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Pharmasset and Roche Obtain FDA Consent to Start a Phase 2b Study With R7128 in Treatment Naive HCV Patients
Date:1/12/2009

and ribavirin
  • 24 weeks of total treatment, with R7128 1000mg bid in combination with pegylated interferon and ribavirin for 8 weeks, followed by a further 16 weeks of pegylated interferon and ribavirin
  • 48 weeks of total treatment, with R7128 1000mg bid in combination with pegylated interferon and ribavirin for 12 weeks, followed by a further 36 weeks of pegylated interferon and ribavirin.
  • A control arm with pegylated interferon and ribavirin for 48 weeks.
  • Patients in the 24 week arms will discontinue treatment at week 24 if they achieved a rapid virological response (RVR), defined as undetectable level of HCV RNA at week 4 ("RVR-guided"). Patients that do not achieve an RVR will continue on the standard of care until week 48.

    According to the current study design, patients will be enrolled as two cohorts, with randomization of the second larger cohort being initiated based on 12 week safety data of the first cohort.

    During 2009, we expect to provide updates on the progress of the trial.

    About R7128

    R7128 is being developed for the treatment of chronic HCV infection. R7128 is a prodrug of PSI-6130, a cytidine nucleoside analog inhibitor of HCV RNA polymerase. A prodrug is a chemically modified form of a molecule designed to enhance the absorption, distribution and metabolic properties of that molecule. R7128 has shown in vitro activity against all of the most common HCV genotypes (1, 2, 3 and 4).

    In a 4-week Phase 1 combination study that was conducted in 81 treatment-naive patients chronically infected with HCV genotype 1, R7128 demonstrated significant short-term antiviral activity with safety and tolerability comparable to placebo with SOC. Results from the 500mg, 1500mg and 1000mg dose cohorts (cohorts 1, 2 and 3) in 81 treatment-naive patients infected with HCV genotype 1 ind
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    SOURCE Pharmasset, Inc.
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