Trial Outcomes & Findings for Quality of Life Measurement in Treatment Naïve Patients With Hepatitis C Virus (HCV) Genotype 1 (GT1) Suffering From Fatigue and Receiving Ombitasvir, Paritaprevir, and Ritonavir and Dasabuvir (Viekirax®/Exviera®) (NCT NCT03002818)
NCT ID: NCT03002818
Last Updated: 2019-10-23
Results Overview
Mean daytime physical activity for 2 eligible weeks (10 working days) prior to the assessment day was derived from a wrist-worn activity tracker (ActiGraph GT9X Link), which measures activity via a 3-axis algorithm. For total daytime physical activity, the measured counts of the activity tracker data minus total sleep counts were used as day-counts. Higher day-counts signify more activity.
COMPLETED
41 participants
Baseline, Day 168
2019-10-23
Participant Flow
Participant milestones
| Measure |
Hepatitis C Virus (HCV) Genotype 1 Participants
Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen)
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Hepatitis C Virus (HCV) Genotype 1 Participants
Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen)
|
|---|---|
|
Overall Study
Decision of the investigator
|
1
|
Baseline Characteristics
Intent to treat (ITT) population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets.
Baseline characteristics by cohort
| Measure |
HCV Genotype 1 Participants
n=41 Participants
Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen)
|
|---|---|
|
Age, Continuous
|
49.4 years
STANDARD_DEVIATION 12.7 • n=41 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
41 Participants
n=41 Participants
|
|
Mean Daytime Physical Activity
sdITT Population
|
1469569 day-counts
STANDARD_DEVIATION 405329 • n=35 Participants • Intent to treat (ITT) population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets.
|
|
Mean Daytime Physical Activity
mITT Population
|
1513166 day-counts
STANDARD_DEVIATION 410686 • n=24 Participants • Intent to treat (ITT) population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets.
|
|
Fatigue Severity Scale (FSS)
sdITT Population
|
5.95 score on a scale
STANDARD_DEVIATION 0.61 • n=37 Participants • Intent to treat (ITT) population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets.
|
|
Fatigue Severity Scale (FSS)
mITT Population
|
5.94 score on a scale
STANDARD_DEVIATION 0.67 • n=24 Participants • Intent to treat (ITT) population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets.
|
|
Sleep Efficiency
sdITT Population
|
89.4 percent of time asleep
STANDARD_DEVIATION 4.58 • n=35 Participants • Intent to treat (ITT) population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets.
|
|
Sleep Efficiency
mITT Population
|
89.8 percent of time asleep
STANDARD_DEVIATION 3.76 • n=24 Participants • Intent to treat (ITT) population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets.
|
PRIMARY outcome
Timeframe: Baseline, Day 168Population: ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets. Participants with an assessment at given time point.
Mean daytime physical activity for 2 eligible weeks (10 working days) prior to the assessment day was derived from a wrist-worn activity tracker (ActiGraph GT9X Link), which measures activity via a 3-axis algorithm. For total daytime physical activity, the measured counts of the activity tracker data minus total sleep counts were used as day-counts. Higher day-counts signify more activity.
Outcome measures
| Measure |
HCV Genotype 1 Participants
n=26 Participants
Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen)
|
|---|---|
|
Change From Baseline at Day 168 in Mean Daytime Physical Activity
Change at Day 168: sdITT Population
|
-108266 day-counts
Standard Deviation 313859
|
|
Change From Baseline at Day 168 in Mean Daytime Physical Activity
Change at Day 168: mITT Population
|
-98373 day-counts
Standard Deviation 325138
|
SECONDARY outcome
Timeframe: Baseline, Days 28, 84, 168Population: ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets. Participants with an assessment at given time point.
Mean daytime physical activity for 2 eligible weeks (10 working days) prior to the assessment day was derived from a wrist-worn activity tracker (ActiGraph GT9X Link), which measures activity via a 3-axis algorithm. For total daytime physical activity, the measured counts of the activity tracker data minus total sleep counts were used as day-counts. Higher day-counts signify more activity.
Outcome measures
| Measure |
HCV Genotype 1 Participants
n=34 Participants
Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen)
|
|---|---|
|
Change From Baseline Over Time in Mean Daytime Physical Activity
Change at Day 28: sdITT Population
|
26990 day-counts
Standard Deviation 211108
|
|
Change From Baseline Over Time in Mean Daytime Physical Activity
Change at Day 28: mITT Population
|
21422 day-counts
Standard Deviation 215104
|
|
Change From Baseline Over Time in Mean Daytime Physical Activity
Change at Day 84: sdITT Population
|
-6448 day-counts
Standard Deviation 198441
|
|
Change From Baseline Over Time in Mean Daytime Physical Activity
Change at Day 84: mITT Population
|
-13020 day-counts
Standard Deviation 197825
|
|
Change From Baseline Over Time in Mean Daytime Physical Activity
Change at Day 168: sdITT Population
|
-108266 day-counts
Standard Deviation 313859
|
|
Change From Baseline Over Time in Mean Daytime Physical Activity
Change at Day 168: mITT Population
|
-98373 day-counts
Standard Deviation 325138
|
SECONDARY outcome
Timeframe: Baseline, Days 28, 84, 168Population: ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets. Participants with an assessment at given time point.
