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Pharmasset Announces the Expansion of the ELECTRON Trial in Chronic Hepatitis C
Date:6/8/2011

aluating 12-week regimens of PSI-7977 400mg QD in combination with ribavirin (RBV) only, and in separate arms with abbreviated durations of Peg-IFN for 4, 8, or 12 weeks in treatment-naive patients with HCV GT2 or GT3. The primary endpoint of the trial is the safety and tolerability of PSI-7977 400mg QD and RBV for 12 weeks, administered with or without Peg-IFN. On May 11, 2011, Pharmasset announced the completed enrollment of Part 1 of ELECTRON in patients with HCV GT 2 or GT 3:

  • PSI-7977 400mg with RBV for 12 weeks (no peginterferon);
  • PSI-7977 400mg with RBV for 12 weeks; Peg-IFN weeks 1-4 only;
  • PSI-7977 400mg with RBV for 12 weeks, Peg-IFN weeks 1-8 only;
  • PSI-7977 400mg with Peg-IFN and RBV for 12 weeks.

In Part 2 of ELECTRON, Pharmasset will enroll an additional 30 patients into exploratory regimens of monotherapy and abbreviated durations of total therapy.  Following on the first four Cohorts of ELECTRON a 5th cohort will be added to explore 7977 400mg monotherapy in treatment-naive patients with HCV GT2 or GT3:

  • PSI-7977 400mg monotherapy for 12 weeks.

With the previously reported 100% SVR12 in naive GT2/3 subjects in PROTON, a 6th and 7th cohort will be added to ELECTRON to explore shorter treatment durations in both GT2/3 naive subjects and HCV GT1 subjects who have documented null responses (less than 2 log(10) IU/mL reduction in HCV RNA after 12 weeks of Peg-IFN/RBV):

  • PSI-7977 400mg with Peg-IFN/RBV for 8 weeks
  • PSI-7977 400mg QD with Peg-IFN/RBV for 12 weeks.

About Pharmasset

Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is the development of oral therapeutics for the treatment of hepatitis C virus
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SOURCE Pharmasset, Inc.
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