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A Study of TMC435 in Combination With PSI-7977 (GS7977) in Chronic Hepatitis C Genotype 1-Infected Prior Null Responders To Peginterferon/Ribavirin Therapy or HCV Treatment-Naive Patients (COSMOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01466790
Recruitment Status : Completed
First Posted : November 8, 2011
Results First Posted : October 22, 2014
Last Update Posted : February 9, 2015
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Janssen R&D Ireland

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: TMC435
Drug: PSI-7977 (GS7977)
Drug: Ribavirin
Enrollment 168
Recruitment Details  
Pre-assignment Details A total of 168 participants enrolled to study. 1 participant who was randomized to Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks group, but never received treatment.
Arm/Group Title Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks Cohort 1: TMC435 and PSI-7977 for 24 Weeks Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks Cohort 1: TMC435 and PSI-7977 for 12 Weeks Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks Cohort 2: TMC435 and PSI-7977 for 24 Weeks Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks Cohort 2: TMC435 and PSI-7977 for 12 Weeks
Hide Arm/Group Description Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase. Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase. Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase. Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase. Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase. Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase. Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase. Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
Period Title: Overall Study
Started 24 [1] 15 27 14 30 16 27 14
Completed 20 14 27 14 27 16 26 13
Not Completed 4 1 0 0 3 0 1 1
Reason Not Completed
Adverse Event             1             0             0             0             2             0             0             0
Lost to Follow-up             2             0             0             0             0             0             0             0
Withdrawal by Subject             1             1             0             0             1             0             1             1
[1]
Not including 1 participant who was randomized to this group, but never received treatment.
Arm/Group Title Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks Cohort 1: TMC435 and PSI-7977 for 24 Weeks Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks Cohort 1: TMC435 and PSI-7977 for 12 Weeks Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks Cohort 2: TMC435 and PSI-7977 for 24 Weeks Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks Cohort 2: TMC435 and PSI-7977 for 12 Weeks Total
Hide Arm/Group Description Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase. Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase. Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase. Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase. Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase. Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase. Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase. Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase. Total of all reporting groups
Overall Number of Baseline Participants 24 15 27 14 30 16 27 14 167
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 24 participants 15 participants 27 participants 14 participants 30 participants 16 participants 27 participants 14 participants 167 participants
56
(27 to 70)
56
(27 to 61)
55
(28 to 67)
55.5
(35 to 68)
58
(28 to 70)
57.5
(49 to 63)
57
(36 to 68)
57.5
(47 to 64)
57
(27 to 70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 15 participants 27 participants 14 participants 30 participants 16 participants 27 participants 14 participants 167 participants
Female
9
  37.5%
9
  60.0%
7
  25.9%
6
  42.9%
9
  30.0%
9
  56.3%
7
  25.9%
4
  28.6%
60
  35.9%
Male
15
  62.5%
6
  40.0%
20
  74.1%
8
  57.1%
21
  70.0%
7
  43.8%
20
  74.1%
10
  71.4%
107
  64.1%
1.Primary Outcome
Title Number of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Planned End of Treatment (EOT)
Hide Description Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at end of treatment and HCV RNA less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 12 weeks after the planned end of treatment.
Time Frame Week 12 and 24 (for the arms treated for 12 weeks) or Week 24 and 36 (for the arms treated for 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.
Arm/Group Title Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks Cohort 1: TMC435 and PSI-7977 for 24 Weeks Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks Cohort 1: TMC435 and PSI-7977 for 12 Weeks Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks Cohort 2: TMC435 and PSI-7977 for 24 Weeks Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks Cohort 2: TMC435 and PSI-7977 for 12 Weeks
Hide Arm/Group Description:
Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
Overall Number of Participants Analyzed 24 15 27 14 30 16 27 14
Measure Type: Number
Unit of Measure: Participants
19 14 26 13 28 16 25 13
2.Secondary Outcome
Title Number of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Planned End of Treatment (EOT)
Hide Description Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at end of treatment and HCV RNA less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 4 weeks after the planned end of treatment.
Time Frame Week 12 and 16 (for the arms treated for 12 weeks) or Week 24 and 28 (for the arms treated for 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.
Arm/Group Title Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks Cohort 1: TMC435 and PSI-7977 for 24 Weeks Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks Cohort 1: TMC435 and PSI-7977 for 12 Weeks Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks Cohort 2: TMC435 and PSI-7977 for 24 Weeks Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks Cohort 2: TMC435 and PSI-7977 for 12 Weeks
Hide Arm/Group Description:
Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
Overall Number of Participants Analyzed 24 15 27 14 30 16 27 14
Measure Type: Number
Unit of Measure: Participants
20 14 26 13 28 16 26 14
3.Secondary Outcome
Title Number of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Planned End of Treatment (EOT)
Hide Description Participants with HCV RNA undetectable at end of treatment and HCV RNA less than (<) 25 IU/mL (detectable or undetectable) at 24 weeks after the planned end of treatment.
