A Phase 2, Open-Label Study of Daclatasvir (BMS-790052) and TMC435 in Combination With or Without Ribavirin (RBV) For Treatment-Naive Subjects or Null Responders to Prior Peginterferon Alfa (PegIFN)/RBV Therapy with Genotype 1 Chronic Hepatitis C

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Investigator: Anne F. Luetkemeyer, MD
Sponsor: Bristol-Myers Squibb Company

Location(s): France; Germany; Hungary; Spain; Argentina

Description

Primary Outcome Measures:
  • Antiviral activity, as determined by the proportion of subjects with  HCV RNA < LOQ at post-treatment Week 12, for each cohort defined by the previous response status, HCV genotype, initial treatment regimen and treatment duration 
Secondary Outcome Measures:
  • On-treatment safety, as measured by the frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events 
  • Proportion of subjects with Sustained virologic response (HCV RNA < LOQ at post-treatment Week 12) by the rs12979860 single nucleotide polymorphisms in the IL28B gene for each treatment arm 
  • Proportion of subjects with Hepatitis C virus Ribonucleic acid < Limit of quantitation (LOQ) ; EOT (End of treatment) , post-treatment Week 24 for each treatment arm, and post-treatment Week 36 for subjects in the 12 week treatment arms 
  • Proportion of subjects with HCV RNA undetectable  post-treatment Week 12 and post-treatment Week 24 for each treatment arm, and post-treatment Week 36