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DRAGON: A Study to Assess the Effectiveness, Safety, and Pharmacokinetics of TMC435 in Combination With Peginterferon Alfa-2a and Ribavirin in Hepatitis-C Infected Patients

Sponsor
Janssen Pharmaceutical K.K. (Industry)
Overall Status
Completed
CT.gov ID
NCT00996476
Collaborator
(none)
92
Enrollment
19
Locations
5
Arms
18
Duration (Months)
4.8
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate effectiveness, safety and pharmacokinetics (Explores what the body does to the medication) of TMC435350 in combination with Peginterferon Alfa-2a and Ribavirin in genotype 1 hepatitis C virus infected Japanese participants who have never received treatment for their hepatitis C infection.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

This is a Phase 2, randomized (The study medication is assigned by chance.), 5-arm, open label (All people know the identity of the intervention.), multicentre (study conducted at multiple sites) study. Approximately, 84 participants will be randomized to 5 different arms in a 2:2:1:1:1 ratio. In treatment arms 1 and 2, participants will receive 12 weeks of triple therapy (use of 3 medications) with TMC435 50 or 100 mg once daily plus Peginterferon Alfa-2a and Ribavirin followed by 12 weeks of treatment with Peginterferon Alfa-2a and Ribavirin. In treatment arms 3 and 4, participants will receive 24 weeks of triple therapy with TMC435 50 or 100 mg once daily plus Peginterferon Alfa-2a and Ribavirin. In treatment arm 5 (control group), participants will receive Peginterferon Alfa-2a and Ribavirin for 48 weeks. This study will consist a screening phase of upto 6 weeks, treatment phase of upto 48 weeks and a post treatment follow-up period of 24 weeks. Safety evaluations will include assessment of adverse events, clinical laboratory tests, vital signs, and cardiovascular safety.

Study Design

Study Type:
Interventional
Actual Enrollment :
92 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II, Randomized, Open-label Study in Japan to Investigate the Efficacy, Safety and Pharmacokinetics of TMC435 as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin in Treatment naïve, Genotype 1, Chronic Hepatitis C Subjects
Study Start Date :
Jul 1, 2009
Actual Primary Completion Date :
Jan 1, 2011
Actual Study Completion Date :
Jan 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: TMC12/PR24 50 mg

Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.

Drug: TMC435
One 50 or 100-mg capsule orally (by mouth), once daily for 12 or 24 weeks

Drug: PegIFNα-2a
One subcutaneous injection of PegIFNα-2a 180 μg once weekly for 12, 24, or 48 weeks.

Drug: RBV
300, 400, or 500-mg tablets orally twice daily for 12, 24, or 48 weeks.
Experimental: TMC12/PR24 100 mg

Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.

Drug: TMC435
One 50 or 100-mg capsule orally (by mouth), once daily for 12 or 24 weeks

Drug: PegIFNα-2a
One subcutaneous injection of PegIFNα-2a 180 μg once weekly for 12, 24, or 48 weeks.

Drug: RBV
300, 400, or 500-mg tablets orally twice daily for 12, 24, or 48 weeks.
Experimental: TMC24/PR24 50 mg

Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.

Drug: TMC435
One 50 or 100-mg capsule orally (by mouth), once daily for 12 or 24 weeks

Drug: PegIFNα-2a
One subcutaneous injection of PegIFNα-2a 180 μg once weekly for 12, 24, or 48 weeks.

Drug: RBV
300, 400, or 500-mg tablets orally twice daily for 12, 24, or 48 weeks.
Experimental: TMC24/PR24 100 mg

Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.

Drug: TMC435
One 50 or 100-mg capsule orally (by mouth), once daily for 12 or 24 weeks

Drug: PegIFNα-2a
One subcutaneous injection of PegIFNα-2a 180 μg once weekly for 12, 24, or 48 weeks.

Drug: RBV
300, 400, or 500-mg tablets orally twice daily for 12, 24, or 48 weeks.
Experimental: PR48 Control

Participants received PegIFNa-2a and ribavirin (PR) for 48 weeks (PR48 control group)

Drug: TMC435
One 50 or 100-mg capsule orally (by mouth), once daily for 12 or 24 weeks

Drug: PegIFNα-2a
One subcutaneous injection of PegIFNα-2a 180 μg once weekly for 12, 24, or 48 weeks.

Drug: RBV
300, 400, or 500-mg tablets orally twice daily for 12, 24, or 48 weeks.

Outcome Measures

Primary Outcome Measures

  1. Change in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels From Baseline to Week 4 [Day 1 (Baseline) and Week 4]

    The table below shows the least-squares (LS) mean change and 95% confidence intervals (CI) change from baseline at Week 4 in HCV RNA levels for participants in the 2 TMC435 50 mg treatment groups combined (TMC12/PR24 50 mg and TMC24/PR24 50 mg) and for participants in the 2 TMC435 100 mg treatment groups combined (TMC12/PR24 100 mg and TMC24/PR24 100 mg). The statistical analyses show the difference in LS mean change from baseline from the PR48 control group and the 95% CI for each dose group (ie, each TMC435 dose group minus PR48 control). NOTE: All outcome measures reported in this study are "Exploratory;" not "Primary" as indicated (refer to Limits and Caveats).

  2. The Percentage of Participants With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels During the Study [Weeks 4, 12, 24 or 48, and EOT (up to Week 24 or 48)]

    The table below shows the percentage of participants in each treatment group with undetectable plasma HCV RNA levels at Weeks 4, 12, 24, 48, and end of treatment (EOT, up to Week 24 or 48). The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the "Number of Participants Analyzed."NOTE: All outcome measures reported in this study are "Exploratory;" not "Primary" as indicated (refer to Limits and Caveats).

  3. The Percentage of Participants With a Decrease of Greater Than or Equal to 2 log10 IU/mL From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Through the Post-treatment Follow-up Period [Days 1 (4 hr), 1 (8 hr), 3, Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24,28, 36, 42, 48, 52, 60, 72, and EOT (up to Week 24 or 48)]

    The table below shows the percentage of participants in each treatment group with a decrease of greater than (>) or equal (=) to 2 log10 IU/mL from baseline in plasma HCV RNA levels at time points during the treatment period and post treatment follow-up period. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the "Number of Participants Analyzed." NOTE: All outcome measures reported in this study are "Exploratory;" not "Primary" as indicated (refer to Limits and Caveats).

  4. The Percentage of Participants With Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Undetectable or Below the Limit of Quantification (<1.2 log10 IU/mL Detectable) During Treatment and During Post Treatment Follow-up [Week 4, 12, 24, 36, 48, EOT (up to Week 24 or 48), and Week 60 and 72]

    The table below shows the percentage of participants in each treatment group with plasma HCV RNA levels undetectable or below the limit of quantification (<1.2 log10 IU/mL detectable ) at time points during treatment and post treatment follow-up.The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the "Number of Participants Analyzed." NOTE: All outcome measures reported in this study are "Exploratory;" not "Primary" as indicated (refer to Limits and Caveats).

  5. The Number of Participants With Viral Breakthrough [Up to EOT (up to Week 24 or 48)]

    The table below shows the number of participants in each treatment group who experienced viral breakthrough during the 48 week treatment period with at least one study medication (TMC435 or PegIFNα-2a and ribavirin). Viral breakthrough is 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 or a confirmed value of plasma HCV RNA of > 2.0 log10 IU/mL in participants whose plasma HCV RNA level had previously been reported below 1.2 log10 IU/mL detectable or undetectable during the treatment period. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the "Number of Participants Analyzed." NOTE: All outcome measures reported in this study are "Exploratory;" not "Primary" as indicated (refer to Limits and Caveats).

  6. The Percentage of Participants With Viral Relapse [Week 36 or 60]

    The table below shows the percentage of participants in each treatment group who experienced viral relapse within 12 weeks (ie, at Week 36 or 60) after actual end of treatment (EOT) (up to Week 24 or 48). Viral relapse was defined as confirmed detectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels during the post treatment follow-up period at Weeks 36 or 60 in participants with undetectable plasma HCV RNA at EOT. The statistical analysis shows the difference in treatments (ie, each TMC435 group minus PR48 control) in viral relapse. NOTE: All outcome measures reported in this study are "Exploratory;" not "Primary" as indicated (refer to Limits and Caveats).