The FSS is a 9-item questionnaire assessing the functional impact of fatigue during the past two weeks on multiple life domains using scales from 1 (strongly disagree) to 7 (strongly agree). The fatigue score is the mean score of the 9 items, with lower scores indicating less fatigue severity. Clinically significant fatigue is usually defined as score equal or above 4. Changes were calculated by the formula "Baseline minus Day 28, Day 84, or Day 168." Therefore the resulting negative values reflect deterioration and resulting positive values reflect improvement.
Outcome measures
| Measure |
HCV Genotype 1 Participants
n=36 Participants
Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen)
|
|---|---|
|
Change From Baseline Over Time in Fatigue Severity Scale (FSS) Score
Change at Day 28: sdITT Population
|
0.69 score on a scale
Standard Deviation 1.01
|
|
Change From Baseline Over Time in Fatigue Severity Scale (FSS) Score
Change at Day 28: mITT Population
|
0.85 score on a scale
Standard Deviation 1.06
|
|
Change From Baseline Over Time in Fatigue Severity Scale (FSS) Score
Change at Day 84: sdITT Population
|
1.68 score on a scale
Standard Deviation 1.54
|
|
Change From Baseline Over Time in Fatigue Severity Scale (FSS) Score
Change at Day 84: mITT Population
|
1.76 score on a scale
Standard Deviation 1.64
|
|
Change From Baseline Over Time in Fatigue Severity Scale (FSS) Score
Change at Day 168: sdITT Population
|
2.60 score on a scale
Standard Deviation 1.62
|
|
Change From Baseline Over Time in Fatigue Severity Scale (FSS) Score
Change at Day 168: mITT Population
|
2.82 score on a scale
Standard Deviation 1.52
|
SECONDARY outcome
Timeframe: Baseline, Days 28, 84, 168Population: ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets. Participants with an assessment at given time point.
Sleep efficiency for 2 eligible weeks (10 working days) prior to the assessment day was derived from a wrist-worn activity tracker (ActiGraph GT9X Link). Sleep efficiency was defined as the percent of time scored as sleep during the sleep period, from 0% to 100%. Changes were calculated by the formula "Baseline minus Day 28, Day 84, or Day 168." Therefore the resulting negative values reflect deterioration and resulting positive values reflect improvement.
Outcome measures
| Measure |
HCV Genotype 1 Participants
n=34 Participants
Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen)
|
|---|---|
|
Change From Baseline Over Time in Sleep Efficiency
Change at Day 28: sdITT Population
|
-0.87 percent of time asleep
Standard Deviation 2.50
|
|
Change From Baseline Over Time in Sleep Efficiency
Change at Day 28: mITT Population
|
-0.44 percent of time asleep
Standard Deviation 2.68
|
|
Change From Baseline Over Time in Sleep Efficiency
Change at Day 84: sdITT Population
|
-0.06 percent of time asleep
Standard Deviation 2.81
|
|
Change From Baseline Over Time in Sleep Efficiency
Change at Day 84: mITT Population
|
0.01 percent of time asleep
Standard Deviation 2.98
|
|
Change From Baseline Over Time in Sleep Efficiency
Change at Day 168: sdITT Population
|
0.61 percent of time asleep
Standard Deviation 3.28
|
|
Change From Baseline Over Time in Sleep Efficiency
Change at Day 168: mITT Population
|
0.74 percent of time asleep
Standard Deviation 3.37
|
SECONDARY outcome
Timeframe: Baseline, Days 28, 84, 168Population: ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets. Participants with an assessment at given time point.
The relationship between the parameters FSS and mean total daytime physical activity as well as for the changes of these parameters between baseline and follow-up visits was analyzed. Given a lake of normal distribution for the FSS data Spearman correlation coefficients were calculated.
