Tablets and Oral Solution, an oral, antiviral medication for the treatment of adults with chronic hepatitis B associated with evidence of hepatitis B viral replication and active liver inflammation. Hepatitis B is a potentially fatal liver disease and has been estimated by the World Health Organization to be the ninth most common cause of death world-wide. In the U.S., the Centers for Disease Control have estimated that there are more than one million persons chronically infected with HBV and it is estimated that only a small percentage of the patients with active disease have been treated. The most important goal of hepatitis B therapy is reducing the progressive liver inflammation that occurs when the immune system attacks hepatitis B-infected liver cells. Epivir-HBV acts directly to interfere with viral replication, leading to reduced inflammatory response to HBV infection in the liver.
Transmission can also occur early in life due to close contact between family members.
Patients should be advised that treatment with Epivir-HBV has not been shown to reduce the risk of transmission of HBV from mother to child or to others through sexual contact or blood contamination. The safety and efficacy of Epivir-HBV were evaluated in four controlled studies conducted primarily in North America, Europe and Asia for 52 weeks in a total of 967 adult patients with chronic HBV infection. All patients had compensated chronic hepatitis B with evidence of viral replication and active liver inflammation. Three of the studies compared Epivir-HBV 100 mg daily with placebo treatment. In addition, the drug was well tolerated in the 52-week studies.