  7. Actual Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values up to Week 24 in the Post-treatment Follow-up Period [Baseline, Week 4, 12, 24, 48, EOT (up to Week 24 or 48), and Weeks 60 and 72]

    The table below shows the mean (standard deviation) of the actual HCV RNA values by treatment group at Baseline and Weeks 4, 12, 24, 48, end of treatment (EOT, up to Weeks 24 or 48), Weeks 60 and 72 (Week 24 in the post-treatment follow-up period). The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the "Number of Participants Analyzed." NOTE: All outcome measures reported in this study are "Exploratory;" not "Primary" as indicated (refer to Limits and Caveats).

  8. The Number of Participants With Alanine Aminotransaminase (ALT) Values Within the Normal Range at the End-of-treatment (EOT) [Day 1, Weeks 24, 48, and EOT (up to Weeks 24 or 48)]

    The table below shows the number of participants whose ALT results were within the normal range on Day 1 (initial day of treatment), Week 24, 48, and EOT (up to Weeks 24 or 48).The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the "Number of Participants Analyzed." NOTE: All outcome measures reported in this study are "Exploratory;" not "Primary" as indicated (refer to Limits and Caveats).

  9. The Percentage of Participants With Sustained Virologic Response (SVR) [SVR4 (up to Week 28 or Week 52), SVR12 (up to Weeks 36 or 60), and SVR24 (up to Weeks 48 or 72)]

    The table below shows the percentage of participants with a SVR4, SVR12, and SVR24 defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) at the end of treatment (EOT) (up to Weeks 24 or 48) and at 4, 12, and 24 weeks, respectively, after the last dose of treatment. NOTE: All outcome measures reported in this study are "Exploratory;" not "Primary" as indicated (refer to Limits and Caveats).

  10. Predose Plasma Concentrations (C0h) of TMC435 (Sparse Blood Sampling) [Weeks 4, 12, and 24]

    The table below shows the mean (standard deviation) predose plasma concentration (C0h) for participants in each treatment group at Weeks 4, 12, and 24. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the "Number of Participants Analyzed." NOTE: All outcome measures reported in this study are "Exploratory;" not "Primary" as indicated (refer to Limits and Caveats).

  11. Predose Plasma Concentrations (C0h) of TMC435 (Intensive Blood Sampling) [Weeks 4 to 6]

    The table below shows the mean predose plasma concentration (C0h) for participants in the 2 TMC435 50 mg treatment groups combined and for participants in the 2 TMC435 100 mg treatment groups combined who had intensive blood samples collected at Weeks 4 to 6. NOTE: All outcome measures reported in this study are "Exploratory;" not "Primary" as indicated (refer to Limits and Caveats).

  12. The Area Under the Plasma Concentration-time Curve From the Time of Administration up to 24 Hours After Dosing (AUC24) for TMC435 [within 15 minutes and at 1, 2, 4, 6, 8, 12, and 24 hours post-dose between Week 4 and Week 6 after the initiation of treatment]

    The table below shows the mean AUC24 of TMC435 for participants in the 2 TMC435 50 mg treatment groups combined (TMC12/PR24 50 mg and TMC24/PR24 50 mg) and for participants in the 2 TMC435 100 mg treatment groups combined (TMC12/PR24 100 mg and TMC24/PR24 100 mg) who had intensive blood samples collected at Weeks 4 to 6. NOTE: All outcome measures reported in this study are "Exploratory;" not "Primary" as indicated (refer to Limits and Caveats).

  13. Time to Reach the Maximum Plasma Concentration (Tmax) of TMC435 [within 15 minutes and at 1, 2, 4, 6, 8, 12, and 24 hours post-dose between Week 4 and Week 6 after the initiation of treatment]

    The table below shows the median time in hours to reach the maximum plasma concentration (tmax) of TMC435 for participants in the 2 TMC435 50 mg treatment groups combined (TMC12/PR24 50 mg and TMC24/PR24 50 mg) and for participants in the 2 TMC435 100 mg treatment groups combined (TMC12/PR24 100 mg and TMC24/PR24 100 mg) who had intensive blood samples collected at Weeks 4 to 6. NOTE: All outcome measures reported in this study are "Exploratory;" not "Primary" as indicated (refer to Limits and Caveats).

  14. The Number of Participants Who Met Virologic Stopping/Continuation Rules and Completed All Study Medications [Week 24]

    The table below shows the number of participants who met response-guided treatment (RGT) stopping criteria in the TMC435 treatment groups. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than 1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20 were to stop all study medication (TMC435, PegIFNα-2a, and ribavirin) at Week 24. All other participants continued PegIFNα-2a and ribavirin until Week 48. NOTE: All outcome measures reported in this study are "Exploratory;" not "Primary" as indicated (refer to Limits and Caveats).

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Participants with documented chronic hepatitis C infection as evidenced by presence of HCV antibody at least 6 months (180 days) prior to the informed consent. - Participants with genotype 1 HCV infection. - Participants with plasma HCV RNA level of ≥ 5.0 log10 IU/mL at screening.
Exclusion Criteria:
  • Participants diagnosed with hepatic cirrhosis or hepatic failure. - Participants with any other liver disease than hepatitis C. - Participants with infection/co-infection with non-genotype 1 HCV.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Amagasaki Japan
2 Hiroshima N/A Japan
3 Kagoshima Japan
4 Kawasaki Japan
5 Kitakyushu Japan
6 Kurume Japan
7 Kyoto Japan
8 Matsumoto Japan
9 Musashino Japan
10 Nishinomiya Japan
11 Ohmura Japan
12 Osaka-Sayama Japan
13 Osaka Japan
14 Sakai Japan
15 Sapporo Japan
16 Suita Japan
17 Tokyo Japan
18 Touon Japan
19 Yokohama Japan

Sponsors and Collaborators

  • Janssen Pharmaceutical K.K.

Investigators

  • Study Director: Janssen Pharmaceutical K.K. Clinical Trial, Janssen Pharmaceutical K.K.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:
NCT00996476
Other Study ID Numbers:
  • CR016402
  • TMC435-TiDP16-C215
First Posted:
Oct 16, 2009
Last Update Posted:
Apr 17, 2014
Last Verified:
Mar 1, 2014
Keywords provided by Janssen Pharmaceutical K.K.
Hepatitis C
Hepatitis C virus
Interferon Alfa-2a
Ribavirin
Viral RNA
Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Simeprevir

Study Results

Participant Flow

Recruitment Details The study was conducted between 6 July 2009 and 1 April 2011 and recruited participants with chronic Hepatitis C Virus (HCV) infection from 25 study centers in Japan. A total of 93 participants were randomized, 92 treated, and 85 completed the study (1 participant in the TMC12/PR24 100 mg arm withdrew consent and did not receive study treatment).
Pre-assignment Detail Treatment-naïve HCV-infected participants were randomized to 1 of 5 treatment arms and received 12 weeks of TMC435 50 or 100 mg once daily with PegIFNα-2a and ribavirin (PR) followed by 12 weeks of PR (Arm 1 and 2); 24 weeks of TMC435 50 or 100 mg once daily with PR (Arms 3 and 4); and, PR for 48 weeks (Arm 5).
Arm/Group Title TMC12/PR24 50 mg TMC12/PR24 100 mg TMC24/PR24 50 mg TMC24/PR24 100 mg PR48 Control
Arm/Group Description Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received PegIFNa-2a and ribavirin (PR) for 48 weeks (PR48 control group)
Period Title: Overall Study
STARTED 27 26 13 13 13
COMPLETED 26 23 12 13 11
NOT COMPLETED 1 3 1 0 2

Baseline Characteristics

Arm/Group Title TMC12/PR24 50 mg TMC12/PR24 100 mg TMC24/PR24 50 mg TMC24/PR24 100 mg PR48 Control Total
Arm/Group Description Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received PegIFNa-2a and ribavirin (PR) for 48 weeks (PR48 control group) Total of all reporting groups
Overall Participants 27 26 13 13 13 92
Age (years) [Median (Full Range) ]
Median (Full Range) [years]
53
56
48
54
54
54
Sex: Female, Male (Count of Participants)
Female
15
55.6%
16
61.5%
7
53.8%
5
38.5%
6
46.2%
49
53.3%
Male
12
44.4%
10
38.5%
6
46.2%
8
61.5%
7
53.8%
43
46.7%

