IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Genotype 1 Chronic Hepatitis C Virus Infection and Cirrhosis
This study has been completed.
Sponsor:
Janssen Infectious Diseases BVBA
Information provided by (Responsible Party):
Janssen Infectious Diseases BVBA
ClinicalTrials.gov Identifier:
NCT02114151
First received: April 2, 2014
Last updated: March 7, 2016
Last verified: March 2016
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Results First Received: January 21, 2016
| Study Type: | Interventional |
|---|---|
| Study Design: | Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Condition: |
Hepatitis C Virus Infection |
| Interventions: |
Drug: Simeprevir Drug: Sofosbuvir |
Participant Flow
Hide Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| A total of 147 participants from the United States and Canada were Screened and 103 were enrolled into the study. All 103 participants who received at least 1 dose of study drug and so were included in intent to treat (ITT) population. |
Reporting Groups
| Description | |
|---|---|
| Simeprevir Plus Sofosbuvir | Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks. |
Participant Flow: Overall Study
| Simeprevir Plus Sofosbuvir | |
|---|---|
| STARTED | 103 |
| COMPLETED | 96 |
| NOT COMPLETED | 7 |
| Death | 1 |
| Lost to Follow-up | 1 |
| Withdrawal by Subject | 5 |
Baseline Characteristics
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Simeprevir Plus Sofosbuvir | Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks. |
Baseline Measures
| Simeprevir Plus Sofosbuvir | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Participants Analyzed [Units: Participants] |
103 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Age [Units: Years] Median (Full Range) |
58 (29 to 69) |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Gender [Units: Participants] |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Female | 20 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Male | 83 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Outcome Measures
| 1. Primary: | Percentage of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Actual End of Treatment (EOT) [ Time Frame: Week 24 ] |
| Measure Type | Primary |
|---|---|
| Measure Title | Percentage of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Actual End of Treatment (EOT) |
| Measure Description | Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 12 weeks after the actual end of treatment. |
| Time Frame | Week 24 |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. |
Reporting Groups
| Description | |
|---|---|
| Simeprevir Plus Sofosbuvir | Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks. |
Measured Values
| Simeprevir Plus Sofosbuvir | |
|---|---|
|
Participants Analyzed [Units: Participants] |
103 |
|
Percentage of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Actual End of Treatment (EOT) [Units: Percentage of Participants] Number (95% Confidence Interval) |
83.5 (75.8 to 91.1) |
No statistical analysis provided for Percentage of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Actual End of Treatment (EOT)
| 2. Secondary: | Percentage of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Actual End of Treatment (EOT) [ Time Frame: Week 16 ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Percentage of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Actual End of Treatment (EOT) |
| Measure Description | Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 4 weeks after the actual end of treatment. |
| Time Frame | Week 16 |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. |
Reporting Groups
| Description | |
|---|---|
| Simeprevir Plus Sofosbuvir | Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks. |
Measured Values
| Simeprevir Plus Sofosbuvir | |
|---|---|
|
Participants Analyzed [Units: Participants] |
103 |
|
Percentage of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Actual End of Treatment (EOT) [Units: Percentage of Participants] Number (95% Confidence Interval) |
86.4 (79.3 to 93.5) |
No statistical analysis provided for Percentage of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Actual End of Treatment (EOT)
| 3. Secondary: | Percentage of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Actual End of Treatment (EOT) [ Time Frame: Week 36 ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Percentage of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Actual End of Treatment (EOT) |
| Measure Description | Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 24 weeks after the actual end of treatment. |
| Time Frame | Week 36 |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. |
Reporting Groups
| Description | |
|---|---|
| Simeprevir Plus Sofosbuvir | Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks. |
Measured Values
