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www.fdanews.com/articles/111894-gilead-sees-encouraging-data-from-two-phase-iii-hepatitis-b-trials

Gilead Sees Encouraging Data from Two Phase III Hepatitis B Trials

November 4, 2008

Gilead Sciences received favorable 96-week data from two Phase III clinical trials evaluating the safety and efficacy of once-daily Viread in adult patients with chronic hepatitis B virus (HBV) infection.

The multicenter, randomized, double-blind trials compared Viread with Hepsera in subjects with chronic hepatitis B and compensated liver disease. After completing 48 weeks of randomized blinded therapy, all eligible patients were rolled over to open-label Viread monotherapy.

Results showed that patients who received Viread for up to 96 weeks experienced sustained suppression of HBV levels in the blood at 91 percent for the first study and 78 percent for the second study, according to Gilead.