Outcome Measures

1. Primary Outcome
Title Change in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels From Baseline to Week 4
Description The table below shows the least-squares (LS) mean change and 95% confidence intervals (CI) change from baseline at Week 4 in HCV RNA levels for participants in the 2 TMC435 50 mg treatment groups combined (TMC12/PR24 50 mg and TMC24/PR24 50 mg) and for participants in the 2 TMC435 100 mg treatment groups combined (TMC12/PR24 100 mg and TMC24/PR24 100 mg). The statistical analyses show the difference in LS mean change from baseline from the PR48 control group and the 95% CI for each dose group (ie, each TMC435 dose group minus PR48 control). NOTE: All outcome measures reported in this study are "Exploratory;" not "Primary" as indicated (refer to Limits and Caveats).
Time Frame Day 1 (Baseline) and Week 4

Outcome Measure Data

Analysis Population Description
The efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.
Arm/Group Title TMC435 50 mg TMC435 100 mg PR48 Control
Arm/Group Description Participants who received TMC435 50 mg in Treatment Groups TMC12/PR24 50 mg and TMC24/PR24 50 mg Participants who received TMC435 100 mg in Treatment Groups TMC12/PR24 100 mg and TMC24/PR24 100 mg Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
Measure Participants 39 37 11
Least Squares Mean (95% Confidence Interval) [log10 IU/mL]
-5.23
(0.55)
-5.24
(0.47)
-2.83
(1.93)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TMC435 50 mg, PR48 Control
Comments Difference in least square (LS) mean change from baseline from the PR48 control group
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter LS means difference
Estimated Value -2.40
Confidence Interval (2-Sided) 95%
-2.83 to -1.97
Parameter Dispersion Type:
Value:
Estimation Comments TMC435 50 mg minus PR48 control
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TMC435 100 mg, PR48 Control
Comments Difference in least square (LS) mean change from baseline from the PR48 control group
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter LS Means difference
Estimated Value -2.41
Confidence Interval (2-Sided) 95%
-2.85 to -1.98
Parameter Dispersion Type:
Value:
Estimation Comments TMC435 100 mg minus PR48 control
2. Primary Outcome
Title The Percentage of Participants With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels During the Study
Description The table below shows the percentage of participants in each treatment group with undetectable plasma HCV RNA levels at Weeks 4, 12, 24, 48, and end of treatment (EOT, up to Week 24 or 48). The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the "Number of Participants Analyzed."NOTE: All outcome measures reported in this study are "Exploratory;" not "Primary" as indicated (refer to Limits and Caveats).
Time Frame Weeks 4, 12, 24 or 48, and EOT (up to Week 24 or 48)

Outcome Measure Data

Analysis Population Description
Efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.
Arm/Group Title TMC12/PR24 50 mg TMC12/PR24 100 mg TMC24/PR24 50 mg TMC24/PR24 100 mg PR48 Control
Arm/Group Description Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
Measure Participants 27 24 13 13 11
Week 4 (n=27, 24, 12, 13, and 11)
85.2
315.6%
100.0
384.6%
83.3
640.8%
92.3
710%
9.1
70%
Week 12 (n=27, 22, 12, 13, and 11)
100.00
370.4%
100.0
384.6%
100.0
769.2%
100.0
769.2%
54.45
418.8%
Week 24 (n=26, 21, 11, 13, and 11)
96.2
356.3%
100.0
384.6%
100.0
769.2%
100.0
769.2%
81.8
629.2%
Week 48 (n=25, 20, 12, 13, and 10)
80.0
296.3%
95.0
365.4%
83.3
640.8%
92.3
710%
90.0
692.3%
EOT (up to Week 24 or 48)
96.3
356.7%
100.0
384.6%
92.3
710%
100.0
769.2%
90.9
699.2%
3. Primary Outcome
Title The Percentage of Participants With a Decrease of Greater Than or Equal to 2 log10 IU/mL From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Through the Post-treatment Follow-up Period
Description The table below shows the percentage of participants in each treatment group with a decrease of greater than (>) or equal (=) to 2 log10 IU/mL from baseline in plasma HCV RNA levels at time points during the treatment period and post treatment follow-up period. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the "Number of Participants Analyzed." NOTE: All outcome measures reported in this study are "Exploratory;" not "Primary" as indicated (refer to Limits and Caveats).
Time Frame Days 1 (4 hr), 1 (8 hr), 3, Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24,28, 36, 42, 48, 52, 60, 72, and EOT (up to Week 24 or 48)

Outcome Measure Data

Analysis Population Description
Efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.
Arm/Group Title TMC12/PR24 50 mg TMC12/PR24 100 mg TMC24/PR24 50 mg TMC24/PR24 100 mg PR48 Control
Arm/Group Description Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
Measure Participants 27 24 13 13 11
Day 1 (4hr)
NA
NaN
NA
NaN
NA
NaN
NA
NaN
NA
NaN
Day 1 (8hr)
NA
NaN
NA
NaN
NA
NaN
NA
NaN
NA
NaN
Day 3
100.0
370.4%
100.0
384.6%
92.3
710%
92.3
710%
18.2
140%
Week 1
100.0
370.4%
100.0
384.6%
100.0
769.2%
100.0
769.2%
27.3
210%
Week 2 (n=27, 24, 12, 13, and 11)
100.0
370.4%
100.0
384.6%
100.0
769.2%
100.0
769.2%
54.5
419.2%
Week 3 (n=27, 24, 12, 13, and 11)
100.0
370.4%
100.0
384.6%
100.0
769.2%
100.0
769.2%
54.5
419.2%
Week 4 (n=27, 24, 12, 13, and 11)
100.0
370.4%
100.0
384.6%
100.0
769.2%
100.0
769.2%
54.5
419.2%
Week 6 (n=27, 23, 12, 13, and 11)
100.0
370.4%
100.0
384.6%
100.0
769.2%
100.0
769.2%
72.7
559.2%
Week 8 (n=27, 22, 12, 13, and 11)
100.0
370.4%
100.0
384.6%
100.0
769.2%
100.0
769.2%
81.8
629.2%
Week 12 (n=27, 22, 12, 13, and 11)
100.0
370.4%
100.0
384.6%
100.0
769.2%
100.0
769.2%
81.8
629.2%
Week 16 (n=26, 22, 12, 13, and 11)
100.0
370.4%
95.5
367.3%
100.0
769.2%
100.0
769.2%
90.9
699.2%
Week 20 (n=26, 22, 12, 13, and 11)
100.0
370.4%
95.5
367.3%
100.0
769.2%
100.0
769.2%
90.9
699.2%
Week 24 (n=26, 21, 11, 13, and 11)
96.2
356.3%
100.0
384.6%
100.0
769.2%
100.0
769.2%
90.9
699.2%
Week 28 (n=26, 21, 11, 13, and 11)
92.3
341.9%
95.2
366.2%
100.0
769.2%
100.0
769.2%
90.9
699.2%
Week 36 (n=26, 21, 12, 13, and 11)
88.5
327.8%
95.2
366.2%
91.7
705.4%
92.3
710%
90.9
699.2%
Week 42 (0, 0, 0, 0, and 10)
NA
NaN
NA
NaN
NA
NaN
NA
NaN
90.0
692.3%
Week 48 (25, 20, 12, 13, and 10)
80.0
296.3%
95.0
365.4%
91.7
705.4%
92.3
710%
100.0
769.2%
EOT (n=27, 24, 13, 13, and 11)
96.3
356.7%
100.0
384.6%
100.0
769.2%
100.0
769.2%
90.9
699.2%
Week 52 ((n=0, 0, 0, 0, and 9)
NA
NaN
NA
NaN
NA
NaN
NA
NaN
88.9
683.8%
Week 60 (0, 0, 0, 0, and 9)
NA
NaN
NA
NaN
NA
NaN
NA
NaN
55.6
427.7%
Week 72 (0, 0, 0, 0, and 8)
NA
NaN
NA
NaN
NA
NaN
NA
NaN
62.5
480.8%
4. Primary Outcome
Title The Percentage of Participants With Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Undetectable or Below the Limit of Quantification (<1.2 log10 IU/mL Detectable) During Treatment and During Post Treatment Follow-up
Description The table below shows the percentage of participants in each treatment group with plasma HCV RNA levels undetectable or below the limit of quantification (<1.2 log10 IU/mL detectable ) at time points during treatment and post treatment follow-up.The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the "Number of Participants Analyzed." NOTE: All outcome measures reported in this study are "Exploratory;" not "Primary" as indicated (refer to Limits and Caveats).
Time Frame Week 4, 12, 24, 36, 48, EOT (up to Week 24 or 48), and Week 60 and 72

