VERITAS: Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Hungary
Study Details
Study Description
Brief Summary
The study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO), work productivity and safety data of the interferon-free regimen of paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), ± dasabuvir (DSV), ± ribavirin in chronic hepatitis C virus infected participants.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease. The prescription of treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer the patient the opportunity to participate in this study. |
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) [12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)]
Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. Participants with missing HCV RNA were counted as virological failure.
Secondary Outcome Measures
- Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 24 Weeks Post-treatment (SVR24) [24 weeks after the last dose of study drug (week 36 or 48 depending on the treatment regimen)]
Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 24 weeks after the last dose of study drug. The Core population with sufficient follow-up data regarding SVR24 included all core population participants who had evaluable HCV RNA data ≥ 126 days after the last actual dose of the ABBVIE REGIMEN or a HCV RNA value ≥ 50 IU/mL at the last measurement post-baseline or had HCV RNA < 50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥ 126 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to adverse event) or virologic failure.
- Percentage of Participants Achieving Virological Response at End of Treatment [End of treatment (week 12 or 24 depending on the treatment regimen)]
Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL.
- Percentage of Participants With Relapse [End of treatment (week 12 or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.]
Relapse was defined as participants with a virologic response (VR; HCV RNA < 50 IU/mL) at end of treatment (EOT) followed by HCV RNA ≥ 50 IU/mL at any time after the end of treatment.
- Number of Participants With Breakthrough [12 or 24 weeks (depending on the treatment regimen)]
Breakthrough was defined as at least one documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment.
- Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment [12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)]
SVR12 non-response was categorized according to the following: On-treatment virologic failure (breakthrough [at least one 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 patients who completed treatment (not more than 7 days shortened); Death; Premature treatment discontinuation with no on-treatment virologic failure; None of the above criteria or missing SVR12 data
- Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category [From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.]
Adherence to the ABBVIE treatment regimen is expressed as a percentage of the target dose and was calculated as: Cumulative dose taken / (initial prescribed dose * planned duration) * 100 The ABBVIE regimen consists of paritaprevir/r and ombitasvir with or without dasabuvir.
- Percentage of Participants With Adherence to Ribavirin by Adherence Category [From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen]
Adherence to ribavirin is expressed as a percentage of the target dose, and was calculated as: Cumulative dose taken / (initial prescribed dose * planned duration) * 100
- Percentage of Ribavirin Treatment Days in Relation to the Target Number of Ribavirin Treatment Days [From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.]
- Number of Participants Who Received Concomitant Medications [From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen]
Concomitant medication other than for chronic hepatitis C used from the time when the decision was made to initiate treatment with paritaprevir/ritonavir and ombitasvir with or without dasabuvir until after the last dose.
- Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies [From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen)]
- Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score [Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment]
The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate visual analog scale (VAS). The VAS assesses overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable). The higher the score the better the health status.
- Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score [Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment]
The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate visual analog scale (VAS). Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score by applying country-specific weights.The range for EQ-5D-5L index score is 0 to 1 where '0' is defined as a health state equivalent to being dead and '1' is full health.The higher the score the better the health status.
- Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism [Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment]
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. Absenteeism indicates the percentage of work time missed due to health problems.
- Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism [Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment]
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. Presenteeism indicates the percentage of impairment while working due to health problems.
- Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP) [Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment]
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 (TWP) indicates the percentage of overall work impairment due to health problems.
- Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment [Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment]
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 (TAI) indicates the percentage of general (non-work) activity impairment due to health problems.
- Change From Baseline in Patient Activation Measure 13 (PAM-13) [Baseline and end of treatment (week 12 or 24 depending on the treatment regimen)]
PAM-13 is a measure used to assess the patient knowledge, skill, and confidence for self-management, consisting of 13 questions. 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). Scores were summed to calculate the overall raw score, then transformed to a scale with a theoretical range 0 to 100, based on calibration tables, with higher PAM scores indicating that the participant is likely to participate more actively in health care processes and takes more responsibility for his or her health.
- Number of Participants Who Participated in the AbbVie Patient Support Program (PSP) [Up to post treatment week 24]
- Utilization of the AbbVie Patient Support Program (PSP) Components [End of treatment (week 12 or 24 depending on the treatment regimen)]
At the end of treatment visit participants were asked to indicate which of the following PSP services they had used: Personal support (e.g., Care Coach) Printed educational material Online educational materials Web-portal App
- Satisfaction With the AbbVie Patient Support Program (PSP) Components [End of treatment (weeks 12 or 24 depending on treatment regimen)]
At the end of treatment visit participants were asked to indicate their level of satisfaction with each of the PSP services they had used.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C (CHC), genotype 1 and 4, receiving combination therapy with the interferon-free paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), ± dasabuvir (DSV), ± ribavirin (PTV/r+OBV±DSV±RBV) according to standard of care and in line with the current local label.
