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

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ClinicalTrials.gov Identifier: NCT00627926
Recruitment Status : Completed
First Posted : March 4, 2008
Results First Posted : July 21, 2011
Last Update Posted : August 8, 2014
Sponsor:
Collaborator:
Tibotec Pharmaceutical Limited
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Biological: Pegylated Interferon Alfa 2a
Drug: Telaprevir
Drug: Ribavirin
Other: Placebo
Enrollment 1095

Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title 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
Hide Arm/Group Description 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 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 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.
Period Title: Overall Study
Started 361 364 363
Completed 202 260 268
Not Completed 159 104 95
Reason Not Completed
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
Arm/Group Title 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
Hide Arm/Group Description 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 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 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 of all reporting groups
Overall Number of Baseline Participants 361 364 363 1088
Hide Baseline Analysis Population Description
The full analysis (FA) set included all randomized subjects who received at least 1 dose of any study drug.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 361 participants 364 participants 363 participants 1088 participants
<=18 years
1
   0.3%
0
   0.0%
0
   0.0%
1
   0.1%
Between 18 and 65 years
357
  98.9%
359
  98.6%
353
  97.2%
1069
  98.3%
>=65 years
3
   0.8%
5
   1.4%
10
   2.8%
18
   1.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 361 participants 364 participants 363 participants 1088 participants
46.8  (10.0) 47.0  (10.9) 46.5  (10.8) 46.8  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 361 participants 364 participants 363 participants 1088 participants
Female
150
  41.6%
153
  42.0%
149
  41.0%
452
  41.5%
Male
211
  58.4%
211
  58.0%
214
  59.0%
636
  58.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 361 participants 364 participants 363 participants 1088 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
1.Primary Outcome
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
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis (FA) set included all randomized subjects who received at least 1 dose of any study drug.
Arm/Group Title 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
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 361 364 363
Measure Type: Number
Unit of Measure: participants
SVR: Protocol Defined 158 250 271
SVR: FDA Guidance 166 261 285
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Comments 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).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 24.9
Confidence Interval (2-Sided) 95%
17.9 to 31.9
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Comments 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).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 30.9
Confidence Interval (2-Sided) 95%
24.1 to 37.7
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 25.7
Confidence Interval (2-Sided) 95%
18.8 to 32.6
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 32.5
Confidence Interval (2-Sided) 95%
25.9 to 39.2
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Subjects With Undetectable HCV RNA at Week 72
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FA set included all randomized subjects who received at least 1 dose of any study drug.
Arm/Group Title 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
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 361 364 363
Measure Type: Number
Unit of Measure: participants
158 243 265
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 23.0
Confidence Interval (2-Sided) 95%
15.9 to 30.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 29.2
Confidence Interval (2-Sided) 95%
22.4 to 36.1
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Subjects Achieving Rapid Viral Response (RVR), Demonstrated by Achieving Undetectable HCV RNA 4 Weeks After Starting Study Treatment
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FA set included all randomized subjects who received at least 1 dose of any study drug.
Arm/Group Title 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
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 361 364 363
Measure Type: Number
Unit of Measure: participants
34 242 246
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 57.1
Confidence Interval (2-Sided) 95%
51.4 to 62.8
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 58.4
Confidence Interval (2-Sided) 95%
52.7 to 64.0
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Subjects Achieving Extended Rapid Viral Response (eRVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FA set included all randomized subjects who received at least 1 dose of any study drug.
Arm/Group Title 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
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 361 364 363
Measure Type: Number
Unit of Measure: participants
29 207 212
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 48.8
Confidence Interval (2-Sided) 95%
43.0 to 54.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 50.4
Confidence Interval (2-Sided) 95%
44.6 to 56.2
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Subjects With Undetectable HCV RNA at Week 12
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FA set included all randomized subjects who received at least 1 dose of any study drug.