Outcome Measure Data

Analysis Population Description
Efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.
Arm/Group Title TMC12/PR24 50 mg TMC12/PR24 100 mg TMC24/PR24 50 mg TMC24/PR24 100 mg PR48 Control
Arm/Group Description Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
Measure Participants 27 24 13 13 11
Week 4 (n=27, 24,12,13, and 11)
100.0
370.4%
100.0
384.6%
100.0
769.2%
100.0
769.2%
18.2
140%
Week 12 (n=27, 22, 12, 13, and 7)
100.0
370.4%
100.0
384.6%
100.0
769.2%
100.0
769.2%
81.8
629.2%
Week 24 (n=26, 21, 11, 13, and 11)
96.2
356.3%
100.0
384.6%
100.0
769.2%
100.0
769.2%
81.8
629.2%
Week 36 (n=26, 21, 11, 12, and 11)
88.5
327.8%
90.5
348.1%
91.7
705.4%
92.3
710%
90.9
699.2%
Week 48 (n=25, 20, 12, 13, and 10)
80.0
296.3%
95.0
365.4%
83.3
640.8%
92.3
710%
90.0
692.3%
EOT (up to Week 24 or 48)
96.3
356.7%
100.0
384.6%
100.0
769.2%
100.0
769.2%
90.9
699.2%
Week 60 (n=0,0,0,0, and 9)
NA
NaN
NA
NaN
NA
NaN
NA
NaN
55.6
427.7%
Week 72 (n=0,0,0,0, and 8)
NA
NaN
NA
NaN
NA
NaN
NA
NaN
62.5
480.8%
5. Primary Outcome
Title The Number of Participants With Viral Breakthrough
Description The table below shows the number of participants in each treatment group who experienced viral breakthrough during the 48 week treatment period with at least one study medication (TMC435 or PegIFNα-2a and ribavirin). Viral breakthrough is 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 or a confirmed value of plasma HCV RNA of > 2.0 log10 IU/mL in participants whose plasma HCV RNA level had previously been reported below 1.2 log10 IU/mL detectable or undetectable during the treatment period. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the "Number of Participants Analyzed." NOTE: All outcome measures reported in this study are "Exploratory;" not "Primary" as indicated (refer to Limits and Caveats).
Time Frame Up to EOT (up to Week 24 or 48)

Outcome Measure Data

Analysis Population Description
The efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.
Arm/Group Title TMC12/PR24 50 mg TMC12/PR24 100 mg TMC24/PR24 50 mg TMC24/PR24 100 mg PR48 Control
Arm/Group Description Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
Measure Participants 27 24 13 13 11
Number [Participants]
0
0%
0
0%
0
0%
0
0%
0
0%
6. Primary Outcome
Title The Percentage of Participants With Viral Relapse
Description The table below shows the percentage of participants in each treatment group who experienced viral relapse within 12 weeks (ie, at Week 36 or 60) after actual end of treatment (EOT) (up to Week 24 or 48). Viral relapse was defined as confirmed detectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels during the post treatment follow-up period at Weeks 36 or 60 in participants with undetectable plasma HCV RNA at EOT. The statistical analysis shows the difference in treatments (ie, each TMC435 group minus PR48 control) in viral relapse. NOTE: All outcome measures reported in this study are "Exploratory;" not "Primary" as indicated (refer to Limits and Caveats).
Time Frame Week 36 or 60

Outcome Measure Data

Analysis Population Description
The efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.
Arm/Group Title TMC12/PR24 50 mg TMC12/PR24 100 mg TMC24/PR24 50 mg TMC24/PR24 100 mg PR48 Control
Arm/Group Description Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
Measure Participants 26 24 12 13 10
Number [Participants]
15.4
57%
12.5
48.1%
16.7
128.5%
7.7
59.2%
40.0
307.7%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TMC435 50 mg, PR48 Control
Comments The difference in the percentage of participants between The TMC12/PR24 50 mg treatment group and the PR48 control group
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value -24.6
Confidence Interval (2-Sided) 95%
-58.3 to 11.8
Parameter Dispersion Type:
Value:
Estimation Comments PR48 control minus TMC12/PR24
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TMC435 100 mg, PR48 Control
Comments The difference in the percentage of participants between The TMC12/PR24 100 mg treatment group and the PR48 control group
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value -27.5
Confidence Interval (2-Sided) 95%
-61.1 to 9.8
Parameter Dispersion Type:
Value:
Estimation Comments PR48 control minus TMC12/PR24
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PR48 Control, PR48 Control
Comments The difference in the percentage of participants between The TMC24/PR24 50 mg treatment group and the PR48 control group
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value -23.3
Confidence Interval (2-Sided) 95%
-59.9 to 19.4
Parameter Dispersion Type:
Value:
Estimation Comments PR48 control minus TMC24/PR24
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection TMC24/PR24 100 mg, PR48 Control
Comments The difference in the percentage of participants between The TMC24/PR24 100 mg treatment group and the PR48 control group
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value -32.3
Confidence Interval (2-Sided) 95%
-66.6 to 8.3
Parameter Dispersion Type:
Value:
Estimation Comments PR48 control minus TMC24/PR24
7. Primary Outcome
Title Actual Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values up to Week 24 in the Post-treatment Follow-up Period
Description The table below shows the mean (standard deviation) of the actual HCV RNA values by treatment group at Baseline and Weeks 4, 12, 24, 48, end of treatment (EOT, up to Weeks 24 or 48), Weeks 60 and 72 (Week 24 in the post-treatment follow-up period). The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the "Number of Participants Analyzed." NOTE: All outcome measures reported in this study are "Exploratory;" not "Primary" as indicated (refer to Limits and Caveats).
Time Frame Baseline, Week 4, 12, 24, 48, EOT (up to Week 24 or 48), and Weeks 60 and 72

Outcome Measure Data

Analysis Population Description
Efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.
Arm/Group Title TMC12/PR24 50 mg TMC12/PR24 100 mg TMC24/PR24 50 mg TMC24/PR24 100 mg PR48 Control
Arm/Group Description Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
Measure Participants 27 27 13 13 11
Baseline
6.19
(0.61)
6.16
(0.48)
6.16
(0.44)
6.43
(0.42)
6.10
(0.38)
Week 4 (n=27, 24, 12, 13, and 11)
0.98
(0.05)
0.95
(0.0)
0.98
(0.06)
0.97
(0.04)
3.38
(1.82)
Week 12 (n=27, 22, 12, 13, and 11)
0.95
(0.0)
0.95
(0.0)
0.95
(0.0)
0.95
(0.0)
1.84
(1.42)
Week 24 (n=26, 21, 11, 13, and 11)
1.12
(0.85)
0.95
(0.0)
0.95
(0.0)
0.95
(0.0)
1.42
(1.16)
Week 48 (n=25, 20, 12, 13, and 10)
1.97
(2.08)
1.22
(1.20)
1.42
(1.3)
1.29
(1.21)
1.11
(0.49)
Week 60 (n=0, 0, 0 ,0, and 9)
NA
(NA)
NA
(NA)
NA
(NA)
NA
(NA)
2.90
(2.31)
Week 72 (n=0, 0, 0 ,0, and 8)
NA
(NA)
NA
(NA)
NA
(NA)
NA
(NA)
2.70
(1.07)
EOT (up to Week 24 or 48)
1.12
(8.4)
0.95
(0.0)
1.17
(0.76)
0.95
(0.0)
1.28
(1.07)
8. Primary Outcome
Title The Number of Participants With Alanine Aminotransaminase (ALT) Values Within the Normal Range at the End-of-treatment (EOT)
Description The table below shows the number of participants whose ALT results were within the normal range on Day 1 (initial day of treatment), Week 24, 48, and EOT (up to Weeks 24 or 48).The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the "Number of Participants Analyzed." NOTE: All outcome measures reported in this study are "Exploratory;" not "Primary" as indicated (refer to Limits and Caveats).
Time Frame Day 1, Weeks 24, 48, and EOT (up to Weeks 24 or 48)

