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Pharmasset Announces R7128 Achieves 85% Rapid Virologic Response in a 4-week Combination Study for the Treatment of Chronic Hepatitis C
Date:1/7/2008

RNA and 85% (17 of 20) achieved undetectable levels of HCV RNA (<15 IU/mL), or RVR. Following 4 weeks of treatment with R7128 500mg BID with Pegasys plus Copegus, patients achieved a mean 3.82 log10 IU/mL decrease in HCV RNA and 30% (6 of 20) achieved RVR. Following 4 weeks of treatment with placebo with Pegasys plus Copegus, patients achieved a mean 2.95 log10 IU/mL decrease in HCV RNA and 10% (1 of 10) achieved RVR. Baseline HCV RNA was similar across the three treatment groups.

Preliminary Safety Summary

Preliminary safety and tolerability reported were similar for R7128 500mg or R7128 1500mg in combination with Pegasys plus Copegus compared to standard of care alone. There were no serious adverse events reported during the 4 week treatment period. The most common adverse events reported across the treatment groups were headache, chills, fatigue, nausea and fever. Grade 4 neutropenia was observed in 5% (1 of 20) of the patients in each active dosing cohort and in 10% (1 of 10) of the placebo patients. All safety laboratory values and adverse events were within the range expected for the standard of care.

Pharmasset plans to report the final safety and antiviral activity data from the combination study at a scientific meeting in the second calendar quarter of 2008. No additional data or study details will be available until such time.

Please see http://www.clinicaltrials.gov or e-mail clinicaltrials@pharmasset.com for more information.

Conference Call

Pharmasset will host a conference call at 4:00PM (ET) on Monday, January 7, 2008 to discuss the R7128 Phase 1 preliminary safety and antiviral activity combination results.

Dial-in Information:

Domestic callers: 1 (800) 925-2151 (US/Canada)

International callers: 1 (913) 312-0657 (International)

Live audio of the conference call will be simultaneously broadcast over the internet via a we
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SOURCE Pharmasset, Inc.
Copyright©2008 PR Newswire.
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