-
If RBV is co-administered with the PTV/r+OBV±DSV±RBV, 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 Subject Information Form and Informed Consent Form prior to inclusion into the study.
-
Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial.
-
Patient has been started on PTV/r+OBV±DSV±RBV therapy no more than one (1) month prior to the study enrollment.
Exclusion Criteria:
• None
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- AbbVie
- IST GmbH, Germany
Investigators
- Study Director: AbbVie Inc., AbbVie
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- P15-709
- HU15-01
Study Results
Participant Flow
| Recruitment Details | This observational study was conducted in 14 medical centers in Hungary experienced in the treatment of chronic hepatitis C (CHC). The first participant entered the study on November 27, 2015 and last patient last visit was on 23 May 2018. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin |
|---|---|
| Arm/Group Description | Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease. The prescription of treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer the patient the opportunity to participate in this study. |
| Period Title: Overall Study | |
| STARTED | 244 |
| Received Treatment | 243 |
| COMPLETED | 233 |
| NOT COMPLETED | 11 |
Baseline Characteristics
| Arm/Group Title | Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin |
|---|---|
| Arm/Group Description | Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease. |
| Overall Participants | 243 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
60
(10.1)
|
| Age, Customized (Count of Participants) | |
| 18-65 years |
178
73.3%
|
| 66-84 years |
65
26.7%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
141
58%
|
| Male |
102
42%
|
| Race/Ethnicity, Customized (Count of Participants) | |
| White |
243
100%
|
| Years Since Diagnosis of HCV Infection (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
9.2
(7.66)
|
| Hepatitis C Virus Genotype (Count of Participants) | |
| Genotype 1a |
9
3.7%
|
| Genotype 1a/1b |
5
2.1%
|
| Genotype 1b |
227
93.4%
|
| Genotype 1b/4 unknown |
1
0.4%
|
| Genotype 1 unknown |
1
0.4%
|
| Cirrhosis Status (Count of Participants) | |
| No cirrhosis |
42
17.3%
|
| Transition to cirrhosis |
29
11.9%
|
| Cirrhosis |
172
70.8%
|
| Pretreatment Status (Count of Participants) | |
| Naive |
83
34.2%
|
| Experienced |
160
65.8%
|
| HCV Ribonucleic Acid (RNA) Level (log10 IU/mL) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [log10 IU/mL] |
5.79
(0.889)
|
| Assigned Treatment (Count of Participants) | |
| 3 DAA without RBV for 12 weeks |
133
54.7%
|
| 3 DAA without RBV for 24 weeks |
5
2.1%
|
| 3 DAA with RBV for 12 weeks |
96
39.5%
|
| 3 DAA with RBV for 24 weeks |
9
3.7%
|
| Co-morbidities (Count of Participants) | |
| Any co-morbidity or co-infection |
197
81.1%
|
| Co-infections |
1
0.4%
|
| Hepatitis B |
1
0.4%
|
| Liver and/or CHC related co-morbidities |
47
19.3%
|
Outcome Measures
| Title | Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) |
|---|---|
| Description | Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. Participants with missing HCV RNA were counted as virological failure. |
| Time Frame | 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Core population, defined as enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). |
| Arm/Group Title | Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin |
|---|---|
| Arm/Group Description | Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease. |
| Measure Participants | 238 |
| Number (95% Confidence Interval) [percentage of participants] |
94.5
38.9%
|
| Title | Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 24 Weeks Post-treatment (SVR24) |
|---|---|
| Description | Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 24 weeks after the last dose of study drug. The Core population with sufficient follow-up data regarding SVR24 included all core population participants who had evaluable HCV RNA data ≥ 126 days after the last actual dose of the ABBVIE REGIMEN or a HCV RNA value ≥ 50 IU/mL at the last measurement post-baseline or had HCV RNA < 50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥ 126 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to adverse event) or virologic failure. |
| Time Frame | 24 weeks after the last dose of study drug (week 36 or 48 depending on the treatment regimen) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Core population with sufficient follow-up data regarding SVR24 |
| Arm/Group Title | Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin |
|---|---|
| Arm/Group Description | Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease. |
| Measure Participants | 232 |
| Number (95% Confidence Interval) [percentage of participants] |
96.6
39.8%
|
| Title | Percentage of Participants Achieving Virological Response at End of Treatment |
|---|---|
| Description | Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL. |
| Time Frame | End of treatment (week 12 or 24 depending on the treatment regimen) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Core population defined as enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). |
| Arm/Group Title | Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin |
|---|---|
| Arm/Group Description | Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease. |
| Measure Participants | 238 |
