An Efficacy and Safety Study of Telaprevir in Patients Infected With Both Chronic Hepatitis C Virus (HCV-1) and Human Immunodeficiency Virus (HIV-1) (INSIGHT)

• Proportion of patients achieving undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
  Proportion of patients achieving sustained virologic response (SVR) undetectable plasma HCV RNA levels 12 weeks after the last planned dose of study medication.
  
  

• Change from baseline in log HCV RNA values [ Time Frame: Baseline and week 48 ] [ Designated as safety issue: No ]
  Change from baseline in log HCV RNA values at each time point during treatment.
  
  
• Proportiond of patients achieving undetectable HCV RNA levels [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
  Proportion of patients achieving SVR24 planned, defined as having undetectable plasma HCV RNA levels 24 weeks after the last planned dose of study medication.
  
  
• Proportion of patients achieving undetectable HCV RNA levels at Week 4 [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
  The proportion of patients who achieve rapid virologic response (RVR) and undetectable HCV RNA levels at Week 4 of treatment.
  
  
• Proportion of patients achieving undetectable HCV RNA levels at Week 12 [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
  Proportion of patients achieving undetectable HCV RNA levels at Week 12 of treatment.
  
  
• Proportion of patients achieving undetectable HCV RNA levels at Week 4 and Week 12 (eRVR) [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
  Proportion of patients achieving undetectable HCV RNA levels at Week 4 and Week 12 of treatment (eRVR).
  
  
• Proportion of patients achieving undetectable HCV RNA at the actual end of treatment [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
  Proportion of patients having undetectable HCV RNA levels at the actual end of treatment (ie, Week 24, Week 48, or early discontinuation).
  
  
• Proportion of patients achieving less than 25 IU/mL [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
  Proportion of patients having less than 25 IU/mL at the planned end of treatment (ie, Week 24 or Week 48).
  
  
• Proportion of patients with on-treatment virologic failure [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
  Proportion of patients with on-treatment virologic failure (an increase greater than 1 log in HCV RNA level from the lowest level reached, or a value of HCV RNA greater than 100 IU/mL in patients whose HCV RNA has previously become less than 25 IU/mL during treatment).
  
  
• Proportion of patients with relapse achieving detectable HCV RNA levels after previously undetectable HCV RNA levels [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
  Proportion of patients who relapse (having confirmed detectable HCV RNA during the follow-up period after previous undetectable HCV RNA levels (less than 25 IU/mL, undetectable) at planned end of treatment.
  
  
• Proportion of patients with relapse achieving detectable HCV RNA levels after previous HCV RNA levels [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
  Proportion of patients who relapse, defined as having confirmed detectable HCV RNA during the follow-up period after previous HCV RNA less than 25 IU/mL at planned end of treatment.
  
  

This is an open-label (both participant and investigator know the name of the medication given at a certain moment), single-arm, multicenter study in HCV treatment-naive and treatment-experienced patients infected with both chronic HCV-1 and HIV-1 to determine the efficacy and safety of telaprevir given with Peg-IFN-alfa-2a and RBV. The study will consist of 3 phases: a screening phase, an open-label treatment phase up to 48 weeks, and a follow-up period of 24 weeks. All patients will receive 12 weeks of treatment with telaprevir given with Peg-IFN-alfa-2a and RBV. At week 12 telaprevir dosing will end and patients will continue on Peg-IFN-alfa-2a and RBV. The total treatment duration in this study will be 24 or 48 weeks depending on the patient's prior HCV treatment status, liver disease status, and individual on-treatment virologic response in this study (equal response guided therapy). The maximum total duration of participation in the study for an individual participant will be approximately 76 weeks (screening included). Approximately 150 patients infected with both chronic HCV-1 and HIV-1 are planned to be enrolled.