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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

rd of care alone, which could translate into improved clinical outcomes with longer treatment periods. In addition, the level of antiviral activity from 500mg to 1500mg provides flexibility in selecting doses for future clinical studies."

R7128 Phase 1 Combination Study Overview

The Phase 1 combination clinical trial was a multiple center, observer- blinded, randomized and placebo-controlled study that was conducted in 50 treatment-naive patients chronically infected with HCV genotype 1. The primary objective was to assess the safety, tolerability and pharmacokinetics of R7128 in combination with Pegasys plus Copegus. The secondary objective was to evaluate the change in HCV RNA after 4 weeks of treatment.

The study investigated two oral dose levels of R7128, 500mg and 1500mg, each administered twice-daily (BID) with once-weekly injections of Pegasys plus Copegus. Each cohort of 25 patients was comprised of 20 patients receiving active R7128 and 5 patients receiving placebo with Pegasys plus Copegus (standard of care). The initial evaluation period reported is 4 weeks.

Preliminary Antiviral Activity Summary

Combined Placebo + R7128 500mg + R7128 1500mg +

Pegasys plus Pegasys plus Pegasys plus

Copegus Copegus Copegus

(Standard of Care) (n=20) (n=20)

(n=10)

Mean Decrease in

HCV RNA (log10 IU/mL)

at 4 Weeks -2.95 -3.82 -5.12

Percentage of Patients

with Undetectable

HCV RNA (<15 IU/mL)

at 4 Weeks (RVR) 10% 30% 85%

Potent antiviral activity was demonstrated following 4 weeks of treatment with R7128 1500mg BID with Pegasys plus Copegus, in which patients achieved a mean 5.12 log10 IU/mL decrease in HCV
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SOURCE Pharmasset, Inc.
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