An observational study in Chronic Hepatitis C, sponsored by AbbVie. Completed. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-06-05.
Sponsored by AbbVie · Observational
The study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO) and work productivity data of the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir +/- dasabuvir) +/- Ribavirin (RBV) in chronic hepatitis C virus (HCV) infected participants in Austria.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 173 is below the median of 250 across 687 observational studies indexed under Hepatitis A.
Browse Hepatitis A studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with chronic infection of HCV Genotype 1 (GT1) or Genotype 4 (GT4)
Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C, genotype (GT)1 or GT4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label
If RBV is co-administered with the ABBVIE REGIMEN, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)
Patients must voluntarily sign and date a patient authorization to use and disclose his/her anonymized health data prior to inclusion into the study
Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial
Exclusion Criteria:
none
Participants with confirmed chronic hepatitis C genotype (GT) 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir +/- dasabuvir) ± Ribavirin (RBV) according to standard of care and in line with the current local label
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
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.
Time frame: 12 Weeks after the last dose of study drug
Percentage of Participants With Virological Response at End of Treatment (EoTR)
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 \[RBV\]).
Time frame: Up to 24 weeks of treatment
Percentage of Participants With On-treatment Virologic Failure (Breakthrough)
The percentage of participants with on-treatment virologic failure (breakthrough \[defined as at least one documented HCV RNA \<50 IU/mL followed by HCV RNA \>= 50 IU/mL during treatment\]).
Time frame: Up to approximately 24 weeks
Percentage of Participants Achieving SVR12 (Core Population Sufficient Follow-up)
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).
Time frame: 12 weeks after last dose of study drug
Percentage of Participants With Post-treatment Relapse
The percentage of participants with relapse (defined as HCV RNA \<50 IU/mL at EoT followed by HCV RNA ≥50 IU/mL)
Time frame: Up to 12 weeks after last dose of study drug
Percentage of Planned Duration of Ribavirin (RBV) Taken
Adherence to RBV is defined as percentage of target dose (adherence=cumulated dose taken/ \[initially prescribed dose x planned duration\]).
Time frame: Up to 24 weeks of treatment
Total Score of Participant Activation According to the Patient Activation Measure (PAM-13) Questionnaire
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.
Time frame: Day 0 and End of Treatment (EoT)
Percentage of Participants With Concomitant Medications
Percentage of participants taking at least 1 concomitant medication
Time frame: Day 0 to end of treatment (up to 24 weeks)
Percentage of Participants With Co-morbidities and/or Co-infections
Percentage of participants with co-morbidities and/or co-infections at baseline (Day 0).
Time frame: Day 0
Quality of Life Measured With the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire
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.
Time frame: Day 0 and post treatment week 12
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
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
Time frame: Day 0 to post treatment week 12
Patient Support Program (PSP) Utilization and Satisfaction Assessment
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.
Time frame: Up to 24 weeks of treatment
Percentage of Participants With Adherence to Planned RBV Target Dose Taken
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%.
Time frame: Up to 24 weeks of treatment
Percentage of Participants Deviating From the Target ABBVIE Regimen Duration
Deviations from the target dose of the ABBVIE REGIMEN were defined as the actual duration is shortened/prolonged (exceedence) for more than 7 days.
Time frame: Up to 24 weeks of treatment
Percentage of Participants With Adherence to Planned ABBVIE Regimen Target Dose Taken
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%.
Time frame: Up to 24 weeks of treatment
| Milestone | ABBVIE REGIMEN +/- Ribavirin (RBV) |
|---|---|
| Started | 171 |
| Completed | 146 |
| Not completed | 25 |
| Withdrew: Failure to return | 10 |
| Withdrew: Insufficient virological response | 2 |
| Withdrew: Withdrawn consent | 1 |
| Withdrew: Death | 1 |
| Withdrew: Not further specified | 11 |
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.
| percentage of participants | ABBVIE REGIMEN +/- Ribavirin (RBV) |
|---|---|
| Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) | 84.8 (78.6 to 89.5) |
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 \[RBV\]).
| percentage of participants | ABBVIE REGIMEN +/- Ribavirin (RBV) |
|---|---|
| Percentage of Participants With Virological Response at End of Treatment (EoTR) | 94.5 (90.0 to 97.1) |
The percentage of participants with on-treatment virologic failure (breakthrough \[defined as at least one documented HCV RNA \<50 IU/mL followed by HCV RNA \>= 50 IU/mL during treatment\]).
