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Pharmasset Presents Clevudine and Racivir Data at the International,HIV Drug Resistance Workshop

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Clonal Analysis of Samples from Virologic Responders Receiving Racivir in Study 201

De La Rosa A, Lloyd R, Otto MJ

Study Conclusion: Racivir effectively reduced viral loads by a mean of 0.7 log10 (80% reduction) in responders harboring the M184V mutation and fewer than 3 TAMs at day 28. Clonal genotypic analysis of virus from responders indicated that the M184V mutation was found on all clones in addition to multidrug resistance-associated mutations observed with first line therapy failure.

About Clevudine

Clevudine is an oral, once-daily pyrimidine nucleoside analog that is in development for the treatment of HBV. Clevudine is approved for HBV in Korea, and it is marketed by Bukwang Pharmaceuticals under the brand name Levovir. In addition to its on-treatment efficacy, Clevudine has demonstrated sustained virologic response (SVR) for HBV, or undetectable virus 24 weeks after stopping therapy. We plan to initiate two Phase 3 clinical trials of Clevudine for registration in the United States, Europe and South America in the third calendar quarter of 2007.

About Racivir

Racivir is an oral, once-daily cytidine nucleoside analog that is in development as an HIV therapy for use in combination with other approved HIV drugs. We have completed a Phase 2 clinical trial, Study 201, to assess the safety, tolerability and antiviral effect of a 600 mg dose of Racivir head-to- head against lamivudine in HIV-infected, treatment-experienced patients with the M184V mutation who have been on lamivudine therapy. Racivir demonstrated antiviral activity in patients harboring HIV with the M184V mutation and less than three thymidine analog mutations. These patients have genotypes consistent with first-line HIV therapy failure and may be candidates for second-line treatment regimens that contain Racivir. Future studies will be designed to explore this potential use of Racivir in a combination therapy for second-line therapy for HIV.

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