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An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Participants (QUEST-2)

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ClinicalTrials.gov Identifier: NCT01290679
Recruitment Status : Completed
First Posted : February 7, 2011
Results First Posted : June 13, 2014
Last Update Posted : June 13, 2014
Sponsor:
Information provided by (Responsible Party):
Janssen R&D Ireland

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: Placebo
Drug: TMC435
Drug: Peginterferon alpha-2a or Peginterferon alpha-2b (PegIFNα-2a/b)
Drug: Ribavirin (RBV)
Enrollment 393
Recruitment Details The study was conducted from 18 January 2011 to 5 February 2013. The study was conducted at 76 sites in 14 countries.
Pre-assignment Details 393 participants were randomly allocated to the 2 treatment arms. 391 participants received at least 1 dose of study medication and were included in the intent-to-treat analysis set.
Arm/Group Title TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Hide Arm/Group Description Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48). Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
Period Title: Overall Study
Started 257 [1] 134 [1]
Completed 241 113
Not Completed 16 21
Reason Not Completed
Adverse Event             2             0
Lost to Follow-up             8             10
Protocol Violation             0             1
Withdrawal by Subject             6             5
Subject Entered Another Trial             0             5
[1]
Not including 1 participant was randomized to this group, but never received treatment.
Arm/Group Title TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48 Total
Hide Arm/Group Description Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48). Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48). Total of all reporting groups
Overall Number of Baseline Participants 257 134 391
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 257 participants 134 participants 391 participants
46
(18 to 73)
47
(18 to 73)
47
(18 to 73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 257 participants 134 participants 391 participants
Female
117
  45.5%
57
  42.5%
174
  44.5%
Male
140
  54.5%
77
  57.5%
217
  55.5%
1.Primary Outcome
Title The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)
Hide Description The table below shows the percentage of participants in each treatment group who achieved a SVR12, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid 12 weeks after planned end of treatment.
Time Frame Week 36 or Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.
Arm/Group Title TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Hide Arm/Group Description:
Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
Overall Number of Participants Analyzed 257 134
Measure Type: Number
Unit of Measure: Percentage of participants
81.3 50.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TMC435 150mg 12Wks PR24/48, PBO 12Wks PR48
Comments The null hypothesis is there is no difference in proportions of SVR12 between the treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions of SVR12
Estimated Value 32.2
Confidence Interval (2-Sided) 95%
23.3 to 41.2
Estimation Comments [Not Specified]
2.Secondary Outcome
Title The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)
Hide Description The table below shows the percentage of participants in each treatment group who achieved a SVRW72, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72.
Time Frame Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.
Arm/Group Title TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Hide Arm/Group Description:
Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
Overall Number of Participants Analyzed 257 134
Measure Type: Number
Unit of Measure: Percentage of participants
78.6 50.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TMC435 150mg 12Wks PR24/48, PBO 12Wks PR48
Comments The null hypothesis is there is no difference in proportions of SVRW72 between the treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions of SVRW72
Estimated Value 29.3
Confidence Interval (2-Sided) 95%
20.2 to 38.5
Estimation Comments [Not Specified]
3.Secondary Outcome
Title The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)
Hide Description The table below shows the percentage of participants in each treatment group who achieved a SVR24, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels 24 weeks after planned end of treatment.
Time Frame Week 48 or Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.
Arm/Group Title TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Hide Arm/Group Description:
Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
Overall Number of Participants Analyzed 257 134
Measure Type: Number
Unit of Measure: Percentage of participants
80.5 50.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TMC435 150mg 12Wks PR24/48, PBO 12Wks PR48
Comments The null hypothesis is there is no difference in proportions of SVR24 between the treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions of SVR24
Estimated Value 31.5
Confidence Interval (2-Sided) 95%
22.5 to 40.5
Estimation Comments [Not Specified]
4.Secondary Outcome
Title The Percentage of Participants Who Achieved a Sustained Virologic Response 4 Weeks After the Planned End of Treatment (SVR4)
Hide Description The table below shows the percentage of participants in each treatment group who achieved a SVR4, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels 4 weeks after planned end of treatment.
Time Frame Week 28 or Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.
Arm/Group Title TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Hide Arm/Group Description:
Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
Overall Number of Participants Analyzed 257 134
Measure Type: Number
Unit of Measure: Percentage of participants
84.8 53.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TMC435 150mg 12Wks PR24/48, PBO 12Wks PR48
Comments The null hypothesis is there is no difference in proportions of SVR4 between the treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions of SVR4
Estimated Value 32.3
Confidence Interval (2-Sided) 95%
23.5 to 41.0
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
Hide Description The table below shows changes from baseline in log10 HCV RNA.