Arm/Group Title 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
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 361 364 363
Measure Type: Number
Unit of Measure: participants
146 277 283
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 35.7
Confidence Interval (2-Sided) 95%
29.0 to 42.4
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 37.5
Confidence Interval (2-Sided) 95%
30.9 to 44.1
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Subjects With Undetectable HCV RNA at End of Treatment (EOT)
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FA set included all randomized subjects who received at least 1 dose of any study drug.
Arm/Group Title 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
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 361 364 363
Measure Type: Number
Unit of Measure: participants
229 295 314
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 17.6
Confidence Interval (2-Sided) 95%
11.2 to 24.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 23.1
Confidence Interval (2-Sided) 95%
17.0 to 29.2
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Subjects With Undetectable HCV RNA 12 Weeks After Last Planned Dose of Study Treatment
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FA set included all randomized subjects who received at least 1 dose of any study drug.
Arm/Group Title 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
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 361 364 363
Measure Type: Number
Unit of Measure: participants
161 255 275
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Statistical Analysis Overview Comparison Group Selection PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 25.5
Confidence Interval (2-Sided) 95%
18.5 to 32.4
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 31.2
Confidence Interval (2-Sided) 95%
24.4 to 37.9
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Number of Subjects With Undetectable HCV RNA 24 Weeks After Last Actual Dose of Study Treatment
Hide 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)
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Hide Analysis Population Description
The FA set included all randomized subjects who received at least 1 dose of any study drug.
Arm/Group Title 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
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 361 364 363
Measure Type: Number
Unit of Measure: participants
158 251 274
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 25.2
Confidence Interval (2-Sided) 95%
18.2 to 32.2
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 31.7
Confidence Interval (2-Sided) 95%
24.9 to 38.5
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Number of Subjects With Viral Relapse Planned and Viral Relapse Actual
Hide 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)
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Hide Analysis Population Description
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).
Arm/Group Title 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
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 229 295 314
Measure Type: Number
Unit of Measure: participants
Viral Relapse Planned 64 28 27
Viral Relapse Actual 64 28 25
10.Secondary Outcome
Title Biochemical Response: Number of Subjects With Grade 3 and 4 Shifts From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels
Hide 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
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Hide Analysis Population Description
The FA set included all randomized subjects who received at least 1 dose of any study drug.
Arm/Group Title 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
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 361 364 363
Measure Type: Number
Unit of Measure: 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
11.Secondary Outcome
Title Noninvasive Markers of Fibrosis: Number of Subjects With Improvement in FibroTest Analysis
Hide 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)
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Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 273 233 261
Measure Type: Number
Unit of Measure: participants
SVR achieved (136, 180, 214) 35 59 84
SVR not achieved (137, 53, 47) 31 12 12
12.Secondary Outcome
Title Fatigue Severity Scale (FSS) Total Score
Hide 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
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Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 361 364 363
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
13.Secondary Outcome
Title Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide 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
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Hide Analysis Population Description
The FA set included all randomized subjects who received at least 1 dose of any study drug.
Arm/Group Title 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
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 361 364 363
Measure Type: Number
Unit of Measure: participants
AEs 354 362 361
SAEs 24 31 33
Time Frame AEs and SAEs During Dosing From Baseline to Week 48
Adverse Event Reporting Description In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
 
Arm/Group Title 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
Hide Arm/Group Description 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 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 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.