| Number (95% Confidence Interval) [percentage of participants] |
97.1
40%
|
| Title | Percentage of Participants With Relapse |
|---|---|
| Description | Relapse was defined as participants with a virologic response (VR; HCV RNA < 50 IU/mL) at end of treatment (EOT) followed by HCV RNA ≥ 50 IU/mL at any time after the end of treatment. |
| Time Frame | End of treatment (week 12 or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Core population with VR at EOT, who completed treatment, and had ≥ 1 HCV RNA measurement ≥ 70 days post-treatment or were a treatment failure between EOT and day 70. |
| Arm/Group Title | Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin |
|---|---|
| Arm/Group Description | Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease. |
| Measure Participants | 225 |
| Number (95% Confidence Interval) [percentage of participants] |
1.3
0.5%
|
| Title | Number of Participants With Breakthrough |
|---|---|
| Description | Breakthrough was defined as at least one documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment. |
| Time Frame | 12 or 24 weeks (depending on the treatment regimen) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Core population with at least one documented HCV RNA < 50 IU/mL while on treatment and at least one on-treatment or EOT measurement thereafter. |
| Arm/Group Title | Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin |
|---|---|
| Arm/Group Description | Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease. |
| Measure Participants | 8 |
| Count of Participants [Participants] |
0
0%
|
| Title | Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment |
|---|---|
| Description | SVR12 non-response was categorized according to the following: On-treatment virologic failure (breakthrough [at least one 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 patients who completed treatment (not more than 7 days shortened); Death; Premature treatment discontinuation with no on-treatment virologic failure; None of the above criteria or missing SVR12 data |
| Time Frame | 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Core population |
| Arm/Group Title | Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin |
|---|---|
| Arm/Group Description | Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease. |
| Measure Participants | 238 |
| On-treatment virologic failure |
2
0.8%
|
| Relapse |
3
1.2%
|
| Death |
3
1.2%
|
| Premature treatment discontinuation |
2
0.8%
|
| None of the above criteria |
3
1.2%
|
| Title | Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category |
|---|---|
| Description | Adherence to the ABBVIE treatment regimen is expressed as a percentage of the target dose and was calculated as: Cumulative dose taken / (initial prescribed dose * planned duration) * 100 The ABBVIE regimen consists of paritaprevir/r and ombitasvir with or without dasabuvir. |
| Time Frame | From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Core population |
| Arm/Group Title | Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin |
|---|---|
| Arm/Group Description | Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease. |
| Measure Participants | 238 |
| > 105% |
3.4
1.4%
|
| > 95% to ≤ 105% |
93.7
38.6%
|
| > 80% to ≤ 95% |
0.8
0.3%
|
| > 50% to ≤ 80% |
0.8
0.3%
|
| ≤ 50% |
1.3
0.5%
|
| Title | Percentage of Participants With Adherence to Ribavirin by Adherence Category |
|---|---|
| Description | Adherence to ribavirin is expressed as a percentage of the target dose, and was calculated as: Cumulative dose taken / (initial prescribed dose * planned duration) * 100 |
| Time Frame | From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen |
Outcome Measure Data
| Analysis Population Description |
|---|
| Core population who were prescribed ribavirin |
| Arm/Group Title | Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin |
|---|---|
| Arm/Group Description | Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease. |
| Measure Participants | 105 |
| > 105% |
1.0
0.4%
|
| > 95% to ≤ 105% |
78.1
32.1%
|
| > 80% to ≤ 95% |
5.7
2.3%
|
| > 50% to ≤ 80% |
6.7
2.8%
|
| ≤ 50% |
8.6
3.5%
|
| Title | Percentage of Ribavirin Treatment Days in Relation to the Target Number of Ribavirin Treatment Days |
|---|---|
| Description | |
| Time Frame | From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Core population who were prescribed ribavirin |
| Arm/Group Title | Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin |
|---|---|
| Arm/Group Description | Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease. |
| Measure Participants | 105 |
| Mean (Standard Deviation) [percentage of days] |
93.1
(22.20)
|
| Title | Number of Participants Who Received Concomitant Medications |
|---|---|
| Description | Concomitant medication other than for chronic hepatitis C used from the time when the decision was made to initiate treatment with paritaprevir/ritonavir and ombitasvir with or without dasabuvir until after the last dose. |
| Time Frame | From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants |
| Arm/Group Title | Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin |
|---|---|
| Arm/Group Description | Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease. |
| Measure Participants | 243 |
| Any concomitant medication |
169
69.5%
|
| Beta blocking agents |
78
32.1%
|
| ACE inhibitors |
53
21.8%
|
