Renewed Hope for a Cure: Extending Pegasys Treatment to 72 Weeks Provides New Treatment Option for Difficult-to-Treat Hepatitis C Patients

Geschrieben am 01-11-2008

Basel, Switzerland, November 1 (ots/PRNewswire) -

- Three New Studies Presented at AASLD Demonstrate Efficacy and
Safety of Extended Treatment in Non-Responders, Relapsers and

Cure rates for certain groups of difficult-to-treat hepatitis C
patients can be improved significantly by extending the treatment
period with PEGASYS(R) (peginterferon alfa-2a (40KD)) and COPEGUS(R)
(ribavirin) to 72 weeks, according to new studies being presented at
AASLD this week in San Francisco.

"Seeking solutions for difficult-to-treat hepatitis C with the
currently-available agents is a priority," said Dr Peter Ferenci,
Professor of Medicine, Medical University of Vienna, Wein, Austria.
"That's why it is so encouraging to see these new data showing that
extending treatment with Pegasys and Copegus offers a greater chance
of a cure to patients where the standard duration of treatment
provides unsatisfactory results. Furthermore, all the studies show
that it is possible to predict a patients' response early on in
treatment - this provides encouragement and reassurance to continue
treatment for patients who have an early response."

"Slow Responders"

"Response-guided therapy" is a new treatment concept in hepatitis
C which seeks to tailor treatment for patients based on how well they
respond. Patients who eliminate the virus from the blood within 4
weeks (rapid virologic response; RVR) can benefit from shortened
treatment while preserving their chances to be cured. Patients who
respond slowly can benefit from extending treatment duration,
resulting in improved chances for a cure.

A new study(1) has found that treatment-naive genotype 1 or 4
patients without RVR but with an early virological response (EVR) by
week 12 have a better chance for a cure, and less chance of relapse,
by extending the treatment duration to 72 weeks.

This prospective, multicentre, randomised study enrolled 552
patients at several centers in Austria. Patients who did not achieve
an RVR but had an EVR were randomised at week 12 to complete either
48 or 72 weeks of treatment. The primary outcome parameter was the
relapse rate after end of follow-up. Relapse rates were shown to
decrease by half in the patients who received 72 weeks of treatment
(relapse rate of 33.6% in the 48 week arm vs. 19% in the 72-week

Relapsers and Non-Responders

Although dramatic advances in the treatment of hepatitis C have
been made in recent years, a significant number of patients do not
achieve a cure with their first course of treatment. For this reason,
seeking solutions for re-treating these patients is of particularly
vital importance.

"Relapsers" are patients who responded to an initial course of
hepatitis C treatment but whose virus returned within six months
after stopping therapy. Now, a new study(2) conducted in Germany has
found that half of these patients (54 out of 107) can achieve a cure
with Pegasys and Copegus re-treatment for 72 weeks. Furthermore, an
RVR after the first 4 weeks was highly predictive of a cure: almost
all patients (97%) with an RVR went on to achieve a cure at the end
of follow-up.

Generally considered the most difficult-to-treat patient group,
"non-responders" are patients who did not respond to an initial
treatment course of at least 12 weeks. REPEAT is a large,
Roche-sponsored study which examined re-treatment with Pegasys and
Copegus in 942 patients who had not responded to PegIntron(TM)
(peginterferon alfa-2b) and Rebetol(R) (ribavirin). The primary
analysis of the study showed that a 72-week course of Pegasys/Copegus
in these patients had the biggest impact on success of treatment,
with a doubling of the SVR rate compared to 48 weeks (16 % vs. 8 %).
Response at treatment week 12 was a strong predictor of successful
treatment: 57% of patients whose virus was undetectable after 12
weeks went on to achieve treatment success with 72 weeks of

A new safety analysis(3) of the study presented this year at
AASLD confirms that the longer treatment duration does not pose a
large additional safety burden on patients and is well tolerated by
patients. The authors examined the incidence of adverse events (AE)
per treatment year, and found a lower incidence in patients treated
for 72 weeks vs. those treated for 48 weeks (8.1 vs. 10.1 AEs).
Furthermore, for every cured patient, the number of adverse events
during treatment was lower in the 72-week arm compared to the 48 week
arm (55 vs. 100). The authors conclude that from an efficacy as well
as a safety perspective, the 72-week regimen of Pegasys and Copegus
is the preferred treatment duration for non-responders to previous
peginterferon alfa-2b/ribavirin therapy.

Notes for Editors

About Chronic Hepatitis C

Hepatitis C (HCV), the most common chronic blood-borne infection,
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. It is a leading cause of
cirrhosis, liver cancer and liver failure, despite the fact that many
patients can be cured.

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, and is a market
leader in virology. It is also active in other major therapeutic
areas such as autoimmune diseases, inflammatory and 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 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 80,000 people. Additional
information is available on the Internet at http://www.roche.com.


1) Ferenci P, Laferl H, Scherzer T, Gschwantler M, Maieron A.
Response-guided therapy with peginterferon alfa-2a (40KD) plus ribavirin
in patients with chronic hepatitis C genotype 1 or 4: Prospective
randomized study of extended therapy in patients without a rapid
virological response. Abstract presented at the American Association for
the Study of Liver Disease; 31 October; San Francisco, California, USA.
2) Kaiser S, Lutze B, Hass H, Werner, C. High sustained virologic
response rates In HCV genotype 1 relapser patients retreated with
peginterferon alfa-2a (40KD) plus ribavirin for 72 weeks. Abstract
presented at the American Association for the Study of Liver Disease; 31
October; San Francisco, California, USA.
3) Marcellin P, Craxi A, Brandão-Mello C, Di Bisceglie A. 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. Abstract presented at the
American Association for the Study of Liver Disease; 31 October; San
Francisco, California, USA.

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

Contact: Mike Nelson, Roche, +41(79)572-5165


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