All-Cause Mortality
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   24/361 (6.65%)   31/364 (8.52%)   33/363 (9.09%) 
Blood and lymphatic system disorders       
anemia  1  4/361 (1.11%)  10/364 (2.75%)  8/363 (2.20%) 
neutropenia  1  1/361 (0.28%)  1/364 (0.27%)  0/363 (0.00%) 
anemia haemolytic  1  0/361 (0.00%)  1/364 (0.27%)  0/363 (0.00%) 
leukopenia  1  1/361 (0.28%)  0/364 (0.00%)  0/363 (0.00%) 
pancytopenia  1  0/361 (0.00%)  1/364 (0.27%)  0/363 (0.00%) 
thrombocytopenia  1  0/361 (0.00%)  1/364 (0.27%)  0/363 (0.00%) 
Cardiac disorders       
atrial fibrillation  1  1/361 (0.28%)  0/364 (0.00%)  1/363 (0.28%) 
angina pectoris  1  1/361 (0.28%)  0/364 (0.00%)  0/363 (0.00%) 
palpitations  1  1/361 (0.28%)  0/364 (0.00%)  0/363 (0.00%) 
Congenital, familial and genetic disorders       
urachal abnormality  1  0/361 (0.00%)  0/364 (0.00%)  1/363 (0.28%) 
Eye disorders       
retinal exudates  1  0/361 (0.00%)  1/364 (0.27%)  0/363 (0.00%) 
retinal haemorrhage  1  0/361 (0.00%)  0/364 (0.00%)  1/363 (0.28%) 
vision blurred  1  1/361 (0.28%)  0/364 (0.00%)  0/363 (0.00%) 
Gastrointestinal disorders       
abdominal pain  1  0/361 (0.00%)  1/364 (0.27%)  0/363 (0.00%) 
anal fistula  1  1/361 (0.28%)  0/364 (0.00%)  0/363 (0.00%) 
colitis ischaemic  1  1/361 (0.28%)  0/364 (0.00%)  0/363 (0.00%) 
diarrhoea  1  1/361 (0.28%)  0/364 (0.00%)  0/363 (0.00%) 
diverticular perforation  1  1/361 (0.28%)  0/364 (0.00%)  0/363 (0.00%) 
inguinal hernia  1  1/361 (0.28%)  0/364 (0.00%)  0/363 (0.00%) 
internal hernia  1  0/361 (0.00%)  1/364 (0.27%)  0/363 (0.00%) 
intestinal ischaemia  1  0/361 (0.00%)  1/364 (0.27%)  0/363 (0.00%) 
pancreatitis  1  0/361 (0.00%)  0/364 (0.00%)  1/363 (0.28%) 
pancreatitis acute  1  0/361 (0.00%)  0/364 (0.00%)  1/363 (0.28%) 
salivary gland calculus  1  0/361 (0.00%)  1/364 (0.27%)  0/363 (0.00%) 
General disorders       
chest pain  1  0/361 (0.00%)  0/364 (0.00%)  1/363 (0.28%) 
non-cardiac chest pain  1  0/361 (0.00%)  0/364 (0.00%)  1/363 (0.28%) 
Hepatobiliary disorders       
cholecystitis  1  0/361 (0.00%)  1/364 (0.27%)  0/363 (0.00%) 
cholelithiasis  1  0/361 (0.00%)  1/364 (0.27%)  0/363 (0.00%) 
hepatic cirrhosis  1  0/361 (0.00%)  0/364 (0.00%)  1/363 (0.28%) 
hepatitis acute  1  0/361 (0.00%)  0/364 (0.00%)  1/363 (0.28%) 
Immune system disorders       
cryoglobulinaemia  1  1/361 (0.28%)  0/364 (0.00%)  0/363 (0.00%) 
Infections and infestations       
Cellulitis  1  1/361 (0.28%)  1/364 (0.27%)  1/363 (0.28%) 
pneumonia  1  0/361 (0.00%)  2/364 (0.55%)  1/363 (0.28%) 
appendicitis  1  1/361 (0.28%)  0/364 (0.00%)  1/363 (0.28%) 
lobar pneumonia  1  0/361 (0.00%)  1/364 (0.27%)  1/363 (0.28%) 
pyelonephritis  1  1/361 (0.28%)  1/364 (0.27%)  0/363 (0.00%) 
