Chronic Hepatitis C
Conditions
Keywords
Chronic Hepatitis C, Dasabuvir, Ombitasvir+Paritaprevir+Ritonavir, Observational Study, Quality of life, Work-ability, Fibrosis, Cirrhosis
Brief summary
The interferon-free combination regimen of paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well controlled conditions. This observational study is the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in Germany in a clinical practice patient population.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
* Treatment-naïve or -experienced patients with confirmed CHC, genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± RBV according to standard of care and in line with 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/or disclose his/her pseudonymized 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
• Adolescents; people not treated according to label
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response (SVR12) | 12 weeks after the last dose of study drug (treatment period was 12 or 24 weeks) | SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (\< 50 IU/mL) 12 weeks after the last actual dose of the ABBVIE REGIMEN. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With On-Treatment Virological Failure or Relapse | Up to post-treatment Week 12 (treatment period was 12 or 24 weeks) | The number of participants meeting the following SVR12 non-response categories: 1. On-treatment virological failure (breakthrough) defined \>= 1 documented HCV RNA \< 50 IU/mL followed by HCV RNA \>= 50 IU/mL during treatment or failure to suppress (each measured on-treatment HCV RNA value \>= 50 IU/mL) 2. Relapse defined as HCV RNA \< 50 IU/mL at EoT followed by HCV RNA \>= 50 IU/mL post-treatment in participants who completed treatment (\<= 7 days shortened). |
| Percentage of Participants With Rapid Virological Response at Week 4 (RVR4) | Week 4 | RVR4 is defined as participants with HCV RNA \< 50 IU/mL at Week 4. |
| Percentage of Participants With Sustained Virological Response 24 Weeks After EoT (SVR24) | 24 Weeks After EoT (treatment period was 12 or 24 weeks) | SVR24 is defined as HCV RNA \< 50 IU/mL 24 Weeks After EoT. |
| Percentage of Participants With Sustained Virological Response 48 Weeks After EoT (SVR48) | 48 Weeks After EoT (treatment period was 12 or 24 weeks) | SVR48 is defined as participants with HCV RNA \< 50 IU/mL 48 weeks after EoT. |
| Change From Baseline in PRISM Over Time | Baseline, 12 and 48 weeks after EoT (treatment period was 12 or 24 weeks) | PRISM is a visual quantitative method to assess the perceived burden of suffering due to illness. The distance between the center of the self (yellow disk) and the illness disk (red disk) is called self-illness separation (SIS) and is measured in cm (range is 0 - 27). The smaller the distance, the higher the burden of suffering. |
| Percentage of Participants With ≥ 1 Comorbidity and/or Co-Infection | up to post-treatment Week 48 (treatment period was 12 or 24 weeks) | — |
| Percentage of Participants Taking ≥ 1 Co-Medication | up to post-treatment Week 48 (treatment period was 12 or 24 weeks) | — |
| Percentage of Participants With Virological Response at End of Treatment (EoTR) | EoT, (treatment period was 12 weeks or 24 weeks) | Virological response is defined as HCV RNA \< 50 IU/mL. End of Treatment (EoT) is defined as the last intake of ABBVIE REGIMEN or RBV. |
| Percentage of Planned Duration of ABBVIE REGIMEN and RBV Taken | Up to Week 12 or Week 24 | Planned duration of treatment was 12 or 24 weeks. |
| Change From Baseline in FACIT-F Scale Over Time | Baseline, EoT (treatment period was 12 or 24 weeks), 12 and 48 weeks after EoT | The FACIT-F Scale is a 13-item questionnaire that assesses self-reported fatigue during the past 7 days and its impact upon daily activities and function. Scores range from 0 - 100, with higher scores indicating a lesser degree of fatigue. |
| Change From Baseline to EoT in PAM-13 Questionnaire | Baseline, EoT (treatment period was 12 or 24 weeks) | The PAM-13 item scale is a measure used to assess the patient knowledge, skill, and confidence for self-management. Scores range from 0 to 100. Higher scores indicate a higher level of knowledge, skill and confidence. |
| Change From Baseline Over Time in WPAI: Total Work Productivity Impairment | Baseline, EoT (treatment period was 12 or 24 weeks),12 and 24 weeks after EoT | The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Total work productivity impairment indicates the percentage of overall work impairment due to health problems. |
