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mick

09/11/07 1:06 AM

#32419 RE: mick #32417

***** Pharmasset announces that R7128 demonstrates safety and potent antiviral activity in HCV-Infected patients (VRUS) 10.40 : Co reports preliminary safety and potent antiviral activity with R7128 following 14 days of monotherapy in 40 patients chronically infected with hepatitis C virus who have failed prior interferon therapy. R7128 demonstrated potent, dose-dependent antiviral activity across the four patient cohorts receiving 750 mg or 1500 mg administered either once-daily or twice-daily for 14 days as monotherapy. The greatest mean decrease in H.C.V R.N.A. from baseline was demonstrated in the patient cohort that received 1500 mg twice-daily, the highest dose of R7128 administered in this study. These patients demonstrated a mean 2.7 log10 IU/mL (>99%) decrease in H.C.V R.N.A. There was no evidence of viral rebound in any dose cohort during the 14 days of dosing. R7128 was generally safe and well tolerated in this Phase 1 multiple ascending dose study. There were no serious adverse events, no adverse events requiring dose modification, no dose-related gastrointestinal adverse events and no clinically significant changes in vital signs, electrocardiograms, hematologic, renal or other laboratory parameters. Based on the results of this study, VRUS and Roche plan to initiate a 28-day study of R7128 in combination with Pegasys plus Copegus in treatment-naive patients chronically infected with H.C.V genotype 1. Patient recruitment for this combination study is expected to begin in late Sep 2007.