Chronic Hepatitis C Virus (HCV)
Conditions
Keywords
Chronic Hepatitis C (HCV), Genotype 1, Paritaprevir, Ritonavir, ombitasvir, Dasabuvir, Sustained Virological Response
Brief summary
This is an observational, prospective, open-label, single-arm, multicenter, real-life study designed to observe the impact of paritaprevir/ritonavir/ombitasvir with dasabuvir regimen (Viekirax®/Exviera®, 3D regimen) on total daytime physical activity and fatigue in participants with HCV GT1.
Interventions
None listed
Sponsors
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Treatment-naïve participants * Mono-infected participants with chronic HCV GT1 * Non-cirrhotic participants * Participants with debilitating fatigue (Fatigue Severity Scale \[FSS\] greater than or equal to 4)
Exclusion criteria
* Participants with sources of fatigue other than HCV (especially, severe depression, cancer and hormonal disorders causing clinically significant fatigue) * Participants with conditions that do not allow to adhere to protocol and use of the device at investigator's discretion * Participants who are wheelchair dependent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline at Day 168 in Mean Daytime Physical Activity | Baseline, Day 168 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Over Time in Fatigue Severity Scale (FSS) Score | Baseline, Days 28, 84, 168 | 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. |
| Change From Baseline Over Time in Sleep Efficiency | Baseline, Days 28, 84, 168 | 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. |
| Correlation Coefficients of FSS and Mean Daytime Physical Activity: sdITT Population | Baseline, Days 28, 84, 168 | 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. |
| Change From Baseline Over Time in Mean Daytime Physical Activity | Baseline, Days 28, 84, 168 | 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. |
| Correlation Coefficients of Change From Baseline Over Time in FSS and Mean Daytime Physical Activity: sdITT Population | Baseline, Days 28, 84, 168 | 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. |
| Correlation Coefficients of Change From Baseline Over Time in FSS and Mean Daytime Physical Activity: mITT Population | Baseline, Days 28, 84, 168 | 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. |
| Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-Treatment | Day 168 (or 12 weeks after the last dose of study drug) | 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). |
| Correlation Coefficients of FSS and Mean Daytime Physical Activity: mITT Population | Baseline, Days 28, 84, 168 | 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. |
Countries
Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HCV Genotype 1 Participants Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen) | 41 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Decision of the investigator | 1 |
Baseline characteristics
| Characteristic | HCV Genotype 1 Participants |
|---|---|
| Age, Continuous | 49.4 years STANDARD_DEVIATION 12.7 |
| Fatigue Severity Scale (FSS) mITT Population | 5.94 score on a scale STANDARD_DEVIATION 0.67 |
| Fatigue Severity Scale (FSS) sdITT Population | 5.95 score on a scale STANDARD_DEVIATION 0.61 |
| Mean Daytime Physical Activity mITT Population | 1513166 day-counts STANDARD_DEVIATION 410686 |
| Mean Daytime Physical Activity sdITT Population | 1469569 day-counts STANDARD_DEVIATION 405329 |
| Race/Ethnicity, Customized Caucasian | 41 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 14 Participants |
| Sleep Efficiency mITT Population | 89.8 percent of time asleep STANDARD_DEVIATION 3.76 |
| Sleep Efficiency sdITT Population | 89.4 percent of time asleep STANDARD_DEVIATION 4.58 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 41 |
| other Total, other adverse events | 9 / 41 |
| serious Total, serious adverse events | 0 / 41 |
Outcome results
Primary
Change From Baseline at Day 168 in Mean Daytime Physical Activity
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.
Time frame: Baseline, Day 168
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. Participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HCV Genotype 1 Participants | Change From Baseline at Day 168 in Mean Daytime Physical Activity | Change at Day 168: sdITT Population | -108266 day-counts | Standard Deviation 313859 |
| HCV Genotype 1 Participants | Change From Baseline at Day 168 in Mean Daytime Physical Activity | Change at Day 168: mITT Population | -98373 day-counts | Standard Deviation 325138 |
Comparison: sdITT (n=26): Change at Day 168 minus Baselinep-value: 0.09195% CI: [-235037, 18504]one-sample t-test
Comparison: mITT (n=24): Change at Day 168 minus Baselinep-value: 0.15295% CI: [-235667, 38921]one-sample t-test
Comparison: sdITT (n=26): Baseline vs. Day 168p-value: 0.091paired t-test
Comparison: mITT (n=24): Baseline vs. Day 168p-value: 0.152paired t-test
Secondary
Change From Baseline Over Time in Fatigue Severity Scale (FSS) Score
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.