| Change From Baseline Over Time in WPAI: Total Activity Impairment | Baseline, EoT (treatment period was 12 or 24 weeks),12 and 24 weeks after EoT | The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Total activity impairment indicates the percentage of general (non-work) activity impairment due to health problems. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies | up to 30 days post treatment (treatment period was 12 weeks or 24 weeks) | An adverse event (AE) is defined as any untoward medical occurrence. If an AE meets any of the following criteria, it is considered serious: results in death, is life threatening, results in hospitalization or prolongation of hospitalization, is a congenital anomaly, results in significant disability/incapacity, or is an important medical event. TEAEs are defined as any reported event that begins or worsens in severity after initiation of study drug through 30 days post-study drug dosing. |
| Mean Duration of of ABBVIE REGIMEN and RBV Taken | Up to Week 12 or Week 24 | Documented by participant interview and/or participant diary. |
Participant flow
Recruitment details
In this prospective, multi-center observational study, adult patients chronic hepatitis C (CHC) virus receiving the interferon-free ABBVIE REGIMEN (paritaprevir/r - ombitasvir with or without dasabuvir) with or without ribavirin (RBV) were offered the opportunity to participate in this study during a routine clinical visit at participating sites.
Pre-assignment details
Per protocol, the Enrolled Population is used to present Participant Flow. Enrolled Population analysis groups are defined according to the participant's HCV genotype/subtype, regardless of ABBVIE Regimen prescribed.
Participants by arm
| Arm | Count |
|---|---|
| 2 DAA+RBV Two direct-acting antivirals (2DAA): paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) plus RBV | 45 |
| 3DAA Three direct-acting antivirals (3DAA): paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) | 266 |
| 3DAA+RBV 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) plus RBV | 159 |
| Total | 470 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 2 | 3 | 0 | 0 |
| Overall Study | Did Not Start Treatment | 0 | 0 | 1 | 1 |
| Overall Study | Failure to Return | 20 | 10 | 7 | 0 |
| Overall Study | Other, Not Specified | 5 | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | 2 DAA+RBV | 3DAA | 3DAA+RBV | Total |
|---|---|---|---|---|
| Age, Continuous | 47 years STANDARD_DEVIATION 11.5 | 55 years STANDARD_DEVIATION 13.6 | 49 years STANDARD_DEVIATION 11.9 | 52 years STANDARD_DEVIATION 13.3 |
| Chronic Illness Therapy-Fatigue (FACIT-F) Scale | 70.8 units on a scale STANDARD_DEVIATION 22.1 | 69.3 units on a scale STANDARD_DEVIATION 23.1 | 67.4 units on a scale STANDARD_DEVIATION 23.1 | 68.8 units on a scale STANDARD_DEVIATION 23 |
| Patient Activation Measure (PAM-13) Questionnaire | 64.1 units on a scale STANDARD_DEVIATION 11.8 | 64.3 units on a scale STANDARD_DEVIATION 10.1 | 63.0 units on a scale STANDARD_DEVIATION 9.49 | 63.8 units on a scale STANDARD_DEVIATION 10.1 |
| Pictorial Representation of Illness and Self-Measure (PRISM) Tool | 13.1 cm STANDARD_DEVIATION 9.16 | 12.3 cm STANDARD_DEVIATION 8.78 | 12.4 cm STANDARD_DEVIATION 8.89 | 12.4 cm STANDARD_DEVIATION 8.84 |
| Race/Ethnicity, Customized Asian/Oriental | 4 Participants | 3 Participants | 5 Participants | 12 Participants |
| Race/Ethnicity, Customized Black | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Other, Not Specified | 0 Participants | 6 Participants | 1 Participants | 7 Participants |
| Race/Ethnicity, Customized White/Caucasian | 41 Participants | 255 Participants | 152 Participants | 448 Participants |
| Sex: Female, Male Female | 10 Participants | 124 Participants | 38 Participants | 172 Participants |
| Sex: Female, Male Male | 35 Participants | 142 Participants | 121 Participants | 298 Participants |
| Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment | 14.2 percentage of work productivity impairme STANDARD_DEVIATION 17.9 | 19.1 percentage of work productivity impairme STANDARD_DEVIATION 28 | 18.1 percentage of work productivity impairme STANDARD_DEVIATION 23.3 | 18.2 percentage of work productivity impairme STANDARD_DEVIATION 25.5 |
| WPAI: Total Activity Impairment | 23.0 percentage of activity impairment STANDARD_DEVIATION 25.8 | 25.9 percentage of activity impairment STANDARD_DEVIATION 27.3 | 28.0 percentage of activity impairment STANDARD_DEVIATION 28.9 | 26.3 percentage of activity impairment STANDARD_DEVIATION 27.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 4 / 266 | 1 / 159 |
| other Total, other adverse events | 7 / 45 | 33 / 266 | 23 / 159 |
| serious Total, serious adverse events | 1 / 45 | 7 / 266 | 5 / 159 |
Outcome results
Percentage of Participants With Sustained Virologic Response (SVR12)
SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (\< 50 IU/mL) 12 weeks after the last actual dose of the ABBVIE REGIMEN.