Time Frame Week 12 and 36 (for the arms treated for 12 weeks) or Week 24 and 48 (for the arms treated for 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.
Arm/Group Title Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks Cohort 1: TMC435 and PSI-7977 for 24 Weeks Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks Cohort 1: TMC435 and PSI-7977 for 12 Weeks Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks Cohort 2: TMC435 and PSI-7977 for 24 Weeks Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks Cohort 2: TMC435 and PSI-7977 for 12 Weeks
Hide Arm/Group Description:
Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
Overall Number of Participants Analyzed 24 15 27 14 30 16 27 14
Measure Type: Number
Unit of Measure: Participants
19 14 26 13 28 16 25 13
4.Secondary Outcome
Title Number of Participants With a Sustained Virologic Response (SVR) at Week 48
Hide Description Participants with HCV RNA undetectable at end of treatment and HCV RNA less than (<) 25 IU/mL (detectable or undetectable) at week 48.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.
Arm/Group Title Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks Cohort 1: TMC435 and PSI-7977 for 24 Weeks Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks Cohort 1: TMC435 and PSI-7977 for 12 Weeks Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks Cohort 2: TMC435 and PSI-7977 for 24 Weeks Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks Cohort 2: TMC435 and PSI-7977 for 12 Weeks
Hide Arm/Group Description:
Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
Overall Number of Participants Analyzed 24 15 27 14 30 16 27 14
Measure Type: Number
Unit of Measure: Participants
19 14 26 13 27 16 24 13
5.Secondary Outcome
Title Number of Participants With Viral Breakthrough
Hide Description Viral breakthrough was defined as confirmed quantifiable HCV RNA after becoming less than (<) lower limit of quantification (LLOQ) or confirmed greater than (>) 1 log10 HCV RNA increase from the lowest level reached on 2 consecutive occasions.
Time Frame Up to End of Treatment [Week 12 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.
Arm/Group Title Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks Cohort 1: TMC435 and PSI-7977 for 24 Weeks Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks Cohort 1: TMC435 and PSI-7977 for 12 Weeks Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks Cohort 2: TMC435 and PSI-7977 for 24 Weeks Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks Cohort 2: TMC435 and PSI-7977 for 12 Weeks
Hide Arm/Group Description:
Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
Overall Number of Participants Analyzed 24 15 27 14 30 16 27 14
Measure Type: Number
Unit of Measure: Participants
0 0 0 0 0 0 0 0
6.Secondary Outcome
Title Number of Participants With Inadequate Virologic Response
Hide Description Inadequate Virologic Response was defined as confirmed detectable HCV RNA at or after Week 8 and not meeting the viral breakthrough definition.
Time Frame Week 8 and End of Treatment [Week 12 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.
Arm/Group Title Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks Cohort 1: TMC435 and PSI-7977 for 24 Weeks Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks Cohort 1: TMC435 and PSI-7977 for 12 Weeks Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks Cohort 2: TMC435 and PSI-7977 for 24 Weeks Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks Cohort 2: TMC435 and PSI-7977 for 12 Weeks
Hide Arm/Group Description:
Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
Overall Number of Participants Analyzed 24 15 27 14 30 16 27 14
Measure Type: Number
Unit of Measure: Participants
0 0 0 0 0 0 0 0
7.Secondary Outcome
Title Number of Participants With Viral Relapse
Hide Description Viral relapse was defined as undetectable HCV RNA at the actual EOT and confirmed quantifiable HCV RNA (>= 25 IU/mL) during follow-up period.
Time Frame During the Follow-up [Week 36 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.
