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Newly approved Baraclude™ reduces virus to undetectable levels in chronic hepatitis B patients

Categories: Baraclude | Chronic hepatitis B

Baraclude Significantly Superior to Lamivudine

MONTREAL, CANADA – (September 20, 2006) – Canadians with chronic hepatitis B virus (HBV) now have a new antiviral medicine, Baraclude (entecavir), that can reduce the serious consequences of their disease. In multiple chronic HBV patient types, long-term use of Baraclude has been shown to reduce the presence of the virus to undetectable levels. Approved in more than 20 countries and regions around the world including the U.S. and the European Union, Baraclude was given an accelerated review by Health Canada because of an urgent need for effective treatments for chronic HBV. Chronic HBV affects an estimated 200,000 to 280,000 Canadians1 and kills about 480 Canadians annually2.

Baraclude has been approved for the treatment of chronic HBV in adults where the virus is multiplying and damaging the liver. It works by lowering the amount of the virus in the body, lowering the ability of the virus to multiply and infect new liver cells, and therefore, improving the condition of the liver. In clinical trials, Baraclude demonstrated significant superiority over lamivudine (the most commonly used oral antiviral therapy for HBV worldwide) in suppressing the ability of the virus to replicate itself and thus, improving the condition of the liver.

“Physicians have very few treatment options for patients with HBV and all current therapies have major limitations. We were glad to see that Health Canada recognized that and shortened its review time to make Baraclude available as quickly as possible,” said Dr. Morris Sherman, University Health Network, Toronto. “Baraclude looks to be the most potent medication we've had to date and it is not associated with the resistance and possible toxicity that have affected current treatments.”

“It is always exciting to see a new treatment option being offered for people living with hepatitis B, because we have had so few options,” said Gary Fagan, President, Canadian Liver Foundation. “Hepatitis B is a serious liver health issue in Canada and one type of hepatitis that is overlooked far too often. Diagnosis and treatment are keys to providing a more hopeful future for those affected. Hepatitis B is the leading cause of liver cancer in Canada and liver cancer is one of the top five most fatal cancers. The good news is many liver cancer deaths may be avoidable if we can just get people treated before serious complications set in.” HBV is the most common carcinogen3 after tobacco and is 100 times more infectious than HIV4.

Previous treatments for chronic HBV have been limited in number and overall efficacy remains suboptimal. A primary concern with lamivudine is the development of resistance during and after treatment which has occasionally been associated with severe and even fatal flares of hepatitis; adefovir is associated with limited efficacy and the potential for kidney toxicity; and interferon has limited efficacy and can cause side effects such as flu-like symptoms, depression and headaches.5

Clinical Trials

Discovered by Bristol-Myers Squibb scientists, Baraclude is a nucleoside analog. Its safety and efficacy were evaluated in three pivotal controlled trials involving more than 1,600 adult patients on five continents. Eight of the trial sites and 184 patients were in Canada. Additional clinical studies investigating Baraclude use in more than 850 patients were conducted in five centres in China, where chronic HBV affects one in 10 people. Baraclude has also been evaluated in a study of 68 patients co-infected with HBV and HIV.

Clinical trial data from two Phase III studies demonstrated that significantly more patients treated with Baraclude achieved undetectable viral loads compared to lamivudine. In Study ETV-027, after up to 48 weeks of treatment with Baraclude, 90 per cent of patients who had never before received a nucleoside, achieved undetectable viral load, compared to only 72 per cent of patients treated with lamivudine. There was no evidence of resistance in Baraclude treated patients, though resistance to lamivudine is well documented.

Side Effects

The most common side effects of Baraclude are headache, fatigue, dizziness and nausea. Though rare, nucleoside analogs have been associated with lactic acidosis (a buildup of acid in the blood) which can be fatal if not treated, and liver enlargement and fat in the liver. People using Baraclude are advised of the signs of these side effects to ensure they seek immediate medical attention should they experience any symptoms.

Patients should not stop taking Baraclude without having discussed this with their physician. HBV symptoms may worsen or become serious if patients stop taking Baraclude. Healthcare providers must conduct blood tests to check the liver function following cessation of the medication.

Hepatitis B

Hepatitis B is a viral infection of the liver caused by the HBV. In Canada, it is estimated that 20,000 new hepatitis B infections are diagnosed each year6. At least 10 per cent of them go on to develop chronic HBV. HBV is spread through blood and other body fluids or by sexual contact.

Half of the people who are infected with HBV do not know they have the virus because they never feel ill. Of this group, 90 per cent will recover and develop protective antibodies. However, the virus will remain in the liver, blood and body fluids of about 10 per cent of people. Because these people don't know they have the disease, they don't seek treatment and remain infected for life, potentially infecting others with whom they have contact. They are called “chronic carriers” and may develop cirrhosis of the liver or liver cancer many years later, and ultimately, they may die of their infection (approximately 15 to 40 per cent of people infected with HBV will develop cirrhosis, liver failure or liver cancer7). When livers are affected by cirrhosis or liver cancer to the point where the organ can no longer function normally, the only treatment option remaining is an organ transplant.

The remaining 50 per cent of people infected with HBV develop acute illness and experience fever, tiredness, loss of appetite and jaundice. While some can experience severe liver damage, most people with acute HBV fully recover and are immune for life.

HBV is a common infection in China, Southeast Asia and parts of Africa where about one person in 10 (10%) is a chronic carrier. In Canada about one person in 200 (0.5 %) is a chronic carrier. Many of Canada's cases are in immigrant populations from high-prevalence regions of the world. It is expected the incidence of HBV in Canada will eventually fall because all Canadian children are now vaccinated in school programs, although that reduction will not be seen for many years.

About Bristol-Myers Squibb Canada

Bristol-Myers Squibb Canada is an indirect wholly-owned subsidiary of Bristol-Myers Squibb Company, a global pharmaceutical and related health care products company whose mission is to extend and enhance human life. Bristol-Myers Squibb Canada Co. is a leading provider of medicines to fight cancer, cardiovascular and metabolic disorders, infectious diseases (including HIV/AIDS), nervous system diseases and serious mental illness. Bristol-Myers Squibb Company is listed on the New York Stock Exchange under the BMY symbol (NYSE:BMY). Bristol-Myers Squibb Canada's operations are headquartered in Montréal, Québec.

For further information, please contact:

Sabrina Tremblay
Director, Public Relations
Bristol-Myers Squibb Canada
(514) 333-2463
[email protected]

1 From (Gagnon, Levy. Costs of hepatitis B in Canada, 2004
Ronald Gold, Your Child's Best Shot, Canadian Paediatric Society, 2002
3 Canadian Liver Foundation Web site,
4 World Health Organization Web site,
5 Hepatitis B Foundation Web site,
6 Ronald Gold, Your Child's Best Shot, Canadian Paediatric Society, 2002
BMS Hepatitis B Fact-Sheet 30/08/2005

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