BASEL, June 29 /PRNewswire-AsiaNet/ –
PEGASYS Offers Greater Benefit Versus Current Standard of Care
Results published today in the prestigious New England Journal of Medicine
have led the study authors to recommend PEGASYS as a first-line treatment for
chronic hepatitis B. The results show that patients with the most common form
of chronic hepatitis B are more likely to achieve lasting remission if they are
treated with PEGASYS (peginterferon alfa-2a (40KD)) compared with lamivudine, a
current standard of care.[i]
These results and conclusions confirm those from another phase III study of
PEGASYS in chronic hepatitis B also published in the New England Journal of
Medicine (NEJM) in 2004. That study showed PEGASYS was more effective in
achieving lasting remission than lamivudine in patients with a more
difficult-to-treat form of the disease.[ii] These authors also concluded that
PEGASYS can be considered as a first-line therapy for chronic hepatitis B.
"The study published this week shows that more patients treated with
PEGASYS achieved the important treatment goal called HBeAg seroconversion,
compared with those treated with lamivudine," said Dr. George Lau,
gastroenterologist at the Queen Mary Hospital, Hong Kong and lead author of the
NEJM paper. "Patients whose hepatitis B is in remission after treatment with
PEGASYS are unlikely to need further treatment, and their risk of developing
cirrhosis, liver failure and liver cancer is reduced. These are all compelling
reasons for using PEGASYS as a first choice in hepatitis B."
Key results from the study
The trial presented in this week’s NEJM enrolled a total of 814 patients
with HBeAg-positive chronic hepatitis B from 15 countries. In this trial,
patients were treated for 48 weeks with PEGASYS 180 mg once weekly plus
placebo, lamivudine 100 mg once daily, or a combination of PEGASYS and
lamivudine. Treatment response was assessed following a 24-week treatment-free
follow-up period.
Six months after the completion of therapy:
- 32% of patients treated with PEGASYS achieved HBeAg seroconversion*,
compared with 19% of those treated with lamivudine. The addition of
lamivudine to PEGASYS did not improve the treatment outcome (27%
achieved HBeAg seroconversion).
- Importantly, HBsAg seroconversion was reported in 16 patients treated
with PEGASYS (with or without lamivudine) and in none of the patients
treated with lamivudine alone. HBsAg seroconversion drastically reduces
the risk of developing liver cancer or cirrhosis and is rarely seen
during clinical trials. This event is considered as close to a cure for
hepatitis B as is possible.
The two NEJM trials are part of one of the largest clinical development
programmes in chronic hepatitis B which includes three global studies in more
than 1,500 patients from 19 countries. The results of these trials demonstrate
that PEGASYS was more effective than lamivudine and conventional interferon in
achieving lasting remission.[i], [ii], [iii]
"Chronic hepatitis B is a devastating disease that affects a huge number of
people around the world," said Charles Gore, President of the European Liver
Patients Association. "We welcome the efforts being made by pharmaceutical
companies to develop increasingly effective drugs to combat it. The approval of
PEGASYS is a step forward in treatment options for patients with hepatitis B."
PEGASYS is currently undergoing regulatory approval around the world and
has received approval for the treatment of chronic hepatitis B in over 40
countries including recent approvals in China and the United States, as well as
in the EU. PEGASYS is the first and only pegylated interferon to be indicated
for the treatment of chronic hepatitis B.
PEGASYS works to fight the disease in two ways: it boosts the immune system
and at the same time, attacks the virus directly. Lamivudine, like other
medications in its class, has a direct antiviral effect only and tends to be
taken indefinitely as the hepatitis B often comes back if patients stop taking
it. However, the virus can become resistant to lamivudine with long-term use,
limiting the effectiveness of the medication.
This latest publication takes the total number of PEGASYS publications in
the NEJM to seven, the highest number of NEJM publications for any pegylated
interferon.
About Chronic Hepatitis B
Chronic hepatitis B is a serious global healthcare problem that affects
over 350 million people worldwide. It is one of the principal causes of chronic
liver disease, cirrhosis, and primary liver cancer. Approximately one million
die from chronic hepatitis B annually, making it the 10th 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.
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 early
detection, 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. Additional information about the Roche Group
is available on the Internet (www.roche.com).
All trademarks used or mentioned in this release are legally protected.
Notes for the editor (recent PEGASYS announcements):
US approval for the treatment of patients with chronic hepatitis B
on May 16, 2005.
EU approval for the treatment of patients with chronic hepatitis B
on February 25, 2005.
Swiss approval for the treatment of patients with chronic hepatitis B
on December 22, 2004.
US approval for PEGASYS in HCV/HIV co-infected patients on February 25,
2005.
EU approval for PEGASYS in HCV/HIV co-infected patients on January 26, 2005.
EU approval for HCV patients with ‘normal’ ALT on November 11, 2004.
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* HBeAg seroconversion is recognised by the AASLD as the recommended
endpoint of treatment
References:
[i] Lau GKK, Piratvisuth T, Luo KX, et al. N Engl J Med 2005;2682-2695.
[ii] Marcellin P, Lau GK, Bonino F, et al. N Engl J Med 2004;351:1206-17.
[iii] Cooksley WG, Piratvisuth T, Lee SD, et al. J Viral Hepat 2003;10:298-305.
SOURCE: Roche Pharmaceuticals
CONTACT: Janet Kettels,
Roche,
+41-79-597-82-85, or
James Smith,
Axon Communications,
+44-208-822-6692
June 30, 2005
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