Time Frame Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.
Arm/Group Title TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Hide Arm/Group Description:
Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
Overall Number of Participants Analyzed 257 134
Mean (Standard Error)
Unit of Measure: log10 IU/mL
Day 3 -3.60  (0.045) -1.22  (0.075)
Week 1 -4.52  (0.043) -1.21  (0.094)
Week 4 -5.28  (0.046) -2.72  (0.138)
Week 12 -5.34  (0.053) -4.21  (0.129)
Week 24 -5.27  (0.062) -4.93  (0.114)
Week 48 -5.83  (0.074) -5.28  (0.084)
6.Secondary Outcome
Title Actual Values of log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
Hide Description The table below shows actual values of log10 HCV RNA levels.
Time Frame Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.
Arm/Group Title TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Hide Arm/Group Description:
Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
Overall Number of Participants Analyzed 257 134
Mean (Standard Error)
Unit of Measure: log10 IU/mL
Day 3 2.777  (0.050) 5.165  (0.107)
Week 1 1.852  (0.400) 5.171  (0.129)
Week 4 1.093  (0.027) 3.657  (0.162)
Week 12 1.027  (0.034) 2.157  (0.141)
Week 24 1.094  (0.049) 1.388  (0.106)
Week 48 1.015  (0.061) 0.960  (0.005)
7.Secondary Outcome
Title Percentage of Participants With On-treatment Virologic Response at All Time Points
Hide Description The table below shows the percentage of participants with Hepatitis C Virus (HCV) ribonucleic acid (RNA) plasma levels below the limit of detection (ie, <25 IU/mL undetectable), the percentage of participants with a HCV RNA plasma level below the limit of quantification (ie, less than [<] 25 IU/mL detectable or undetectable), the percentage of participants with plasma levels of HCV RNA <100 IU/mL, the percentage of HCV-Infected participants with virologic responses of a greater than or equal to 2 log10 change from baseline in plasma levels of HCV RNA.
Time Frame Day 3, Week 1, Week 2, Week 8, Week 16, Week 20, Week 28, Week 36, and Week 42
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.
Arm/Group Title TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Hide Arm/Group Description:
Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
Overall Number of Participants Analyzed 257 134
Measure Type: Number
Unit of Measure: Percentage of participants
Day 3:<25 IU/mL undetectable 0.4 0
Week 1:<25 IU/mL undetectable 6.3 1.5
Week 2:<25 IU/mL undetectable 31.7 3.8
Week 8:<25 IU/mL undetectable 93.7 31.3
Week 16:<25 IU/mL undetectable 96.3 65.5
Week 20:<25 IU/mL undetectable 95.9 68.2
Week 28:<25 IU/mL undetectable 66.7 88.0
Week 36:<25 IU/mL undetectable 100.0 95.3
Week 42:<25 IU/mL undetectable 100.0 95.0
Day 3:<25 IU/mL detectable or undetectable 4.7 0
Week 1:<25 IU/mL detectable or undetectable 37.0 2.3
Week 2:<25 IU/mL detectable or undetectable 80.7 12.0
Week 8:<25 IU/mL detectable or undetectable 98.0 45.0
Week 16:<25 IU/mL detectable or undetectable 98.0 73.5
Week 20:<25 IU/mL detectable or undetectable 97.1 79.1
Week 28:<25 IU/mL detectable or undetectable 77.8 97.8
Week 36:<25 IU/mL detectable or undetectable 100.0 98.8
Week 42:<25 IU/mL detectable or undetectable 100.0 100.0
Day 3:<100 IU/mL 15.3 1.5
Week 1:<100 IU/mL 65.7 6.0
Week 2:<100 IU/mL 92.0 14.3
Week 8:<100 IU/mL 98.8 50.4
Week 16:<100 IU/mL 98.8 77.0
Week 20:<100 IU/mL 98.0 83.6
Week 28:<100 IU/mL 77.8 97.8
Week 36:<100 IU/mL 100.0 98.8
Week 42:<100 IU/mL 100.0 100.0
Day 3:> or = 2 log 10 change from baseline 96.9 20.8
Week 1:> or =2 log 10 change from baseline 99.6 24.1
Week 2:> or =2 log 10 change from baseline 99.6 39.8
Week 8:> or =2 log 10 change from baseline 99.6 80.2
Week 16:> or =2 log 10 change from baseline 99.2 97.3
Week 20:> or =2 log 10 change from baseline 98.8 93.6
Week 28:> or =2 log 10 change from baseline 88.9 100.0
Week 36:> or =2 log 10 change from baseline 100.0 98.8
Week 42:> or =2 log 10 change from baseline 100.0 100.0
8.Secondary Outcome
Title The Percentage of Participants Achieving a Rapid Virologic Response (RVR)
Hide Description The table below shows the percentage of participants in each treatment group who achieved a RVR, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels after receiving 4 weeks of treatment.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.
