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BMS Announces Baraclude (entecavir) Now Available In The UK For Treatment Of Chronic Hepatitis B
  21 Sep 2006 - 0:00am (PDT)
Bristol-Myers Squibb announced today that Baraclude (entecavir) is now available in the UK on prescription for the treatment of chronic hepatitis B virus infection.
Baraclude, developed by Bristol-Myers Squibb, is an oral antiviral therapy that inhibits the replication of the hepatitis B virus (HBV). Baraclude is indicated for use in adults with chronic hepatitis B infection with compensated liver disease and evidence of active viral replication, evidence of persistent elevations of the blood levels of aminotransferases - a marker for liver disease - and active liver disease as determined by biopsy.
"Hepatitis B is a serious disease and it is important for the medical community to have additional options to treat patients," said Professor Howard Thomas, Head of the Liver Unit at St Mary's Hospital and Professor of Medicine at Imperial College. "With Baraclude now available, we have an important new medication to treat chronic hepatitis B in the UK and lower patients' viral load to undetectable levels, thereby reducing the risk of developing liver cirrhosis and liver cancer."
Chronic hepatitis B infection is a potentially life-threatening disease and is a serious global public health issue. The Department of Health estimates that 0.3% of the UK population is chronically infected with hepatitis B, equivalent to some 180,000 people.1 Approximately 2 billion people worldwide have been infected by hepatitis B and more than 350 million people worldwide have chronic hepatitis B.1,2
Chronic hepatitis B infection is the 10th leading cause of death worldwide, resulting in up to 1.2 million deaths annually caused by chronic hepatitis, cirrhosis and hepatocellular carcinoma, a form of liver cancer.3 Chronic hepatitis B infection is the leading cause of hepatocellular carcinoma.3 The hepatitis B virus is 100 times more infectious than HIV, the virus that causes AIDS.1
Measuring the amount of the hepatitis B virus in a person's bloodstream - also known as the viral load - can be an important way to predict their progression to serious liver disease and liver cancer. Recent studies have shown that among hepatitis B patients who have the highest viral load levels, there is a significantly increased future risk of eventually developing cirrhosis and liver cancer.4
The benefits seen in studies of Baraclude relate to its ability to slow the progression of chronic HBV infection. This was shown in three separate clinical studies in which patients were naive to previous antiviral treatment, in patients with resistance to lamivudine (another anti-hepatitis B agent), infected by wild type virus (HBeAg positive) or pre-core mutant virus (HBeAg negative) or had compensated liver disease.5,6,7
After 48 weeks of treatment - or two years for those with only a virological response initially - Baraclude achieved responses higher or similar to lamivudine, with regard to improvement in the liver inflammation and degree of liver fibrosis (scarring) caused by HBV, reduction in the amount of virus in the blood, normalisation of liver function and seroconversion.6,8 Among nucleoside-naive patients without evidence of lamivudine resistance at baseline, no resistance has emerged through 96 weeks of treatment with Baraclude. Furthermore, Baraclude was well-tolerated, similar to lamivudine.9
Baraclude has a favourable benefit-risk profile based on the efficacy, resistance and safety profile from clinical studies, supporting its use in the treatment of chronic hepatitis B infection in adults.5,6,7
About Baraclude (entecavir)
The global Baraclude clinical trial programme was the first to compare two antivirals, Baraclude and lamivudine (the most commonly used oral antiviral therapy for the treatment of chronic hepatitis B worldwide) and involved over 1,600 patients worldwide. Bristol-Myers Squibb is continuing to evaluate and monitor consenting chronic hepatitis B patients who participated in the Baraclude clinical trial programme.
Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.
Baraclude is a trademark of Bristol-Myers Squibb.
Refer to the Baraclude Summary of Product Characteristics for further information or contact Caroline Almeida, Bristol-Myers Squibb Pharmaceuticals Ltd, Tel: 01895 52 3519 for a copy.
1. Hepatitis B: Out of the shadows: A report into the impact of hepatitis B on the nation's health. (2004) Foundation for Liver Research. London.
2. World Health Organization. Hepatitis B. Available at: http://www.who.int/mediacentre/factsheets/fs204/en/ Accessed at March 17, 2006.
3. Lavanchy, D., Hepatitis B epidemiology, disease burden, treatment, and current and emerging prevention and control measures. Journal of Viral Hepatitis. 2004; 11(2):97.
4. Chien-Jen Chen, et al. Risk of Hepatocellular Carcinoma Across a Biological Gradient of Serum Hepatitis B Virus DNA Level. JAMA, 2006: 295:65-73.
5. Chang T, et al. A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B. The New England Journal of Medicine, 2006: 354:1001-1010.
6. Lai C, et al. Entecavir versus lamivudine for patients with HBeAg-Negative chronic hepatitis B. The New England Journal of Medicine, 2006: 354:1011-1020.
7. Sherman M, et al. Entecavir for treatment of lamivudine-refractory, HBeAg- positive chronic hepatitis B. Gastroenterology 2006;130:2039-2049.
8. Shouval D, et al. Continued virologic and biochemical improvement through 96 weeks of entecavir treatment in HBeAG(-) chronic hepatitis B patients (study ETV-027). 41st Annual Meeting of the European Association for the Study of Liver Disease (EASL), April 2006, Abstract 45.
9. Colonno R, et al. Entecavir two year resistance update: no resistance observed in nucleoside naive patients with low frequency of resistance in lamivudine refractory patients. 56th Annual Meeting of the American Association for the Study of Liver Disease (AASLD), November 2005, Poster 962.
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