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In 2007, 4,519 cases of acute hepatitis B were reported to the Centers for Disease Control and Prevention (CDC); however, the actual number of new infections is estimated by the agency to be about tenfold higher. According to CDC, an estimated 0.8 to 1.4 million people have chronic HBV infection in the United States.

Since the introduction of routine vaccination against HBV, there has been a significant decline in U.S. cases among children and adolescents, the group with the largest increase in hepatitis B vaccination coverage. However, chronic HBV infection remains a major problem. Many of the 1 million people chronically infected with HBV do not know they are infected. Most cases of chronic HBV infection in the United States are found in immigrants or refugees from Asia, Africa, the Pacific Islands, and Eastern Europe. People from these areas of the world should be tested to find out if they are chronically infected. Worldwide, approximately 350 million people are chronically infected with HBV and approximately 1 million of these people die each year from cirrhosis leading to liver failure or liver cancer

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