Arm/Group Title TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Hide Arm/Group Description:
Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
Overall Number of Participants Analyzed 257 134
Measure Type: Number
Unit of Measure: Percentage of participants
79.2 12.8
9.Secondary Outcome
Title The Percentage of Participants Achieving a Early Virologic Response (EVR)
Hide Description The table below shows the percentage of participants who achieved an EVR, defined as having a change from baseline in plasma Hepatitis C virus ribonucleic acid of 2 log10 at Week 12.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.
Arm/Group Title TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Hide Arm/Group Description:
Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
Overall Number of Participants Analyzed 257 134
Measure Type: Number
Unit of Measure: Percentage of participants
98.8 89.8
10.Secondary Outcome
Title The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)
Hide Description The table below shows the percentage of participants in each treatment group who had a cEVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 12.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.
Arm/Group Title TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Hide Arm/Group Description:
Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
Overall Number of Participants Analyzed 257 134
Measure Type: Number
Unit of Measure: Percentage of participants
96.8 44.9
11.Secondary Outcome
Title The Percentage of Participants Achieving a Extended Rapid Virologic Response (eRVR)
Hide Description The table below shows the percentage of participants in each treatment group who had a eRVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 4 and 12.
Time Frame Weeks 4 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.
Arm/Group Title TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Hide Arm/Group Description:
Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
Overall Number of Participants Analyzed 257 134
Measure Type: Number
Unit of Measure: Percentage of participants
78.3 13.4
12.Secondary Outcome
Title The Percentage of Participants With <1 log10 Decrease in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Week 4
Hide Description The table below shows the percentage of participants in each treatment group with <1 log10 HCV RNA decrease at Week 4.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.
Arm/Group Title TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Hide Arm/Group Description:
Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
Overall Number of Participants Analyzed 257 134
Measure Type: Number
Unit of Measure: Percentage of participants
0.4 17.3
13.Secondary Outcome
Title Percentage of Participants With in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels >1000 IU/mL at Week 4
Hide Description The table below shows the percentage of participants in each treatment group with HCV RNA levels >1000 IU/mL at Week 4.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.
Arm/Group Title TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Hide Arm/Group Description:
Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
Overall Number of Participants Analyzed 257 134
Measure Type: Number
Unit of Measure: Percentage of participants
1.2 61.2
14.Secondary Outcome
Title Percentage of Participants With Null Response
Hide Description The table below shows the percentage of participants with null response, defined as <2 log10 reduction in Hepatitis C virus ribonucleic acid at Week 12 compared to baseline.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.
Arm/Group Title TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Hide Arm/Group Description:
Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
Overall Number of Participants Analyzed 257 134
Measure Type: Number
Unit of Measure: Percentage of participants
1.2 10.2
15.Secondary Outcome
Title Percentage of Participants With Partial Response
Hide Description The table below shows the percentage of participants with partial response, defined as =>2 log10 reduction in Hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 compared to baseline, but not achieving undetectable HCV RNA while on treatment.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.
Arm/Group Title TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Hide Arm/Group Description:
Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
Overall Number of Participants Analyzed 257 134
Measure Type: Number
Unit of Measure: Percentage of participants
0.4 17.3
16.Secondary Outcome
Title Percentage of Participants With Viral Breakthrough
Hide Description The table below shows the percentage of participants with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (<25 IU/mL undetectable).
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.
Arm/Group Title TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Hide Arm/Group Description:
Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
Overall Number of Participants Analyzed 257 134
Measure Type: Number
Unit of Measure: Percentage of participants
4.7 10.4
17.Secondary Outcome
Title Percentage of Participants With Viral Relapse
Hide Description The table below shows the percentage of participants with viral relapse, defined as having confirmed detectable plasma level of Hepatitis C virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (<25 IU/mL undetectable) at the end of treatment.
Time Frame Up to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.