Outcome measures
| Measure |
HCV Genotype 1 Participants
n=35 Participants
Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen)
|
|---|---|
|
Correlation Coefficients of FSS and Mean Daytime Physical Activity: sdITT Population
Baseline
|
0.300 Spearman correlation coefficient
|
|
Correlation Coefficients of FSS and Mean Daytime Physical Activity: sdITT Population
Day 28
|
0.131 Spearman correlation coefficient
|
|
Correlation Coefficients of FSS and Mean Daytime Physical Activity: sdITT Population
Day 84
|
-0.022 Spearman correlation coefficient
|
|
Correlation Coefficients of FSS and Mean Daytime Physical Activity: sdITT Population
Day 168
|
0.195 Spearman correlation coefficient
|
SECONDARY outcome
Timeframe: Baseline, Days 28, 84, 168Population: ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets. Participants with an assessment at given time point.
The relationship between the parameters FSS and mean total daytime physical activity as well as for the changes of these parameters between baseline and follow-up visits was analyzed. Given a lake of normal distribution for the FSS data Spearman correlation coefficients were calculated.
Outcome measures
| Measure |
HCV Genotype 1 Participants
n=24 Participants
Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen)
|
|---|---|
|
Correlation Coefficients of FSS and Mean Daytime Physical Activity: mITT Population
Baseline
|
0.253 Spearman correlation coefficient
|
|
Correlation Coefficients of FSS and Mean Daytime Physical Activity: mITT Population
Day 28
|
0.386 Spearman correlation coefficient
|
|
Correlation Coefficients of FSS and Mean Daytime Physical Activity: mITT Population
Day 84
|
-0.058 Spearman correlation coefficient
|
|
Correlation Coefficients of FSS and Mean Daytime Physical Activity: mITT Population
Day 168
|
0.128 Spearman correlation coefficient
|
SECONDARY outcome
Timeframe: Baseline, Days 28, 84, 168Population: ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets. Participants with an assessment at given time point.
The relationship between the parameters FSS and mean total daytime physical activity as well as for the changes of these parameters between baseline and follow-up visits was analyzed. Given a lake of normal distribution for the FSS data Spearman correlation coefficients were calculated.
Outcome measures
| Measure |
HCV Genotype 1 Participants
n=34 Participants
Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen)
|
|---|---|
|
Correlation Coefficients of Change From Baseline Over Time in FSS and Mean Daytime Physical Activity: sdITT Population
Baseline minus Day 28
|
0.228 Spearman correlation coefficient
|
|
Correlation Coefficients of Change From Baseline Over Time in FSS and Mean Daytime Physical Activity: sdITT Population
Baseline minus Day 84
|
-0.044 Spearman correlation coefficient
|
|
Correlation Coefficients of Change From Baseline Over Time in FSS and Mean Daytime Physical Activity: sdITT Population
Baseline minus Day 168
|
0.195 Spearman correlation coefficient
|
SECONDARY outcome
Timeframe: Baseline, Days 28, 84, 168Population: ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets. Participants with an assessment at given time point.
The relationship between the parameters FSS and mean total daytime physical activity as well as for the changes of these parameters between baseline and follow-up visits was analyzed. Given a lake of normal distribution for the FSS data Spearman correlation coefficients were calculated.
Outcome measures
| Measure |
HCV Genotype 1 Participants
n=24 Participants
Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen)
|
|---|---|
|
Correlation Coefficients of Change From Baseline Over Time in FSS and Mean Daytime Physical Activity: mITT Population
Baseline minus Day 28
|
0.135 Spearman correlation coefficient
|
|
Correlation Coefficients of Change From Baseline Over Time in FSS and Mean Daytime Physical Activity: mITT Population
Baseline minus Day 84
|
-0.065 Spearman correlation coefficient
|
|
Correlation Coefficients of Change From Baseline Over Time in FSS and Mean Daytime Physical Activity: mITT Population
Baseline minus Day 168
|
0.169 Spearman correlation coefficient
|
SECONDARY outcome
Timeframe: Day 168 (or 12 weeks after the last dose of study drug)Population: ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets.
SVR12 defined as hepatitis C virus ribonucleic acid (HCV RNA) not detectable 12 weeks after the last actual dose of paritaprevir/ritonavir/ombitasvir with dasabuvir regimen (Viekirax®/Exviera®, 3D regimen).
Outcome measures
| Measure |
HCV Genotype 1 Participants
n=41 Participants
Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen)
|
|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-Treatment
ITT Population
|
97.6 percentage of participants
Interval 95.2 to 100.0
|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-Treatment
sdITT Population
|
97.3 percentage of participants
Interval 92.3 to 100.0
|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-Treatment
mITT Population
|
95.8 percentage of participants
Interval 88.3 to 100.0
|
Adverse Events
HCV Genotype 1 Participants
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HCV Genotype 1 Participants
n=41 participants at risk
Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen)
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
14.6%
6/41 • Number of events 6 • From first dose of study drug up to Day 168
|
|
Nervous system disorders
Dizziness
|
7.3%
3/41 • Number of events 3 • From first dose of study drug up to Day 168
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER