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FDA Approves Gilead's Antiretroviral Viread for Use as Hepatitis B Treatment

August 13, 2008

Gilead Sciences on Monday announced that it has received FDA approval to market its antiretroviral drug Viread as a hepatitis B treatment, the AP/International Herald Tribune reports (AP/International Herald Tribune, 8/12). According to Gilead estimates, more than 400 million people worldwide have hepatitis B, an infection that affects the liver and is prevalent in Asia. The disease is the leading cause of liver cancer, and complications associated with hepatitis B result in up to 1.2 million deaths annually.

Viread, which has been available in the U.S. as an HIV/AIDS treatment since 2001, works by blocking an enzyme necessary for hepatitis B replication in liver cells (Reuters India, 8/12). According to Gilead, FDA joins regulators in Australia, Europe, Turkey and New Zealand in allowing the company to market Viread as a treatment for hepatitis B (AP/International Herald Tribune, 8/12).

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