| Diuretics |
42
17.3%
|
| Peptic ulcer / gastro-oesophageal reflux disease |
42
17.3%
|
| Calcium channel blockers |
34
14%
|
| Blood glucose-lowering drugs |
27
11.1%
|
| Mineral supplements |
25
10.3%
|
| Title | Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies |
|---|---|
| Description | |
| Time Frame | From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants |
| Arm/Group Title | Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin |
|---|---|
| Arm/Group Description | Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease. |
| Measure Participants | 243 |
| Adverse events |
29
11.9%
|
| Serious adverse events |
6
2.5%
|
| Pregnancies |
0
0%
|
| Title | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score |
|---|---|
| Description | The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate visual analog scale (VAS). The VAS assesses overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable). The higher the score the better the health status. |
| Time Frame | Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Core population with available data at baseline and each time point. |
| Arm/Group Title | Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV | Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV |
|---|---|---|
| Arm/Group Description | Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir without ribavirin for 12 or 24 weeks. | Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks. |
| Measure Participants | 128 | 102 |
| End of treatment |
5.70
|
2.77
|
| 12 weeks after end of treatment |
9.18
|
5.98
|
| 24 weeks after end of treatment |
10.5
|
6.07
|
| Title | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score |
|---|---|
| Description | The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate visual analog scale (VAS). Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score by applying country-specific weights.The range for EQ-5D-5L index score is 0 to 1 where '0' is defined as a health state equivalent to being dead and '1' is full health.The higher the score the better the health status. |
| Time Frame | Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Core population with available data at baseline and each time point. |
| Arm/Group Title | Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV | Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV |
|---|---|---|
| Arm/Group Description | Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir without ribavirin for 12 or 24 weeks. | Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks. |
| Measure Participants | 124 | 103 |
| End of treatment |
0.02
|
0.02
|
| 12 weeks after end of treatment |
0.03
|
0.04
|
| 24 weeks after end of treatment |
0.04
|
0.04
|
| Title | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism |
|---|---|
| Description | 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. Absenteeism indicates the percentage of work time missed due to health problems. |
| Time Frame | Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Core population who were employed and with available data at baseline and each time point. |
| Arm/Group Title | Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin |
|---|---|
| Arm/Group Description | Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease. |
| Measure Participants | 68 |
| End of treatment |
-2.1
(21.6)
|
| 12 weeks after end of treatment |
-1.7
(22.2)
|
| 24 weeks after end of treatment |
1.0
(19.6)
|
| Title | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism |
|---|---|
| Description | 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. Presenteeism indicates the percentage of impairment while working due to health problems. |
| Time Frame | Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Core population who were employed and with available data at baseline and each time point. |
| Arm/Group Title | Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin |
|---|---|
| Arm/Group Description | Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease. |
| Measure Participants | 81 |
| End of treatment |
0.6
(28.8)
|
| 12 weeks after end of treatment |
-5.7
(25.1)
|
| 24 weeks after end of treatment |
-7.3
(23.3)
|
| Title | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP) |
|---|---|
| Description | 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 (TWP) indicates the percentage of overall work impairment due to health problems. |
| Time Frame | Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Core population who were employed and with available data at baseline and each time point. |
| Arm/Group Title | Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin |
|---|---|
| Arm/Group Description | Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease. |
| Measure Participants | 78 |
| End of treatment |
-2.3
(34.5)
|
| 12 weeks after end of treatment |
-8.1
(30.5)
|
| 24 weeks after end of treatment |
-7.3
(27.3)
|
| Title | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment |
|---|---|
| Description | 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 (TAI) indicates the percentage of general (non-work) activity impairment due to health problems. |
| Time Frame | Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Core population with available data at baseline and each time point. |
| Arm/Group Title | Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin |
|---|---|
