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Phase III Study Evaluating Gilead's Viread for the Treatment of,Chronic Hepatitis B Virus Meets Primary Endpoint

"We believe Viread has the potential to be an important treatment option for patients with chronic hepatitis B and look forward to sharing detailed data from this study at a scientific conference later this year."

Study 102 is one of two Phase III pivotal studies evaluating the efficacy, safety and tolerability of Viread for the treatment of chronic hepatitis B. The second study (Study 103), a 48-week trial among patients with hepatitis B "e" antigen (HBeAg)-positive chronic hepatitis B, is expected to be complete later this year.

The active ingredient in Viread, tenofovir DF, is currently the most prescribed molecule in the United States for combination HIV therapy. Viread received approval as an anti-HIV medication from the U.S. Food and Drug Administration (FDA) in October 2001 and from the European Commission in February 2002. Viread is not approved as a treatment for chronic hepatitis B, and data from this analysis have not been reviewed by the FDA.

Study Design

Study 102 is a multi-center, randomized, double-blind Phase III clinical trial that compares the efficacy, safety and tolerability of Viread and Hepsera over 48-weeks among patients with HBeAg-negative/anti-HBe positive (presumed pre-core mutant) chronic hepatitis B. Three hundred and seventy-five patients were randomized in a 2:1 ratio to receive either tenofovir DF (300 mg once daily; n=250) or Hepsera (10 mg once daily; n=125).

About Viread (tenofovir disoproxil fumarate)

In the United States, Viread is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Viread should not be used in combination with the fixed-dose combination products Truvada(R) or Atripla(TM) because they already contain Viread.

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with other antiretrovirals. Viread is not approved for t
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