| Primary | 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. | 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. | Posted | | Number | | percentage of participants | | 12 weeks after the last dose of study drug (treatment period was 12 or 24 weeks) | | | | ID | Title | Description |
|---|
| OG000 | All Participants | Treatment-naïve or -experienced participants with confirmed CHC genotype 1 or 4, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label | | OG001 | All Genotype 1 Participants | Treatment-naïve or -experienced participants with confirmed CHC genotype 1, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label. | | OG002 | Genotype 1a Participants | Treatment-naïve or -experienced participants with confirmed CHC G1a (includes all GT1-participants except participants with GT1b or GT1b/4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label. | | OG003 | Genotype 1b Participants | Treatment-naïve or -experienced participants with confirmed CHC genotype 1b (G1b; includes G1b/G4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) according to standard of care and in line with the current local label. | | OG004 | Genotype 4 Participants | Treatment-naïve or -experienced participants with confirmed CHC genotype 4 (G4; non-G1), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label. |
| | Units | Counts |
|---|
| Participants | - OG000470
- OG001423
- OG002145
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00088.1
- OG00188.4
- OG00277.9
- OG003
|
|
| |
| Secondary | 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. | 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). | Posted | | Number | | percentage of participants | | EoT, (treatment period was 12 weeks or 24 weeks) | | | | ID | Title | Description |
|---|
| OG000 | All Participants | Treatment-naïve or -experienced participants with confirmed CHC genotype 1 or 4, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label | | OG001 | All Genotype 1 Participants | Treatment-naïve or -experienced participants with confirmed CHC genotype 1, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label. | | OG002 | Genotype 1a Participants | |
|
| Secondary | Number of Participants With On-Treatment Virological Failure or Relapse | The number of participants meeting the following SVR12 non-response categories:
- 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)
- 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).
| 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. | Posted | | Count of Participants | | Participants | | Up to post-treatment Week 12 (treatment period was 12 or 24 weeks) | | | | ID | Title | Description |
|---|
| OG000 | All Participants | Treatment-naïve or -experienced participants with confirmed CHC genotype 1 or 4, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label. | | OG001 | All Genotype 1 Participants | Treatment-naïve or -experienced participants with confirmed CHC genotype 1, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label. |
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| Secondary | 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. | 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). | Posted | | Number | | percentage of participants | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | Treatment-naïve or -experienced participants with confirmed CHC genotype 1 or 4, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label. | | OG001 | All Genotype 1 Participants | Treatment-naïve or -experienced participants with confirmed CHC genotype 1, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label. | | OG002 | Genotype 1a Participants | Treatment-naïve or -experienced participants with confirmed CHC G1a (includes all GT1-participants except participants with GT1b or GT1b/4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label. |
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| Secondary | 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. | 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. | Posted | | Number | | percentage of participants | | 24 Weeks After EoT (treatment period was 12 or 24 weeks) | | | | ID | Title | Description |
|---|
| OG000 | All Participants | Treatment-naïve or -experienced participants with confirmed CHC genotype 1 or 4, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label | | OG001 | All Genotype 1 Participants | Treatment-naïve or -experienced participants with confirmed CHC genotype 1, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label. | | OG002 | Genotype 1a Participants | |
|
| Secondary | 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. | 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. | Posted | | Number | | percentage of participants | | 48 Weeks After EoT (treatment period was 12 or 24 weeks) | | | | ID | Title | Description |
|---|
| OG000 | All Participants | Treatment-naïve or -experienced participants with confirmed chronic hepatitis C (CHC), genotype 1 or 4, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) according to standard of care and in line with the current local label | | OG001 | Genotype 1 Participants | Treatment-naïve or -experienced participants with confirmed CHC genotype 1, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label. | | OG002 | Genotype 1a Participants |
|
| Secondary | 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. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | cm | | Baseline, 12 and 48 weeks after EoT (treatment period was 12 or 24 weeks) | | | | ID | Title | Description |
|---|
| OG000 | 2 DAA+RBV | 2DAA: paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) plus RBV | | OG001 | 3DAA | 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) | | OG002 | 3DAA+RBV | 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) + RBV |
| |
| Secondary | Percentage of Participants With ≥ 1 Comorbidity and/or Co-Infection | | 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). | Posted | | Number | | percentage of participants | | up to post-treatment Week 48 (treatment period was 12 or 24 weeks) | | | | ID | Title | Description |
|---|
