Study Design (2)

• Randomization stratified by HCV genotype (1 vs. non-1) and viral titre (low vs. high, defined as _ or >2 million copies/mL, respectively) and by geographic region

• Pre-planned distribution of genotypes

  • Genotype non 1 and 1 LVT 1:1:1:1
  • Genotype 1 HVT 1:1:4:4

• Treatment duration blinded until week 24

• Ribavirin dose blinded throughout study

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Contains some very important points:

Make clear that duration and dose were blinded

Protocol-defined distribution of geno 1, HVT was unequal:

• highly unlikely that 24 wks would be optimal in this population

• FDA request that we test some

• (if required) re-treatment of 48 wks with standard dose RBV offered to all Group A/B relapsers