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A Study to Assess the Safety, Tolerability and Efficacy of TMC435 Along With Pegylated Interferon Alpha-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Patients Co-infected With Human Immunodeficiency Virus-Type 1

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ClinicalTrials.gov Identifier: NCT01479868
Recruitment Status : Completed
First Posted : November 28, 2011
Results First Posted : October 29, 2014
Last Update Posted : October 29, 2014
Sponsor:
Information provided by (Responsible Party):
Janssen R&D Ireland

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C Virus Genotype-1
Interventions Drug: TMC435
Drug: Pegylated interferon alpha-2a
Drug: Ribavirin
Enrollment 109

Recruitment Details  
Pre-assignment Details  
Arm/Group Title TMC435 150mg 12Wks PR24/48
Hide Arm/Group Description Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
Period Title: Overall Study
Started 106 [1]
Completed 97
Not Completed 9
Reason Not Completed
Adverse Event             1
Lost to Follow-up             4
Protocol Violation             1
Withdrawal by Subject             1
Sponsor's Decision             1
Initiation of new HCV Therapy             1
[1]
Restricted to subject who received at least one dose of treatment (TMC435/RBV/PegIFN).
Arm/Group Title TMC435 150mg 12Wks PR24/48
Hide Arm/Group Description Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
Overall Number of Baseline Participants 106
Hide Baseline Analysis Population Description
Analysis population included all participants who received at least 1 dose of study drug.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 106 participants
48
(27 to 67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants
Female
16
  15.1%
Male
90
  84.9%
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response at Week 12 (SVR 12)
Hide Description The SVR 12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than (<) 25 international unit per milliliter (IU/mL) undetectable at the actual end of treatment (EOT), and HCV RNA levels <25 IU/mL undetectable or HCV RNA levels <25 IU/mL detectable at 12 Weeks after end of treatment.
Time Frame 12 weeks after end of treatment (Week 24 or 48)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population included all participants who received at least 1 dose of study drug.
Arm/Group Title TMC435 150mg 12Wks PR24/48
Hide Arm/Group Description:
Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
Overall Number of Participants Analyzed 106
Measure Type: Number
Unit of Measure: percentage of participants
73.6
2.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response at Week 24 (SVR 24)
Hide Description The SVR 24 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than (<) 25 international unit per milliliter (IU/mL) undetectable at the actual end of treatment (EOT), and HCV RNA levels <25 IU/mL undetectable or HCV RNA levels <25 IU/mL detectable at 24 weeks after end of treatment.
Time Frame 24 weeks after end of treatment (Week 24 or 48)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all perticipants who had at least 1 dose of study drug.
Arm/Group Title TMC435 150mg 12Wks PR24/48
Hide Arm/Group Description:
Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
Overall Number of Participants Analyzed 106
Measure Type: Number
Unit of Measure: percentage of participants
72.6
3.Secondary Outcome
Title Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Less Than (<) 25 International Units (IU/mL) Undetectable or Detectable/Undetectable
Hide Description Percentage of participants with HCV RNA less than (<) 25 IU/mL undetectable (undet.) or detectable (det.)/undetectable at specific time points were observed.
Time Frame Week 4, 12, 24, 36, and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who had at least 1 dose of study drug. Here, "N" (number of participants analyzed) is the number of participants analyzed for this outcome measure, "n" is the number of participants analyzed for this outcome measure at specific time points.
Arm/Group Title TMC435 150mg 12Wks PR24/48
Hide Arm/Group Description:
Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
Overall Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: percentage of participants
Week 4: < 25 IU/mL HCV-RNA undet. (n=105) 65.7
Week 4:< 25 IU/mL HCV-RNA det./undet. (n=105) 88.6
Week 12:< 25 IU/mL HCV-RNA undet. (n=97) 94.8
Week 12:< 25 IU/mL HCV-RNA det./undet. (n=97) 97.9
Week 24:< 25 IU/mL HCV-RNA undet. (n=90) 90.0
Week 24:< 25 IU/mL HCV-RNA det./undet. (n=90) 93.3
Week 48:< 25 IU/mL HCV-RNA undet. (n=20) 100
Week 48:< 25 IU/mL HCV-RNA det./undet. (n=20) 100
4.Secondary Outcome
Title Percentage of Participants With On-treatment Failure
Hide Description Participants were considered as an on-treatment failure if, at actual end of treatment (EOT), there was confirmed detectable HCV RNA levels.
