Trial Outcomes & Findings for Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Austria (REAL) (NCT NCT02582658)
NCT ID: NCT02582658
Last Updated: 2019-06-05
Results Overview
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels \< 50 IU/mL 12 weeks after the last actual dose of study drug.
COMPLETED
173 participants
12 Weeks after the last dose of study drug
2019-06-05
Participant Flow
A total of 173 patients were enrolled in the study; 2 patients never started treatment and were excluded from the safety (SP; N=171); 6 patients were excluded from the core population (CP; N=165), defined as all SP patients who met eligibility criteria and were adequately treated according to the standard of care and local label recommendations.
Participant milestones
| Measure |
ABBVIE REGIMEN +/- Ribavirin (RBV)
ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir
|
|---|---|
|
Overall Study
STARTED
|
171
|
|
Overall Study
COMPLETED
|
146
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
| Measure |
ABBVIE REGIMEN +/- Ribavirin (RBV)
ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir
|
|---|---|
|
Overall Study
Failure to Return
|
10
|
|
Overall Study
Insufficient Virological Response
|
2
|
|
Overall Study
Withdrawn Consent
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Not further specified
|
11
|
Baseline Characteristics
Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Austria (REAL)
Baseline characteristics by cohort
| Measure |
ABBVIE REGIMEN +/- Ribavirin (RBV)
n=165 Participants
ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir
|
|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 13.7 • n=93 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
115 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White/Caucasin
|
158 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian/Oriental
|
4 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 12 Weeks after the last dose of study drugPopulation: The Core Population (CP) was defined as all patients in the safety population (SP; all enrolled subjects who received at least 1 dose of study drug) who met eligibility criteria and were adequately treated according to the standard of care and within local label recommendations.
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels \< 50 IU/mL 12 weeks after the last actual dose of study drug.
Outcome measures
| Measure |
ABBVIE REGIMEN +/- Ribavirin (RBV)
n=165 Participants
ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir.
|
|---|---|
|
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
|
84.8 percentage of participants
Interval 78.6 to 89.5
|
SECONDARY outcome
Timeframe: Up to 24 weeks of treatmentPopulation: Core Population (CP)
The percentage of participants with virological response (HCV RNA \<50 IU/mL) at end of treatment (EoT, defined as last intake of ABBVIE REGIMEN or ribavirin \[RBV\]).
Outcome measures
| Measure |
ABBVIE REGIMEN +/- Ribavirin (RBV)
n=165 Participants
ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir.
|
|---|---|
|
Percentage of Participants With Virological Response at End of Treatment (EoTR)
|
94.5 percentage of participants
Interval 90.0 to 97.1
|
SECONDARY outcome
Timeframe: Up to approximately 24 weeksPopulation: Core Population (CP)
The percentage of participants with on-treatment virologic failure (breakthrough \[defined as at least one documented HCV RNA \<50 IU/mL followed by HCV RNA \>= 50 IU/mL during treatment\]).
Outcome measures
| Measure |
ABBVIE REGIMEN +/- Ribavirin (RBV)
n=165 Participants
ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir.
|
|---|---|
|
Percentage of Participants With On-treatment Virologic Failure (Breakthrough)
|
1.2 percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeks after last dose of study drugPopulation: CP subjects with evaluable HCV RNA data ≥70 days after last dose AbbVie Regimen, or HCV RNA value ≥50IU/mL at last measurement postbaseline, or HCV RNA \<50IU /mL at last measurement postbaseline, but no HCV RNA value ≥70 days after last dose AbbVie Regimen due to safety or virologic failure (relapse reported but date/value of HCV RNA test missing).
SVR12 is defined as HCV RNA levels \< 50 IU/mL 12 weeks after the last actual dose of study drug in the Core Population Sufficient Follow-up (CPSFU).
Outcome measures
| Measure |
ABBVIE REGIMEN +/- Ribavirin (RBV)
n=146 Participants
ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir.
|
|---|---|
|
Percentage of Participants Achieving SVR12 (Core Population Sufficient Follow-up)
|
95.9 percentage of participants
Interval 91.3 to 98.1
|
SECONDARY outcome
Timeframe: Up to 12 weeks after last dose of study drugPopulation: Core Population (CP)
The percentage of participants with relapse (defined as HCV RNA \<50 IU/mL at EoT followed by HCV RNA ≥50 IU/mL)
Outcome measures
| Measure |
ABBVIE REGIMEN +/- Ribavirin (RBV)
n=165 Participants
ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir.
|
|---|---|
|
Percentage of Participants With Post-treatment Relapse
|
0.0 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 24 weeks of treatmentPopulation: All participants in the Core Population (CP) who received RBV
Adherence to RBV is defined as percentage of target dose (adherence=cumulated dose taken/ \[initially prescribed dose x planned duration\]).
