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Title: Tenofovir Approved for Treatment of Chronic Hepatitis B in Adults
URL: http://www.pslgroup.com/dg/22819E.htm
Doctor's Guide
August 12, 2008

FOSTER CITY, Calif -- August 12, 2008 -- The US Food and Drug Administration has granted marketing approval for tenofovir disoproxil fumarate (Viread) for the treatment of chronic hepatitis B.

Tenofovir disoproxil fumarate is also indicated for the treatment of chronic hepatitis B in adults. The drug is administered as a once-daily tablet and works by blocking hepatitis B virus DNA polymerase.

"[Tenofovir] will be an important new treatment option and its approval represents a significant step forward in the fight against chronic hepatitis B," said Ira Jacobson, MD, Division of Gastroenterology and Hepatology, Weill Cornell Medical College, New York, New York.

The approval is based on data from 2 ongoing, randomised, double-blind, phase 3 clinical trials which compared tenofovir disoproxil fumarate to adefovir dipivoxil over 48 weeks of treatment. Results from both studies show that a significantly greater percentage of patients with chronic hepatitis B who received tenofovir disoproxil fumarate achieved a complete response to treatment compared with those who received adefovir dipivoxil.


SOURCE: Gilead Sciences, Inc.

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