urinary tract infection  1  0/361 (0.00%)  0/364 (0.00%)  2/363 (0.55%) 
abscess  1  0/361 (0.00%)  0/364 (0.00%)  1/363 (0.28%) 
abscess limb  1  0/361 (0.00%)  1/364 (0.27%)  0/363 (0.00%) 
acute sinusitis  1  0/361 (0.00%)  1/364 (0.27%)  0/363 (0.00%) 
bacteraemia  1  0/361 (0.00%)  0/364 (0.00%)  1/363 (0.28%) 
cellulitis staphylococcal  1  0/361 (0.00%)  1/364 (0.27%)  0/363 (0.00%) 
escherichia bacteraemia  1  0/361 (0.00%)  1/364 (0.27%)  0/363 (0.00%) 
gastroenteritis  1  0/361 (0.00%)  1/364 (0.27%)  0/363 (0.00%) 
gastroenteritis viral  1  0/361 (0.00%)  0/364 (0.00%)  1/363 (0.28%) 
lung abscess  1  0/361 (0.00%)  1/364 (0.27%)  0/363 (0.00%) 
lymphangitis  1  0/361 (0.00%)  1/364 (0.27%)  0/363 (0.00%) 
perirectal abscess  1  1/361 (0.28%)  0/364 (0.00%)  0/363 (0.00%) 
respiratory tract infection  1  0/361 (0.00%)  0/364 (0.00%)  1/363 (0.28%) 
staphylococcal abscess  1  0/361 (0.00%)  0/364 (0.00%)  1/363 (0.28%) 
staphylococcal infection  1  0/361 (0.00%)  0/364 (0.00%)  1/363 (0.28%) 
subcutaneous abscess  1  0/361 (0.00%)  1/364 (0.27%)  0/363 (0.00%) 
tuberculosis  1  1/361 (0.28%)  0/364 (0.00%)  0/363 (0.00%) 
Injury, poisoning and procedural complications       
thermal burn  1  1/361 (0.28%)  0/364 (0.00%)  0/363 (0.00%) 
Metabolism and nutrition disorders       
dehydration  1  1/361 (0.28%)  0/364 (0.00%)  0/363 (0.00%) 
hyponatraemia  1  0/361 (0.00%)  1/364 (0.27%)  0/363 (0.00%) 
Musculoskeletal and connective tissue disorders       
back pain  1  0/361 (0.00%)  0/364 (0.00%)  1/363 (0.28%) 
costochondritis  1  0/361 (0.00%)  0/364 (0.00%)  1/363 (0.28%) 
intervertebral disc  1  1/361 (0.28%)  0/364 (0.00%)  0/363 (0.00%) 
pain in extremity  1  1/361 (0.28%)  0/364 (0.00%)  0/363 (0.00%) 
rheumatoid arthritis  1  1/361 (0.28%)  0/364 (0.00%)  0/363 (0.00%) 
Nervous system disorders       
syncope  1  0/361 (0.00%)  0/364 (0.00%)  3/363 (0.83%) 
convulsion  1  2/361 (0.55%)  0/364 (0.00%)  0/363 (0.00%) 
migraine  1  1/361 (0.28%)  1/364 (0.27%)  0/363 (0.00%) 
altered state of consciousness  1  0/361 (0.00%)  0/364 (0.00%)  1/363 (0.28%) 
global amnesia  1  1/361 (0.28%)  0/364 (0.00%)  0/363 (0.00%) 
Psychiatric disorders       
anxiety  1  1/361 (0.28%)  0/364 (0.00%)  1/363 (0.28%) 
completed suicide  1  1/361 (0.28%)  0/364 (0.00%)  0/363 (0.00%) 
depression  1  0/361 (0.00%)  1/364 (0.27%)  0/363 (0.00%) 
insomnia  1  1/361 (0.28%)  0/364 (0.00%)  0/363 (0.00%) 
panic attack  1  1/361 (0.28%)  0/364 (0.00%)  0/363 (0.00%) 
psychotic disorder  1  0/361 (0.00%)  0/364 (0.00%)  1/363 (0.28%) 
Renal and urinary disorders       
renal failure acute  1  2/361 (0.55%)  0/364 (0.00%)  0/363 (0.00%) 
nephrolithiasis  1  1/361 (0.28%)  0/364 (0.00%)  0/363 (0.00%) 
urinary retention  1  1/361 (0.28%)  0/364 (0.00%)  0/363 (0.00%) 
