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FDA Approves Viread(R) For Chronic Hepatitis B

By Pharmaceutical Processing | August 12, 2008

The FDA has approved Viread(R) (tenofovir disoproxil fumarate) as a treatment option for adults with chronic hepatitis B, a serious liver disease. Chronic hepatitis B affects an estimated 2 million people in the United States and is the leading cause of liver cancer worldwide.Caused by the hepatitis B virus (HBV), a pathogen that is up to 100 times more infectious than the AIDS virus, chronic hepatitis B disproportionately affects Asian Americans, who represent nearly half of all cases and are one of the fastest-growing population groups in the country. Because chronic HBV infection can persist for years without causing noticeable symptoms, the disease is known as a “silent killer” and many people are unaware they are infected. New treatment options are urgently needed – 1 in 4 people with the disease ultimately die from serious complications such as chronic liver disease, cirrhosis or liver cancer. Viread is taken as a once-daily tablet, and works by blocking the enzyme that is necessary for the hepatitis B virus to replicate in liver cells. Viread has been available in the United States as a part of combination therapy for HIV infection since 2001, and its active ingredient is the most-prescribed compound in HIV therapy.

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