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New 12 Week, Interferon-Free Treatment Arms Added to All-Oral Combination Study of PSI-7977 and Daclatasvir (BMS-790052) for HCV Genotype 1
Date:11/4/2011

his Phase IIa trial completed enrollment in September 2011 with approximately 84 subjects with chronic HCV genotypes 1, 2 or 3 who have not been treated previously. The primary endpoint of the trial is sustained virologic response (SVR). Subjects were randomized equally across each of the following arms:

  • PSI-7977 400mg QD for 7 days, then add daclatasvir 60mg QD for a further 23 weeks in genotype 1 subjects;
  • PSI-7977 400mg QD for 7 days, then add daclatasvir 60mg QD for a further 23 weeks in genotype 2 or 3 subjects;
  • PSI-7977 400mg QD and daclatasvir 60mg QD for 24 weeks in genotype 1 subjects;
  • PSI-7977 400mg QD and daclatasvir 60mg QD for 24 weeks in genotype 2 or 3 subjects;
  • PSI-7977 400mg QD, daclatasvir 60mg QD and ribavirin for 24 weeks in genotype 1 subjects;
  • PSI-7977 400mg QD, daclatasvir 60mg QD and ribavirin for 24 weeks in genotype 2 or 3 subjects.

Four new treatment arms are now being added to the study; two in genotype 1 treatment-naïve subjects and two in subjects who have failed therapy with pegylated interferon and ribavirin in combination with telaprevir or boceprevir. One hundred and twenty patients will be enrolled in the following four arms (2:2:1:1):

  • PSI-7977 400mg QD and daclatasvir 60mg QD for 12 weeks in HCV genotype 1 treatment-naïve patients;
  • PSI-7977 400mg QD, daclatasvir 60mg QD and ribavirin for 12 weeks in HCV genotype 1 treatment-naive patients;
  • PSI-7977 400mg QD and daclatasvir 60mg QD for 12 weeks in genotype 1 HCV patients who have previously failed telaprevir or boceprevir treatment;
  • PSI-7977 400mg QD, daclatasvir 60mg QD and ribavirin for 12 weeks in HCV genotype 1 patients who have previously failed telaprevir or boceprevir treatment.

Additional details can be found at www.clinicaltrials.gov'/>"/>

SOURCE Pharmasset, Inc.
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