Outcome measures
| Measure |
ABBVIE REGIMEN +/- Ribavirin (RBV)
n=60 Participants
ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir.
|
|---|---|
|
Percentage of Planned Duration of Ribavirin (RBV) Taken
|
95.7 percentage of planned RBV dose taken
Standard Deviation 16.96
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 and End of Treatment (EoT)Population: Core Population (CP)
The PAM-13 item scale is a measure used to assess the patient knowledge, skill, and confidence for self-management. Each of the 13 items can be answered with one of four possible response options, which are "disagree strongly" (1), "disagree" (2), "agree" (3), "agree strongly" (4). Responses are summed and averaged to come up with an overall score of level 1 through level 4. The responses to the 13 questions are summed and transformed into a PAM Score between 0 and 100; a higher score indicates more knowledge and confidence to take action for self-management.
Outcome measures
| Measure |
ABBVIE REGIMEN +/- Ribavirin (RBV)
n=165 Participants
ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir.
|
|---|---|
|
Total Score of Participant Activation According to the Patient Activation Measure (PAM-13) Questionnaire
PAM-13 Day 0
|
63.3 score on a scale
Standard Deviation 10.9
|
|
Total Score of Participant Activation According to the Patient Activation Measure (PAM-13) Questionnaire
PAM-13 EOT
|
62.6 score on a scale
Standard Deviation 10.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 to end of treatment (up to 24 weeks)Population: The safety population (SP) was defined as enrolled patients who received at least 1 dose of ABBVIE REGIMEN.
Percentage of participants taking at least 1 concomitant medication
Outcome measures
| Measure |
ABBVIE REGIMEN +/- Ribavirin (RBV)
n=171 Participants
ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir.
|
|---|---|
|
Percentage of Participants With Concomitant Medications
Patients Taking at least 1 co-medication
|
49.1 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Analgesics
|
12.3 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Antidepressants
|
11.7 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Beta blocking agents
|
9.9 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Calcium channel blockers
|
8.8 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Thyroid therapy
|
7.6 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Vitamins
|
5.8 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Blood glucose lowering drugs
|
4.7 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Drugs used in addictive disorders
|
4.7 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
ACE inhibitors
|
4.1 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Angriotensin II antagonists
|
4.1 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Anti-asthmatics
|
4.1 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Benzodiazepine derivatives
|
4.1 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Antithrombotic
|
3.5 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Drugs for peptic ulcer/gastroesophageal reflux dis
|
3.5 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Angiotensin II Antagonists
|
2.9 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Antipsychotics
|
2.9 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Diuretics
|
2.9 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
ACE inhibitors, combinations
|
2.3 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Insulin and analogues
|
2.3 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Mineral supplements
|
2.3 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Antieplieptics
|
1.8 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Anti-inflammatory and antirheumatic products
|
1.8 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Drugs used in benign prostatic hypertrophy
|
1.8 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Herbal medicine
|
1.8 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Vasodilators for cardiac diseases
|
1.8 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Anti-dementia drugs
|
1.2 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Antibacterials
|
1.2 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Anti-gout preparations
|
1.2 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Drugs for functional gastrointestinal disorders
|
1.2 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
HMG COA reductase inhibitors
|
1.2 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Hypnotics and sedatives
|
1.2 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Immunosuppressive agents
|
1.2 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Lipotropics
|
1.2 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Vasoprotectives
|
1.2 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Anti-adrenergic antihypertensives
|
0.6 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Antibiotics for dermatological use
|
0.6 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Antiemetics and anti nauseants
|
0.6 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Antigloucoma
|
0.6 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Antihistamines
|
0.6 percentage of participants
|
|
Percentage of Participants With Concomitant Medications
Antineoplastic/immunomodulating agents, cytostatic
|
0.6 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0Population: Core Population (CP)
Percentage of participants with co-morbidities and/or co-infections at baseline (Day 0).
Outcome measures
| Measure |
ABBVIE REGIMEN +/- Ribavirin (RBV)
n=165 Participants
ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir.