| Arm/Group Description | Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease. |
| Measure Participants | 194 |
| End of treatment |
-0.5
(29.4)
|
| 12 weeks after end of treatment |
-6.7
(28.4)
|
| 24 weeks after end of treatment |
-8.5
(26.6)
|
| Title | Change From Baseline in Patient Activation Measure 13 (PAM-13) |
|---|---|
| Description | PAM-13 is a measure used to assess the patient knowledge, skill, and confidence for self-management, consisting of 13 questions. 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). Scores were summed to calculate the overall raw score, then transformed to a scale with a theoretical range 0 to 100, based on calibration tables, with higher PAM scores indicating that the participant is likely to participate more actively in health care processes and takes more responsibility for his or her health. |
| Time Frame | Baseline and end of treatment (week 12 or 24 depending on the treatment regimen) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Core population with available data at baseline and end of treatment. |
| Arm/Group Title | Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV | Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV |
|---|---|---|
| Arm/Group Description | Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir without ribavirin for 12 or 24 weeks. | Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks. |
| Measure Participants | 98 | 90 |
| Least Squares Mean (95% Confidence Interval) [units on a scale] |
0.85
|
0.22
|
| Title | Number of Participants Who Participated in the AbbVie Patient Support Program (PSP) |
|---|---|
| Description | |
| Time Frame | Up to post treatment week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Core population |
| Arm/Group Title | Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin |
|---|---|
| Arm/Group Description | Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease. |
| Measure Participants | 238 |
| Count of Participants [Participants] |
179
73.7%
|
| Title | Utilization of the AbbVie Patient Support Program (PSP) Components |
|---|---|
| Description | At the end of treatment visit participants were asked to indicate which of the following PSP services they had used: Personal support (e.g., Care Coach) Printed educational material Online educational materials Web-portal App |
| Time Frame | End of treatment (week 12 or 24 depending on the treatment regimen) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Core population who participated in the PSP |
| Arm/Group Title | Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin |
|---|---|
| Arm/Group Description | Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease. |
| Measure Participants | 179 |
| Any |
141
58%
|
| Personal support |
134
55.1%
|
| Printed educational material |
128
52.7%
|
| Online educational material |
58
23.9%
|
| Web-portal |
65
26.7%
|
| App |
54
22.2%
|
| None/missing |
38
15.6%
|
| Title | Satisfaction With the AbbVie Patient Support Program (PSP) Components |
|---|---|
| Description | At the end of treatment visit participants were asked to indicate their level of satisfaction with each of the PSP services they had used. |
| Time Frame | End of treatment (weeks 12 or 24 depending on treatment regimen) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Core population who participated in the PSP with available data |
| Arm/Group Title | Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin |
|---|---|
| Arm/Group Description | Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease. |
| Measure Participants | 179 |
| Very good |
95
39.1%
|
| Good |
33
13.6%
|
| Satisfactory |
6
2.5%
|
| Poor |
0
0%
|
| Very good |
50
20.6%
|
| Good |
42
17.3%
|
| Satisfactory |
11
4.5%
|
| Poor |
1
0.4%
|
| Very good |
21
8.6%
|
| Good |
27
11.1%
|
| Satisfactory |
8
3.3%
|
| Poor |
0
0%
|
| Very good |
24
9.9%
|
| Good |
23
9.5%
|
| Satisfactory |
8
3.3%
|
| Poor |
1
0.4%
|
| Very good |
14
5.8%
|
| Good |
31
12.8%
|
| Satisfactory |
2
0.8%
|
| Poor |
0
0%
|
Adverse Events
| Time Frame | From first dose of study drug to 30 days after last dose (16 to 28 weeks depending on treatment regimen) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV | Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV | ||
| Arm/Group Description | Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir without ribavirin for12 or 24 weeks. | Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks. | ||
All Cause Mortality |
||||
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV | Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/138 (0%) | 3/105 (2.9%) | ||
Serious Adverse Events |
||||
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV | Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/138 (2.2%) | 4/105 (3.8%) | ||
| Blood and lymphatic system disorders | ||||
| ANAEMIA | 0/138 (0%) | 0 | 1/105 (1%) | 1 |
| Cardiac disorders | ||||
| CARDIAC FAILURE | 0/138 (0%) | 0 | 1/105 (1%) | 1 |
| General disorders | ||||
| GENERAL PHYSICAL HEALTH DETERIORATION | 0/138 (0%) | 0 | 1/105 (1%) | 1 |
| OEDEMA PERIPHERAL | 1/138 (0.7%) | 1 | 0/105 (0%) | 0 |
| Infections and infestations | ||||
| SEPSIS | 0/138 (0%) | 0 | 1/105 (1%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| INTERVERTEBRAL DISC DISORDER | 1/138 (0.7%) | 1 | 0/105 (0%) | 0 |
| Surgical and medical procedures | ||||
| HOSPITALISATION | 1/138 (0.7%) | 1 | 0/105 (0%) | 0 |
| