A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV)

This study has been completed.
Sponsor:
Collaborator:
Tibotec Pharmaceutical Limited
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT00627926
First received: February 22, 2008
Last updated: July 16, 2014
Last verified: July 2014
Results First Received: June 22, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hepatitis C
Interventions: Biological: Pegylated Interferon Alfa 2a
Drug: Telaprevir
Drug: Ribavirin
Other: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 1095 subjects were enrolled, of which 7 subjects discontinued the study prior to study drug administration. A total of 1088 subjects started treatment.

Reporting Groups
  Description
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.

Participant Flow:   Overall Study
    PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week     Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week     Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week  
STARTED     361     364     363  
COMPLETED     202     260     268  
NOT COMPLETED     159     104     95  
Adverse Event                 26                 37                 36  
Death                 1                 0                 0  
Lost to Follow-up                 4                 3                 4  
Withdrawal by Subject                 2                 1                 0  
Lack of Efficacy                 118                 40                 38  
Noncompliance/unspecified                 8                 23                 17  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The full analysis (FA) set included all randomized subjects who received at least 1 dose of any study drug.

Reporting Groups
  Description
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
Total Total of all reporting groups

Baseline Measures
    PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week     Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week     Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week     Total  
Number of Participants  
[units: participants]
  361     364     363     1088  
Age  
[units: participants]
       
<=18 years     1     0     0     1  
Between 18 and 65 years     357     359     353     1069  
>=65 years     3     5     10     18  
Age  
[units: years]
Mean ± Standard Deviation
  46.8  ± 10.0     47.0  ± 10.9     46.5  ± 10.8     46.8  ± 10.6  
Gender  
[units: participants]
       
Female     150     153     149     452  
Male     211     211     214     636  
Region of Enrollment  
[units: participants]
       
North America     214     227     214     655  
Europe     106     100     104     310  
Argentina     8     6     3     17  
Australia     14     14     18     46  
Israel     19     17     24     60  



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment   [ Time Frame: 24 weeks after last planned dose of study treatment (up to Week 72) ]

Measure Type Primary
Measure Title Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment
Measure Description The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. Two results are reported: 1) Protocol defined SVR: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA between end of treatment visit (up to Week 48) and 24 weeks after last planned dose (up to Week 72); 2) SVR as per FDA guidance (snapshot analysis): undetectable HCV RNA at 24 weeks after the last planned dose of study treatment. Analysis was based only on the HCV RNA assessment in visit window (+/-2 weeks); if there were more than 1 assessment in the window, the last measurement was used.
Time Frame 24 weeks after last planned dose of study treatment (up to Week 72)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The full analysis (FA) set included all randomized subjects who received at least 1 dose of any study drug.

Reporting Groups
  Description
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.

Measured Values
    PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week     Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week     Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week  
Number of Participants Analyzed  
[units: participants]
  361     364     363  
Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment  
[units: participants]
     
SVR: Protocol Defined     158     250     271  
SVR: FDA Guidance     166     261     285  


Statistical Analysis 1 for Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment
Groups [1] PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week vs. Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Difference in percentage [2] 24.9
95% Confidence Interval ( 17.9 to 31.9 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  SVR Protocol Defined: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA between end of treatment visit (up to Week 48) and 24 weeks after last planned dose (up to Week 72).
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment
Groups [1] PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week vs. Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Difference in percentage [2] 30.9
95% Confidence Interval ( 24.1 to 37.7 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  SVR Protocol Defined: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA between end of treatment visit (up to Week 48) and 24 weeks after last planned dose (up to Week 72).
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment
Groups [1] PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week vs. Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Difference in percentage [2] 25.7
95% Confidence Interval ( 18.8 to 32.6 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  SVR FDA Guidance: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment. Analysis was based only on the HCV RNA assessment in visit window (+/-2 weeks); if there were more than 1 assessment in the window, the last measurement was used.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment
Groups [1] PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week vs. Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Difference in percentage [2] 32.5
95% Confidence Interval ( 25.9 to 39.2 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  SVR FDA Guidance: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment. Analysis was based only on the HCV RNA assessment in visit window (+/-2 weeks); if there were more than 1 assessment in the window, the last measurement was used.
[2] Other relevant estimation information:
  No text entered.