|
|---|---|
|
Percentage of Participants With Co-morbidities and/or Co-infections
Immunologically medicated disease
|
1.2 percentage of participants
|
|
Percentage of Participants With Co-morbidities and/or Co-infections
All co-morbidities and co-infections
|
57.6 percentage of participants
|
|
Percentage of Participants With Co-morbidities and/or Co-infections
HCV co-infections
|
1.8 percentage of participants
|
|
Percentage of Participants With Co-morbidities and/or Co-infections
Liver and/or CHC related co-morbidities
|
5.5 percentage of participants
|
|
Percentage of Participants With Co-morbidities and/or Co-infections
Chronic kidney disease
|
3.0 percentage of participants
|
|
Percentage of Participants With Co-morbidities and/or Co-infections
Psychiatric disorders
|
15.2 percentage of participants
|
|
Percentage of Participants With Co-morbidities and/or Co-infections
Diabetes mellitus
|
9.7 percentage of participants
|
|
Percentage of Participants With Co-morbidities and/or Co-infections
Lipid disorder
|
5.5 percentage of participants
|
|
Percentage of Participants With Co-morbidities and/or Co-infections
Hyperthyroidism
|
0.6 percentage of participants
|
|
Percentage of Participants With Co-morbidities and/or Co-infections
Hypothyroidism
|
8.5 percentage of participants
|
|
Percentage of Participants With Co-morbidities and/or Co-infections
Cardiovascular disease
|
23.0 percentage of participants
|
|
Percentage of Participants With Co-morbidities and/or Co-infections
Psychoactive substance dependency
|
10.9 percentage of participants
|
|
Percentage of Participants With Co-morbidities and/or Co-infections
Other
|
20.6 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 and post treatment week 12Population: Core Population (CP)
The EQ-5D-5L is a health state utility instrument that evaluates preference for health status (utility). The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from -0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. The EQ-5D visual analogue scale (VAS) records the participant's self-rated health status on a vertical graduated scale from 0 to 100, with 0 indicating the worst imaginable health state and 100 indicating the best imaginable health state. An increase in EQ-5D-5L VAS score indicates improvement.
Outcome measures
| Measure |
ABBVIE REGIMEN +/- Ribavirin (RBV)
n=165 Participants
ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir.
|
|---|---|
|
Quality of Life Measured With the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire
EQ-5D-5L: Index Score Basline
|
0.83 score on a scale
Standard Deviation 0.17
|
|
Quality of Life Measured With the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire
EQ-5D-5L: Index Score 12 Weeks EOT
|
0.88 score on a scale
Standard Deviation 0.15
|
|
Quality of Life Measured With the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire
EQ-5D-5L: VAS Score Basline
|
70.4 score on a scale
Standard Deviation 19.5
|
|
Quality of Life Measured With the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire
EQ-5D-5L: VAS Score 12 Weeks EOT
|
79.4 score on a scale
Standard Deviation 17.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 to post treatment week 12Population: Core Population (CP)
The WPAI questionnaire was used to measure work absenteeism, work presenteeism, work productivity impairment and daily activity impairment. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity: Presenteeism - percentage of impairment while working due to health problem; Total work productivity impairment - percentage of overall work impairment due to health problem Absenteeism - percentage of work time missed due to health problem; Total activity impairment - percentage of general (non-work) activity impairment due to health problem
Outcome measures
| Measure |
ABBVIE REGIMEN +/- Ribavirin (RBV)
n=165 Participants
ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir.
|
|---|---|
|
Change in Mean Score From Baseline to 12 Weeks After End of Treatment (EOT) in Work Productivity and Activity Impairment (WPAI) Version 2: Hepatitis C Questionnaire
Change from baseline in absenteeism
|
0.1 percentage
Standard Deviation 0.4
|
|
Change in Mean Score From Baseline to 12 Weeks After End of Treatment (EOT) in Work Productivity and Activity Impairment (WPAI) Version 2: Hepatitis C Questionnaire
Change from baseline in presenteeism
|
-10.6 percentage
Standard Deviation 17.3
|
|
Change in Mean Score From Baseline to 12 Weeks After End of Treatment (EOT) in Work Productivity and Activity Impairment (WPAI) Version 2: Hepatitis C Questionnaire
Change from baseline in total work impairment
|
-10.5 percentage
Standard Deviation 17.2
|
|
Change in Mean Score From Baseline to 12 Weeks After End of Treatment (EOT) in Work Productivity and Activity Impairment (WPAI) Version 2: Hepatitis C Questionnaire
Change from baseline in total activity impairment
|
-8.3 percentage
Standard Deviation 29.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 24 weeks of treatmentPopulation: Core Population (CP)
The AbbVie PSP included educational and information material (including printed, online, pillbox), digital and mobile resource (web-portal), digital and mobile resources (reminders). The PSP utilization and satisfaction assessment evaluated the frequency of utilization (usually daily, several times per week, usually once weekly, less than once weekly) and patient's overall satisfaction (very good, good, satisfactory) with their respective PSP.
