April 19, 2004

DATA SUPPORT LONG-TERM USE OF GILEAD'S HEPSERA FOR TREATING CHRONIC HEPATITS B

New data presented in Berlin at the annual meeting of the European Association for the Study of the Liver support the use of Gilead Sciences Inc.'s pharma name Hepsera (adefovir dipivoxil) 10 mg among patients with hepatitis B e antigen-negative (HbeAg) chronic hepatitis B virus.

In the trial, patients were randomized to receive Hepsera 10 mg or placebo for a period of 96 weeks. At the conclusion of this study, patients who were treated with Hepsera during the second year of the trial were offered the drug for an additional three years.

Results showed that among patients who received continuous treatment with Hepsera through 144 weeks (n=70), 79 percent achieved undetectable levels of serum HBV DNA, defined as less than 1,000 copies per ml, compared with 69 percent of placebo-treated patients at 96 weeks.

At week 144, the median reduction in serum HBV DNA levels in Hepsera-treated patients was 3.63 log10 copies per ml.

Furthermore, Hepsera provided sustained improvement in liver function through 144 weeks of treatment, as measured by blood levels of the liver enzyme alanine aminotransferase (ALT). Moreover, 88 percent of patients (n=62) with ALT levels above the upper limit of normal at baseline returned to normal by week 144.

"The durable antiviral efficacy, good tolerability profile and low rate of resistance we continue to see in this study suggest that Hepsera is a valuable treatment option for patients with HBeAg-negative hepatitis B," said Dr. Stephanos Hadziyannis of the Henry Dunant Hospital in Athens, Greece, and lead investigator of the trial.