Outcome Measure Data

Analysis Population Description
The efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.
Arm/Group Title TMC12/PR24 50 mg TMC12/PR24 100 mg TMC24/PR24 50 mg TMC24/PR24 100 mg All TMC435 PR48 Control
Arm/Group Description Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. TMC435 50 mg or 100 mg capsule orally once daily for 12 or 24 weeks Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
Measure Participants 27 24 13 13 77 11
Day 1 (n=27, 24, 13, 13, 77, and 11)
15
55.6%
15
57.7%
7
53.8%
7
53.8%
44
338.5%
7
7.6%
Week 24 (n=26, 21, 11, 13, 71, and 11)
24
88.9%
18
69.2%
11
84.6%
11
84.6%
64
492.3%
8
8.7%
Week 48 (n=25, 20, 12, 13, 70, and 10)
24
88.9%
20
76.9%
12
92.3%
12
92.3%
68
523.1%
8
8.7%
EOT (Weeks 24 or 48)
23
85.2%
24
92.3%
13
100%
11
84.6%
71
546.2%
9
9.8%
9. Primary Outcome
Title The Percentage of Participants With Sustained Virologic Response (SVR)
Description The table below shows the percentage of participants with a SVR4, SVR12, and SVR24 defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) at the end of treatment (EOT) (up to Weeks 24 or 48) and at 4, 12, and 24 weeks, respectively, after the last dose of treatment. NOTE: All outcome measures reported in this study are "Exploratory;" not "Primary" as indicated (refer to Limits and Caveats).
Time Frame SVR4 (up to Week 28 or Week 52), SVR12 (up to Weeks 36 or 60), and SVR24 (up to Weeks 48 or 72)

Outcome Measure Data

Analysis Population Description
The efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.
Arm/Group Title TMC12/PR24 50 mg TMC12/PR24 100 mg TMC24/PR24 50 mg TMC24/PR24 100 mg PR48 Control
Arm/Group Description Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
Measure Participants 27 24 13 13 11
SVR4 (up to Week 28 or 52)
88.9
329.3%
95.8
368.5%
92.3
710%
92.3
710%
63.6
489.2%
SVR12 (up to Week 36 or 60)
85.2
315.6%
79.2
304.6%
84.6
650.8%
92.3
710%
45.5
350%
SVR24 (up to Week 48 or 72)
77.8
288.1%
79.2
304.6%
76.9
591.5%
92.3
710%
45.5
350%
10. Primary Outcome
Title Predose Plasma Concentrations (C0h) of TMC435 (Sparse Blood Sampling)
Description The table below shows the mean (standard deviation) predose plasma concentration (C0h) for participants in each treatment group at Weeks 4, 12, and 24. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the "Number of Participants Analyzed." NOTE: All outcome measures reported in this study are "Exploratory;" not "Primary" as indicated (refer to Limits and Caveats).
Time Frame Weeks 4, 12, and 24

Outcome Measure Data

Analysis Population Description
Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.
Arm/Group Title TMC12/PR24 50 mg TMC12/PR24 100 mg TMC24/PR24 50 mg TMC24/PR24 100 mg
Arm/Group Description Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
Measure Participants 20 22 10 9
Week 4 (n=20, 22, 10, and 9)
238
(207)
1229
(1573)
194
(156)
1816
(1429)
Week 12 (n=26, 20, 12, and 12)
261
(237)
1483
(1825)
221
(209)
2546
(3011)
Week 24 (n=0, 0, 10, 10)
NA
(NA)
NA
(NA)
310
(322)
2204
(3002)
11. Primary Outcome
Title Predose Plasma Concentrations (C0h) of TMC435 (Intensive Blood Sampling)
Description The table below shows the mean predose plasma concentration (C0h) for participants in the 2 TMC435 50 mg treatment groups combined and for participants in the 2 TMC435 100 mg treatment groups combined who had intensive blood samples collected at Weeks 4 to 6. NOTE: All outcome measures reported in this study are "Exploratory;" not "Primary" as indicated (refer to Limits and Caveats).
Time Frame Weeks 4 to 6

Outcome Measure Data

Analysis Population Description
Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom intensive blood samples were drawn and who received at least 1 dose of study medication.
Arm/Group Title TMC435 50 mg TMC435 100 mg
Arm/Group Description Participants who received TMC435 50 mg in Treatment Groups TMC12/PR24 50 mg and TMC24/PR24 50 mg Participants who received TMC435 100 mg in Treatment Groups TMC12/PR24 100 mg and TMC24/PR24 100 mg
Measure Participants 14 12
Mean (Standard Deviation) [ng/mL]
192
(134)
1732
(2669)
12. Primary Outcome
Title The Area Under the Plasma Concentration-time Curve From the Time of Administration up to 24 Hours After Dosing (AUC24) for TMC435
Description The table below shows the mean AUC24 of TMC435 for participants in the 2 TMC435 50 mg treatment groups combined (TMC12/PR24 50 mg and TMC24/PR24 50 mg) and for participants in the 2 TMC435 100 mg treatment groups combined (TMC12/PR24 100 mg and TMC24/PR24 100 mg) who had intensive blood samples collected at Weeks 4 to 6. NOTE: All outcome measures reported in this study are "Exploratory;" not "Primary" as indicated (refer to Limits and Caveats).
Time Frame within 15 minutes and at 1, 2, 4, 6, 8, 12, and 24 hours post-dose between Week 4 and Week 6 after the initiation of treatment

Outcome Measure Data

Analysis Population Description
Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom intensive blood samples were drawn and who received at least 1 dose of study medication.
Arm/Group Title TMC435 50 mg TMC435 100 mg
Arm/Group Description Participants who received TMC435 50 mg in Treatment Groups TMC12/PR24 50 mg and TMC24/PR24 50 mg Participants who received TMC435 100 mg in Treatment Groups TMC12/PR24 100 mg and TMC24/PR24 100 mg
Measure Participants 14 12
Mean (Standard Deviation) [ng∙h/mL]
11182
(7763)
60197
(65364)
13. Primary Outcome
Title Time to Reach the Maximum Plasma Concentration (Tmax) of TMC435
Description The table below shows the median time in hours to reach the maximum plasma concentration (tmax) of TMC435 for participants in the 2 TMC435 50 mg treatment groups combined (TMC12/PR24 50 mg and TMC24/PR24 50 mg) and for participants in the 2 TMC435 100 mg treatment groups combined (TMC12/PR24 100 mg and TMC24/PR24 100 mg) who had intensive blood samples collected at Weeks 4 to 6. NOTE: All outcome measures reported in this study are "Exploratory;" not "Primary" as indicated (refer to Limits and Caveats).
Time Frame within 15 minutes and at 1, 2, 4, 6, 8, 12, and 24 hours post-dose between Week 4 and Week 6 after the initiation of treatment

Outcome Measure Data

Analysis Population Description
Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom intensive blood samples were drawn and who received at least 1 dose of study medication.
Arm/Group Title TMC435 50 mg TMC435 100 mg
Arm/Group Description Participants who received TMC435 50 mg in Treatment Groups TMC12/PR24 50 mg and TMC24/PR24 50 mg Participants who received TMC435 100 mg in Treatment Groups TMC12/PR24 100 mg and TMC24/PR24 100 mg
Measure Participants 14 12
Median (Full Range) [Hours]
5.97
(725)
6.00
(3446)
14. Primary Outcome
Title The Number of Participants Who Met Virologic Stopping/Continuation Rules and Completed All Study Medications
Description The table below shows the number of participants who met response-guided treatment (RGT) stopping criteria in the TMC435 treatment groups. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than 1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20 were to stop all study medication (TMC435, PegIFNα-2a, and ribavirin) at Week 24. All other participants continued PegIFNα-2a and ribavirin until Week 48. NOTE: All outcome measures reported in this study are "Exploratory;" not "Primary" as indicated (refer to Limits and Caveats).
Time Frame Week 24

Outcome Measure Data

Analysis Population Description
The efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.
Arm/Group Title TMC12/PR24 50 mg TMC12/PR24 100 mg TMC24/PR24 50 mg TMC24/PR24 100 mg PR48 Control
Arm/Group Description Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
Measure Participants 27 26 13 13 11
Number [Participants]
25
92.6%
22
84.6%
10
76.9%
12
92.3%
0
0%

