Telaprevir in Combination With Peginterferon and Ribavirin in Treatment-experienced Black/African American Subjects.

• Proportion of subjects who achieve SVR 24 weeks after last actual dose of study drug by prior response. [ Time Frame: 24 weeks after last actual dose of study drug ] [ Designated as safety issue: No ]
• Proportion of subjects who achieve undetectable HCV RNA at Week 4 and at Week 12 (eRVR) by prior response [ Time Frame: up to Week 12 ] [ Designated as safety issue: No ]
• Proportion of subjects who relapse, overall and by treatment completion status, defined as having undetectable HCV RNA at actual end of treatment followed by detectable HCV RNA during follow-up, by prior response [ Time Frame: up to Week 72 ] [ Designated as safety issue: No ]
• Proportion of subjects who have on-treatment virologic failure, defined as meeting futility rule or completing assigned treatment duration and having detectable HCV RNA at the end of treatment, prior response. [ Time Frame: up to Week 48 ] [ Designated as safety issue: No ]
• Safety as indicated by adverse events, clinical laboratory results, electrocardiograms and vital signs [ Time Frame: up to Week 52 ] [ Designated as safety issue: Yes ]
• Amino acid sequence of the HCV NS34A protease region [ Time Frame: Baseline up through 48 weeks after subject becomes detectable ] [ Designated as safety issue: No ]
• Pharmacokinetics of telaprevir, Peg-IFN and RBV [ Time Frame: up to Week 12 ] [ Designated as safety issue: No ]
• Proportion of subjects who experience viral breakthrough,defined as having ≥1 log increase from nadir or confirmed detectable HCV RNA after undetectable HCV RNA, by prior response. [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]

The purpose of this study is to collect additional data in treatment-experienced Black/African Americans that can be used to guide treatment decisions in this patient population.

• Drug: Telaprevir
  1125mg tablets for 12 weeks
  Other Name: Incivek, VX-950
• Drug: ribavirin
  1000mg-1200mg based on body weight for 24 weeks
  Other Name: Copegus
• Biological: peginterferon alfa-2a
  180 mcg/week for 24 weeks
  Other Name: Pegasys
• Drug: ribavirin
  1000mg-1200mg based on body weight for 48 weeks
  Other Name: Copegus
• Biological: peginterferon alfa-2a
  180 mcg/week for 48 weeks
  Other Name: Pegasys
• Drug: ribavirin
  1000mg-1200mg based on body weight for either 24 or 48 weeks
  Other Name: Copegus
• Biological: peginterferon alfa-2a
  180 mcg/week for either 24 or 48 weeks
  Other Name: Pegasys

• Experimental: Relapsers (eRVR+)

  Relapsers (eRVR+):Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks followed by Peg-IFN-alfa-2a + RBV for 12 weeks

  eRVR+: undetectable HCV RNA at Weeks 4 and 12

  Interventions:

  • Drug: Telaprevir
  • Drug: ribavirin
  • Biological: peginterferon alfa-2a
• Experimental: Relapsers (eRVR-)

  Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 36 weeks

  eRVR-: undetectable HCV RNA at Weeks 4 and 12

  Interventions:

  • Drug: Telaprevir
  • Drug: ribavirin
  • Biological: peginterferon alfa-2a
• Experimental: Null/Partial
  All Null/Partial subjects receive Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 36 weeks
  Interventions:

  • Drug: Telaprevir
  • Drug: ribavirin
  • Biological: peginterferon alfa-2a
• Experimental: Other
  Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 12
  Interventions:

  • Drug: Telaprevir
  • Drug: ribavirin
  • Biological: peginterferon alfa-2a

Inclusion Criteria:

• Male and female subjects, 18 to 70 years of age, inclusive
• Subjects self-identify as Black/African American
• Subjects have genotype 1 CHC and laboratory evidence of HCV infection for at least 6 months
• Subjects did not achieve SVR24 after at least 1 prior course of Peg-IFN/RBV therapy of standard duration

Exclusion Criteria:

• Subjects have received previous treatment with telaprevir or any other protease inhibitor(s) for CHC
• Subjects who have evidence of hepatic decompensation
• Subjects have diagnosed or suspected hepatocellular carcinoma
• Subjects have any other cause of significant liver disease in addition to HCV
• Subjects are currently abusing illicit drugs or alcohol, or have history of illicit substance or alcohol abuse within 2 years before the screening visit
• Subjects who participated in any investigational drug study within 90 days before dosing