Time Frame Week 1 to 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who received at least 1 dose of study drug.
Arm/Group Title TMC435 150mg 12Wks PR24/48
Hide Arm/Group Description:
Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
Overall Number of Participants Analyzed 106
Measure Type: Number
Unit of Measure: percentage of participants
17
5.Secondary Outcome
Title Percentage of Participants With Viral Breakthrough
Hide Description Confirmed increase of more than 1 log10 IU per mL in HCV RNA level from the lowest level reached, or a confirmed HCV RNA level of more than 100 IU per mL in participants whose HCV RNA levels had previously been below the limit of quantification (less than 25 IU per mL detectable) or undetectable (less than 25 IU per mL undetectable), while on study therapy.
Time Frame Week 1 to 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who received at least 1 dose of study drug.
Arm/Group Title TMC435 150mg 12Wks PR24/48
Hide Arm/Group Description:
Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
Overall Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: percentage of participants
11.4
6.Secondary Outcome
Title Percentage of Participants With Viral Relapse
Hide Description Participants were considered to have a viral relapse when, at actual end of treatment, HCV RNA levels were less than 25 IU per mL undetectable; and during the follow-up period, HCV RNA levels were more than or equal to 25 IU per mL.
Time Frame Week 1 to 72
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who received at least 1 dose of study drug. Here, "N" (number of participants analyzed) is the number of participants analyzed for this outcome measure.
Arm/Group Title TMC435 150mg 12Wks PR24/48
Hide Arm/Group Description:
Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
Overall Number of Participants Analyzed 87
Measure Type: Number
Unit of Measure: percentage of participants
10.3
7.Secondary Outcome
Title Percentage of Participants With Normalized Alanine Aminotransferase Levels
Hide Description Participants with normalized alanine aminotransferase levels observed whose alanine aminotransferase levels were out of range at Baseline.
Time Frame Baseline up to Week 72
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who received at least 1 dose of study drug. Here "N" signifies participants evaluable for this measure.
Arm/Group Title TMC435 150mg 12Wks PR24/48
Hide Arm/Group Description:
Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
Overall Number of Participants Analyzed 65
Measure Type: Number
Unit of Measure: percentage of participants
81.5
8.Secondary Outcome
Title Percentage of Human Immunodeficiency Virus (HIV) Participants With Virologic Failure
Hide Description Participants had confirmed HIV virologic failure if HIV viral load values were greater than or equal to 50 or 200 copies/mL among those who previously had less than 50 copies/mL.
Time Frame Baseline to Week 72.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received potent anti-HIV treatment with a combination of more than 3 anti-antiretroviral therapies to reduce HIV RNA viral load to undetectable levels were analyzed.
Arm/Group Title TMC435 150mg 12Wks PR24/48
Hide Arm/Group Description:
Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
Overall Number of Participants Analyzed 93
Measure Type: Number
Unit of Measure: percentage of participants
Greater than or equal to 50 copies/mL 5.4
Greater than or equal to 200 copies/mL 2.2
9.Secondary Outcome
Title Mean Change From Baseline in Log10 Plasma Human Immunodeficiency Virus (HIV) Viral Load
Hide Description [Not Specified]
Time Frame Baseline (Day 1), Week 2, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60 and 72
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received potent anti-HIV treatment with a combination of more than 3 antiretroviral therapies to reduce HIV RNA viral load to undetectable levels were analyzed. Here "n" signifies participants evaluable for this measure at specified time point.
Arm/Group Title TMC435 150mg 12Wks PR24/48
Hide Arm/Group Description:
Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
Overall Number of Participants Analyzed 93
Mean (Standard Deviation)
Unit of Measure: copies per milliliter
Baseline (n=93) 1.3726  (0.25796)
Change at Week 2 (n=91) -0.0724  (0.23857)
Change at Week 4 (n=93) -0.0704  (0.25817)
Change at Week 8 (n=92) -0.0442  (0.40974)
Change at Week 12 (n=90) -0.0655  (0.30510)
Change at Week 16 (n=88) -0.0829  (0.23986)
Change at Week 20 (n=86) -0.0847  (0.25111)
Change at Week 24 (n=88) -0.0689  (0.24785)
Change at Week 28 (n=82) -0.0564  (0.26319)
Change at Week 36 (n=85) 0.0004  (0.24395)
Change at Week 42 (n=35) -0.0623  (0.29365)
Change at Week 48 (n=79) -0.0041  (0.36177)
Change at Week 52 (n=36) 0.0011  (0.20767)
Change at Week 60 (n=40) -0.0184  (0.20940)
Change at Week 72 (n=38) -0.0265  (0.18323)
Change at End of study (n=93) 0.0099  (0.33435)
10.Secondary Outcome
Title Mean Change From Baseline in CD4+ Cell Count
Hide Description [Not Specified]
Time Frame Baseline (Day 1), Week 2, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60 and 72
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received potent anti-HIV treatment with a combination of more than 3 antiretroviral therapies to reduce HIV RNA viral load to undetectable levels were analyzed. Here, "n" is the number of participants analyzed for this outcome measure at spcific time points.
Arm/Group Title TMC435 150mg 12Wks PR24/48
Hide Arm/Group Description:
Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
Overall Number of Participants Analyzed 93
Mean (Standard Deviation)
Unit of Measure: cell counts per microliter
Baseline (n=93) 640.3  (243.11)
Change at Week 2 (n=89) -95.0  (190.34)
Change at Week 4 (n=91) -171.5  (170.67)
Change at Week 8 (n=92) -244.2  (185.04)
Change at Week 12 (n=91) -271.7  (194.49)
Change at Week 16 (n=88) -275.5  (183.96)
Change at Week 20 (n=84) -283.5  (175.27)
Change at Week 24 (n=89) -288.8  (202.31)
Change at Week 28 (n=82) -252.3  (203.45)
Change at Week 36 (n=83) -198.7  (225.62)
Change at Week 42 (n=33) -336.8  (240.64)
Change at Week 48 (n=77) -166.6  (248.25)
Change at Week 52 (n=35) -202.7  (222.89)
Change at Week 60 (n=40) -90.6  (189.74)
Change at Week 72 (n=38) -62.9  (175.61)
Change at End of Study (n=93) -51.1  (178.20)
11.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count in Percentage
Hide Description [Not Specified]
Time Frame Baseline (Day 1), Week 2, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60 and 72
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received potent anti-HIV treatment with a combination of more than 3 antiretroviral therapies to reduce HIV RNA viral load to undetectable levels were analyzed. Here, "n" is the number of participants analyzed for this outcome measure at spcific time points.
Arm/Group Title TMC435 150mg 12Wks PR24/48
Hide Arm/Group Description:
Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
Overall Number of Participants Analyzed 93
Mean (Standard Deviation)
Unit of Measure: percentage of lymphocyte
Baseline (n=93) 31.65  (8.390)
Change at Week 2 (n=89) 0.42  (6.490)
Change at Week 4 (n=91) 2.50  (5.943)
Change at Week 8 (n=92) 3.85  (5.930)
Change at Week 12 (n=91) 3.93  (6.264)
Change at Week 16 (n=88) 5.47  (6.301)
Change at Week 20 (n=84) 5.27  (6.961)
Change at Week 24 (n=89) 5.50  (7.029)
Change at Week 28 (n=82) 3.79  (6.759)
Change at Week 36 (n=83) 2.75  (6.492)
Change at Week 42 (n=33) 6.41  (6.213)
Change at Week 48 (n=77) 2.09  (7.356)
Change at Week 52 (n=35) 3.26  (6.838)
Change at Week 60 (n=40) 0.25  (5.296)
Change at Week 72 (n=38) 0.70  (4.406)
Change at End of study (n=93) 0.13  (6.169)
12.Secondary Outcome
Title Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Hide Description An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to Day 126 that were absent before treatment or that worsened relative to pre-treatment state.
Time Frame Week 1 to Week 72
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug.