Arm/Group Title Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks Cohort 1: TMC435 and PSI-7977 for 24 Weeks Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks Cohort 1: TMC435 and PSI-7977 for 12 Weeks Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks Cohort 2: TMC435 and PSI-7977 for 24 Weeks Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks Cohort 2: TMC435 and PSI-7977 for 12 Weeks
Hide Arm/Group Description:
Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
Overall Number of Participants Analyzed 24 15 27 14 30 16 27 14
Measure Type: Number
Unit of Measure: Participants
1 0 1 1 0 0 2 1
Time Frame Up to Week 48
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks Cohort 1 and 2: TMC435 and PSI-7977 for 24 Weeks Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks Cohort 1 and 2: TMC435 and PSI-7977 for 12 Weeks
Hide Arm/Group Description Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase. Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase. Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase. Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
All-Cause Mortality
Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks Cohort 1 and 2: TMC435 and PSI-7977 for 24 Weeks Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks Cohort 1 and 2: TMC435 and PSI-7977 for 12 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks Cohort 1 and 2: TMC435 and PSI-7977 for 24 Weeks Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks Cohort 1 and 2: TMC435 and PSI-7977 for 12 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/54 (5.56%)   1/31 (3.23%)   0/54 (0.00%)   0/28 (0.00%) 
Blood and lymphatic system disorders         
Anaemia * 1  0/54 (0.00%)  1/31 (3.23%)  0/54 (0.00%)  0/28 (0.00%) 
Eye disorders         
Retinal tear * 1  1/54 (1.85%)  0/31 (0.00%)  0/54 (0.00%)  0/28 (0.00%) 
Visual impairment * 1  1/54 (1.85%)  0/31 (0.00%)  0/54 (0.00%)  0/28 (0.00%) 
Hepatobiliary disorders         
Cholelithiasis * 1  1/54 (1.85%)  0/31 (0.00%)  0/54 (0.00%)  0/28 (0.00%) 
Injury, poisoning and procedural complications         
Toxicity to various agents * 1  1/54 (1.85%)  0/31 (0.00%)  0/54 (0.00%)  0/28 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 14.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks Cohort 1 and 2: TMC435 and PSI-7977 for 24 Weeks Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks Cohort 1 and 2: TMC435 and PSI-7977 for 12 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   48/54 (88.89%)   25/31 (80.65%)   42/54 (77.78%)   17/28 (60.71%) 
Blood and lymphatic system disorders         
Anaemia * 1  13/54 (24.07%)  0/31 (0.00%)  6/54 (11.11%)  0/28 (0.00%) 
Cardiac disorders         
Sinus bradycardia * 1  0/54 (0.00%)  2/31 (6.45%)  0/54 (0.00%)  0/28 (0.00%) 
Gastrointestinal disorders         
Abdominal pain * 1  2/54 (3.70%)  3/31 (9.68%)  0/54 (0.00%)  0/28 (0.00%) 
Abdominal pain upper * 1  5/54 (9.26%)  0/31 (0.00%)  2/54 (3.70%)  0/28 (0.00%) 
Constipation * 1  4/54 (7.41%)  1/31 (3.23%)  4/54 (7.41%)  1/28 (3.57%) 
Diarrhoea * 1  1/54 (1.85%)  5/31 (16.13%)  3/54 (5.56%)  2/28 (7.14%) 
Dry mouth * 1  3/54 (5.56%)  0/31 (0.00%)  2/54 (3.70%)  0/28 (0.00%) 
Dyspepsia * 1  3/54 (5.56%)  1/31 (3.23%)  2/54 (3.70%)  0/28 (0.00%) 
Gastrooesophageal reflux disease * 1  5/54 (9.26%)  0/31 (0.00%)  0/54 (0.00%)  2/28 (7.14%) 
Nausea * 1  7/54 (12.96%)  4/31 (12.90%)  9/54 (16.67%)  6/28 (21.43%) 
Toothache * 1  0/54 (0.00%)  2/31 (6.45%)  1/54 (1.85%)  0/28 (0.00%) 
Vomiting * 1  3/54 (5.56%)  1/31 (3.23%)  1/54 (1.85%)  0/28 (0.00%) 
General disorders         
Chills * 1  3/54 (5.56%)  0/31 (0.00%)  1/54 (1.85%)  0/28 (0.00%) 
