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Pharmasset Announces Initiation of Combination Study of Clevudine and Viread(R) for HBV by French National Agency for Research on AIDS and Viral Hepatitis (ANRS)
Date:7/8/2008

unique mechanism of action as a non-chain terminating nucleoside analog HBV polymerase inhibitor may demonstrate additive antiviral benefit in combination with tenofovir's recently demonstrated antiviral potency in HBV," stated Dr. Michelle Berrey, Pharmasset's Chief Medical Officer. "We also plan to reproduce the results from earlier studies demonstrating clevudine's ability to provide a sustained virologic response in patients with eAg negative chronic HBV infection, as either monotherapy or in combination, offering infected individuals and their physicians an important new treatment option."

Ongoing Registration Studies for New Drug Application (NDA)

The ongoing clevudine Phase 3 registration program includes two 48-week clinical trials designed to demonstrate the superiority of clevudine 30mg over Hepsera(R) (adefovir dipivoxil) 10mg, each administered once-daily as monotherapy. Pharmasset plans to submit the 48-week data from these studies to the FDA as the basis for the clevudine marketing approval. Please see http://www.clinicaltrials.gov or e-mail clinicaltrials@pharmasset.com for more information about the clevudine registration studies.

South Korean Registration Studies for Clevudine

Bukwang received marketing approval for clevudine from the South Korean FDA based on two 24-week, placebo-controlled, double-blind, randomized, multi-center South Korean Phase 3 registration trials in 337 patients. Study 301 enrolled 248 HBeAg+ patients who received clevudine 30 mg or a placebo once-daily, and Study 302 enrolled 89 HBeAg- patients who received clevudine 30 mg or a placebo once-daily. All patients were evaluated for an additional 24 weeks of follow-up care without clevudine treatment.

At 24 weeks on treatment with clevudine, 59% of HBeAg+ patients achieved undetectable HBV DNA and 92% of HBeAg- patients achieved undetec
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SOURCE Pharmasset, Inc.
Copyright©2008 PR Newswire.
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