Reproductive system and breast disorders       
metrorrhagia  1  0/361 (0.00%)  0/364 (0.00%)  1/363 (0.28%) 
Respiratory, thoracic and mediastinal disorders       
dyspnoea  1  0/361 (0.00%)  0/364 (0.00%)  1/363 (0.28%) 
Skin and subcutaneous tissue disorders       
rash  1  0/361 (0.00%)  3/364 (0.82%)  2/363 (0.55%) 
pruritus  1  1/361 (0.28%)  1/364 (0.27%)  0/363 (0.00%) 
eczema  1  0/361 (0.00%)  1/364 (0.27%)  0/363 (0.00%) 
leukocytoclastic vasculitis  1  1/361 (0.28%)  0/364 (0.00%)  0/363 (0.00%) 
rash maculo-papular  1  0/361 (0.00%)  0/364 (0.00%)  1/363 (0.28%) 
stevens-johnson syndrome  1  0/361 (0.00%)  1/364 (0.27%)  0/363 (0.00%) 
Vascular disorders       
hypotension  1  0/361 (0.00%)  1/364 (0.27%)  0/363 (0.00%) 
phlebitis  1  0/361 (0.00%)  0/364 (0.00%)  1/363 (0.28%) 
thrombophlebitis  1  1/361 (0.28%)  0/364 (0.00%)  0/363 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   354/361 (98.06%)   362/364 (99.45%)   361/363 (99.45%) 
Blood and lymphatic system disorders       
anaemia  1  70/361 (19.39%)  141/364 (38.74%)  135/363 (37.19%) 
neutropenia  1  68/361 (18.84%)  62/364 (17.03%)  51/363 (14.05%) 
Eye disorders       
vision blurred  1  27/361 (7.48%)  26/364 (7.14%)  29/363 (7.99%) 
Gastrointestinal disorders       
nausea  1  112/361 (31.02%)  146/364 (40.11%)  156/363 (42.98%) 
diarrhoea  1  80/361 (22.16%)  115/364 (31.59%)  102/363 (28.10%) 
vomiting  1  38/361 (10.53%)  55/364 (15.11%)  55/363 (15.15%) 
haemorrhoids  1  13/361 (3.60%)  43/364 (11.81%)  43/363 (11.85%) 
anorectal discomfort  1  13/361 (3.60%)  30/364 (8.24%)  46/363 (12.67%) 
abdominal pain  1  34/361 (9.42%)  28/364 (7.69%)  20/363 (5.51%) 
dyspepsia  1  23/361 (6.37%)  15/364 (4.12%)  33/363 (9.09%) 
constipation  1  12/361 (3.32%)  26/364 (7.14%)  27/363 (7.44%) 
anal pruritus  1  7/361 (1.94%)  25/364 (6.87%)  31/363 (8.54%) 
dry mouth  1  15/361 (4.16%)  32/364 (8.79%)  33/363 (9.09%) 
abdominal pain upper  1  27/361 (7.48%)  20/364 (5.49%)  31/363 (8.54%) 
General disorders       
fatigue  1  206/361 (57.06%)  211/364 (57.97%)  207/363 (57.02%) 
influenza like illness  1  101/361 (27.98%)  105/364 (28.85%)  102/363 (28.10%) 
pyrexia  1  87/361 (24.10%)  108/364 (29.67%)  95/363 (26.17%) 
irritability  1  64/361 (17.73%)  68/364 (18.68%)  80/363 (22.04%) 
asthenia  1  58/361 (16.07%)  62/364 (17.03%)  56/363 (15.43%) 
chills  1  54/361 (14.96%)  65/364 (17.86%)  46/363 (12.67%) 
injection site erythema  1  33/361 (9.14%)  46/364 (12.64%)  38/363 (10.47%) 
pain  1  28/361 (7.76%)  30/364 (8.24%)  18/363 (4.96%) 
Infections and infestations       
urinary tract infection  1  13/361 (3.60%)  22/364 (6.04%)  17/363 (4.68%) 
upper respiratory tract infection  1  18/361 (4.99%)  19/364 (5.22%)  9/363 (2.48%) 