| percentage of participants | ABBVIE REGIMEN +/- Ribavirin (RBV) |
|---|---|
| Percentage of Participants With On-treatment Virologic Failure (Breakthrough) | 1.2 |
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).
| percentage of participants | ABBVIE REGIMEN +/- Ribavirin (RBV) |
|---|---|
| Percentage of Participants Achieving SVR12 (Core Population Sufficient Follow-up) | 95.9 (91.3 to 98.1) |
The percentage of participants with relapse (defined as HCV RNA \<50 IU/mL at EoT followed by HCV RNA ≥50 IU/mL)
| percentage of participants | ABBVIE REGIMEN +/- Ribavirin (RBV) |
|---|---|
| Percentage of Participants With Post-treatment Relapse | 0.0 |
Adherence to RBV is defined as percentage of target dose (adherence=cumulated dose taken/ \[initially prescribed dose x planned duration\]).
| percentage of planned RBV dose taken | ABBVIE REGIMEN +/- Ribavirin (RBV) |
|---|---|
| Percentage of Planned Duration of Ribavirin (RBV) Taken | 95.7 ± 16.96 |
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.
| score on a scale | ABBVIE REGIMEN +/- Ribavirin (RBV) |
|---|---|
| PAM-13 Day 0 | 63.3 ± 10.9 |
| PAM-13 EOT | 62.6 ± 10.3 |
Percentage of participants taking at least 1 concomitant medication
| percentage of participants | ABBVIE REGIMEN +/- Ribavirin (RBV) |
|---|---|
| Patients Taking at least 1 co-medication | 49.1 |
| Analgesics | 12.3 |
| Antidepressants | 11.7 |
| Beta blocking agents | 9.9 |
| Calcium channel blockers | 8.8 |
| Thyroid therapy | 7.6 |
| Vitamins | 5.8 |
| Blood glucose lowering drugs | 4.7 |
| Drugs used in addictive disorders | 4.7 |
| ACE inhibitors | 4.1 |
| Angriotensin II antagonists | 4.1 |
| Anti-asthmatics | 4.1 |
| Benzodiazepine derivatives | 4.1 |
| Antithrombotic | 3.5 |
| Drugs for peptic ulcer/gastroesophageal reflux dis | 3.5 |
| Angiotensin II Antagonists | 2.9 |
| Antipsychotics | 2.9 |
| Diuretics | 2.9 |
| ACE inhibitors, combinations | 2.3 |
| Insulin and analogues | 2.3 |
| Mineral supplements | 2.3 |
| Antieplieptics | 1.8 |
| Anti-inflammatory and antirheumatic products | 1.8 |
| Drugs used in benign prostatic hypertrophy | 1.8 |
| Herbal medicine | 1.8 |
| Vasodilators for cardiac diseases | 1.8 |
| Anti-dementia drugs | 1.2 |
| Antibacterials | 1.2 |
| Anti-gout preparations | 1.2 |
| Drugs for functional gastrointestinal disorders | 1.2 |
| HMG COA reductase inhibitors | 1.2 |
| Hypnotics and sedatives | 1.2 |
| Immunosuppressive agents | 1.2 |
| Lipotropics | 1.2 |
| Vasoprotectives | 1.2 |
| Anti-adrenergic antihypertensives | 0.6 |
| Antibiotics for dermatological use | 0.6 |
| Antiemetics and anti nauseants | 0.6 |
| Antigloucoma | 0.6 |
| Antihistamines | 0.6 |
| Antineoplastic/immunomodulating agents, cytostatic | 0.6 |
Percentage of participants with co-morbidities and/or co-infections at baseline (Day 0).
| percentage of participants | ABBVIE REGIMEN +/- Ribavirin (RBV) |
|---|---|
| All co-morbidities and co-infections | 57.6 |
| HCV co-infections | 1.8 |
| Liver and/or CHC related co-morbidities | 5.5 |
| Chronic kidney disease | 3.0 |
| Psychiatric disorders | 15.2 |
| Diabetes mellitus | 9.7 |
| Lipid disorder | 5.5 |
| Hyperthyroidism | 0.6 |
| Hypothyroidism | 8.5 |
| Cardiovascular disease | 23.0 |
| Immunologically medicated disease | 1.2 |
| Psychoactive substance dependency | 10.9 |
| Other | 20.6 |
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.
