Pegasys found superior to current hepatitis B treatments
October 28 2003 - 1:50AM
PR Newswire (US)
Pegasys found superior to current hepatitis B treatments Basel,
Switzerland, October 28 /PRNewswire/ -- - New study shows Pegasys
more effective than lamivudine in most difficult-to-treat form of
Hepatitis B disease In patients infected with the most
difficult-to-treat hepatitis B virus (HBeAg negative or 'variant'
HBV), Pegasys is more effective than lamivudine and the addition of
lamivudine to Pegasys does not provide additional efficacy,
according to results presented at a conference(*) today. This Phase
III study, conducted in 13 countries, is the largest multinational
study of pegylated interferon in patients with 'variant' hepatitis
B virus and it is the first large-scale head-to-head study to
compare Roche's pegylated interferon against lamivudine. Lamivudine
is the most commonly used therapy for infections with the hepatitis
B virus. "With Pegasys, we have for the first time a hepatitis B
therapy which can produce a high sustained treatment response, and
this is extremely encouraging to physicians looking for treatment
solutions," said Professor Patrick Marcellin, Hepatologist from the
H�pital Beaujon, Clichy, France and the lead investigator for the
study. "What is also important is that with Pegasys we have a
defined treatment period, which is what most patients want." "These
are highly encouraging results for physicians and patients in the
fight against this serious liver infection," said William M. Burns,
Head of the Pharmaceutical Division at Roche. "Based on these
extremely positive results, we plan to file Pegasys in hepatitis B
with health authorities next year." About the study The 537
patients enrolled in the study, all of whom had HBeAg negative HBV
and raised blood levels of ALT, a specific liver enzyme serving as
a marker for liver inflammation, were treated for 48 weeks with
either Pegasys 180 (g once weekly plus placebo, lamivudine 100 mg
once daily or a combination of the two. They were then observed for
a further 24 weeks with no treatment. The treatment was considered
effective if ALT levels fell to normal and viral DNA levels, a
measure for the concentration of virus in the bloodstream, were
reduced below 20,000 copies/ml at the end of the follow-up period.
Viral load and ALT levels significantly impacted At the end of the
follow-up period, the study found for the two primary endpoints
that: * 42.9% of patients treated with Pegasys monotherapy reduced
their hepatitis B viral DNA to less than 20,000 copies per/ml
compared to only 29.3% of those treated with lamivudine. This
result is statistically highly significant. The combination of
Pegasys and lamivudine yielded a reduction in hepatitis B viral DNA
in 44.1% of patients, demonstrating that the addition of lamivudine
to Pegasys does not improve the treatment outcome. * In addition
Pegasys had a better impact on ALT than lamivudine: 59.3 per cent
of patients treated with Pegasys had their elevated ALT levels
return to normal; compared to only 44.2% of lamivudine-treated
patients. The combination of Pegasys and lamivudine (59.8%) was not
statistically different to Pegasys alone. Patients typically
relapse after treatment is stopped HBeAg negative HBV, also known
as 'variant' or 'pre-core mutant' hepatitis B, is caused by a
genetic mutation to the virus. Patients infected with the HBeAg
negative HBV are more likely to have severe destructive
inflammatory changes to their liver and fibrosis when they first
see their physician than those infected with the HBeAg positive
disease. Patients typically relapse after treatment is stopped.
HBeAg negative HBV accounts for approximately 40 per cent of cases
in the US and over 80 per cent of cases in Southern Europe. "We
have shown previously that Pegasys is an effective treatment for
the more common HBeAg-positive strain of HBV,(i)" said Professor
Graham Cooksley, Senior Principal Research Fellow, Clinical
Research Centre, Royal Brisbane Hospital, Australia. "These results
mean we can now also use Pegasys with confidence to treat patients
with the more challenging HBeAg negative strain of the disease."