Arm/Group Title TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Hide Arm/Group Description:
Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
Overall Number of Participants Analyzed 257 134
Measure Type: Number
Unit of Measure: Percentage of participants
12.3 23.9
18.Secondary Outcome
Title Percentage of Participants Who Completed All Study Treatment at Week 24 Because of the Treatment Duration Rule
Hide Description The table below shows the percentage of participants in the TMC435 treatment group who met the treatment duration rule (ie, having hepatitis C virus [HCV] ribonucleic acid [RNA] levels <25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA levels at Week 12) and completed treatment with PegIFNα-2a and RBV for 24 weeks. Participants in the TMC435 treatment group not meeting RGT criteria and participants in the placebo group were treated with PegIFNα-2a and RBV treatment for 48 weeks.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.
Arm/Group Title TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Hide Arm/Group Description:
Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
Overall Number of Participants Analyzed 257 134
Measure Type: Number
Unit of Measure: Percentage of participants
89.5 NA [1] 
[1]
RGT criteria did not apply to PBO arm
19.Secondary Outcome
Title Percentage of Participants With On-treatment Failure
Hide Description The table below shows percentage of participants with on-treatment failure defined as confirmed detectable Hepatitis C virus ribonucleic acid levels at actual end of treatment.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.
Arm/Group Title TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Hide Arm/Group Description:
Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
Overall Number of Participants Analyzed 257 134
Measure Type: Number
Unit of Measure: Percentage of participants
7.0 32.1
20.Secondary Outcome
Title Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable or Detectable
Hide Description The table below shows the median time in days to reach HCV RNA levels <25 IU/mL undetectable or detectable.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.
Arm/Group Title TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Hide Arm/Group Description:
Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
Overall Number of Participants Analyzed 257 134
Median (95% Confidence Interval)
Unit of Measure: Days
14
(14 to 15)
85
(57 to 112)
21.Secondary Outcome
Title Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable
Hide Description The table below shows the median time in days to reach HCV RNA levels <25 IU/mL undetectable.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.
Arm/Group Title TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Hide Arm/Group Description:
Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
Overall Number of Participants Analyzed 257 134
Median (95% Confidence Interval)
Unit of Measure: Days
29
(28 to 29)
113
(85 to 141)
22.Secondary Outcome
Title Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <100 IU/mL
Hide Description The table below shows the median time in days to reach HCV RNA levels <100 IU/mL.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.
Arm/Group Title TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Hide Arm/Group Description:
Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
Overall Number of Participants Analyzed 257 134
Median (95% Confidence Interval)
Unit of Measure: Days
8 [1] 
(NA to NA)
71
(57 to 86)
[1]
The 95% CI could not be calculated due to very low number of failures in the TMC435 group.
23.Secondary Outcome
Title Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <1000 IU/mL
Hide Description The table below shows the median time in days to reach HCV RNA levels <1000 IU/mL.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.
Arm/Group Title TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Hide Arm/Group Description:
Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
Overall Number of Participants Analyzed 257 134
Median (95% Confidence Interval)
Unit of Measure: Days
4
(3 to 4)
57
(56 to 58)
24.Secondary Outcome
Title The Percentage of Participants With Viral Breakthrough at Different Time Points
Hide Description The table below shows the percentage of participants at different time points with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma HCV ribonucleic acid (RNA) level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (<25 IU/mL undetectable).
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.
Arm/Group Title TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Hide Arm/Group Description:
Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
Overall Number of Participants Analyzed 257 134
Measure Type: Number
Unit of Measure: Percentage of participants
< 12 Weeks 1.2 3.7
Week 12 - Week 24 3.3 6.4
> Week 24 12.5 2.1
25.Secondary Outcome
Title Time From End-of-treatment to Viral Relapse
Hide Description The table below shows the mean number of days to viral relapse, defined as participants having confirmed detectable plasma level of Hepatitis C Virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (<25 IU/mL undetectable) at the end of treatment.
Time Frame Up to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.
Arm/Group Title TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Hide Arm/Group Description:
Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
Overall Number of Participants Analyzed 257 134
Mean (Standard Error)
Unit of Measure: Days
229.77  (4.29) 77.74  (2.34)
26.Secondary Outcome
Title The Percentage of Participants With Normalization of Alanine Aminotransferase (ALT)
Hide Description The percentage of participants analyzed were those with baseline ALT values out of the normal range (ie, 164 of 257 participants in the TMC435 treatment group and 79 of 134 participants in the Placebo group had ALT values at baseline that were out of the normal range.). Normalization of ALT values means that ALT values out of the normal range returned to within the normal range.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.
Arm/Group Title TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Hide Arm/Group Description:
Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
Overall Number of Participants Analyzed 169 79
Measure Type: Number
Unit of Measure: Percentage of participants
79.9 81.0
27.Secondary Outcome
Title Median Time to Normalization of Alanine Aminotransferase (ALT) Levels
Hide Description The table below shows the median time in weeks to normalization of ALT levels.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.