2.  Secondary:   Number of Subjects With Undetectable HCV RNA at Week 72   [ Time Frame: Week 72 (24 weeks after last dose for subjects with a planned treatment duration of 48 weeks and 48 weeks after last dose for subjects with planned treatment duration of 24 weeks) ]

Measure Type Secondary
Measure Title Number of Subjects With Undetectable HCV RNA at Week 72
Measure Description The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.
Time Frame Week 72 (24 weeks after last dose for subjects with a planned treatment duration of 48 weeks and 48 weeks after last dose for subjects with planned treatment duration of 24 weeks)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FA set included all randomized subjects who received at least 1 dose of any study drug.

Reporting Groups
  Description
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.

Measured Values
    PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week     Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week     Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week  
Number of Participants Analyzed  
[units: participants]
  361     364     363  
Number of Subjects With Undetectable HCV RNA at Week 72  
[units: participants]
  158     243     265  


Statistical Analysis 1 for Number of Subjects With Undetectable HCV RNA at Week 72
Groups [1] PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week vs. Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Difference in percentage [2] 23.0
95% Confidence Interval ( 15.9 to 30.0 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Number of Subjects With Undetectable HCV RNA at Week 72
Groups [1] PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week vs. Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Difference in percentage [2] 29.2
95% Confidence Interval ( 22.4 to 36.1 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.



3.  Secondary:   Number of Subjects Achieving Rapid Viral Response (RVR), Demonstrated by Achieving Undetectable HCV RNA 4 Weeks After Starting Study Treatment   [ Time Frame: Week 4 ]

Measure Type Secondary
Measure Title Number of Subjects Achieving Rapid Viral Response (RVR), Demonstrated by Achieving Undetectable HCV RNA 4 Weeks After Starting Study Treatment
Measure Description The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment.
Time Frame Week 4  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FA set included all randomized subjects who received at least 1 dose of any study drug.

Reporting Groups
  Description
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.

Measured Values
    PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week     Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week     Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week  
Number of Participants Analyzed  
[units: participants]
  361     364     363  
Number of Subjects Achieving Rapid Viral Response (RVR), Demonstrated by Achieving Undetectable HCV RNA 4 Weeks After Starting Study Treatment  
[units: participants]
  34     242     246  


Statistical Analysis 1 for Number of Subjects Achieving Rapid Viral Response (RVR), Demonstrated by Achieving Undetectable HCV RNA 4 Weeks After Starting Study Treatment
Groups [1] PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week vs. Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Difference in percentage [2] 57.1
95% Confidence Interval ( 51.4 to 62.8 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Number of Subjects Achieving Rapid Viral Response (RVR), Demonstrated by Achieving Undetectable HCV RNA 4 Weeks After Starting Study Treatment
Groups [1] PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week vs. Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Difference in percentage [2] 58.4
95% Confidence Interval ( 52.7 to 64.0 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.



4.  Secondary:   Number of Subjects Achieving Extended Rapid Viral Response (eRVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12   [ Time Frame: Week 4 and Week 12 ]

Measure Type Secondary
Measure Title Number of Subjects Achieving Extended Rapid Viral Response (eRVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12
Measure Description The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both Week 4 and Week 12.
Time Frame Week 4 and Week 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FA set included all randomized subjects who received at least 1 dose of any study drug.

Reporting Groups
  Description
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.

Measured Values
    PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week     Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week     Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week  
Number of Participants Analyzed  
[units: participants]
  361     364     363  
Number of Subjects Achieving Extended Rapid Viral Response (eRVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12  
[units: participants]
  29     207     212  


Statistical Analysis 1 for Number of Subjects Achieving Extended Rapid Viral Response (eRVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12
Groups [1] PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week vs. Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Difference in percentage [2] 48.8
95% Confidence Interval ( 43.0 to 54.6 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Number of Subjects Achieving Extended Rapid Viral Response (eRVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12
Groups [1] PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week vs. Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Difference in percentage [2] 50.4
95% Confidence Interval ( 44.6 to 56.2 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.



5.  Secondary:   Number of Subjects With Undetectable HCV RNA at Week 12   [ Time Frame: Week 12 ]

Measure Type Secondary
Measure Title Number of Subjects With Undetectable HCV RNA at Week 12
Measure Description The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.
Time Frame Week 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FA set included all randomized subjects who received at least 1 dose of any study drug.

