Better 48-week efficacy with Viread vs Hepsera

21 November 2007

Gilead Sciences presented strong 48-week data from two Phase III pivotal trials, Studies 102 and 103, evaluating the safety and efficacy of once-daily Viread (tenofovir disoproxil fumarate) among adult patients with chronic hepatitis B virus infection, at the annual meeting of the American Association for the Study of Liver Diseases, in Boston, Massachusetts.

Studies 102 and 103 compared Viread to Gilead's Hepsera (adefovir dipivoxil) among patients with HBeAg-negative (presumed pre-core mutant) chronic hepatitis B and patients with HBeAg-positive hepatitis B, respectively. Results from both studies show that patients who received Viread for 48 weeks experienced superior efficacy results compared to those who were treated with Hepsera, as shown by the significantly higher percentage of Viread subjects in each trial achieving the primary efficacy endpoint. 48-week data show that Viread was well-tolerated by patients in both studies, Gilead noted.

"The efficacy and tolerability results observed among patients in the Viread arm of the study are impressive," said Patrick Marcellin, the principal investigator for Study 102. "Hepsera is commonly considered today's standard-of-care in chronic hepatitis B therapy and these data demonstrate that, with Viread, it may be possible to achieve an even greater antiviral response and further improve outcomes for patients," he added.

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