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Pharmasset Reports Positive Results from its HCV Clinical Programs
Date:1/6/2011

PRINCETON, N.J., Jan. 6, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq: VRUS), announced today positive data from interim analyses of two of its clinical programs: the HCV genotype 2 or 3 (GT2/3) arm of the PSI-7977 Phase 2b trial and the 14 day PSI-938 monotherapy cohort of the dual nucleotide study.  

Pipeline Update and 2011 HighlightsPSI-7977In August 2010, we began dosing of PSI-7977 in combination with pegylated interferon and ribavirin (Peg-IFN/RBV) in a Phase 2b study. This study is evaluating PSI-7977 200mg QD, 400mg QD, or placebo in combination with Peg-IFN/RBV in approximately 125 treatment-naive patients with HCV genotype 1 (GT1), and PSI-7977 400mg QD with Peg-IFN/RBV in an open-label arm in patients with HCV GT2 or GT3. HCV GT1 patients receive an RVR-directed regimen of 12 weeks of PSI-7977/Peg-IFN/RBV followed by 12 or 36 weeks of Peg-IFN/RBV. The HCV GT2/3 patients receive 12 weeks of PSI-7977/Peg-IFN/RBV with no additional therapy.  The primary goal of the study is to assess the safety and tolerability of PSI-7977 in combination with Peg-IFN/RBV for 12 weeks. The primary efficacy endpoint of the study is the proportion of patients who achieve SVR12 and SVR24, defined as HCV RNA below the limit of detection (<15 IU/ml) 12 and 24 weeks, respectively, after the discontinuation of all therapy. Enrollment of this Phase 2b trial has been completed.

Twenty five treatment-naive patients with HCV GT2/3 patients were enrolled in the open label arm.  24/25 patients completed 12 weeks of PSI-7977 400mg QD with Peg-IFN/RBV; one patient was lost to follow-up after the first visit. A preliminary analysis of all data available at the end of 12 weeks of dosing revealed no serious adverse events and no discontinuations due to adverse events. The most commonly reported adverse events (AEs) overall were nausea, headache, chills, and f
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