Time frame: 12 weeks after the last dose of study drug (treatment period was 12 or 24 weeks)
Population: Core Population: Participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype; the prescribed ABBVIE REGIMEN was known) with sufficient follow-up data regarding SVR12.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Sustained Virologic Response (SVR12) | 88.1 percentage of participants |
| All Genotype 1 Participants | Percentage of Participants With Sustained Virologic Response (SVR12) | 88.4 percentage of participants |
| Genotype 1a Participants | Percentage of Participants With Sustained Virologic Response (SVR12) | 77.9 percentage of participants |
| Genotype 1b Participants | Percentage of Participants With Sustained Virologic Response (SVR12) | 93.9 percentage of participants |
| Genotype 4 Participants | Percentage of Participants With Sustained Virologic Response (SVR12) | 85.1 percentage of participants |
Change From Baseline in FACIT-F Scale Over Time
The FACIT-F Scale is a 13-item questionnaire that assesses self-reported fatigue during the past 7 days and its impact upon daily activities and function. Scores range from 0 - 100, with higher scores indicating a lesser degree of fatigue.
Time frame: Baseline, EoT (treatment period was 12 or 24 weeks), 12 and 48 weeks after EoT
Population: Core Population: Participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype; the prescribed ABBVIE REGIMEN was known). Participants with a measurement at given time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| All Participants | Change From Baseline in FACIT-F Scale Over Time | 12 Weeks EoT | 12.5 score on a scale |
| All Participants | Change From Baseline in FACIT-F Scale Over Time | EoT | 4.17 score on a scale |
| All Participants | Change From Baseline in FACIT-F Scale Over Time | 48 Weeks EoT | 13.3 score on a scale |
| All Genotype 1 Participants | Change From Baseline in FACIT-F Scale Over Time | 12 Weeks EoT | 9.92 score on a scale |
| All Genotype 1 Participants | Change From Baseline in FACIT-F Scale Over Time | EoT | 6.45 score on a scale |
| All Genotype 1 Participants | Change From Baseline in FACIT-F Scale Over Time | 48 Weeks EoT | 9.68 score on a scale |
| Genotype 1a Participants | Change From Baseline in FACIT-F Scale Over Time | EoT | 4.49 score on a scale |
| Genotype 1a Participants | Change From Baseline in FACIT-F Scale Over Time | 48 Weeks EoT | 10.3 score on a scale |
| Genotype 1a Participants | Change From Baseline in FACIT-F Scale Over Time | 12 Weeks EoT | 10.2 score on a scale |
Change From Baseline in PRISM Over Time
PRISM is a visual quantitative method to assess the perceived burden of suffering due to illness. The distance between the center of the self (yellow disk) and the illness disk (red disk) is called self-illness separation (SIS) and is measured in cm (range is 0 - 27). The smaller the distance, the higher the burden of suffering.
