JEDDAH, 16 August 2006 — Hepatitis B is the 10th leading cause of death worldwide, causing 1.2 million deaths annually, and chronic Hepatitis B infection is the No. 1 cause of hepatocellular carcinoma, a form of liver cancer. The Hepatitis B virus (HBV) is 100 times more infectious than HIV, the virus that causes AIDS, according to a Bristol-Myers Squibb study released here yesterday.
Measuring the amount of the HBV in a person’s bloodstream — also known as the viral load — can be an important way to predict a person’s 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.
Chronic Hepatitis B infection is a potentially life-threatening disease and is a serious global public health issue. The virus has infected more than two billion people worldwide and about 400 million others have chronic Hepatitis B. In Europe, an estimated one million people are infected with Hepatitis B each year.
“Hepatitis B is a serious disease and it’s important for patients and physicians to have potent treatments with good tolerability,” said Michael Manns, chairman and director, department of gastroenterology, hepatology and endocrinology, Hannover Medical School, Germany. “With the approval of Baraclude by the European Commission, we’ve an important new medication to treat chronic Hepatitis B and lower patients’ viral load to undetectable levels,” he said.
“Chronic Hepatitis B burdens millions of people in our region and we believe Baraclude represents an innovative treatment option,” said Beatrice Cazala, president, Middle East, Europe and Africa for Bristol-Myers Squibb. “We’re focused on finding ways to extend and enhance the lives of chronically-infected Hepatitis B patients across the entire region, including western Europe, but also in other countries with high prevalence such as Turkey, Russia and Greece.”
The benefits seen in studies of Baraclude relate to its ability to slow the progression of chronic HBV infection. This was shown in three clinical studies in patients naïve to previous antiviral treatment and in patients with resistance to lamivudine, another anti-Hepatitis B agent, infected by wild type virus (HBeAg positive), pre-core mutant virus (HBeAg negative) and with compensated liver disease.
After 48 weeks of treatment — or two years for those with only a virological response initially — patients receiving Baraclude achieved greater or similar responses compared to patients receiving lamivudine, with regard to improvement in the liver inflammation and degree of liver fibrosis (scarring) caused by Hepatitis B virus (HBV), reduction in the amount of virus in the blood, normalization of liver function and seroconversion. Among nucleoside-naïve patients without evidence of lamivudine resistance at baseline, no resistance has emerged through 96 weeks of treatment with Baraclude. What is more, it was well tolerated, similar to lamivudine.
Baraclude has a favorable benefit-risk profile based on the efficacy, resistance and safety data from clinical studies, supporting its use in the treatment of chronic Hepatitis B infection in adults.