Adverse Events

Time Frame Up to approximately 52 weeks (includes all serious and other adverse events that newly occurred or worsened after treatment with TMC435, PegIFNα-2b or ribavirin, until the end date of the last study medication intake + 28 days).
Adverse Event Reporting Description
Arm/Group Title TMC12/PR24 50 mg TMC12/PR24 100 mg TMC24/PR24 50 mg TMC24/PR24 100 mg PR48 Control
Arm/Group Description Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48. Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. Participants received PegIFNa-2a and ribavirin (PR) for 48 weeks (PR48 control group)
All Cause Mortality
TMC12/PR24 50 mg TMC12/PR24 100 mg TMC24/PR24 50 mg TMC24/PR24 100 mg PR48 Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
Serious Adverse Events
TMC12/PR24 50 mg TMC12/PR24 100 mg TMC24/PR24 50 mg TMC24/PR24 100 mg PR48 Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/27 (0%) 3/26 (11.5%) 1/13 (7.7%) 1/13 (7.7%) 0/13 (0%)
General disorders
Malaise 0/27 (0%) 1/26 (3.8%) 0/13 (0%) 0/13 (0%) 0/13 (0%)
Injury, poisoning and procedural complications
Incorrect dose administered 0/27 (0%) 0/26 (0%) 0/13 (0%) 1/13 (7.7%) 0/13 (0%)
Nervous system disorders
Cerebral infarction 0/27 (0%) 1/26 (3.8%) 0/13 (0%) 0/13 (0%) 0/13 (0%)
Subarachnoid haemorrhage 0/27 (0%) 1/26 (3.8%) 0/13 (0%) 0/13 (0%) 0/13 (0%)
Reproductive system and breast disorders
Vulvar erosion 0/27 (0%) 1/26 (3.8%) 0/13 (0%) 0/13 (0%) 0/13 (0%)
Skin and subcutaneous tissue disorders
Rash 0/27 (0%) 0/26 (0%) 1/13 (7.7%) 0/13 (0%) 0/13 (0%)
Other (Not Including Serious) Adverse Events
TMC12/PR24 50 mg TMC12/PR24 100 mg TMC24/PR24 50 mg TMC24/PR24 100 mg PR48 Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 27/27 (100%) 26/26 (100%) 13/13 (100%) 13/13 (100%) 13/13 (100%)
Blood and lymphatic system disorders
Anaemia 8/27 (29.6%) 6/26 (23.1%) 5/13 (38.5%) 5/13 (38.5%) 5/13 (38.5%)
Cardiac disorders
Palpitations 1/27 (3.7%) 1/26 (3.8%) 0/13 (0%) 0/13 (0%) 2/13 (15.4%)
Congenital, familial and genetic disorders
Dermoid cyst 0/27 (0%) 0/26 (0%) 0/13 (0%) 0/13 (0%) 1/13 (7.7%)
Ear and labyrinth disorders
Ear discomfort 0/27 (0%) 2/26 (7.7%) 0/13 (0%) 0/13 (0%) 0/13 (0%)
Endocrine disorders
Hyperthyroidism 0/27 (0%) 0/26 (0%) 1/13 (7.7%) 0/13 (0%) 0/13 (0%)
Hypothyroidism 0/27 (0%) 0/26 (0%) 0/13 (0%) 0/13 (0%) 1/13 (7.7%)
Thyroid disorder 0/27 (0%) 0/26 (0%) 0/13 (0%) 1/13 (7.7%) 0/13 (0%)
Eye disorders
Asthenopia 1/27 (3.7%) 0/26 (0%) 1/13 (7.7%) 1/13 (7.7%) 1/13 (7.7%)
Cataract 0/27 (0%) 0/26 (0%) 0/13 (0%) 1/13 (7.7%) 0/13 (0%)
Conjunctival deposit 0/27 (0%) 0/26 (0%) 1/13 (7.7%) 0/13 (0%) 0/13 (0%)
Conjunctival haemorrhage 0/27 (0%) 0/26 (0%) 0/13 (0%) 1/13 (7.7%) 0/13 (0%)
Conjunctivitis 0/27 (0%) 0/26 (0%) 0/13 (0%) 1/13 (7.7%) 0/13 (0%)
Dry eye 0/27 (0%) 0/26 (0%) 0/13 (0%) 1/13 (7.7%) 0/13 (0%)
Eye pain 0/27 (0%) 1/26 (3.8%) 1/13 (7.7%) 0/13 (0%) 0/13 (0%)
Keratoconjunctivitis sicca 0/27 (0%) 0/26 (0%) 0/13 (0%) 0/13 (0%) 1/13 (7.7%)
Macular oedema 0/27 (0%) 0/26 (0%) 0/13 (0%) 1/13 (7.7%) 0/13 (0%)
Ocular discomfort 0/27 (0%) 0/26 (0%) 1/13 (7.7%) 0/13 (0%) 0/13 (0%)
Punctate keratitis 0/27 (0%) 0/26 (0%) 1/13 (7.7%) 0/13 (0%) 0/13 (0%)
Retinal degeneration 0/27 (0%) 0/26 (0%) 0/13 (0%) 0/13 (0%) 1/13 (7.7%)
Retinal exudates 1/27 (3.7%) 2/26 (7.7%) 1/13 (7.7%) 2/13 (15.4%) 0/13 (0%)
Retinal haemorrhage 0/27 (0%) 2/26 (7.7%) 1/13 (7.7%) 0/13 (0%) 1/13 (7.7%)
Retinal vein occlusion 1/27 (3.7%) 0/26 (0%) 0/13 (0%) 1/13 (7.7%) 0/13 (0%)
Retinopathy 0/27 (0%) 2/26 (7.7%) 0/13 (0%) 1/13 (7.7%) 3/13 (23.1%)
Visual acuity reduced 0/27 (0%) 0/26 (0%) 0/13 (0%) 0/13 (0%) 1/13 (7.7%)
Vitreous floaters 0/27 (0%) 0/26 (0%) 1/13 (7.7%) 0/13 (0%) 1/13 (7.7%)
Gastrointestinal disorders
Abdominal discomfort 6/27 (22.2%) 3/26 (11.5%) 3/13 (23.1%) 1/13 (7.7%) 2/13 (15.4%)
Abdominal distension 0/27 (0%) 0/26 (0%) 0/13 (0%) 1/13 (7.7%) 0/13 (0%)
Abdominal pain 1/27 (3.7%) 0/26 (0%) 0/13 (0%) 0/13 (0%) 1/13 (7.7%)
Abdominal pain upper 1/27 (3.7%) 4/26 (15.4%) 1/13 (7.7%) 0/13 (0%) 0/13 (0%)
Abdominal tenderness 0/27 (0%) 0/26 (0%) 0/13 (0%) 1/13 (7.7%) 0/13 (0%)
Anorectal discomfort 0/27 (0%) 0/26 (0%) 1/13 (7.7%) 0/13 (0%) 0/13 (0%)
Cheilitis 1/27 (3.7%) 0/26 (0%) 0/13 (0%) 0/13 (0%) 1/13 (7.7%)
Constipation 4/27 (14.8%) 1/26 (3.8%) 1/13 (7.7%) 2/13 (15.4%) 2/13 (15.4%)
Diarrhoea 4/27 (14.8%) 6/26 (23.1%) 3/13 (23.1%) 0/13 (0%) 5/13 (38.5%)
Dyspepsia 0/27 (0%) 0/26 (0%) 0/13 (0%) 0/13 (0%) 1/13 (7.7%)
Enterocolitis 0/27 (0%) 1/26 (3.8%) 0/13 (0%) 0/13 (0%) 1/13 (7.7%)
Faeces hard 0/27 (0%) 0/26 (0%) 0/13 (0%) 1/13 (7.7%) 0/13 (0%)
Gastritis 0/27 (0%) 1/26 (3.8%) 1/13 (7.7%) 0/13 (0%) 0/13 (0%)
Gastrointestinal disorder 0/27 (0%) 0/26 (0%) 1/13 (7.7%) 0/13 (0%) 0/13 (0%)
Glossodynia 0/27 (0%) 0/26 (0%) 1/13 (7.7%) 0/13 (0%) 0/13 (0%)
Haemorrhoids 1/27 (3.7%) 0/26 (0%) 0/13 (0%) 0/13 (0%) 1/13 (7.7%)
Nausea 5/27 (18.5%) 5/26 (19.2%) 2/13 (15.4%) 1/13 (7.7%) 0/13 (0%)
Periodontitis 1/27 (3.7%) 3/26 (11.5%) 0/13 (0%) 1/13 (7.7%) 0/13 (0%)
Stomatitis 7/27 (25.9%) 5/26 (19.2%) 5/13 (38.5%) 2/13 (15.4%) 2/13 (15.4%)
Tongue disorder 0/27 (0%) 0/26 (0%) 1/13 (7.7%) 0/13 (0%) 0/13 (0%)
Vomiting 1/27 (3.7%) 1/26 (3.8%) 2/13 (15.4%) 2/13 (15.4%) 2/13 (15.4%)
General disorders
Chest discomfort 0/27 (0%) 0/26 (0%) 2/13 (15.4%) 0/13 (0%) 0/13 (0%)
Chills 1/27 (3.7%) 1/26 (3.8%) 1/13 (7.7%) 1/13 (7.7%) 0/13 (0%)
Fatigue 0/27 (0%) 0/26 (0%) 2/13 (15.4%) 0/13 (0%) 0/13 (0%)
Feeling abnormal 0/27 (0%) 0/26 (0%) 1/13 (7.7%) 0/13 (0%) 1/13 (7.7%)
Feeling cold 0/27 (0%) 0/26 (0%) 0/13 (0%) 1/13 (7.7%) 1/13 (7.7%)
Injection site erythema 3/27 (11.1%) 2/26 (7.7%) 1/13 (7.7%) 2/13 (15.4%) 1/13 (7.7%)
Injection site pruritus 1/27 (3.7%) 1/26 (3.8%) 0/13 (0%) 0/13 (0%) 1/13 (7.7%)
Injection site reaction 7/27 (25.9%) 2/26 (7.7%) 6/13 (46.2%) 5/13 (38.5%) 3/13 (23.1%)
Malaise 17/27 (63%) 15/26 (57.7%) 8/13 (61.5%) 7/13 (53.8%) 8/13 (61.5%)
Pyrexia 18/27 (66.7%) 10/26 (38.5%) 7/13 (53.8%) 7/13 (53.8%) 7/13 (53.8%)
Thirst 0/27 (0%) 1/26 (3.8%) 1/13 (7.7%) 0/13 (0%) 1/13 (7.7%)
Hepatobiliary disorders
Hepatic function abnormal 1/27 (3.7%) 0/26 (0%) 0/13 (0%) 1/13 (7.7%) 0/13 (0%)
Hyperbilirubinaemia 0/27 (0%) 5/26 (19.2%) 2/13 (15.4%) 3/13 (23.1%) 0/13 (0%)
Infections and infestations
Bronchitis 0/27 (0%) 0/26 (0%) 1/13 (7.7%) 1/13 (7.7%) 0/13 (0%)
Cellulitis 0/27 (0%) 0/26 (0%) 0/13 (0%) 0/13 (0%) 1/13 (7.7%)
Cystitis 2/27 (7.4%) 0/26 (0%) 0/13 (0%) 1/13 (7.7%) 1/13 (7.7%)
Enteritis infectious 0/27 (0%) 0/26 (0%) 1/13 (7.7%) 0/13 (0%) 0/13 (0%)
Gastroenteritis 2/27 (7.4%) 0/26 (0%) 0/13 (0%) 1/13 (7.7%) 0/13 (0%)
Influenza 0/27 (0%) 0/26 (0%) 0/13 (0%) 2/13 (15.4%) 0/13 (0%)
Nasopharyngitis 9/27 (33.3%) 4/26 (15.4%) 4/13 (30.8%) 2/13 (15.4%) 3/13 (23.1%)
Onychomycosis 0/27 (0%) 0/26 (0%) 0/13 (0%) 1/13 (7.7%) 0/13 (0%)
Oral herpes 1/27 (3.7%) 2/26 (7.7%) 0/13 (0%) 0/13 (0%) 0/13 (0%)
Otitis externa 1/27 (3.7%) 0/26 (0%) 0/13 (0%) 1/13 (7.7%) 0/13 (0%)
Pharyngitis 3/27 (11.1%) 1/26 (3.8%) 0/13 (0%) 0/13 (0%) 0/13 (0%)
Pneumonia 0/27 (0%) 0/26 (0%) 0/13 (0%) 1/13 (7.7%) 0/13 (0%)
Vaginal infection 0/27 (0%) 0/26 (0%) 1/13 (7.7%) 0/13 (0%) 0/13 (0%)
Injury, poisoning and procedural complications
Contusion 1/27 (3.7%) 0/26 (0%) 0/13 (0%) 0/13 (0%) 1/13 (7.7%)
Excoriation 0/27 (0%) 0/26 (0%) 0/13 (0%) 0/13 (0%) 1/13 (7.7%)
Procedural pain 0/27 (0%) 1/26 (3.8%) 0/13 (0%) 1/13 (7.7%) 0/13 (0%)
Radius fracture 0/27 (0%) 0/26 (0%) 0/13 (0%) 0/13 (0%) 1/13 (7.7%)
Scratch 0/27 (0%) 0/26 (0%) 0/13 (0%) 1/13 (7.7%) 0/13 (0%)
Investigations
Alanine aminotransferase increased 1/27 (3.7%) 1/26 (3.8%) 0/13 (0%) 1/13 (7.7%) 1/13 (7.7%)
Alpha-1 acid glycoprotein increased 5/27 (18.5%) 1/26 (3.8%) 2/13 (15.4%) 0/13 (0%) 2/13 (15.4%)
Blood alkaline phosphatase increased 0/27 (0%) 1/26 (3.8%) 0/13 (0%) 1/13 (7.7%) 1/13 (7.7%)
Blood amylase increased 0/27 (0%) 0/26 (0%) 0/13 (0%) 2/13 (15.4%) 0/13 (0%)
Blood bilirubin increased 3/27 (11.1%) 6/26 (23.1%) 1/13 (7.7%) 3/13 (23.1%) 0/13 (0%)
Blood calcium decreased 1/27 (3.7%) 0/26 (0%) 2/13 (15.4%) 1/13 (7.7%) 1/13 (7.7%)
Blood lactate dehydrogenase increased 1/27 (3.7%) 2/26 (7.7%) 2/13 (15.4%) 0/13 (0%) 2/13 (15.4%)
Blood phosphorus decreased 2/27 (7.4%) 0/26 (0%) 1/13 (7.7%) 2/13 (15.4%) 0/13 (0%)
Blood thyroid stimulating hormone decreased 0/27 (0%) 0/26 (0%) 0/13 (0%) 1/13 (7.7%) 0/13 (0%)
Blood thyroid stimulating hormone increased 0/27 (0%) 0/26 (0%) 1/13 (7.7%) 1/13 (7.7%) 1/13 (7.7%)
Blood triglycerides increased 1/27 (3.7%) 1/26 (3.8%) 2/13 (15.4%) 2/13 (15.4%) 3/13 (23.1%)
Blood uric acid increased 4/27 (14.8%) 2/26 (7.7%) 1/13 (7.7%) 0/13 (0%) 0/13 (0%)
Electrocardiogram T wave inversion 0/27 (0%) 0/26 (0%) 1/13 (7.7%) 0/13 (0%) 0/13 (0%)
Haematocrit decreased 4/27 (14.8%) 6/26 (23.1%) 4/13 (30.8%) 3/13 (23.1%) 4/13 (30.8%)
Haemoglobin decreased 8/27 (29.6%) 12/26 (46.2%) 7/13 (53.8%) 7/13 (53.8%) 6/13 (46.2%)
Lipase increased 0/27 (0%) 2/26 (7.7%) 0/13 (0%) 3/13 (23.1%) 1/13 (7.7%)
Liver function test abnormal 0/27 (0%) 0/26 (0%) 0/13 (0%) 1/13 (7.7%) 0/13 (0%)
Mean cell haemoglobin concentration decreased 0/27 (0%) 0/26 (0%) 0/13 (0%) 1/13 (7.7%) 0/13 (0%)
Mean cell volume increased 0/27 (0%) 0/26 (0%) 1/13 (7.7%) 0/13 (0%) 0/13 (0%)
Neutrophil count decreased 12/27 (44.4%) 14/26 (53.8%) 10/13 (76.9%) 12/13 (92.3%) 9/13 (69.2%)
Platelet count decreased 5/27 (18.5%) 4/26 (15.4%) 4/13 (30.8%) 6/13 (46.2%) 6/13 (46.2%)
Protein urine present 0/27 (0%) 0/26 (0%) 1/13 (7.7%) 0/13 (0%) 2/13 (15.4%)
Red blood cell count decreased 4/27 (14.8%) 6/26 (23.1%) 5/13 (38.5%) 3/13 (23.1%) 4/13 (30.8%)
Tri-iodothyronine free decreased 0/27 (0%) 0/26 (0%) 0/13 (0%) 0/13 (0%) 1/13 (7.7%)
Weight decreased 1/27 (3.7%) 3/26 (11.5%) 2/13 (15.4%) 0/13 (0%) 2/13 (15.4%)