Time frame: Baseline, 12 and 48 weeks after EoT (treatment period was 12 or 24 weeks)
Population: Core Population: Participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype; the prescribed ABBVIE REGIMEN was known). Participants with a measurement at given time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| All Participants | Change From Baseline in PRISM Over Time | 48 Weeks EoT | 10.2 cm |
| All Participants | Change From Baseline in PRISM Over Time | 12 Weeks EoT | 5.41 cm |
| All Genotype 1 Participants | Change From Baseline in PRISM Over Time | 48 Weeks EoT | 10.1 cm |
| All Genotype 1 Participants | Change From Baseline in PRISM Over Time | 12 Weeks EoT | 7.05 cm |
| Genotype 1a Participants | Change From Baseline in PRISM Over Time | 12 Weeks EoT | 5.31 cm |
| Genotype 1a Participants | Change From Baseline in PRISM Over Time | 48 Weeks EoT | 10.3 cm |
Change From Baseline Over Time in WPAI: Total Activity Impairment
The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Total activity impairment indicates the percentage of general (non-work) activity impairment due to health problems.
Time frame: Baseline, EoT (treatment period was 12 or 24 weeks),12 and 24 weeks after EoT
Population: Core Population: Participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (the prescribed ABBVIE REGIMEN was known). Overall: participants with a measurement at Baseline; data rows = participants with a measurement at Baseline and given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Change From Baseline Over Time in WPAI: Total Activity Impairment | EoT | -2.1 percentage impairment of activity | Standard Deviation 30.9 |
| All Participants | Change From Baseline Over Time in WPAI: Total Activity Impairment | 12 Weeks EoT | -11.9 percentage impairment of activity | Standard Deviation 27 |
| All Participants | Change From Baseline Over Time in WPAI: Total Activity Impairment | 24 Weeks EoT | -13.4 percentage impairment of activity | Standard Deviation 25.9 |
| All Genotype 1 Participants | Change From Baseline Over Time in WPAI: Total Activity Impairment | EoT | 7.0 percentage impairment of activity | Standard Deviation 25.2 |
| All Genotype 1 Participants | Change From Baseline Over Time in WPAI: Total Activity Impairment | 12 Weeks EoT | -7.7 percentage impairment of activity | Standard Deviation 22 |
| All Genotype 1 Participants | Change From Baseline Over Time in WPAI: Total Activity Impairment | 24 Weeks EoT | -11.3 percentage impairment of activity | Standard Deviation 22.8 |
| Genotype 1a Participants | Change From Baseline Over Time in WPAI: Total Activity Impairment | 24 Weeks EoT | -12.3 percentage impairment of activity | Standard Deviation 24 |
| Genotype 1a Participants | Change From Baseline Over Time in WPAI: Total Activity Impairment | EoT | -3.0 percentage impairment of activity | Standard Deviation 28.9 |
| Genotype 1a Participants | Change From Baseline Over Time in WPAI: Total Activity Impairment | 12 Weeks EoT | -13.3 percentage impairment of activity | Standard Deviation 24.8 |
| Genotype 1b Participants | Change From Baseline Over Time in WPAI: Total Activity Impairment | 24 Weeks EoT | -16.3 percentage impairment of activity | Standard Deviation 30.3 |
| Genotype 1b Participants | Change From Baseline Over Time in WPAI: Total Activity Impairment | EoT | -2.8 percentage impairment of activity | Standard Deviation 35.5 |
| Genotype 1b Participants | Change From Baseline Over Time in WPAI: Total Activity Impairment | 12 Weeks EoT | -10.5 percentage impairment of activity | Standard Deviation 31.6 |
Change From Baseline Over Time in WPAI: Total Work Productivity Impairment
The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Total work productivity impairment indicates the percentage of overall work impairment due to health problems.
Time frame: Baseline, EoT (treatment period was 12 or 24 weeks),12 and 24 weeks after EoT
Population: Core Population: Participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (the prescribed ABBVIE REGIMEN was known). Overall: participants with a measurement at Baseline; data rows = participants with a measurement at Baseline and given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Change From Baseline Over Time in WPAI: Total Work Productivity Impairment | EoT | 5.5 percentage of overall work impairment | Standard Deviation 31.4 |
| All Participants | Change From Baseline Over Time in WPAI: Total Work Productivity Impairment | 24 Weeks EoT | -7.4 percentage of overall work impairment | Standard Deviation 22.1 |
| All Participants | Change From Baseline Over Time in WPAI: Total Work Productivity Impairment | 12 Weeks EoT | -4.3 percentage of overall work impairment | Standard Deviation 23.4 |
| All Genotype 1 Participants | Change From Baseline Over Time in WPAI: Total Work Productivity Impairment | EoT | 5.0 percentage of overall work impairment | Standard Deviation 36.4 |
| All Genotype 1 Participants | Change From Baseline Over Time in WPAI: Total Work Productivity Impairment | 24 Weeks EoT | -3.2 percentage of overall work impairment | Standard Deviation 33.6 |
| All Genotype 1 Participants | Change From Baseline Over Time in WPAI: Total Work Productivity Impairment | 12 Weeks EoT | -4.2 percentage of overall work impairment | Standard Deviation 11.9 |
| Genotype 1a Participants | Change From Baseline Over Time in WPAI: Total Work Productivity Impairment | 12 Weeks EoT | -3.8 percentage of overall work impairment | Standard Deviation 21.5 |
| Genotype 1a Participants | Change From Baseline Over Time in WPAI: Total Work Productivity Impairment | EoT | 4.4 percentage of overall work impairment | Standard Deviation 27.1 |
| Genotype 1a Participants | Change From Baseline Over Time in WPAI: Total Work Productivity Impairment | 24 Weeks EoT | -7.2 percentage of overall work impairment | Standard Deviation 22.1 |
| Genotype 1b Participants | Change From Baseline Over Time in WPAI: Total Work Productivity Impairment | EoT | 7.5 percentage of overall work impairment | Standard Deviation 36.3 |
| Genotype 1b Participants | Change From Baseline Over Time in WPAI: Total Work Productivity Impairment | 24 Weeks EoT | -9.7 percentage of overall work impairment | Standard Deviation 15.6 |
| Genotype 1b Participants | Change From Baseline Over Time in WPAI: Total Work Productivity Impairment | 12 Weeks EoT | -5.4 percentage of overall work impairment | Standard Deviation 29.6 |
Change From Baseline to EoT in PAM-13 Questionnaire
The PAM-13 item scale is a measure used to assess the patient knowledge, skill, and confidence for self-management. Scores range from 0 to 100. Higher scores indicate a higher level of knowledge, skill and confidence.
Time frame: Baseline, EoT (treatment period was 12 or 24 weeks)
Population: Core Population: Participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype; the prescribed ABBVIE REGIMEN was known). Participants with a measurement at given time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| All Participants | Change From Baseline to EoT in PAM-13 Questionnaire | 1.91 score on a scale |
| All Genotype 1 Participants | Change From Baseline to EoT in PAM-13 Questionnaire | 0.01 score on a scale |
| Genotype 1a Participants | Change From Baseline to EoT in PAM-13 Questionnaire | -0.74 score on a scale |
Mean Duration of of ABBVIE REGIMEN and RBV Taken
Documented by participant interview and/or participant diary.
Time frame: Up to Week 12 or Week 24
Population: Safety Population: all enrolled participants who received at least one dose of the ABBVIE REGIMEN (the prescribed ABBVIE REGIMEN was known) and had an assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Mean Duration of of ABBVIE REGIMEN and RBV Taken | ABBVIE REGIMEN | 83 days | Standard Deviation 11.7 |
| All Participants | Mean Duration of of ABBVIE REGIMEN and RBV Taken | RBV | 81 days | Standard Deviation 18.1 |
| All Genotype 1 Participants | Mean Duration of of ABBVIE REGIMEN and RBV Taken | RBV | 84 days | Standard Deviation 3.4 |
| All Genotype 1 Participants | Mean Duration of of ABBVIE REGIMEN and RBV Taken | ABBVIE REGIMEN | 84 days | Standard Deviation 3.4 |
| Genotype 1a Participants | Mean Duration of of ABBVIE REGIMEN and RBV Taken | ABBVIE REGIMEN | 83 days | Standard Deviation 9.7 |
| Genotype 1b Participants | Mean Duration of of ABBVIE REGIMEN and RBV Taken | ABBVIE REGIMEN | 84 days | Standard Deviation 15.6 |
| Genotype 1b Participants | Mean Duration of of ABBVIE REGIMEN and RBV Taken | RBV | 81 days | Standard Deviation 20.5 |
Number of Participants With On-Treatment Virological Failure or Relapse
The number of participants meeting the following SVR12 non-response categories: 1. On-treatment virological failure (breakthrough) defined \>= 1 documented HCV RNA \< 50 IU/mL followed by HCV RNA \>= 50 IU/mL during treatment or failure to suppress (each measured on-treatment HCV RNA value \>= 50 IU/mL) 2. Relapse defined as HCV RNA \< 50 IU/mL at EoT followed by HCV RNA \>= 50 IU/mL post-treatment in participants who completed treatment (\<= 7 days shortened).
Time frame: Up to post-treatment Week 12 (treatment period was 12 or 24 weeks)
Population: Core Population: Participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype; the prescribed ABBVIE REGIMEN was known). Participants with non-response 12 weeks after EoT.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants With On-Treatment Virological Failure or Relapse | Relapse | 5 Participants |
| All Participants | Number of Participants With On-Treatment Virological Failure or Relapse | On-Treatment Virological Failure | 6 Participants |
| All Genotype 1 Participants | Number of Participants With On-Treatment Virological Failure or Relapse | Relapse | 5 Participants |
| All Genotype 1 Participants | Number of Participants With On-Treatment Virological Failure or Relapse | On-Treatment Virological Failure | 3 Participants |
| Genotype 1a Participants | Number of Participants With On-Treatment Virological Failure or Relapse | Relapse | 1 Participants |
| Genotype 1a Participants | Number of Participants With On-Treatment Virological Failure or Relapse | On-Treatment Virological Failure | 3 Participants |
| Genotype 1b Participants | Number of Participants With On-Treatment Virological Failure or Relapse | On-Treatment Virological Failure | 0 Participants |
| Genotype 1b Participants | Number of Participants With On-Treatment Virological Failure or Relapse | Relapse | 4 Participants |
| Genotype 4 Participants | Number of Participants With On-Treatment Virological Failure or Relapse | Relapse | 0 Participants |
| Genotype 4 Participants | Number of Participants With On-Treatment Virological Failure or Relapse | On-Treatment Virological Failure | 3 Participants |
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies
An adverse event (AE) is defined as any untoward medical occurrence. If an AE meets any of the following criteria, it is considered serious: results in death, is life threatening, results in hospitalization or prolongation of hospitalization, is a congenital anomaly, results in significant disability/incapacity, or is an important medical event. TEAEs are defined as any reported event that begins or worsens in severity after initiation of study drug through 30 days post-study drug dosing.
Time frame: up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Population: Safety Population: all enrolled participants who received at least one dose of the ABBVIE REGIMEN (the prescribed ABBVIE REGIMEN was known). Pregnancy data presented for female participants only.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies | ≥ 1 TEAE | 124 Participants |
| All Participants | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies | Pregnancy | 0 Participants |
| All Participants | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies | ≥ 1 Serious TEAE | 13 Participants |
| All Genotype 1 Participants | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies | ≥ 1 TEAE | 16 Participants |
| All Genotype 1 Participants | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies | Pregnancy | 0 Participants |
| All Genotype 1 Participants | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies | ≥ 1 Serious TEAE | 1 Participants |
| Genotype 1a Participants | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies | ≥ 1 Serious TEAE | 7 Participants |
| Genotype 1a Participants | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies | ≥ 1 TEAE | 65 Participants |
| Genotype 1a Participants | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies | Pregnancy | 0 Participants |
| Genotype 1b Participants | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies | ≥ 1 TEAE | 43 Participants |
| Genotype 1b Participants | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies | Pregnancy | 0 Participants |
| Genotype 1b Participants | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies | ≥ 1 Serious TEAE | 5 Participants |
Percentage of Participants Taking ≥ 1 Co-Medication
Time frame: up to post-treatment Week 48 (treatment period was 12 or 24 weeks)
Population: Safety Population: all enrolled participants who received at least one dose of the ABBVIE REGIMEN (the prescribed ABBVIE REGIMEN was known).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants Taking ≥ 1 Co-Medication | 59.1 percentage of participants |
| All Genotype 1 Participants | Percentage of Participants Taking ≥ 1 Co-Medication | 64.4 percentage of participants |
| Genotype 1a Participants | Percentage of Participants Taking ≥ 1 Co-Medication | 54.1 percentage of participants |
| Genotype 1b Participants | Percentage of Participants Taking ≥ 1 Co-Medication | 66.0 percentage of participants |
Percentage of Participants With ≥ 1 Comorbidity and/or Co-Infection
Time frame: up to post-treatment Week 48 (treatment period was 12 or 24 weeks)
Population: Core Population: Participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype; the prescribed ABBVIE REGIMEN was known).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With ≥ 1 Comorbidity and/or Co-Infection | 70.0 percentage of participants |
| All Genotype 1 Participants | Percentage of Participants With ≥ 1 Comorbidity and/or Co-Infection | 69.3 percentage of participants |
| Genotype 1a Participants | Percentage of Participants With ≥ 1 Comorbidity and/or Co-Infection | 71.0 percentage of participants |
| Genotype 1b Participants | Percentage of Participants With ≥ 1 Comorbidity and/or Co-Infection | 68.3 percentage of participants |
| Genotype 4 Participants | Percentage of Participants With ≥ 1 Comorbidity and/or Co-Infection | 76.6 percentage of participants |
Percentage of Participants With Rapid Virological Response at Week 4 (RVR4)
RVR4 is defined as participants with HCV RNA \< 50 IU/mL at Week 4.
Time frame: Week 4
Population: Core Population: Participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype; the prescribed ABBVIE REGIMEN was known).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Rapid Virological Response at Week 4 (RVR4) | 57.0 percentage of participants |
| All Genotype 1 Participants | Percentage of Participants With Rapid Virological Response at Week 4 (RVR4) | 57.2 percentage of participants |
| Genotype 1a Participants | Percentage of Participants With Rapid Virological Response at Week 4 (RVR4) | 62.1 percentage of participants |
| Genotype 1b Participants | Percentage of Participants With Rapid Virological Response at Week 4 (RVR4) | 54.7 percentage of participants |
| Genotype 4 Participants | Percentage of Participants With Rapid Virological Response at Week 4 (RVR4) | 55.3 percentage of participants |
Percentage of Participants With Sustained Virological Response 24 Weeks After EoT (SVR24)
SVR24 is defined as HCV RNA \< 50 IU/mL 24 Weeks After EoT.
Time frame: 24 Weeks After EoT (treatment period was 12 or 24 weeks)
Population: Core Population: Participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype; the prescribed ABBVIE REGIMEN was known) with sufficient follow-up data regarding SVR24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Sustained Virological Response 24 Weeks After EoT (SVR24) | 95.0 percentage of participants |
| All Genotype 1 Participants | Percentage of Participants With Sustained Virological Response 24 Weeks After EoT (SVR24) | 95.4 percentage of participants |
| Genotype 1a Participants | Percentage of Participants With Sustained Virological Response 24 Weeks After EoT (SVR24) | 92.8 percentage of participants |
| Genotype 1b Participants | Percentage of Participants With Sustained Virological Response 24 Weeks After EoT (SVR24) | 96.5 percentage of participants |
| Genotype 4 Participants | Percentage of Participants With Sustained Virological Response 24 Weeks After EoT (SVR24) | 91.9 percentage of participants |
Percentage of Participants With Sustained Virological Response 48 Weeks After EoT (SVR48)
SVR48 is defined as participants with HCV RNA \< 50 IU/mL 48 weeks after EoT.
