New Pegasys Data Show Hepatitis B Patients Achieve Highly Positive Treatment Response That Comes as Close to a Cure as Possible
BASEL, Switzerland, April 26/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.
Source: Roche
Contact: Mike Nelson, Roche, +41-(79)-572-5165; Michelle Marchione, Axon Communications, +44(0)208-439-9449
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