| score on a scale | ABBVIE REGIMEN +/- Ribavirin (RBV) |
|---|---|
| EQ-5D-5L: Index Score Basline | 0.83 ± 0.17 |
| EQ-5D-5L: Index Score 12 Weeks EOT | 0.88 ± 0.15 |
| EQ-5D-5L: VAS Score Basline | 70.4 ± 19.5 |
| EQ-5D-5L: VAS Score 12 Weeks EOT | 79.4 ± 17.3 |
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
| percentage | ABBVIE REGIMEN +/- Ribavirin (RBV) |
|---|---|
| Change from baseline in absenteeism | 0.1 ± 0.4 |
| Change from baseline in presenteeism | -10.6 ± 17.3 |
| Change from baseline in total work impairment | -10.5 ± 17.2 |
| Change from baseline in total activity impairment | -8.3 ± 29.5 |
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.
| percentage of participants | ABBVIE REGIMEN +/- Ribavirin (RBV) |
|---|---|
| Participants Using at least 1 PSP since last visit | 65.4 |
| Personal support - satisfaction Very Good | 34.6 |
| Personal support satisfaction - Good | 7.7 |
| Personal support satisfaction - Satisfactory | 3.8 |
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%.
| percentage of participants | ABBVIE REGIMEN +/- Ribavirin (RBV) |
|---|---|
| > 105% Adherence | 3.3 |
| >95% - <=105% Adherence | 85.0 |
| >80% - <=95% Adherence | 1.7 |
| >50% - <=80% Adherence | 5.0 |
| <=50% Adherence | 5.0 |
Deviations from the target dose of the ABBVIE REGIMEN were defined as the actual duration is shortened/prolonged (exceedence) for more than 7 days.
| percentage of participants | ABBVIE REGIMEN +/- Ribavirin (RBV) |
|---|---|
| Early discontinuation | 7.9 |
| Exeedance | 1.8 |
| Not deviated | 90.3 |
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%.
| percentage of participants | ABBVIE REGIMEN +/- Ribavirin (RBV) |
|---|---|
| > 105% Adherence | 1.8 |
| >95% - <=105% Adherence | 88.5 |
| >80% - <=95% Adherence | 3.0 |
| >50% - <=80% Adherence | 3.6 |
| <=50% Adherence | 3.0 |
Collected over 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).. Non-serious events are listed at a 4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ABBVIE REGIMEN +/- Ribavirin (RBV) | — | 5/171 (2.9%) | 27/171 (15.8%) |
| Event | ABBVIE REGIMEN +/- Ribavirin (RBV) |
|---|---|
| DiarrheaGastrointestinal disorders | 1/171 |
| VomitingGastrointestinal disorders | 1/171 |
| Cardiac FailureCardiac disorders | 1/171 |
| VertigoEar and labyrinth disorders | 1/171 |
| FatigueGeneral disorders | 1/171 |
| Drug HypersensitivityImmune system disorders | 1/171 |
| BronchitisInfections and infestations | 1/171 |
| Hepatocellular CarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/171 |
| Chronic Kidney DiseaseRenal and urinary disorders | 1/171 |
| Event | ABBVIE REGIMEN +/- Ribavirin (RBV) |
|---|---|
| FatigueGeneral disorders | 13/171 |
| HeadacheNervous system disorders | 8/171 |
| NauseaGastrointestinal disorders | 7/171 |
| PruritusSkin and subcutaneous tissue disorders | 7/171 |
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.
| Age, Continuous(years) | ABBVIE REGIMEN +/- Ribavirin (RBV) |
|---|---|
| Mean | 53 ± 13.7 |
| Sex: Female, Male(Participants) | ABBVIE REGIMEN +/- Ribavirin (RBV) |
|---|---|
| Female | 50 |
| Male | 115 |
| Race/Ethnicity, Customized(Participants) | ABBVIE REGIMEN +/- Ribavirin (RBV) |
|---|---|
| White/Caucasin | 158 |
| Asian/Oriental | 4 |
| Other | 3 |
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