Reporting Groups
  Description
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.

Measured Values
    PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week     Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week     Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week  
Number of Participants Analyzed  
[units: participants]
  361     364     363  
Number of Subjects With Undetectable HCV RNA at Week 12  
[units: participants]
  146     277     283  


Statistical Analysis 1 for Number of Subjects With Undetectable HCV RNA at Week 12
Groups [1] PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week vs. Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Difference in percentage [2] 35.7
95% Confidence Interval ( 29.0 to 42.4 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Number of Subjects With Undetectable HCV RNA at Week 12
Groups [1] PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week vs. Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Difference in percentage [2] 37.5
95% Confidence Interval ( 30.9 to 44.1 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.



6.  Secondary:   Number of Subjects With Undetectable HCV RNA at End of Treatment (EOT)   [ Time Frame: End of treatment (up to Week 48) ]

Measure Type Secondary
Measure Title Number of Subjects With Undetectable HCV RNA at End of Treatment (EOT)
Measure Description The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.
Time Frame End of treatment (up to Week 48)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FA set included all randomized subjects who received at least 1 dose of any study drug.

Reporting Groups
  Description
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.

Measured Values
    PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week     Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week     Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week  
Number of Participants Analyzed  
[units: participants]
  361     364     363  
Number of Subjects With Undetectable HCV RNA at End of Treatment (EOT)  
[units: participants]
  229     295     314  


Statistical Analysis 1 for Number of Subjects With Undetectable HCV RNA at End of Treatment (EOT)
Groups [1] PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week vs. Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Difference in percentage [2] 17.6
95% Confidence Interval ( 11.2 to 24.0 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Number of Subjects With Undetectable HCV RNA at End of Treatment (EOT)
Groups [1] PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week vs. Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Difference in percentage [2] 23.1
95% Confidence Interval ( 17.0 to 29.2 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.



7.  Secondary:   Number of Subjects With Undetectable HCV RNA 12 Weeks After Last Planned Dose of Study Treatment   [ Time Frame: 12 weeks after last planned dose of study treatment (up to Week 60) ]

Measure Type Secondary
Measure Title Number of Subjects With Undetectable HCV RNA 12 Weeks After Last Planned Dose of Study Treatment
Measure Description The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.
Time Frame 12 weeks after last planned dose of study treatment (up to Week 60)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FA set included all randomized subjects who received at least 1 dose of any study drug.

Reporting Groups
  Description
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.

Measured Values
    PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week     Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week     Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week  
Number of Participants Analyzed  
[units: participants]
  361     364     363  
Number of Subjects With Undetectable HCV RNA 12 Weeks After Last Planned Dose of Study Treatment  
[units: participants]
  161     255     275  


Statistical Analysis 1 for Number of Subjects With Undetectable HCV RNA 12 Weeks After Last Planned Dose of Study Treatment
Groups [1] PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week vs. Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Difference in percentage [2] 25.5
95% Confidence Interval ( 18.5 to 32.4 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Number of Subjects With Undetectable HCV RNA 12 Weeks After Last Planned Dose of Study Treatment
Groups [1] PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week vs. Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Difference in percentage [2] 31.2
95% Confidence Interval ( 24.4 to 37.9 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.



8.  Secondary:   Number of Subjects With Undetectable HCV RNA 24 Weeks After Last Actual Dose of Study Treatment   [ Time Frame: 24 weeks after last actual dose of study treatment (up to Week 72) ]

Measure Type Secondary
Measure Title Number of Subjects With Undetectable HCV RNA 24 Weeks After Last Actual Dose of Study Treatment
Measure Description The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.
Time Frame 24 weeks after last actual dose of study treatment (up to Week 72)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FA set included all randomized subjects who received at least 1 dose of any study drug.

Reporting Groups
  Description
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.