| OG000 | All Participants | Treatment-naïve or -experienced participants with confirmed chronic hepatitis C (CHC), genotype 1 or 4, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) according to standard of care and in line with the current local label. | | OG001 | Genotype 1 Participants | Treatment-naïve or -experienced participants with confirmed CHC genotype 1, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label. | | OG002 | Genotype 1a Participants | Treatment-naïve or -experienced participants with confirmed CHC G1a (includes all GT1-participants except participants with GT1b or GT1b/4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label. |
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| Secondary | Percentage of Participants Taking ≥ 1 Co-Medication | | Safety Population: all enrolled participants who received at least one dose of the ABBVIE REGIMEN (the prescribed ABBVIE REGIMEN was known). | Posted | | Number | | percentage of participants | | up to post-treatment Week 48 (treatment period was 12 or 24 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Total |
- 2DAA: paritaprevir/ritonavir - ombitasvir [ABBVIE REGIMEN]) plus RBV
- 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir [ABBVIE REGIMEN])
- 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) plus RBV
| | OG001 | 2 DAA+RBV | 2DAA: paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) plus RBV | | OG002 | 3DAA | 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) | | OG003 | 3DAA+RBV | 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) plus RBV |
| |
| Secondary | Mean Duration of of ABBVIE REGIMEN and RBV Taken | Documented by participant interview and/or participant diary. | 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. | Posted | | Mean | Standard Deviation | days | | Up to Week 12 or Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Total |
- 2DAA: paritaprevir/ritonavir - ombitasvir [ABBVIE REGIMEN]) plus RBV
- 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir [ABBVIE REGIMEN])
- 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) plus RBV
| | OG001 | 2 DAA+RBV | 2DAA: paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) plus RBV | | OG002 | 3DAA | 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) | | OG003 | 3DAA+RBV | 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) plus RBV |
| |
| Secondary | Percentage of Planned Duration of ABBVIE REGIMEN and RBV Taken | Planned duration of treatment was 12 or 24 weeks. | 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. | Posted | | Mean | Standard Deviation | percentage of planned treatment duration | | Up to Week 12 or Week 24 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | Treatment-naïve or -experienced participants with confirmed CHC genotype 1 or 4, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label. | | OG001 | All Genotype 1 Participants | Treatment-naïve or -experienced participants with confirmed CHC genotype 1, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label. | | OG002 | Genotype 1a Participants | |
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| Secondary | 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. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | score on a scale | | Baseline, EoT (treatment period was 12 or 24 weeks), 12 and 48 weeks after EoT | | | | ID | Title | Description |
|---|
| OG000 | 2 DAA+RBV | 2DAA: paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) plus RBV | | OG001 | 3DAA | 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) | | OG002 | 3DAA+RBV | 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) plus RBV |
| |
| Secondary | 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. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | score on a scale | | Baseline, EoT (treatment period was 12 or 24 weeks) | | | | ID | Title | Description |
|---|
| OG000 | 2 DAA+RBV | 2DAA: paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) plus RBV | | OG001 | 3DAA | 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) | | OG002 | 3DAA+RBV | 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) plus RBV |
| |
| Secondary | 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. | 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. | Posted | | Mean | Standard Deviation | percentage of overall work impairment | | Baseline, EoT (treatment period was 12 or 24 weeks),12 and 24 weeks after EoT | | | | ID | Title | Description |
|---|
| OG000 | Total | 2DAA: paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) plus RBV or 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir [ABBVIE REGIMEN]) or 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) + RBV | | OG001 | 2 DAA+RBV | 2DAA: paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) plus RBV |
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| Secondary | 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. | 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. | Posted | | Mean | Standard Deviation | percentage impairment of activity | | Baseline, EoT (treatment period was 12 or 24 weeks),12 and 24 weeks after EoT | | | | ID | Title | Description |
|---|
| OG000 | Total | 2DAA: paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) plus RBV or 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir [ABBVIE REGIMEN]) or 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) + RBV | | OG001 | 2 DAA+RBV | 2DAA: paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) plus RBV |
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| Secondary | 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. | 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. | Posted | | Count of Participants | | Participants | | up to 30 days post treatment (treatment period was 12 weeks or 24 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Total | 2DAA: paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) plus RBV or 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir [ABBVIE REGIMEN]) or 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) + RBV | | OG001 | 2 DAA+RBV | Two direct-acting antivirals (2DAA): paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) plus RBV | | OG002 | 3DAA |
|