White blood cell count decreased 16/27 (59.3%) 15/26 (57.7%) 10/13 (76.9%) 12/13 (92.3%) 10/13 (76.9%)
White blood cells urine positive 0/27 (0%) 0/26 (0%) 0/13 (0%) 0/13 (0%) 1/13 (7.7%)
Metabolism and nutrition disorders
Decreased appetite 4/27 (14.8%) 6/26 (23.1%) 4/13 (30.8%) 1/13 (7.7%) 3/13 (23.1%)
Hypertriglyceridaemia 1/27 (3.7%) 0/26 (0%) 0/13 (0%) 0/13 (0%) 1/13 (7.7%)
Hyperuricaemia 0/27 (0%) 0/26 (0%) 1/13 (7.7%) 1/13 (7.7%) 1/13 (7.7%)
Hypo HDL cholesterolaemia 0/27 (0%) 0/26 (0%) 1/13 (7.7%) 0/13 (0%) 0/13 (0%)
Hypocholesterolaemia 0/27 (0%) 0/26 (0%) 0/13 (0%) 1/13 (7.7%) 0/13 (0%)
Hypokalaemia 0/27 (0%) 0/26 (0%) 2/13 (15.4%) 0/13 (0%) 1/13 (7.7%)
Musculoskeletal and connective tissue disorders
Arthralgia 9/27 (33.3%) 7/26 (26.9%) 6/13 (46.2%) 5/13 (38.5%) 2/13 (15.4%)
Back pain 4/27 (14.8%) 1/26 (3.8%) 1/13 (7.7%) 2/13 (15.4%) 1/13 (7.7%)
Flank pain 0/27 (0%) 0/26 (0%) 0/13 (0%) 0/13 (0%) 1/13 (7.7%)
Intervertebral disc protrusion 0/27 (0%) 0/26 (0%) 1/13 (7.7%) 0/13 (0%) 0/13 (0%)
Muscle spasms 0/27 (0%) 0/26 (0%) 0/13 (0%) 0/13 (0%) 1/13 (7.7%)
Musculoskeletal discomfort 0/27 (0%) 2/26 (7.7%) 0/13 (0%) 0/13 (0%) 0/13 (0%)
Musculoskeletal pain 0/27 (0%) 0/26 (0%) 0/13 (0%) 0/13 (0%) 1/13 (7.7%)
Musculoskeletal stiffness 0/27 (0%) 0/26 (0%) 1/13 (7.7%) 1/13 (7.7%) 1/13 (7.7%)
Myalgia 4/27 (14.8%) 6/26 (23.1%) 4/13 (30.8%) 1/13 (7.7%) 2/13 (15.4%)
Neck pain 0/27 (0%) 0/26 (0%) 0/13 (0%) 1/13 (7.7%) 0/13 (0%)
Nervous system disorders
Dizziness 2/27 (7.4%) 0/26 (0%) 1/13 (7.7%) 0/13 (0%) 0/13 (0%)
Dizziness postural 1/27 (3.7%) 0/26 (0%) 0/13 (0%) 0/13 (0%) 1/13 (7.7%)
Dysgeusia 3/27 (11.1%) 1/26 (3.8%) 1/13 (7.7%) 1/13 (7.7%) 0/13 (0%)
Head discomfort 0/27 (0%) 0/26 (0%) 0/13 (0%) 0/13 (0%) 1/13 (7.7%)
Headache 14/27 (51.9%) 13/26 (50%) 8/13 (61.5%) 6/13 (46.2%) 8/13 (61.5%)
Hypoaesthesia 0/27 (0%) 0/26 (0%) 1/13 (7.7%) 1/13 (7.7%) 1/13 (7.7%)
Paraesthesia 0/27 (0%) 0/26 (0%) 0/13 (0%) 1/13 (7.7%) 0/13 (0%)
Somnolence 2/27 (7.4%) 1/26 (3.8%) 0/13 (0%) 1/13 (7.7%) 0/13 (0%)
Syncope 2/27 (7.4%) 0/26 (0%) 0/13 (0%) 0/13 (0%) 0/13 (0%)
Psychiatric disorders
Anxiety disorder 0/27 (0%) 0/26 (0%) 1/13 (7.7%) 0/13 (0%) 0/13 (0%)
Depression 1/27 (3.7%) 0/26 (0%) 1/13 (7.7%) 0/13 (0%) 0/13 (0%)
Depressive symptom 0/27 (0%) 0/26 (0%) 0/13 (0%) 0/13 (0%) 1/13 (7.7%)
Insomnia 10/27 (37%) 5/26 (19.2%) 5/13 (38.5%) 3/13 (23.1%) 2/13 (15.4%)
Sleep disorder 0/27 (0%) 0/26 (0%) 1/13 (7.7%) 0/13 (0%) 0/13 (0%)
Renal and urinary disorders
Cystitis-like symptom 0/27 (0%) 0/26 (0%) 1/13 (7.7%) 0/13 (0%) 0/13 (0%)
Pollakiuria 0/27 (0%) 0/26 (0%) 1/13 (7.7%) 0/13 (0%) 1/13 (7.7%)
Reproductive system and breast disorders
Galactorrhoea 0/27 (0%) 0/26 (0%) 1/13 (7.7%) 0/13 (0%) 0/13 (0%)
Metrorrhagia 0/27 (0%) 1/26 (3.8%) 0/13 (0%) 1/13 (7.7%) 0/13 (0%)
Respiratory, thoracic and mediastinal disorders
Cough 4/27 (14.8%) 3/26 (11.5%) 0/13 (0%) 1/13 (7.7%) 2/13 (15.4%)
Interstitial lung disease 1/27 (3.7%) 0/26 (0%) 0/13 (0%) 0/13 (0%) 1/13 (7.7%)
Oropharyngeal discomfort 1/27 (3.7%) 3/26 (11.5%) 0/13 (0%) 0/13 (0%) 0/13 (0%)
Oropharyngeal pain 3/27 (11.1%) 3/26 (11.5%) 0/13 (0%) 1/13 (7.7%) 1/13 (7.7%)
Rhinorrhoea 1/27 (3.7%) 3/26 (11.5%) 0/13 (0%) 0/13 (0%) 0/13 (0%)
Skin and subcutaneous tissue disorders
Alopecia 11/27 (40.7%) 6/26 (23.1%) 5/13 (38.5%) 3/13 (23.1%) 6/13 (46.2%)
Asteatosis 0/27 (0%) 0/26 (0%) 0/13 (0%) 0/13 (0%) 2/13 (15.4%)
Dermatitis contact 2/27 (7.4%) 1/26 (3.8%) 0/13 (0%) 0/13 (0%) 0/13 (0%)
Dry skin 1/27 (3.7%) 2/26 (7.7%) 0/13 (0%) 2/13 (15.4%) 0/13 (0%)
Eczema 0/27 (0%) 2/26 (7.7%) 0/13 (0%) 1/13 (7.7%) 0/13 (0%)
Eczema asteatotic 2/27 (7.4%) 0/26 (0%) 0/13 (0%) 0/13 (0%) 0/13 (0%)
Erythema 2/27 (7.4%) 0/26 (0%) 0/13 (0%) 0/13 (0%) 1/13 (7.7%)
Pruritus 5/27 (18.5%) 4/26 (15.4%) 0/13 (0%) 6/13 (46.2%) 0/13 (0%)
Rash 17/27 (63%) 15/26 (57.7%) 7/13 (53.8%) 8/13 (61.5%) 6/13 (46.2%)
Seborrhoeic dermatitis 0/27 (0%) 0/26 (0%) 0/13 (0%) 0/13 (0%) 2/13 (15.4%)
Urticaria 4/27 (14.8%) 0/26 (0%) 0/13 (0%) 0/13 (0%) 0/13 (0%)
Vascular disorders
Hot flush 0/27 (0%) 0/26 (0%) 1/13 (7.7%) 0/13 (0%) 0/13 (0%)
Hypertension 3/27 (11.1%) 0/26 (0%) 0/13 (0%) 0/13 (0%) 1/13 (7.7%)
Orthostatic hypotension 0/27 (0%) 0/26 (0%) 1/13 (7.7%) 0/13 (0%) 0/13 (0%)

Limitations/Caveats

All outcome measures reported in this study are "Exploratory;" not "Primary" as indicated. "Primary" was chosen for each outcome measure because "Exploratory" is not available as an outcome measure type.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.

Results Point of Contact

Name/Title DIrector
Organization Janssen Pharmaceutical K.K., Japan
Phone 81 3 44115639
Email
Responsible Party:
Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:
NCT00996476
Other Study ID Numbers:
  • CR016402
  • TMC435-TiDP16-C215
First Posted:
Oct 16, 2009
Last Update Posted:
Apr 17, 2014
Last Verified:
Mar 1, 2014