Investigations       
weight decreased  1  22/361 (6.09%)  13/364 (3.57%)  24/363 (6.61%) 
Metabolism and nutrition disorders       
anorexia  1  39/361 (10.80%)  55/364 (15.11%)  53/363 (14.60%) 
decreased appetite  1  30/361 (8.31%)  36/364 (9.89%)  36/363 (9.92%) 
Musculoskeletal and connective tissue disorders       
myalgia  1  77/361 (21.33%)  76/364 (20.88%)  54/363 (14.88%) 
arthralgia  1  68/361 (18.84%)  56/364 (15.38%)  49/363 (13.50%) 
back pain  1  43/361 (11.91%)  25/364 (6.87%)  28/363 (7.71%) 
pain in extremity  1  13/361 (3.60%)  8/364 (2.20%)  19/363 (5.23%) 
Nervous system disorders       
headache  1  142/361 (39.34%)  156/364 (42.86%)  148/363 (40.77%) 
dizziness  1  49/361 (13.57%)  50/364 (13.74%)  57/363 (15.70%) 
distrubance in attention  1  33/361 (9.14%)  29/364 (7.97%)  25/363 (6.89%) 
dysgeusia  1  14/361 (3.88%)  36/364 (9.89%)  34/363 (9.37%) 
Psychiatric disorders       
insomnia  1  111/361 (30.75%)  116/364 (31.87%)  117/363 (32.23%) 
depression  1  79/361 (21.88%)  61/364 (16.76%)  66/363 (18.18%) 
anxiety  1  44/361 (12.19%)  33/364 (9.07%)  35/363 (9.64%) 
affect lability  1  12/361 (3.32%)  5/364 (1.37%)  17/363 (4.68%) 
Respiratory, thoracic and mediastinal disorders       
cough  1  86/361 (23.82%)  76/364 (20.88%)  61/363 (16.80%) 
dyspnoea  1  50/361 (13.85%)  52/364 (14.29%)  47/363 (12.95%) 
dyspnoea exertional  1  23/361 (6.37%)  27/364 (7.42%)  26/363 (7.16%) 
pharyngolaryngeal pain  1  19/361 (5.26%)  25/364 (6.87%)  28/363 (7.71%) 
Skin and subcutaneous tissue disorders       
pruritus  1  131/361 (36.29%)  165/364 (45.33%)  181/363 (49.86%) 
rash  1  88/361 (24.38%)  129/364 (35.44%)  133/363 (36.64%) 
alopecia  1  73/361 (20.22%)  81/364 (22.25%)  83/363 (22.87%) 
dry skin  1  66/361 (18.28%)  66/364 (18.13%)  63/363 (17.36%) 
rash papular  1  15/361 (4.16%)  20/364 (5.49%)  24/363 (6.61%) 
pruritus generalised  1  13/361 (3.60%)  22/364 (6.04%)  22/363 (6.06%) 
rash erythematous  1  16/361 (4.43%)  13/364 (3.57%)  17/363 (4.68%) 
rash pruritic  1  11/361 (3.05%)  17/364 (4.67%)  16/363 (4.41%) 
eczema  1  14/361 (3.88%)  18/364 (4.95%)  10/363 (2.75%) 
rash maculo-papular  1  7/361 (1.94%)  10/364 (2.75%)  23/363 (6.34%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
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.
Results Point of Contact
Name/Title: Jeff Chodakewitz, M.D.
Organization: Vertex Pharmaceuticals Incorporated
Phone: 617-341-6777
Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT00627926     History of Changes
Other Study ID Numbers: VX07-950-108
First Submitted: February 22, 2008
First Posted: March 4, 2008
Results First Submitted: June 22, 2011
Results First Posted: July 21, 2011
Last Update Posted: August 8, 2014