Outcome measures
| Measure |
ABBVIE REGIMEN +/- Ribavirin (RBV)
n=26 Participants
ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir.
|
|---|---|
|
Patient Support Program (PSP) Utilization and Satisfaction Assessment
Participants Using at least 1 PSP since last visit
|
65.4 percentage of participants
|
|
Patient Support Program (PSP) Utilization and Satisfaction Assessment
Personal support - satisfaction Very Good
|
34.6 percentage of participants
|
|
Patient Support Program (PSP) Utilization and Satisfaction Assessment
Personal support satisfaction - Good
|
7.7 percentage of participants
|
|
Patient Support Program (PSP) Utilization and Satisfaction Assessment
Personal support satisfaction - Satisfactory
|
3.8 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 24 weeks of treatmentPopulation: All participants in the Core Population (CP) who received RBV
Adherence to RBV is defined as percentage of target dose (adherence=cumulated number of pills taken / \[initially prescribed number of pills x planned duration\]) and categorized as follows: \>105%, \>95% - \<=105%, \>80% - \<=95%, \>50% - \<=80%, \<=50%.
Outcome measures
| Measure |
ABBVIE REGIMEN +/- Ribavirin (RBV)
n=60 Participants
ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir.
|
|---|---|
|
Percentage of Participants With Adherence to Planned RBV Target Dose Taken
> 105% Adherence
|
3.3 percentage of participants
|
|
Percentage of Participants With Adherence to Planned RBV Target Dose Taken
>95% - <=105% Adherence
|
85.0 percentage of participants
|
|
Percentage of Participants With Adherence to Planned RBV Target Dose Taken
>80% - <=95% Adherence
|
1.7 percentage of participants
|
|
Percentage of Participants With Adherence to Planned RBV Target Dose Taken
>50% - <=80% Adherence
|
5.0 percentage of participants
|
|
Percentage of Participants With Adherence to Planned RBV Target Dose Taken
<=50% Adherence
|
5.0 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 24 weeks of treatmentPopulation: Core Population (CP)
Deviations from the target dose of the ABBVIE REGIMEN were defined as the actual duration is shortened/prolonged (exceedence) for more than 7 days.
Outcome measures
| Measure |
ABBVIE REGIMEN +/- Ribavirin (RBV)
n=165 Participants
ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir.
|
|---|---|
|
Percentage of Participants Deviating From the Target ABBVIE Regimen Duration
Early discontinuation
|
7.9 percentage of participants
|
|
Percentage of Participants Deviating From the Target ABBVIE Regimen Duration
Exeedance
|
1.8 percentage of participants
|
|
Percentage of Participants Deviating From the Target ABBVIE Regimen Duration
Not deviated
|
90.3 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 24 weeks of treatmentPopulation: Core Population (CP)
Adherence to the ABBVIE REGIMEN was defined as percentage of target dose (adherence=cumulated number of pills taken / \[initially prescribed number of pills x planned duration\]) and categorized as follows: \>105%, \>95% to \<=105%, \>80% to \<=95%, \>50% to \<=80%, \<=50%.
Outcome measures
| Measure |
ABBVIE REGIMEN +/- Ribavirin (RBV)
n=165 Participants
ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir.
|
|---|---|
|
Percentage of Participants With Adherence to Planned ABBVIE Regimen Target Dose Taken
> 105% Adherence
|
1.8 percentage of participants
|
|
Percentage of Participants With Adherence to Planned ABBVIE Regimen Target Dose Taken
>95% - <=105% Adherence
|
88.5 percentage of participants
|
|
Percentage of Participants With Adherence to Planned ABBVIE Regimen Target Dose Taken
>80% - <=95% Adherence
|
3.0 percentage of participants
|
|
Percentage of Participants With Adherence to Planned ABBVIE Regimen Target Dose Taken
>50% - <=80% Adherence
|
3.6 percentage of participants
|
|
Percentage of Participants With Adherence to Planned ABBVIE Regimen Target Dose Taken
<=50% Adherence
|
3.0 percentage of participants
|
Adverse Events
ABBVIE REGIMEN +/- Ribavirin (RBV)
Serious adverse events
| Measure |
ABBVIE REGIMEN +/- Ribavirin (RBV)
n=171 participants at risk
ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.58%
1/171 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days post-study drug dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.58%
1/171 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days post-study drug dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug.
|
|
Cardiac disorders
Cardiac Failure
|
0.58%
1/171 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days post-study drug dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.58%
1/171 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days post-study drug dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug.
|
|
General disorders
Fatigue
|
0.58%
1/171 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days post-study drug dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug.
|
|
Immune system disorders
Drug Hypersensitivity
|
0.58%
1/171 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days post-study drug dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.58%
1/171 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days post-study drug dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular Carcinoma
|
0.58%
1/171 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days post-study drug dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug.
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.58%
1/171 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days post-study drug dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug.
|
Other adverse events
| Measure |
ABBVIE REGIMEN +/- Ribavirin (RBV)
n=171 participants at risk
ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir
|
|---|---|
|
General disorders
Fatigue
|
7.6%
13/171 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days post-study drug dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
4.1%
7/171 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days post-study drug dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug.
|
|
Nervous system disorders
Headache
|
4.7%
8/171 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days post-study drug dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.1%
7/171 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days post-study drug dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug.
|
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