Measured Values
    PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week     Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week     Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week  
Number of Participants Analyzed  
[units: participants]
  361     364     363  
Number of Subjects With Undetectable HCV RNA 24 Weeks After Last Actual Dose of Study Treatment  
[units: participants]
  158     251     274  


Statistical Analysis 1 for Number of Subjects With Undetectable HCV RNA 24 Weeks After Last Actual Dose of Study Treatment
Groups [1] PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week vs. Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Difference in percentage [2] 25.2
95% Confidence Interval ( 18.2 to 32.2 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Number of Subjects With Undetectable HCV RNA 24 Weeks After Last Actual Dose of Study Treatment
Groups [1] PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week vs. Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Difference in percentage [2] 31.7
95% Confidence Interval ( 24.9 to 38.5 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.



9.  Secondary:   Number of Subjects With Viral Relapse Planned and Viral Relapse Actual   [ Time Frame: After last dose of study drug up to 24 week antiviral follow-up (up to Week 72) ]

Measure Type Secondary
Measure Title Number of Subjects With Viral Relapse Planned and Viral Relapse Actual
Measure Description Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. For viral relapse, 2 analyses were performed: planned and actual. The planned analyses was measured from the end of treatment (EOT) visit to 24 weeks after the last planned dose of study treatment. The actual analyses was measured from the EOT visit to 24 weeks after the last actual dose of study treatment.
Time Frame After last dose of study drug up to 24 week antiviral follow-up (up to Week 72)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis population included subjects who completed their assigned study drug treatment and had undetectable HCV RNA at the completion of treatment (up to Week 48).

Reporting Groups
  Description
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.

Measured Values
    PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week     Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week     Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week  
Number of Participants Analyzed  
[units: participants]
  229     295     314  
Number of Subjects With Viral Relapse Planned and Viral Relapse Actual  
[units: participants]
     
Viral Relapse Planned     64     28     27  
Viral Relapse Actual     64     28     25  

No statistical analysis provided for Number of Subjects With Viral Relapse Planned and Viral Relapse Actual



10.  Secondary:   Biochemical Response: Number of Subjects With Grade 3 and 4 Shifts From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels   [ Time Frame: Baseline up to Week 48 ]

Measure Type Secondary
Measure Title Biochemical Response: Number of Subjects With Grade 3 and 4 Shifts From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels
Measure Description Criteria for grading severity (toxicity) of ALT and AST: Grade 0 (<1.25*upper limit of normal [ULN]); Grade 1 (mild=1.25 to 2.5*ULN); Grade 2 (moderate=2.6 to 5.0*ULN); Grade 3 (severe= greater than 5.0 to 20.0*ULN); Grade 4 (life-threatening= greater than 20.0*ULN). Number of subjects with Grade 3 shift (from Grade 0, Grade 1 or Grade 2 baseline) and Grade 4 shift (from Grade 0, Grade 1, Grade 2 or Grade 3 baseline) are reported. If a subject experienced more than 1 severity grade shifts during post baseline assessments, the maximum severity grade shift was considered.
Time Frame Baseline up to Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FA set included all randomized subjects who received at least 1 dose of any study drug.

Reporting Groups
  Description
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.

Measured Values
    PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week     Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week     Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week  
Number of Participants Analyzed  
[units: participants]
  361     364     363  
Biochemical Response: Number of Subjects With Grade 3 and 4 Shifts From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels  
[units: participants]
     
ALT Grade 3 toxicity grade shift     12     5     6  
ALT Grade 4 toxicity grade shift     0     1     0  
AST Grade 3 toxicity grade shift     19     7     10  
AST Grade 4 toxicity grade shift     1     0     0  

No statistical analysis provided for Biochemical Response: Number of Subjects With Grade 3 and 4 Shifts From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels



11.  Secondary:   Noninvasive Markers of Fibrosis: Number of Subjects With Improvement in FibroTest Analysis   [ Time Frame: Baseline through 24 weeks after last planned dose of study treatment (up to Week 72) ]

Measure Type Secondary
Measure Title Noninvasive Markers of Fibrosis: Number of Subjects With Improvement in FibroTest Analysis
Measure Description FibroTest analysis was a biomarker analysis test used to generate a score that was correlated with the degree of liver damage. The FibroTest score was calculated from the results of a six-parameter blood test, combining six serum markers (alpha-2-macroglobulin, haptoglobin, apolipoprotein A1, gamma-glutamyl transpeptidase, total bilirubin, and alanine transaminase). The FibroTest score (F score) may range from 0.00 (Grade F0) to 1.00 (Grade F4), where F0= no fibrosis and F4=cirrhosis. Results were presented separately for subjects who achieved SVR at 24 weeks after the last planned dose of study treatment and those who did not achieve SVR at 24 weeks after the last planned dose of study treatment. Improvement was defined as decrease of at least 1 grade relative to baseline.
Time Frame Baseline through 24 weeks after last planned dose of study treatment (up to Week 72)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FA set included all randomized subjects who received at least 1 dose of any study drug. Here "number of participants analyzed" signifies those subjects who were evaluable for FibroTest Analysis and "n" signifies those subjects who were evaluable for FibroTest Analysis in specified category for each treatment arm, respectively.

