Viread approved for chronic hepatitis B

Aug 11 2008

The FDA has approved Viread (tenofovir disoproxil fumarate) as a treatment option for adults with chronic hepatitis B, a serious liver disease.

Chronic hepatitis B is a common and potentially fatal liver disease caused by the hepatitis B virus, which is up to 100 times more easily transmitted than HIV. Chronic hepatitis B can produce no symptoms in its earlier stages, meaning many individuals are unaware that they are infected until they have advanced liver disease.

Complications commonly associated with chronic hepatitis B include scarring of the liver (cirrhosis), liver failure and liver cancer. More than 400 million people are estimated to be chronically infected with HBV worldwide and, without treatment, up to one quarter of those will ultimately die of liver disease.

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.