| Simeprevir Plus Sofosbuvir | |
|---|---|
|
Participants Analyzed [Units: Participants] |
103 |
|
Percentage of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Actual End of Treatment (EOT) [Units: Percentage of Participants] Number (95% Confidence Interval) |
82.5 (74.7 to 90.3) |
No statistical analysis provided for Percentage of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Actual End of Treatment (EOT)
| 4. Secondary: | Percentage of Participants With On-treatment Virologic Response [ Time Frame: Week 2, 4 and End of Treatment (Week 12) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Percentage of Participants With On-treatment Virologic Response |
| Measure Description | On-treatment virologic response was determined by HCV RNA results satisfying a specified threshold. <LLOQ undetectable was considered as threshold at any time point. The LLOQ value is 25 IU/mL. EOT=End of Treatment. |
| Time Frame | Week 2, 4 and End of Treatment (Week 12) |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here ‘n’ specifies those participants who were evaluated for this outcome measure at given time point. |
Reporting Groups
| Description | |
|---|---|
| Simeprevir Plus Sofosbuvir | Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks. |
Measured Values
| Simeprevir Plus Sofosbuvir | |
|---|---|
|
Participants Analyzed [Units: Participants] |
103 |
|
Percentage of Participants With On-treatment Virologic Response [Units: Percentage of Participants] |
|
| Week 2: < 100 IU/mL (n=102) | 90.2 |
| Week 2: < 25 IU/mL (n=102) | 68.6 |
| Week 2: < 25 IU/mL Detectable (n=102) | 44.1 |
| Week 2: < 25 IU/mL Undetectable (n=102) | 24.5 |
| Week 4: < 100 IU/mL (n=102) | 99.0 |
| Week 4: < 25 IU/mL (n=102) | 99.0 |
| Week 4: < 25 IU/mL Detectable (n=102) | 15.7 |
| Week 4: < 25 IU/mL Undetectable (n=102) | 83.3 |
| EOT (Week 12): < 100 IU/mL (n=103) | 97.1 |
| EOT (Week 12): < 25 IU/mL (n=103) | 97.1 |
| EOT (Week 12): < 25 IU/mL Detectable (n=103) | 0 |
| EOT (Week 12): < 25 IU/mL Undetectable (n=103) | 97.1 |
No statistical analysis provided for Percentage of Participants With On-treatment Virologic Response
| 5. Secondary: | Percentage of Participants With On-treatment Failure [ Time Frame: Week 12 ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Percentage of Participants With On-treatment Failure |
| Measure Description | On-treatment failure is defined as participants who do not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of study drug treatment. |
| Time Frame | Week 12 |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Intent-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug. |
Reporting Groups
| Description | |
|---|---|
| Simeprevir Plus Sofosbuvir | Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks. |
Measured Values
| Simeprevir Plus Sofosbuvir | |
|---|---|
|
Participants Analyzed [Units: Participants] |
103 |
|
Percentage of Participants With On-treatment Failure [Units: Percentage of Participants] |
2.9 |
No statistical analysis provided for Percentage of Participants With On-treatment Failure
| 6. Secondary: | Percentage of Participants With Viral Breakthrough [ Time Frame: Up to End of Treatment (Week 12) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Percentage of Participants With Viral Breakthrough |
| Measure Description | Viral breakthrough was defined as confirmed greater than (>) 1 log10 increase in HCV RNA from nadir or confirmed HCV RNA >100 IU/mL in participants who had previously achieved HCV RNA < LLOQ (25 IU/mL). |
| Time Frame | Up to End of Treatment (Week 12) |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. |
Reporting Groups
| Description | |
|---|---|
| Simeprevir Plus Sofosbuvir | Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks. |
Measured Values
| Simeprevir Plus Sofosbuvir | |
|---|---|
|
Participants Analyzed [Units: Participants] |
103 |
|
Percentage of Participants With Viral Breakthrough [Units: Percentage of Participants] |
1.9 |
No statistical analysis provided for Percentage of Participants With Viral Breakthrough
| 7. Secondary: | Percentage of Participants With Viral Relapse [ Time Frame: During the Follow-up (Week 24) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Percentage of Participants With Viral Relapse |
| Measure Description | Viral relapse was defined as participants who did not achieve SVR12 and had HCV RNA < LLOQ (25 IU/mL) undetectable at EOT and had HCV RNA >= LLOQ (25 IU/mL) during the follow-up period. |
| Time Frame | During the Follow-up (Week 24) |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure. |
Reporting Groups
| Description | |
|---|---|
| Simeprevir Plus Sofosbuvir | Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks. |
Measured Values
| Simeprevir Plus Sofosbuvir | |
|---|---|
|
Participants Analyzed [Units: Participants] |
99 |
|
Percentage of Participants With Viral Relapse [Units: Percentage of Participants] |
13.1 |
No statistical analysis provided for Percentage of Participants With Viral Relapse
| 8. Secondary: | Change From Baseline in Hepatitis C Symptom and Impact Questionnaire Version 4 (HCV-SIQv4) Overall Body System Score (OBSS) up to Follow-up Week 12 [ Time Frame: Baseline, Week 4, Week 12 and Follow-Up Week 12 ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Change From Baseline in Hepatitis C Symptom and Impact Questionnaire Version 4 (HCV-SIQv4) Overall Body System Score (OBSS) up to Follow-up Week 12 |
| Measure Description | The HCV-SIQv4 OBSS was a self-administered questionnaire that contained 33 items: 29 questions developed to assess severity or frequency of symptoms associated with HCV or its treatment, 3 questions regarding the impact of symptoms on work/school attendance, and 1 question regarding the impact of symptoms on daily activities. A symptom severity score (the mean of responses to the 29 symptom items); each symptom score was transformed to have a range from 0 to 100 (most severe). Higher HCV SIQv4 scores indicates worse symptom severity, more time missed from work/school, and more impairment in daily activities, respectively. |
| Time Frame | Baseline, Week 4, Week 12 and Follow-Up Week 12 |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point. |
Reporting Groups
| Description | |
|---|---|
| Simeprevir Plus Sofosbuvir | Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks. |
Measured Values
| Simeprevir Plus Sofosbuvir | |
|---|---|
|
Participants Analyzed [Units: Participants] |
98 |
|
Change From Baseline in Hepatitis C Symptom and Impact Questionnaire Version 4 (HCV-SIQv4) Overall Body System Score (OBSS) up to Follow-up Week 12 [Units: Units on a Scale] Mean (Standard Error) |
|
| Baseline (n=98) | 17.4 (1.47) |
| Change at Week 4 (n=96) | -4.9 (1.23) |
| Change at Week 12 (n=89) | -4.7 (1.39) |
| Change at Follow-up Week 12 (n=94) | -5.8 (1.36) |
No statistical analysis provided for Change From Baseline in Hepatitis C Symptom and Impact Questionnaire Version 4 (HCV-SIQv4) Overall Body System Score (OBSS) up to Follow-up Week 12
| 9. Secondary: | Change From Baseline in Fatigue Severity Score (FSS) up to Follow-up Week 24 [ Time Frame: Baseline, Week 12, Follow-up Week 12 and 24 ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Change From Baseline in Fatigue Severity Score (FSS) up to Follow-up Week 24 |
| Measure Description | The FSS was a self-administered questionnaire with 9 items developed to assess disabling fatigue that has been used extensively in studies of chronic HCV infection. Item responses were measured on a 7-point Likert scale ranging from strongly disagree (1 point) to strongly agree (7 points). The 9 items were averaged to produce a total score; a lower total score indicates less severe fatigue. FSS scores have a range from 1 to 7 where higher scores indicate more severe fatigue. |
| Time Frame | Baseline, Week 12, Follow-up Week 12 and 24 |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point. |
Reporting Groups
| Description | |
|---|---|
| Simeprevir Plus Sofosbuvir | Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks. |
Measured Values
| Simeprevir Plus Sofosbuvir | |
|---|---|
|
Participants Analyzed [Units: Participants] |
96 |
|
Change From Baseline in Fatigue Severity Score (FSS) up to Follow-up Week 24 [Units: Units on a Scale] Mean (Standard Error) |
|
| Baseline (n=96) | 3.4 (0.18) |
| Change at Week 12 (n=86) | -0.4 (0.18) |
| Change at Follow-up Week 12 (n=92) | -0.6 (0.16) |
| Change at Follow-up Week 24 (n=86) | -0.8 (0.18) |
No statistical analysis provided for Change From Baseline in Fatigue Severity Score (FSS) up to Follow-up Week 24
| 10. Secondary: | Percentage of Participants With Depression by Using Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: Baseline, Week 12, Follow-up Week 12 and 24 ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Percentage of Participants With Depression by Using Center for Epidemiologic Studies Depression Scale (CES-D) |
| Measure Description | The CES-D Scale assessed how often during the past week participants experienced 20 symptoms commonly associated with major depression. The CES-D scores range from 0 (no symptoms) to 60 (all 20 symptoms most or all of the time during the past 5 to 7 days). The CES-D scores between 16 and 23 points indicate mild to moderate depressive illness while CES-D scores >=23 indicate probable major depressive illness. |
| Time Frame | Baseline, Week 12, Follow-up Week 12 and 24 |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point. |
Reporting Groups
| Description | |
|---|---|
| Simeprevir Plus Sofosbuvir | Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks. |
Measured Values
| Simeprevir Plus Sofosbuvir | |
|---|---|
|
Participants Analyzed [Units: Participants] |
96 |
|
Percentage of Participants With Depression by Using Center for Epidemiologic Studies Depression Scale (CES-D) [Units: Percentage of Participants] |
|
| Baseline: No Depression (n=96) | 67.7 |
| Baseline: Mild to Moderate Depression (n=96) | 16.7 |
| Baseline: Severe Depression (n=96) | 15.6 |
| Week 12: No Depression (n=88) | 77.3 |
| Week 12: Mild to Moderate Depression (n=88) | 15.9 |
| Week 12: Severe Depression (n=88) | 6.8 |
| Follow-up Week 12: No Depression (n=94) | 79.8 |
| Follow-up Week12:Mild to Moderate Depression(n=94) | 6.4 |
| Follow-up Week 12: Severe Depression (n=94) | 13.8 |
| Follow-up Week 24: No Depression (n=88) | 79.5 |
| Follow-up Week24:Mild to Moderate Depression(n=88) | 10.2 |
| Follow-up Week 24: Severe Depression (n=88) | 10.2 |
No statistical analysis provided for Percentage of Participants With Depression by Using Center for Epidemiologic Studies Depression Scale (CES-D)
| 11. Secondary: | Change From Baseline in EuroQol 5 Dimension Questionnaire (EQ-5D) up to Follow-up Week 24 [ Time Frame: Baseline, Follow-up Week 12 and 24 ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Change From Baseline in EuroQol 5 Dimension Questionnaire (EQ-5D) up to Follow-up Week 24 |
| Measure Description | The EQ-5D questionnaire was a brief, generic health-related quality of life (HRQOL) assessment that could also be used to incorporate participant preferences into health economic evaluations. The EQ-5D questionnaire assessed HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a "thermometer" visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health). |
| Time Frame | Baseline, Follow-up Week 12 and 24 |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point. |
Reporting Groups
| Description | |
|---|---|
| Simeprevir Plus Sofosbuvir | Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks. |
Measured Values
| Simeprevir Plus Sofosbuvir | |
|---|---|
|
Participants Analyzed [Units: Participants] |
96 |
|
Change From Baseline in EuroQol 5 Dimension Questionnaire (EQ-5D) up to Follow-up Week 24 [Units: Units on a Scale] Mean (Standard Error) |
|
| Baseline (n=96) | 70.1 (2.17) |
| Change at Follow-up Week 12 (n=92) | 9.8 (1.90) |
| Change at Follow-up Week 24 (n=86) | 9.5 (1.75) |
No statistical analysis provided for Change From Baseline in EuroQol 5 Dimension Questionnaire (EQ-5D) up to Follow-up Week 24
| 12. Secondary: | Number of Participants Not Achieving SVR Showing Emerging Mutation at Time of Failure in HCV NS3/4A Sequence and NS5B up to Follow-up Week 24 [ Time Frame: Baseline, Day 3, Week 1, 2, 3, 4, 8, 12, Follow-up Week 4, 12 and 24 ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Number of Participants Not Achieving SVR Showing Emerging Mutation at Time of Failure in HCV NS3/4A Sequence and NS5B up to Follow-up Week 24 |
| Measure Description | Sequencing of the HCV nonstructural protein 3/4A (NS3/4A) and nonstructural protein 5B (NS5B) genes was done to identify pre-existing sequence polymorphisms and characterize emerging HCV viral variants in participants not achieving SVR. Sequencing data is available for 16 participants. |
| Time Frame | Baseline, Day 3, Week 1, 2, 3, 4, 8, 12, Follow-up Week 4, 12 and 24 |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure. |
Reporting Groups
| Description | |
|---|---|
| Simeprevir Plus Sofosbuvir | Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks. |
Measured Values
| Simeprevir Plus Sofosbuvir | |
|---|---|
|
Participants Analyzed [Units: Participants] |
16 |
|
Number of Participants Not Achieving SVR Showing Emerging Mutation at Time of Failure in HCV NS3/4A Sequence and NS5B up to Follow-up Week 24 [Units: Participants] |
|
| HCV NS3 | 13 |
| NS5B | 0 |
No statistical analysis provided for Number of Participants Not Achieving SVR Showing Emerging Mutation at Time of Failure in HCV NS3/4A Sequence and NS5B up to Follow-up Week 24
Show Serious Adverse Events
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
More Information
Certain Agreements:
Results Point of Contact:
| 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. | ||||||
The agreement is:
|
Results Point of Contact:
Name/Title: Associate Director
Organization: Janssen Infectious Diseases - Diagnostics BVBA
e-mail: ClinicalTrialDisclosure@its.jnj.com
Organization: Janssen Infectious Diseases - Diagnostics BVBA
e-mail: ClinicalTrialDisclosure@its.jnj.com
| Responsible Party: | Janssen Infectious Diseases BVBA |
| ClinicalTrials.gov Identifier: | NCT02114151 History of Changes |
| Other Study ID Numbers: |
CR103431 TMC435HPC3018 ( Other Identifier: Janssen Infectious Diseases BVBA ) |
| Study First Received: | April 2, 2014 |
| Results First Received: | January 21, 2016 |
| Last Updated: | March 7, 2016 |