Healthcare Industry News:  BARACLUDE 


 News Release - August 29, 2008

Bristol-Myers Squibb Welcomes NICE Guidance Recommending Baraclude(R) (entecavir) as a Treatment Option for Chronic Hepatitis B

UXBRIDGE, England, August 29 (HSMN NewsFeed) -- NICE (National Institute for Health and Clinical Excellence) has published guidance that recommends BARACLUDE® (entecavir) as an option for treatment of eligible patients with chronic hepatitis B (CHB). Entecavir is a potent anti-viral treatment for chronic Hepatitis B that has been shown to be more effective at suppressing the virus than the most widely used anti-viral treatment (lamivudine)(1) and has shown minimal emergence of resistance in new patients treated with it (entecavir) for up to 5 years.(2)

Richard Marsh, Director of External Affairs and Market Access, Bristol-Myers Squibb said, "This is good news for patients with chronic Hepatitis B. We welcome the publication of NICE's final guidance on BARACLUDE, recommending it as a treatment option for chronic Hepatitis B in line with its licence. PCTs are now required to make funding available for BARACLUDE for patients prescribed it by their specialist. Bristol-Myers Squibb will continue to work proactively with clinicians and PCTs to enable access to BARACLUDE for those patients who will benefit from it.

"Chronic Hepatitis B is a leading cause of liver cirrhosis and liver cancer. It is highly infectious, growing in prevalence in the UK and an increasing cost to NHS resources. BARACLUDE is a clinically effective and cost effective treatment for all eligible patients with chronic Hepatitis B. Its favourable resistance profile, in particular, makes it a very valuable treatment option for patients and for the NHS. NICE's new guidance endorses this view."

Notes to editors

Interviews available with clinicians, patients and patient group representatives.

NICE Final Guidance

- Entecavir, within its marketing authorisation, is recommended as an
option for the treatment of people with chronic HBeAg-positive or
HBeAg-negative hepatitis B in whom antiviral treatment is
indicated.(10) This guidance does not apply to people with chronic
hepatitis B who also have hepatitis C, hepatitis D or HIV. Further
information can be found at

Treatment of Chronic Hepatitis B (CHB)

- CHB is a highly infectious and potentially fatal disease which is
effectively treated with anti-viral drugs that reduce the amount of
virus (viral load) in the blood to an undetectable level

- Over 60%(4) of patients treated with the most widely-used (over 5
years) anti-viral (lamivudine)(1) develop resistance(4) This identifies
the need to access treatment options to which patients do not develop

- The aims of CHB treatment with antivirals are to achieve sustained
suppression of the virus, avoid treatment resistance and prevent
serious liver disease. The preferred anti-viral therapy should combine
superior efficacy (compared to other antiviral treatments) with low
resistance rates

- It is estimated that management of CHB could cost the NHS from GBP26m
to GBP375m annually(5). The total cost to the economy, including time
lost at work, is likely to be substantially higher

Background on CHB

- Hepatitis B is the most serious type of viral hepatitis(6)

- HBV is 100 times more infectious than HIV(5) and is the 10th most
common cause of death worldwide(9)

- 325,000 people in the UK suffer from chronic HBV(6) which is the
leading cause of liver cancer and cirrhosis of the liver(8)

- There is an estimated 7,700 new cases of CHB each year(5)

- 15 to 25 percent of chronic hepatitis B patients will die of
liver-related diseases(8)

- The cost of treating CHB is less than one third of the cost of caring
for patients whose disease becomes too far advanced to treat
effectively with anti-virals(7)

BARACLUDE (Entecavir)

- Entecavir is an oral antiviral therapy specifically designed to provide
rapid and sustained suppression of viral replication with minimal
development of resistance, reducing viral load to undetectable levels
in the majority of new patients with CHB. It is available as 0.5mg and
1mg tablets and is prescribed for once a day use(3)

- Entecavir is generally well tolerated(3)

- There is minimal emergence of resistance in new patients treated with
entecavir for up to 5 years(2)

- Entecavir is approved for use in more than 60 countries/regions around
the world


(1) IMS prescription data on file, February 2008.

(2) Tenney DJ et al. Asia-Pacific Association for the Study of the Liver
(APASL), Seoul, 23-26 March 2008 (0212).

(3) BARACLUDE (entecavir) SPC, January 2008.

(4) Lok, A. S. F., et al. Long-Term Safety of. Lamivudine Treatment in
Patients With Chronic Hepatitis B, Gastroenterology 2003;125:

(5) Foundation for Liver Research. Hepatitis B: Out of the Shadows;
October 2004

(6) Hep B Foundation UK. Rising Curve - Discussion paper Nov 2007

(7) Brown RE, et al.Hepatitis B management costs in France, Italy, Spain
and the United Kingdom. J Clin Gastroenterol 2004;38 (Suppl. 3):

(8) Wyoming Department of Health. Basic Information on Hepatitis A,
Hepatitis B and Hepatitis C. Available at: Accessed March 17, 2006

(9) Lavanchy, D. Hepatitis B epidemiology, disease burden, treatment, and
current and emerging prevention and control measures. Journal of
Viral Hepatitis. 2004; 11(2):97.

(10) NICE Entecavir FAD, June 2008.

Source: Bristol-Myers Squibb

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