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Pharmasset Commences Dosing in Phase 3 Registration Studies of Clevudine for HBV
Date:10/1/2007

ectable virus 24 weeks after stopping therapy, which clevudine previously demonstrated in Bukwang's South Korean registration studies.

At week 72, HBeAg- patients in Study 306 who have been treated with clevudine and have suppressed HBV DNA and normalized ALT levels will be randomized to continue active clevudine or switch to placebo. The purpose is to determine the proportion of patients who sustain a virologic response 24 weeks after stopping clevudine treatment at week 96. HBeAg+ patients in Study 305 that have been treated with either clevudine or Hepsera and undergo eAg seroconversion (loss of eAg with suppressed HBV DNA and normalized ALT) will discontinue therapy at week 72. SVR will be assessed in these HBeAg+ patients for clevudine and Hepsera 24 weeks after stopping treatment at week 96.

South Korean Registration Studies for Clevudine

Bukwang received marketing approval for clevudine from the South Korean FDA based on two 24-week, randomized (3:1), double-blind, placebo-controlled, 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.

After 24 weeks of clevudine treatment, 59% of HBeAg+ patients achieved undetectable HBV DNA (<300 copies/mL) and 92% of HBeAg- patients achieved undetectable HBV DNA. These results were statistically significant compared to placebo. In addition to the potent antiviral suppression, 16% of the HBeAg- patients who received clevudine demonstrated a sustained virologic response (SVR) 24 weeks after stopping therapy, versus 0% of the patients who had received the placebo. In Study 303, a South Korean open-label, follow-on study of clevudine, Bukwang observed similar findings to those noted above for Studie
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SOURCE Pharmasset, Inc.
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