Arm/Group Title TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Hide Arm/Group Description:
Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
Overall Number of Participants Analyzed 257 134
Median (95% Confidence Interval)
Unit of Measure: Weeks
2.14
(1.29 to 2.14)
4.14
(4.14 to 12.00)
28.Secondary Outcome
Title Plasma Concentration of TMC435: Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h)
Hide Description The table below shows the mean (standard deviation) values of the area under the plasma concentration-time curve from time of administration to 24 hours after dosing for TMC435.
Time Frame At protocol-specified time points from the time of administration up to 24 hours after dosing at Weeks 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.
Arm/Group Title TMC435 150mg 12Wks PR24/48
Hide Arm/Group Description:
Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
Overall Number of Participants Analyzed 255
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
56611  (66935.4)
29.Secondary Outcome
Title Plasma Concentration of TMC435: Predose Plasma Concentration (C0h)
Hide Description The table below shows the mean (standard deviation) of C0h values of TMC435. NOTE: the timing of collection of blood samples post-dose for analysis at Week 2, 4, 8, and 12 was not specifed; only the interval was between blood samples was specified (ie, 2 samples collected 2 hours apart at Week 2, 4, 8, and 12).
Time Frame Blood samples tested were taken before administration of TMC435 and at 2 random time points after dosing (taken atleast 2 hours apart from each other) at Week 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.
Arm/Group Title TMC435 150mg 12Wks PR24/48
Hide Arm/Group Description:
Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
Overall Number of Participants Analyzed 255
Mean (Standard Deviation)
Unit of Measure: ng/mL
1902  (2781.1)
30.Secondary Outcome
Title Plasma Concentration of TMC435: Systemic Clearance (CL)
Hide Description The table below shows the mean (standard deviation) of CL values of TMC435. NOTE: the pre-dose CL values taken at Weeks, 2, 4, 8, and 12 were averaged and then the mean values from all participants were averaged to provide the final value reported below.
Time Frame At protocol-specified time points at Weeks 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.
Arm/Group Title TMC435 150mg 12Wks PR24/48
Hide Arm/Group Description:
Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
Overall Number of Participants Analyzed 255
Mean (Standard Deviation)
Unit of Measure: L/h
5.23  (3.767)
31.Secondary Outcome
Title Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for the Fatigue Severity Scale (FSS) Total Scores
Hide Description Study participants completed FSS questionnaires during study visits before treatment and throughout follow-up to rate the severity and impact of fatigue experienced in the preceding 2 weeks. FSS total scores are the average of nine questions with a range from 1 [no fatigue] to 7 [worst fatigue]; the possible score range from baseline to Week 60 would be 60-420 and to Week 72 would be 72-504. The average FSS total score from baseline to Week 60 and to Week 72 was calculated for each participant and then the average of those values were calculated to show the average FSS total score for each treatment group. The null hypothesis was that there would be no difference between the treatment arms in the FSS total score. The Table below shows the lease squares (LS) mean estimates of the area under the curve (AUC) at Week 72 (as well as at Week 60) and the statistical comparison between treatment groups.
Time Frame Baseline to Week 60 and Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.
Arm/Group Title TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Hide Arm/Group Description:
Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
Overall Number of Participants Analyzed 256 133
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale*weeks
Week 60
208.418
(199.4881 to 217.3476)
225.194
(213.8370 to 236.5513)
Week 72
240.695
(230.1386 to 251.2542)
259.532
(246.0810 to 272.9834)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TMC435 150mg 12Wks PR24/48, PBO 12Wks PR48
Comments Fatigue Severity Score AUC60
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Piecewise Linear Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean differences
Estimated Value -16.776
Confidence Interval (2-Sided) 95%
-29.1502 to -4.4025
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.3081
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TMC435 150mg 12Wks PR24/48, PBO 12Wks PR48
Comments Fatigue Severity Score AUC72
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method Piecewise Linear Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean differences
Estimated Value -18.837
Confidence Interval (2-Sided) 95%
-33.4933 to -4.1801
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.4715
Estimation Comments [Not Specified]
32.Secondary Outcome
Title Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Overall Work Productivity Due to Hepatitis C Virus (HCV) Infection and Its Treatment
Hide Description Impairment in overall work productivity was measured using the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire completed by participants throughout the study. WPAI Overall Productivity Scores ranged from 0% to 100% (higher WPAI scores indicated greater impairment in productivity). The average WPAI score from baseline to Week 72 was calculated for each participant and then the average of those values were calculated to show the average WPAI score for each treatment group. The null hypothesis was there is no statistically significant difference between the treatment groups in the AUC for the change from baseline to Week 72 (AUC72) in WPAI Productivity Scores. The Table below shows WPAI Productivity Scores at Week 72 (as well as at Week 60) from the model used to calculate the AUC and the statistical comparison between treatment groups.
