A Dose Ranging Study Of PF-00868554 In Combination With PEGASYS And COPEGUS In Patients With Chronic Hepatitis C Genotype 1 Infection

• Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Full Analysis Set [ Time Frame: Baseline, Week 4 ]
  Plasma HCV RNA levels were measured using the Roche COBAS Taqman assay (limit of detection: 25 international unit per milliliter [IU/mL]). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements.
• Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Modified Analysis Set [ Time Frame: Baseline, Week 4 ]
  Plasma HCV RNA levels were measured using the Roche COBAS Taqman assay (limit of detection: 25 IU/mL). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements.

• Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) [ Time Frame: Week 4, 12, 48, 60, 72 ]
  Proportion of participants achieving undetectable plasma HCV RNA at Week 4 (rapid virologic response), at Week 12 (early virologic response), at Week 48 (end of treatment response), at Week 60 (sustained virologic response; 12 weeks after cessation of therapy), at Week 72 (sustained virologic response; 24 weeks after cessation of therapy) were summarized. Undetectable viral load was defined as HCV RNA <25 IU/mL.
• Alanine Aminotransferase (ALT) Levels [ Time Frame: Week 4, 12, 48, 72 ]
• Population Pharmacokinetics (PK) of PF-00868554 [ Time Frame: 1, 2 and 6 hours post-dose on Day 1; 0 hour (pre-dose) on Day 7, 14, 21; 0 hour (pre-dose), 2, 6 hours post-dose on Day 28 ]
  Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.

• To assess the safety and tolerability of PF-00868554 when administered in combination with pegIFN-a and RBV [ Time Frame: 4 weeks ]
• To assess the pharmacokinetics of PF-00868554 when administered in combination with pegIFN-a and RBV [ Time Frame: 4 weeks ]
• To assess the effect of four weeks of PF-00868554 therapy on long-term response to pegIFN-a/RBV therapy. [ Time Frame: 72 weeks ]

• Drug: PF-00868554
  500 mg BID administered as 5x100 mg tablets for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks.
• Drug: PF-00868554
  300 mg BID administered as 3x100 mg tablets for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks
• Drug: PF-00868554
  200 mg BID administered as 2x100 mg tablets for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks
• Drug: Placebo
  Placebo administered for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks

• Experimental: A
  500 mg BID
  Intervention: Drug: PF-00868554
• Experimental: B
  300 mg BID
  Intervention: Drug: PF-00868554
• Experimental: C
  200 mg BID
  Intervention: Drug: PF-00868554
• Placebo Comparator: D
  Placebo
  Intervention: Drug: Placebo

Inclusion Criteria:

• Treatment naive (no prior treatment with IFN-a +/- RBV regimens.
• Subjects who have discontinued IFN-a containing regimens after <2 weeks of therapy due to tolerability issues are considered treatment naive.
• HCV RNA > 100,000 IU/mL at screening.
• Genotype 1.
• A diagnosis of chronic HCV infection for at least 6 months.

Exclusion Criteria:

• Evidence of acute or chronic infection with HIV or HBV.
• Exposure within the previous three months to an investigational anti-HCV agent.
• Evidence of severe or decompensated liver disease.
• Subjects with liver disease unrelated to HCV infection.