Reporting Groups
  Description
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.

Measured Values
    PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week     Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week     Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week  
Number of Participants Analyzed  
[units: participants]
  273     233     261  
Noninvasive Markers of Fibrosis: Number of Subjects With Improvement in FibroTest Analysis  
[units: participants]
     
SVR achieved (136, 180, 214)     35     59     84  
SVR not achieved (137, 53, 47)     31     12     12  

No statistical analysis provided for Noninvasive Markers of Fibrosis: Number of Subjects With Improvement in FibroTest Analysis



12.  Secondary:   Fatigue Severity Scale (FSS) Total Score   [ Time Frame: Baseline, Week 4, 12, 24, 36, 48, 72 ]

Measure Type Secondary
Measure Title Fatigue Severity Scale (FSS) Total Score
Measure Description FSS was a 9-item questionnaire where each item was scored on a scale of 1 to 7 (higher scores indicated higher influence of fatigue). FSS total score was calculated as the average of individual items on the questionnaire and FSS total score ranged from 1 to 7, where higher score indicated higher influence of fatigue.
Time Frame Baseline, Week 4, 12, 24, 36, 48, 72  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FA set included all randomized subjects who received at least 1 dose of any study drug. Here "n" signifies those participants who were evaluable for this measure at given time points for each group, respectively.

Reporting Groups
  Description
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.

Measured Values
    PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week     Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week     Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week  
Number of Participants Analyzed  
[units: participants]
  361     364     363  
Fatigue Severity Scale (FSS) Total Score  
[units: units on a scale]
Mean ± Standard Deviation
     
Baseline (n=343, 351, 346)     3.0  ± 1.66     3.2  ± 1.63     3.0  ± 1.72  
Week 4 (n=334, 326, 329)     4.1  ± 1.74     4.4  ± 1.74     4.5  ± 1.75  
Week 12 (n=329, 310, 312)     4.4  ± 1.69     4.4  ± 1.68     4.8  ± 1.68  
Week 24 (n=317, 307, 304)     4.3  ± 1.73     4.3  ± 1.71     4.3  ± 1.79  
Week 36 (n=296, 282, 297)     4.1  ± 1.80     3.4  ± 1.84     3.3  ± 1.86  
Week 48 (n=286, 282, 294)     4.0  ± 1.82     3.0  ± 1.75     3.1  ± 1.85  
Week 72 (n=296, 270, 289)     2.9  ± 1.77     2.6  ± 1.56     2.6  ± 1.67  

No statistical analysis provided for Fatigue Severity Scale (FSS) Total Score



13.  Secondary:   Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to Week 48 ]

Measure Type Secondary
Measure Title Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measure Description AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. "Study drug" includes all investigational agents (including placebo, if applicable) administered during the course of the study.
Time Frame Baseline up to Week 48  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FA set included all randomized subjects who received at least 1 dose of any study drug.

Reporting Groups
  Description
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.

Measured Values
    PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week     Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week     Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week  
Number of Participants Analyzed  
[units: participants]
  361     364     363  
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)  
[units: participants]
     
AEs     354     362     361  
SAEs     24     31     33  

No statistical analysis provided for Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jeff Chodakewitz, M.D.
Organization: Vertex Pharmaceuticals Incorporated
phone: 617-341-6777
e-mail: Jeff_Chodakewitz@vrtx.com


No publications provided by Vertex Pharmaceuticals Incorporated

Publications automatically indexed to this study:

Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT00627926     History of Changes
Other Study ID Numbers: VX07-950-108
Study First Received: February 22, 2008
Results First Received: June 22, 2011
Last Updated: July 16, 2014
Health Authority: United States: Food and Drug Administration