster (PO1873) presented at Annual
Meeting of the American Association for the Study of Liver Diseases
(AASLD); 31 October - 4 November 2008; San Francisco, California,
USA.

(4) AIDS Epidemic Update. 2006. (Accessed April 15, 2009, at
http://www.who.int/hiv/mediacentre/2006_EpiUpdate_en.pdf).

(5) World Health Organization. Initiative for Vaccine Research,
Viral Cancers, Hepatitis C. 2006. (Accessed April 15, 2009, at http:/
/www.who.int/vaccine_research/diseases/viral_cancers/en/index2.html).

(6) Siebert U, Muhlberger N and Zeuzem S. Pan European
Perspectives on Hepatitis C. Volume 1: Burden of Disease. Pages; 6, 8
& 10.

COMM00367 April 2009

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

Contact:
Contacts: Mike Nelson, Roche, +41-79-572-5165, mike.nelson@roche.com;
Shanchari Guha Roy, Ketchum, +44(0)207-611-3631,
shanchari.guharoy@ketchum.com