Safety and Efficacy of BMS-790052 Plus Standard of Care in Japanese Patients (Pegylated-interferon Alpha-2a and Ribavirin)

• Safety and tolerability, as measured by the frequency of SAEs, discontinuations due to AEs, and Grade 3 - 4 laboratory abnormalities [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
• Safety and tolerability, as measured by the frequency of SAEs, discontinuations due to AEs, and Grade 3 - 4 laboratory abnormalities [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]

• Antiviral activity, as determined by the proportion of subjects with extended rapid virologic response (eRVR), defined as HCV RNA < 15 IU/mL [ Time Frame: at both Weeks 4 and 12 ] [ Designated as safety issue: Yes ]
• Safety and tolerability, as measured by the frequency of SAEs, discontinuations due to AEs, and Grade 3 - 4 laboratory abnormalities [ Time Frame: Weeks 4 and 12 ] [ Designated as safety issue: Yes ]

• Proportion of subjects with rapid virologic response (RVR), defined as undetectable HCV RNA [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
• Proportion of subjects with complete early virologic response (cEVR), defined as undetectable HCV RNA from baseline [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
• Proportions of subjects with 12-week sustained virologic response (SVR12), defined as undetectable HCV RNA [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
• Proportions of subjects with 24-week sustained virologic response (SVR24), defined as undetectable HCV RNA [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
• Resistant variants associated with virologic failure [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
• Resistant variants associated with virologic failure [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
• Resistant variants associated with virologic failure [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]

• Proportion of subjects with rapid virologic response (RVR), defined as HCV RNA < 15 IU/mL [ Time Frame: at Week 4 ] [ Designated as safety issue: Yes ]
• Proportion of subjects with early virologic response (EVR), defined as ≥ 2 log10 decrease in HCV RNA from baseline [ Time Frame: at Week 12 ] [ Designated as safety issue: Yes ]
• Proportion of subjects with a sustained virologic response (SVR), defined as HCV RNA < 15 IU/mL at follow-up (SVR12) and (SVR24), respectively [ Time Frame: Week 12 (SVR12) and Week 24 (SVR24), respectively ] [ Designated as safety issue: Yes ]
• Resistant variants associated with clinical failure [ Time Frame: Weeks 4, 12, post-treatment Week 24 ] [ Designated as safety issue: Yes ]

The purpose of this study is to identify at least 1 dose of BMS-790052, that when combined with peginterferon-alfa (PegIFNα) and ribavirin (RBV) for the treatment of chronically infected HCV genotype 1 treatment-naïve and non-responder to standard of care subjects is safe, well tolerated, and efficacious

• Drug: BMS-790052
  Tablets, Oral, 10 mg, daily, 24-48 weeks
• Drug: BMS-790052
  Tablets, Oral, 60 mg, daily, 24-48 weeks
• Drug: Placebo
  Tablets, Oral, 0 mg, daily, 48 weeks
• Drug: Peginterferon alfa-2a
  Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
  Other Name: Pegasys®
• Drug: Ribavirin
  Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
  Other Name: Copegus®

• Experimental: Arm A (BMS-790052, plus Peginterferon alfa-2a, Ribavirin)
  Treatment Naive
  Interventions:

  • Drug: BMS-790052
  • Drug: Peginterferon alfa-2a
  • Drug: Ribavirin
• Experimental: Arm B (BMS-790052, plus Peginterferon alfa-2a, Ribavirin)
  Treatment Naive
  Interventions:

  • Drug: BMS-790052
  • Drug: Peginterferon alfa-2a
  • Drug: Ribavirin
• Placebo Comparator: Arm C (Placebo, plus Peginterferon alfa-2a, Ribavirin)
  Treatment Naive
  Interventions:

  • Drug: Placebo
  • Drug: Peginterferon alfa-2a
  • Drug: Ribavirin
• Experimental: Arm D (BMS-790052, plus peginterferon alfa-2a, Ribavirin)
  Non-Responder
  Interventions:

  • Drug: BMS-790052
  • Drug: Peginterferon alfa-2a
  • Drug: Ribavirin
• Experimental: Arm E (BMS-790052, plus Peginterferon alfa-2a, Ribavirin)
  Non-Responder
  Interventions:

  • Drug: BMS-790052
  • Drug: Peginterferon alfa-2a
  • Drug: Ribavirin

Inclusion Criteria:

• Subjects chronically infected with HCV genotype 1
• HCV RNA viral load ≥ 10*5* IU/mL (100,000 IU/mL) at screening
• The current standard of care naïve or non-responder

Exclusion Criteria:

• Cirrhosis
• HCC
• Co-infection with HBV, HIV-1 or HIV-2