Time frame: 48 Weeks After EoT (treatment period was 12 or 24 weeks)
Population: Core Population: Participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype; the prescribed ABBVIE REGIMEN was known) with sufficient follow-up data regarding SVR48.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Sustained Virological Response 48 Weeks After EoT (SVR48) | 92.7 percentage of participants |
| All Genotype 1 Participants | Percentage of Participants With Sustained Virological Response 48 Weeks After EoT (SVR48) | 93.2 percentage of participants |
| Genotype 1a Participants | Percentage of Participants With Sustained Virological Response 48 Weeks After EoT (SVR48) | 89.0 percentage of participants |
| Genotype 1b Participants | Percentage of Participants With Sustained Virological Response 48 Weeks After EoT (SVR48) | 95.1 percentage of participants |
| Genotype 4 Participants | Percentage of Participants With Sustained Virological Response 48 Weeks After EoT (SVR48) | 88.0 percentage of participants |
Percentage of Participants With Virological Response at End of Treatment (EoTR)
Virological response is defined as HCV RNA \< 50 IU/mL. End of Treatment (EoT) is defined as the last intake of ABBVIE REGIMEN or RBV.
Time frame: EoT, (treatment period was 12 weeks or 24 weeks)
Population: Core Population: Participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype; the prescribed ABBVIE REGIMEN was known).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Virological Response at End of Treatment (EoTR) | 93.4 percentage of participants |
| All Genotype 1 Participants | Percentage of Participants With Virological Response at End of Treatment (EoTR) | 94.8 percentage of participants |
| Genotype 1a Participants | Percentage of Participants With Virological Response at End of Treatment (EoTR) | 89.0 percentage of participants |
| Genotype 1b Participants | Percentage of Participants With Virological Response at End of Treatment (EoTR) | 97.8 percentage of participants |
| Genotype 4 Participants | Percentage of Participants With Virological Response at End of Treatment (EoTR) | 80.9 percentage of participants |
Percentage of Planned Duration of ABBVIE REGIMEN and RBV Taken
Planned duration of treatment was 12 or 24 weeks.
Time frame: Up to Week 12 or Week 24
Population: Core Population: Participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype; the prescribed ABBVIE REGIMEN was known). Participants taking specified study drug with non-missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Percentage of Planned Duration of ABBVIE REGIMEN and RBV Taken | RBV | 95.4 percentage of planned treatment duration | Standard Deviation 17.55 |
| All Participants | Percentage of Planned Duration of ABBVIE REGIMEN and RBV Taken | ABBVIE REGIMEN | 98.7 percentage of planned treatment duration | Standard Deviation 9.74 |
| All Genotype 1 Participants | Percentage of Planned Duration of ABBVIE REGIMEN and RBV Taken | ABBVIE REGIMEN | 98.6 percentage of planned treatment duration | Standard Deviation 10.18 |
| All Genotype 1 Participants | Percentage of Planned Duration of ABBVIE REGIMEN and RBV Taken | RBV | 94.1 percentage of planned treatment duration | Standard Deviation 19.72 |
| Genotype 1a Participants | Percentage of Planned Duration of ABBVIE REGIMEN and RBV Taken | RBV | 95.3 percentage of planned treatment duration | Standard Deviation 17.68 |
| Genotype 1a Participants | Percentage of Planned Duration of ABBVIE REGIMEN and RBV Taken | ABBVIE REGIMEN | 97.7 percentage of planned treatment duration | Standard Deviation 12.94 |
| Genotype 1b Participants | Percentage of Planned Duration of ABBVIE REGIMEN and RBV Taken | ABBVIE REGIMEN | 99.1 percentage of planned treatment duration | Standard Deviation 8.39 |
| Genotype 1b Participants | Percentage of Planned Duration of ABBVIE REGIMEN and RBV Taken | RBV | 83.5 percentage of planned treatment duration | Standard Deviation 30.68 |
| Genotype 4 Participants | Percentage of Planned Duration of ABBVIE REGIMEN and RBV Taken | ABBVIE REGIMEN | 99.8 percentage of planned treatment duration | Standard Deviation 3.91 |
| Genotype 4 Participants | Percentage of Planned Duration of ABBVIE REGIMEN and RBV Taken | RBV | 99.8 percentage of planned treatment duration | Standard Deviation 3.91 |