Arm/Group Title TMC435 150mg 12Wks PR24/48
Hide Arm/Group Description:
Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
Overall Number of Participants Analyzed 106
Measure Type: Number
Unit of Measure: participants
TEAEs 102
TESAEs 6
Time Frame Week 1 to Week 72
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TMC435 150mg 12Wks PR24/48
Hide Arm/Group Description Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
All-Cause Mortality
TMC435 150mg 12Wks PR24/48
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
TMC435 150mg 12Wks PR24/48
Affected / at Risk (%)
Total   11/106 (10.38%) 
Blood and lymphatic system disorders   
Anaemia * 1  1/106 (0.94%) 
Cardiac disorders   
Angina pectoris * 1  1/106 (0.94%) 
Gastrointestinal disorders   
Anal haemorrhage * 1  1/106 (0.94%) 
Colitis * 1  1/106 (0.94%) 
General disorders   
General physical health deterioration * 1  1/106 (0.94%) 
Hepatobiliary disorders   
Hyperbilirubinaemia * 1  1/106 (0.94%) 
Infections and infestations   
Catheter site infection * 1  1/106 (0.94%) 
Injury, poisoning and procedural complications   
Thoracic vertebral fracture * 1  1/106 (0.94%) 
Investigations   
Aspartate aminotransferase increased * 1  1/106 (0.94%) 
Metabolism and nutrition disorders   
Malnutrition * 1  1/106 (0.94%) 
Musculoskeletal and connective tissue disorders   
Cervical spinal stenosis * 1  1/106 (0.94%) 
Intervertebral disc protrusion * 1  1/106 (0.94%) 
Psychiatric disorders   
Mental status changes * 1  1/106 (0.94%) 
Psychotic disorder * 1  1/106 (0.94%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea * 1  2/106 (1.89%) 
Pneumothorax * 1  1/106 (0.94%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 14.1
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
Affected / at Risk (%)
Total   103/106 (97.17%) 
Blood and lymphatic system disorders   
Neutropenia * 1  33/106 (31.13%) 
Anaemia * 1  30/106 (28.30%) 
Thrombocytopenia * 1  6/106 (5.66%) 
Gastrointestinal disorders   
Nausea * 1  31/106 (29.25%) 
Diarrhoea * 1  25/106 (23.58%) 
Vomiting * 1  14/106 (13.21%) 
Constipation * 1  12/106 (11.32%) 
General disorders   
Fatigue * 1  48/106 (45.28%) 
Influenza like illness * 1  25/106 (23.58%) 
Asthenia * 1  24/106 (22.64%) 
Pyrexia * 1  12/106 (11.32%) 
Chills * 1  9/106 (8.49%) 
Injection site reaction * 1  8/106 (7.55%) 
Pain * 1  7/106 (6.60%) 
Injection site erythema * 1  6/106 (5.66%) 
Infections and infestations   
Nasopharyngitis * 1  7/106 (6.60%) 
Upper respiratory tract infection * 1  7/106 (6.60%) 
Investigations   
Weight decreased * 1  13/106 (12.26%) 
Neutrophil count decreased * 1  6/106 (5.66%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  21/106 (19.81%) 
Musculoskeletal and connective tissue disorders   
Myalgia * 1  17/106 (16.04%) 
Arthralgia * 1  15/106 (14.15%) 
Back pain * 1  8/106 (7.55%) 
Pain in extremity * 1  6/106 (5.66%) 
Nervous system disorders   
Headache * 1  35/106 (33.02%) 
Dizziness * 1  13/106 (12.26%) 
Psychiatric disorders   
Insomnia * 1  27/106 (25.47%) 
Mood altered * 1  20/106 (18.87%) 
Depression * 1  19/106 (17.92%) 
Anxiety * 1  13/106 (12.26%) 
Sleep disorder * 1  6/106 (5.66%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  11/106 (10.38%) 
Dyspnoea * 1  10/106 (9.43%) 
Oropharyngeal pain * 1  9/106 (8.49%) 
Skin and subcutaneous tissue disorders   
Pruritus * 1  19/106 (17.92%) 
Dry skin * 1  16/106 (15.09%) 
Eczema * 1  8/106 (7.55%) 
Alopecia * 1  7/106 (6.60%) 
Rash * 1  7/106 (6.60%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 14.1
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: Director & Study Responsible Scientist
Organization: Janssen Research & Development
Responsible Party: Janssen R&D Ireland
ClinicalTrials.gov Identifier: NCT01479868     History of Changes
Obsolete Identifiers: NCT01727323
Other Study ID Numbers: CR018334
TMC435-TiDP16-C212 ( Other Identifier: Janssen Research & Development, LLC )
First Submitted: October 18, 2011
First Posted: November 28, 2011
Results First Submitted: August 26, 2014
Results First Posted: October 29, 2014
Last Update Posted: October 29, 2014