Time frame: Baseline, Days 28, 84, 168
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. Participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HCV Genotype 1 Participants | 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 |
| HCV Genotype 1 Participants | 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 |
| HCV Genotype 1 Participants | 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 |
| HCV Genotype 1 Participants | 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 |
| HCV Genotype 1 Participants | 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 |
| HCV Genotype 1 Participants | 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 |
Comparison: sdITT: mean change Baseline minus Day 16895% CI: [2.063, 3.137]
Comparison: mITT: mean change Baseline minus Day 16895% CI: [2.212, 3.428]
Comparison: sdITT (n=37): Baseline vs. Day 168p-value: <0.001Paired Wilcoxon Test
Comparison: mITT (n=24): Baseline vs. Day 168p-value: <0.001Paired Wilcoxon Test
Comparison: sdITT (n=35): Baseline vs. Day 28p-value: <0.001Paired Wilcoxon Test
Comparison: mITT (n=22): Baseline vs. Day 28p-value: <0.001Paired Wilcoxon Test
Comparison: sdITT (n=36): Baseline vs. Day 84p-value: <0.001Paired Wilcoxon Test
Comparison: mITT (n=23): Baseline vs. Day 84p-value: <0.001Paired Wilcoxon Test
Secondary
Change From Baseline Over Time in Mean Daytime Physical Activity
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.
Time frame: Baseline, Days 28, 84, 168
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. Participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HCV Genotype 1 Participants | Change From Baseline Over Time in Mean Daytime Physical Activity | Change at Day 28: sdITT Population | 26990 day-counts | Standard Deviation 211108 |
| HCV Genotype 1 Participants | Change From Baseline Over Time in Mean Daytime Physical Activity | Change at Day 28: mITT Population | 21422 day-counts | Standard Deviation 215104 |
| HCV Genotype 1 Participants | Change From Baseline Over Time in Mean Daytime Physical Activity | Change at Day 84: sdITT Population | -6448 day-counts | Standard Deviation 198441 |
| HCV Genotype 1 Participants | Change From Baseline Over Time in Mean Daytime Physical Activity | Change at Day 84: mITT Population | -13020 day-counts | Standard Deviation 197825 |
| HCV Genotype 1 Participants | Change From Baseline Over Time in Mean Daytime Physical Activity | Change at Day 168: sdITT Population | -108266 day-counts | Standard Deviation 313859 |
| HCV Genotype 1 Participants | Change From Baseline Over Time in Mean Daytime Physical Activity | Change at Day 168: mITT Population | -98373 day-counts | Standard Deviation 325138 |
Comparison: sdITT (n=34): Baseline vs. Day 28p-value: 0.461paired t-test
Comparison: mITT (n=24): Baseline vs. Day 28p-value: 0.63paired t-test
Comparison: sdITT (n=32): Baseline vs. Day 84p-value: 0.855paired t-test
Comparison: mITT (n=24): Baseline vs. Day 84p-value: 0.75paired t-test
Secondary
Change From Baseline Over Time in Sleep Efficiency
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.
