Pharmasset and Roche Obtain FDA Consent to Start a Phase 2b Study with R7128 in Treatment Naive HCV Patients
Princeton, NJ -- January 12, 2009 -- Pharmasset, Inc. (Nasdaq: VRUS)
announced today that they and their development partner, Roche, have agreed
with the FDA on the final design for a phase 2b trial with R7128, a
nucleoside inhibitor of hepatitis C (HCV), slated to initiate in the first
quarter of this year.
• 24 weeks of total treatment, with R7128 500 mg bid [twice-daily] in combination with pegylated interferon and ribavirin for 12 weeks, followed by 12 weeks of pegylated interferon and ribavirin
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.
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