Fatigue * 1  21/54 (38.89%)  10/31 (32.26%)  14/54 (25.93%)  7/28 (25.00%) 
Influenza like illness * 1  1/54 (1.85%)  2/31 (6.45%)  0/54 (0.00%)  0/28 (0.00%) 
Oedema peripheral * 1  4/54 (7.41%)  0/31 (0.00%)  0/54 (0.00%)  0/28 (0.00%) 
Hepatobiliary disorders         
Hyperbilirubinaemia * 1  2/54 (3.70%)  1/31 (3.23%)  4/54 (7.41%)  0/28 (0.00%) 
Immune system disorders         
Seasonal allergy * 1  3/54 (5.56%)  0/31 (0.00%)  0/54 (0.00%)  1/28 (3.57%) 
Infections and infestations         
Bronchitis * 1  2/54 (3.70%)  2/31 (6.45%)  0/54 (0.00%)  0/28 (0.00%) 
Oral herpes * 1  4/54 (7.41%)  0/31 (0.00%)  0/54 (0.00%)  0/28 (0.00%) 
Sinusitis * 1  1/54 (1.85%)  2/31 (6.45%)  3/54 (5.56%)  0/28 (0.00%) 
Upper respiratory tract infection * 1  3/54 (5.56%)  2/31 (6.45%)  6/54 (11.11%)  1/28 (3.57%) 
Urinary tract infection * 1  3/54 (5.56%)  2/31 (6.45%)  1/54 (1.85%)  0/28 (0.00%) 
Injury, poisoning and procedural complications         
Sunburn * 1  1/54 (1.85%)  0/31 (0.00%)  2/54 (3.70%)  2/28 (7.14%) 
Investigations         
Blood amylase increased * 1  2/54 (3.70%)  2/31 (6.45%)  4/54 (7.41%)  0/28 (0.00%) 
Blood creatine phosphokinase increased * 1  4/54 (7.41%)  2/31 (6.45%)  6/54 (11.11%)  1/28 (3.57%) 
Lipase increased * 1  2/54 (3.70%)  1/31 (3.23%)  3/54 (5.56%)  0/28 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  1/54 (1.85%)  1/31 (3.23%)  2/54 (3.70%)  2/28 (7.14%) 
Back pain * 1  2/54 (3.70%)  1/31 (3.23%)  1/54 (1.85%)  2/28 (7.14%) 
Myalgia * 1  3/54 (5.56%)  3/31 (9.68%)  3/54 (5.56%)  1/28 (3.57%) 
Neck pain * 1  3/54 (5.56%)  0/31 (0.00%)  2/54 (3.70%)  1/28 (3.57%) 
Pain in extremity * 1  4/54 (7.41%)  2/31 (6.45%)  2/54 (3.70%)  0/28 (0.00%) 
Nervous system disorders         
Dizziness * 1  7/54 (12.96%)  5/31 (16.13%)  3/54 (5.56%)  1/28 (3.57%) 
Headache * 1  11/54 (20.37%)  7/31 (22.58%)  9/54 (16.67%)  6/28 (21.43%) 
Memory impairment * 1  1/54 (1.85%)  2/31 (6.45%)  1/54 (1.85%)  0/28 (0.00%) 
Psychiatric disorders         
Abnormal dreams * 1  0/54 (0.00%)  0/31 (0.00%)  3/54 (5.56%)  1/28 (3.57%) 
Insomnia * 1  9/54 (16.67%)  2/31 (6.45%)  5/54 (9.26%)  4/28 (14.29%) 
Respiratory, thoracic and mediastinal disorders         
Cough * 1  8/54 (14.81%)  2/31 (6.45%)  3/54 (5.56%)  1/28 (3.57%) 
Dyspnoea exertional * 1  3/54 (5.56%)  0/31 (0.00%)  3/54 (5.56%)  0/28 (0.00%) 
Oropharyngeal pain * 1  0/54 (0.00%)  2/31 (6.45%)  2/54 (3.70%)  1/28 (3.57%) 
Skin and subcutaneous tissue disorders         
Alopecia * 1  1/54 (1.85%)  3/31 (9.68%)  3/54 (5.56%)  1/28 (3.57%) 
Dermatitis * 1  1/54 (1.85%)  0/31 (0.00%)  3/54 (5.56%)  0/28 (0.00%) 
Dry skin * 1  4/54 (7.41%)  1/31 (3.23%)  2/54 (3.70%)  2/28 (7.14%) 
Photosensitivity reaction * 1  1/54 (1.85%)  2/31 (6.45%)  1/54 (1.85%)  0/28 (0.00%) 
Pruritus * 1  9/54 (16.67%)  1/31 (3.23%)  5/54 (9.26%)  3/28 (10.71%) 
Rash * 1  7/54 (12.96%)  3/31 (9.68%)  8/54 (14.81%)  1/28 (3.57%) 
Vascular disorders         
Hypertension * 1  2/54 (3.70%)  2/31 (6.45%)  5/54 (9.26%)  0/28 (0.00%) 
*
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
Layout table for Results Point of Contact information
Name/Title: Medical Leader
Organization: Janssen Research & Development, LLC
EMail: ClinicalTrialDisclosure@its.jnj.com
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Responsible Party: Janssen R&D Ireland
ClinicalTrials.gov Identifier: NCT01466790    
Other Study ID Numbers: CR018724
TMC435HPC2002 ( Other Identifier: Janssen R&D Ireland )
First Submitted: November 3, 2011
First Posted: November 8, 2011
Results First Submitted: October 17, 2014
Results First Posted: October 22, 2014
Last Update Posted: February 9, 2015