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

FOSTER CITY, Calif.--(BUSINESS WIRE)--Jun 6, 2007 - Gilead Sciences, Inc. (Nasdaq:GILD) today announced that Study 102, a Phase III clinical trial evaluating the company's once-daily anti-HIV drug Viread (tenofovir disoproxil fumarate or tenofovir DF) 300 mg as a potential treatment for chronic hepatitis B virus (HBV) infection, met its primary efficacy endpoint. The study shows that Viread is non-inferior to the company's once-daily antiviral drug Hepsera(R) (adefovir dipivoxil) among patients with HBeAg-negative/anti-HBe positive (presumed pre-core mutant) chronic HBV infection. The primary efficacy endpoint, the proportion of patients with a complete response at week 48, was defined by serum HBV DNA levels below 400 copies/mL and histologic improvement characterized by at least a two point reduction in the Knodell necroinflammatory score (a measure of necro-inflammation - an inflammatory process in the liver including or leading to death of liver cells) with no concurrent worsening of fibrosis (scarring of liver tissue).

At 48 weeks, 70.8 percent of patients in the Viread arm (n=250) had a complete response compared to 48.8 percent in the Hepsera arm (n=125; p less than 0.001). The most commonly observed treatment-emergent adverse events of moderate intensity or higher were abdominal pain, back pain, headache, respiratory infections, creatinine phosphokinase and transaminase elevations. The incidence of these events was comparable between the Viread and Hepsera arms of the study. In addition, the incidence of grade 3 or 4 laboratory abnormalities was comparable between the two arms. Full study results will be submitted for presentation at an upcoming scientific meeting.

"Chronic hepatitis B remains a serious disease that impacts more than one million people in the United States and an estimated 400 million people worldwide," said Franck Rousseau, MD, Vice President, Clinical Research, Gilead Sciences.
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