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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

table 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. 80% of HBeAg- patients had undetectable HBV DNA 12 weeks after completing a 48-week course of therapy.

Clevudine was generally safe and well-tolerated by patients with chronic HBV. There was no meaningful difference between clevudine and placebo in the incidence of serious adverse events during treatment in Studies 301 and 302 and during follow-up except that a higher percentage of placebo-treated patients had elevated liver enzyme levels than patients treated with clevudine.

About Pharmasset

Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is on the development of oral therapeutics for the treatment of hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV).

Pharmasset is currently developing three product candidates. Clevudine, for the treatment of chronic HBV infection, is in Phase 3 clinical trials for registration in the Americas and Europe. Clevudine is already approved for HBV in South Korea and marketed by Bukwang Pharmaceuticals in South Korea under the brand name Levovir. R7128, an oral treatment for chronic HCV infection, is in a Phase 1/2 clinical trial through a strategic collaboration with Roche. Racivir, which is being developed for the treatment of HIV in combination with other approved HIV drugs, has completed a Phase 2 clinical trial.

Contact

Kurt Leutzinger

Chief Financial Officer


SOURCE Pharmasset, Inc.
Copyright©2008 PR Newswire.
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2. Pharmasset Nominates PSI-7851 as a Lead Development Candidate for the Treatment of Chronic Hepatitis C
3. Pharmasset Commences Dosing R7128 Cohorts 3 and 4 for the Treatment of Chronic Hepatitis C
4. Pharmasset Presents Results of 4-Week Combination Study of R7128 for the Treatment of Chronic Hepatitis C
5. Pharmasset Reports First Fiscal Quarter 2008 Financial Results
6. Roche and Pharmasset To Present the R7128 Monotherapy Resistance Profile
7. Pharmasset Announces R7128 Achieves 85% Rapid Virologic Response in a 4-week Combination Study for the Treatment of Chronic Hepatitis C
8. Pharmasset Announces Clevudine and R7128 Presentations at HEP-DART
9. Pharmasset Commences Dosing in 28-Day Combination Study of R7128 with Pegasys(R) plus Copegus(R) for Hepatitis C
10. Pharmasset Commences Dosing in Phase 3 Registration Studies of Clevudine for HBV
11. Pharmasset Presents R7128 Phase 1 Single Ascending Dose Study in Healthy Volunteers
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