About Hepatitis B Hepatitis B is a blood-born virus that attacks
the liver and is the most common serious liver infection in the
world. The hepatitis B virus is highly contagious and is relatively
easy to transmit from one infected individual to another. It is 100
times more infectious than the HIV virus. Despite a highly
effective vaccine, more than two billion people have been infected
by HBV and 350 million people have chronic infection, which can be
easily transmitted by blood-to-blood contact, during birth, sex,
and by sharing needles. HBV and HCV rank among the top four causes
of cancer deaths in most countries in Asia and the Western Pacific
rim.(ii) For those chronically infected with HBV, treatment is the
only option. About Pegasys Pegasys, a new generation hepatitis
therapy that is different by design, provides significant benefit
over conventional interferon therapy in patients infected with HBV
and HCV. The benefits of Pegasys are derived from its new
generation large 40 kilodalton branched-chain polyethylene glycol
(PEG) construction, which allows for constant viral suppression
over the course of a full week. Pegasys also distributes more
readily to the liver (the primary site of infection) than
conventional interferon. In HCV Pegasys provides superior efficacy
compared to conventional interferon combination therapy in HCV
patients of all genotypes. Pegasys is the only pegylated interferon
available as a ready-to-administer solution. Each weekly
subcutaneous injection contains 180 mcg of pegylated interferon
alfa-2a which is the approved dose for all patients, regardless of
body weight. Roche in hepatitis Roche is committed to the viral
hepatitis disease area, having introduced Roferon-A for hepatitis B
and C, followed by Pegasys in hepatitis C and now Pegasys also
demonstrates superior efficacy over current treatments:
conventional interferon and lamivudine in hepatitis B. Roche has
also launched its own brand of ribavirin, Copegus, to be used in
conjunction with Roferon A or Pegasys for HCV. Roche also
manufactures HBV and HCV diagnostic and monitoring systems: The
COBAS AMPLICOR(tm) Test, and the AMPLICOR(tm) MONITOR Test, two
testing systems used to detect the presence of, and quantity of,
HBV DNA or HCV RNA in a person's blood. Roche's commitment to
hepatitis has been further reinforced by the in-licensing of
Levovirin, an alternative antiviral. Levovirin will be studied with
the objective of demonstrating superior tolerability over the
current standard, ribavirin. About Roche Headquartered in Basel,
Switzerland, Roche is one of the world's leading innovation-driven
healthcare groups. Its core businesses are pharmaceuticals and
diagnostics. Roche is number one in the global diagnostics market,
the leading supplier of pharmaceuticals for cancer and a leader in
virology and transplantation. As a supplier of products and
services for the 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 employs roughly 65,000
people in 150 countries. The Group has alliances and R&D
agreements with numerous partners, including majority ownership
interests in Genentech and Chugai. All trademarks used or mentioned
in this release are legally protected. (*) 54th American
Association for the Study of Liver Diseases (AASLD) Annual Meeting
NOTES TO THE EDITOR: * New guidelines on HBV were recently
developed by the European Association for the Study of Liver
(EASL).(iii) Conventional interferon monotherapy was recommended as
the first therapeutic approach when treating these patients. The
EASL Jury noted however, that the optimal treatment of hepatitis B
will require regular revision in light of new data. References: (i)
Cooksley, W. Graham E et al. Peginterferon alfa-2a (40KD): An
advance in the treatment of HBeAg-Positive Chronic Hepatitis B. J.
Viral Hepatitis. 2003;10:298-305 (ii) Chu, CM. Natural History of
Chronic Hepatitis B Virus Infection in Adults with Emphasis on the
Occurrence of Cirrhosis and Hepatocellular carcinoma. J
Gastroenterol. Hepatol. 2000;15 (suppl.):E25-30. (iii) EASL
International Consensus Conference on Hepatitis B. 13-14 September,
2002: Geneva, Switzerland. Consensus statement (short version). J
Hepatol, 2003.38:533-40. DATASOURCE: Roche Contact: F. Hoffmann-La
Roche Ltd, Corporate Communications, Tel: +41 (0)61 - 688 88 88,
Fax: +41 (0)61 - 688 27 75, http://www.roche.com/
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