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Pharmasset Announces the Initiation of an Interferon-Free Phase 3 Program with PSI-7977 for HCV
Date:11/1/2011

Medical Officer. "We continue to believe that interferon remains the greatest impediment to care for a majority of the millions of individuals living with HCV.  PSI-7977 has demonstrated high cure rates, without viral resistance, and across HCV genotypes; we hope to confirm these benefits in these registrational studies."

About FISSON

FISSION will be conducted at more than 100 centers in the US, Europe and other territories. The trial will enroll approximately 500 treatment-naive patients with HCV genotype 2 or 3 into one of two open-label regimens:

  • PSI-7977 400 mg QD with ribavirin for 12 weeks
  • the current standard-of-care for HCV GT2/3, pegylated interferon and ribavirin for 24 weeks

The study will include patients with and without cirrhosis, and will enroll a greater proportion of patients with HCV genotype 3, who are less likely to achieve an SVR with the currently available therapy, pegylated interferon and ribavirin.  The primary endpoint of the trial will be SVR12. Enrollment is anticipated to begin by the end of 2011.

About POSITRON

POSITRON will be conducted at more than 100 centers in the US, Europe and other territories.  The trial will enroll patients with HCV genotype 2 or 3 who cannot take interferon into one of two blinded regimens:

  • PSI-7977 400 mg QD with ribavirin for 12 weeks
  • placebo PSI-7977 and placebo ribavirin

POSITRON will enroll approximately 225 patients with or without cirrhosis.  The primary endpoint of the trial will be SVR12. Enrollment is anticipated to begin in the first quarter of 2012.

About NEUTRINO

NEUTRINO will enroll approximately 280 patients who cannot take interferon. The study will be conducted at more than 100 centers in the US, Europe and other territories. The final design of the trial will be based on em
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SOURCE Pharmasset, Inc.
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