Time frame: Baseline, Days 28, 84, 168
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. Participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HCV Genotype 1 Participants | Change From Baseline Over Time in Sleep Efficiency | Change at Day 28: mITT Population | -0.44 percent of time asleep | Standard Deviation 2.68 |
| HCV Genotype 1 Participants | Change From Baseline Over Time in Sleep Efficiency | Change at Day 84: mITT Population | 0.01 percent of time asleep | Standard Deviation 2.98 |
| HCV Genotype 1 Participants | Change From Baseline Over Time in Sleep Efficiency | Change at Day 28: sdITT Population | -0.87 percent of time asleep | Standard Deviation 2.5 |
| HCV Genotype 1 Participants | Change From Baseline Over Time in Sleep Efficiency | Change at Day 84: sdITT Population | -0.06 percent of time asleep | Standard Deviation 2.81 |
| HCV Genotype 1 Participants | Change From Baseline Over Time in Sleep Efficiency | Change at Day 168: sdITT Population | 0.61 percent of time asleep | Standard Deviation 3.28 |
| HCV Genotype 1 Participants | Change From Baseline Over Time in Sleep Efficiency | Change at Day 168: mITT Population | 0.74 percent of time asleep | Standard Deviation 3.37 |
Comparison: sdITT: mean change Baseline minus Day 16895% CI: [-0.651, 1.871]
Comparison: mITT: mean change Baseline minus Day 16895% CI: [-0.608, 2.088]
Comparison: sdITT (n=37): Baseline vs. Day 168p-value: 0.381Paired Wilcoxon Test
Comparison: mITT (n=24): Baseline vs. Day 168p-value: 0.304Paired Wilcoxon Test
Comparison: sdITT (n=35): Baseline vs. Day 28p-value: 0.014Paired Wilcoxon Test
Comparison: mITT (n=22): Baseline vs. Day 28p-value: 0.278Paired Wilcoxon Test
Comparison: sdITT (n=36): Baseline vs. Day 84p-value: 0.881Paired Wilcoxon Test
Comparison: sdITT (n=23): Baseline vs. Day 84p-value: 0.775Paired Wilcoxon Test
Secondary
Correlation Coefficients of Change From Baseline Over Time in FSS and Mean Daytime Physical Activity: mITT Population
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.
Time frame: Baseline, Days 28, 84, 168
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. Participants with an assessment at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HCV Genotype 1 Participants | 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 |
| HCV Genotype 1 Participants | 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 |
| HCV Genotype 1 Participants | 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
Correlation Coefficients of Change From Baseline Over Time in FSS and Mean Daytime Physical Activity: sdITT Population
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.
Time frame: Baseline, Days 28, 84, 168
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. Participants with an assessment at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HCV Genotype 1 Participants | 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 |
| HCV Genotype 1 Participants | 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 |
| HCV Genotype 1 Participants | 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
Correlation Coefficients of FSS and Mean Daytime Physical Activity: mITT Population
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.
Time frame: Baseline, Days 28, 84, 168
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. Participants with an assessment at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HCV Genotype 1 Participants | Correlation Coefficients of FSS and Mean Daytime Physical Activity: mITT Population | Baseline | 0.253 Spearman correlation coefficient |
| HCV Genotype 1 Participants | Correlation Coefficients of FSS and Mean Daytime Physical Activity: mITT Population | Day 28 | 0.386 Spearman correlation coefficient |
| HCV Genotype 1 Participants | Correlation Coefficients of FSS and Mean Daytime Physical Activity: mITT Population | Day 84 | -0.058 Spearman correlation coefficient |
| HCV Genotype 1 Participants | Correlation Coefficients of FSS and Mean Daytime Physical Activity: mITT Population | Day 168 | 0.128 Spearman correlation coefficient |
Secondary
Correlation Coefficients of FSS and Mean Daytime Physical Activity: sdITT Population
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.
Time frame: Baseline, Days 28, 84, 168
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. Participants with an assessment at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HCV Genotype 1 Participants | Correlation Coefficients of FSS and Mean Daytime Physical Activity: sdITT Population | Baseline | 0.300 Spearman correlation coefficient |
| HCV Genotype 1 Participants | Correlation Coefficients of FSS and Mean Daytime Physical Activity: sdITT Population | Day 28 | 0.131 Spearman correlation coefficient |
| HCV Genotype 1 Participants | Correlation Coefficients of FSS and Mean Daytime Physical Activity: sdITT Population | Day 84 | -0.022 Spearman correlation coefficient |
| HCV Genotype 1 Participants | Correlation Coefficients of FSS and Mean Daytime Physical Activity: sdITT Population | Day 168 | 0.195 Spearman correlation coefficient |
Secondary
Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-Treatment
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).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HCV Genotype 1 Participants | Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-Treatment | ITT Population | 97.6 percentage of participants |
| HCV Genotype 1 Participants | Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-Treatment | sdITT Population | 97.3 percentage of participants |
| HCV Genotype 1 Participants | Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-Treatment | mITT Population | 95.8 percentage of participants |