Time Frame Baseline to Week 60 and Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.
Arm/Group Title TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Hide Arm/Group Description:
Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
Overall Number of Participants Analyzed 256 133
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale*weeks
Week 60
1628.075
(1492.3021 to 1763.8485)
1910.235
(1730.5026 to 2089.9681)
Week 72
1781.768
(1622.4802 to 1941.0560)
2106.131
(1894.8814 to 2317.3811)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TMC435 150mg 12Wks PR24/48, PBO 12Wks PR48
Comments Impairment in Work Productivity AUC60
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Piecewise Linear Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean differences
Estimated Value -282.160
Confidence Interval (2-Sided) 95%
-489.1252 to -75.1949
Parameter Dispersion
Type: Standard Error of the mean
Value: 105.4927
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TMC435 150mg 12Wks PR24/48, PBO 12Wks PR48
Comments Impairment in Work Productivity AUC72
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Piecewise Linear Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean differences
Estimated Value -324.363
Confidence Interval (2-Sided) 95%
-567.7080 to -81.0182
Parameter Dispersion
Type: Standard Error of the mean
Value: 124.0260
Estimation Comments [Not Specified]
33.Secondary Outcome
Title Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Daily Activities Due to Hepatitis C Virus (HCV) Infection and Its Treatment
Hide Description Impairment in daily activity was measured using the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire, Question 6. The possible impairment in WPAI daily activity score range from baseline to Week 60 was 0-6000 and to Week 72 was 0-7200, with the higher scores indicating more impairment in daily activities. The average WPAI impairment in daily activity score from baseline to Week 72 was calculated for each participant and then the average of those values were calculated to show the average WPAI impairment in daily activity score for each treatment group. The null hypothesis was there is no statistically significant difference between the treatment arms in the AUC for the change from baseline to Week 72 (AUC72) in WPAI impairment in daily activity scores. The Table below shows the WPAI Impairment in daily activity scores at Week 72 (as well as at Week 60) and the statistical analysis between treatment groups.
Time Frame Baseline to Week 60 and Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.
Arm/Group Title TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Hide Arm/Group Description:
Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
Overall Number of Participants Analyzed 256 133
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale*weeks
Week 60
1580.635
(1445.8307 to 1715.4397)
1863.071
(1684.4355 to 2041.7065)
Week 72
1727.079
(1568.9831 to 1885.1745)
2056.283
(1846.3791 to 2266.1868)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TMC435 150mg 12Wks PR24/48, PBO 12Wks PR48
Comments Impairment in Daily Activities AUC60
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method Piecewise linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Differences
Estimated Value -282.436
Confidence Interval (2-Sided) 95%
-488.4150 to -76.4566
Parameter Dispersion
Type: Standard Error of the mean
Value: 104.9894
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TMC435 150mg 12Wks PR24/48, PBO 12Wks PR48
Comments Impairment in Daily Activities AUC72
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Piecewise Linear Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean differences
Estimated Value -329.204
Confidence Interval (2-Sided) 95%
-571.3389 to -87.0695
Parameter Dispersion
Type: Standard Error of the mean
Value: 123.4080
Estimation Comments [Not Specified]
34.Secondary Outcome
Title Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Time Missed From Work Due to Hepatitis C Virus (HCV) Infection and Its Treatment
Hide Description Hours missed from work because of HCV infection or its treatment was assessed by measuring the change from baseline in the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire Absenteeism score (time missed from work). The possible WPAI WPAI absenteeism score range from baseline to Week 60 was 0-6000 and to Week 72 was 0-7200, with the higher scores indicating more impairment in WPAI absenteeism. The average WPAI absenteeism score from baseline to Week 60/72 was calculated for each participant and then the average of those values calculated for each treatment group. The area under the curve (AUC60/AUC72) over time from baseline to Week 60/72 was derived from a piecewise-linear model allowing the slopes to change at Week 4, 12, 24, 36, 48 and 60. The null hypothesis was there is no statistically significant difference between the treatment arms in the area under the curve (AUC) from baseline to Week 72 (AUC72) in WPAI absenteeism score.
Time Frame Baseline to Week 60 and Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.
Arm/Group Title TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Hide Arm/Group Description:
Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
Overall Number of Participants Analyzed 182 89
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale*weeks
Week 60
653.642
(511.4925 to 795.7918)
840.495
(637.5293 to 1043.4599)
Week 72
698.223
(533.6236 to 862.8224)
886.425
(650.2224 to 1122.6266)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TMC435 150mg 12Wks PR24/48, PBO 12Wks PR48
Comments Time Missed from Work AUC60
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.125
Comments [Not Specified]
Method Piecewise linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean differences
Estimated Value -186.852
Confidence Interval (2-Sided) 95%
-425.4109 to 51.7059
Parameter Dispersion
Type: Standard Error of the mean
Value: 121.4741
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TMC435 150mg 12Wks PR24/48, PBO 12Wks PR48
Comments Time Missed from Work AUC72
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.183
Comments [Not Specified]
Method Piecewise linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean differences
Estimated Value -188.202
Confidence Interval (2-Sided) 95%
-465.5070 to 89.1040
Parameter Dispersion
Type: Standard Error of the mean
Value: 141.1702
Estimation Comments [Not Specified]
Time Frame 72 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Hide Arm/Group Description Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48). Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
All-Cause Mortality
TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Affected / at Risk (%) Affected / at Risk (%)
Total   16/257 (6.23%)   10/134 (7.46%) 
Blood and lymphatic system disorders     
Anaemia * 1  2/257 (0.78%)  1/134 (0.75%) 
Pancytopenia * 1  0/257 (0.00%)  1/134 (0.75%) 
Cardiac disorders     
Angina unstable * 1  0/257 (0.00%)  1/134 (0.75%) 
Ear and labyrinth disorders     
Mixed deafness * 1  1/257 (0.39%)  0/134 (0.00%) 
Endocrine disorders     
Hyperthyroidism * 1  1/257 (0.39%)  0/134 (0.00%) 
Eye disorders     
Hyphaema * 1  1/257 (0.39%)  0/134 (0.00%) 
Visual impairment * 1  1/257 (0.39%)  0/134 (0.00%) 
Retinal ischaemia * 1  0/257 (0.00%)  1/134 (0.75%) 
Gastrointestinal disorders     
Enterocutaneous fistula * 1  1/257 (0.39%)  0/134 (0.00%) 
Pancreatitis acute * 1  0/257 (0.00%)  1/134 (0.75%) 
Vomiting * 1  0/257 (0.00%)  1/134 (0.75%) 
General disorders     
Death * 1  1/257 (0.39%)  0/134 (0.00%) 
Hepatobiliary disorders     
Autoimmune hepatitis * 1  1/257 (0.39%)  0/134 (0.00%) 
Cholecystitis acute * 1  0/257 (0.00%)  1/134 (0.75%) 
Infections and infestations     
Anal abscess * 1  1/257 (0.39%)  0/134 (0.00%) 
Lymphadenitis bacterial * 1  1/257 (0.39%)  0/134 (0.00%) 
Urinary tract infection * 1  1/257 (0.39%)  0/134 (0.00%) 
Respiratory tract infection viral * 1  0/257 (0.00%)  1/134 (0.75%) 
Viral infection * 1  0/257 (0.00%)  1/134 (0.75%) 
Injury, poisoning and procedural complications     
Meniscus lesion * 1  0/257 (0.00%)  1/134 (0.75%) 
Metabolism and nutrition disorders     
Fluid overload * 1  1/257 (0.39%)  0/134 (0.00%) 
Dehydration * 1  0/257 (0.00%)  1/134 (0.75%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  1/257 (0.39%)  0/134 (0.00%) 
Muscle spasms * 1  1/257 (0.39%)  0/134 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon cancer * 1  1/257 (0.39%)  0/134 (0.00%) 
Nervous system disorders     
Epilepsy * 1  1/257 (0.39%)  0/134 (0.00%) 
Memory impairment * 1  1/257 (0.39%)  0/134 (0.00%) 
Syncope * 1  1/257 (0.39%)  0/134 (0.00%) 
Loss of consciousness * 1  0/257 (0.00%)  1/134 (0.75%) 
Neuropathy peripheral * 1  0/257 (0.00%)  1/134 (0.75%) 
Thoracic outlet syndrome * 1  0/257 (0.00%)  1/134 (0.75%) 
Psychiatric disorders     
Aggression * 1  1/257 (0.39%)  0/134 (0.00%) 
Drug abuse * 1  0/257 (0.00%)  1/134 (0.75%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism * 1  0/257 (0.00%)  1/134 (0.75%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TMC435 150mg 12Wks PR24/48 PBO 12Wks PR48
Affected / at Risk (%) Affected / at Risk (%)
Total   243/257 (94.55%)   131/134 (97.76%) 
Blood and lymphatic system disorders     
Neutropenia * 1  49/257 (19.07%)  29/134 (21.64%) 
Anaemia * 1  46/257 (17.90%)  33/134 (24.63%) 
Thrombocytopenia * 1  13/257 (5.06%)  9/134 (6.72%) 
Leukopenia * 1  10/257 (3.89%)  7/134 (5.22%) 
Gastrointestinal disorders     
Nausea * 1  63/257 (24.51%)  24/134 (17.91%) 
Diarrhoea * 1  34/257 (13.23%)  12/134 (8.96%) 
Vomiting * 1  17/257 (6.61%)  7/134 (5.22%) 
Dry mouth * 1  13/257 (5.06%)  6/134 (4.48%) 
Abdominal pain * 1  12/257 (4.67%)  7/134 (5.22%) 
Abdominal pain upper * 1  11/257 (4.28%)  12/134 (8.96%) 
Constipation * 1  8/257 (3.11%)  7/134 (5.22%) 
General disorders     
Fatigue * 1  95/257 (36.96%)  56/134 (41.79%) 
Pyrexia * 1  80/257 (31.13%)  53/134 (39.55%) 
Influenza like illness * 1  66/257 (25.68%)  35/134 (26.12%) 
Asthenia * 1  59/257 (22.96%)  38/134 (28.36%) 
Chills * 1  21/257 (8.17%)  12/134 (8.96%) 
Injection site erythema * 1  15/257 (5.84%)  9/134 (6.72%) 
Infections and infestations     
Influenza * 1  5/257 (1.95%)  8/134 (5.97%) 
Sinusitis * 1  5/257 (1.95%)  7/134 (5.22%) 
Investigations     
Weight decreased * 1  14/257 (5.45%)  6/134 (4.48%) 
Neutrophil count decreased * 1  8/257 (3.11%)  7/134 (5.22%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  46/257 (17.90%)  21/134 (15.67%) 
Musculoskeletal and connective tissue disorders     
Myalgia * 1  58/257 (22.57%)  28/134 (20.90%) 
Arthralgia * 1  32/257 (12.45%)  14/134 (10.45%) 
Back pain * 1  25/257 (9.73%)  13/134 (9.70%) 
Muscle spasms * 1  8/257 (3.11%)  7/134 (5.22%) 
Nervous system disorders     
Headache * 1  101/257 (39.30%)  49/134 (36.57%) 
Dizziness * 1  21/257 (8.17%)  9/134 (6.72%) 
Disturbance in attention * 1  13/257 (5.06%)  8/134 (5.97%) 
Dysgeusia * 1  6/257 (2.33%)  7/134 (5.22%) 
Psychiatric disorders     
Insomnia * 1  51/257 (19.84%)  21/134 (15.67%) 
Depression * 1  29/257 (11.28%)  19/134 (14.18%) 
Mood altered * 1  22/257 (8.56%)  15/134 (11.19%) 
Anxiety * 1  17/257 (6.61%)  6/134 (4.48%) 
Sleep disorder * 1  13/257 (5.06%)  5/134 (3.73%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  32/257 (12.45%)  22/134 (16.42%) 
Dyspnoea * 1  23/257 (8.95%)  11/134 (8.21%) 
Skin and subcutaneous tissue disorders     
Pruritus * 1  65/257 (25.29%)  34/134 (25.37%) 
Rash * 1  46/257 (17.90%)  15/134 (11.19%) 
Alopecia * 1  43/257 (16.73%)  27/134 (20.15%) 
Dry skin * 1  28/257 (10.89%)  18/134 (13.43%) 
Eczema * 1  4/257 (1.56%)  9/134 (6.72%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 14.0
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: Global Clinical Development Manager
Organization: Jan-Cil France
Responsible Party: Janssen R&D Ireland
ClinicalTrials.gov Identifier: NCT01290679     History of Changes
Other Study ID Numbers: CR017380
TMC435-TiDP16-C216 ( Other Identifier: Janssen R&D Ireland )
2010-021174-11 ( EudraCT Number )
First Submitted: January 7, 2011
First Posted: February 7, 2011
Results First Submitted: February 3, 2014
Results First Posted: June 13, 2014
Last Update Posted: June 13, 2014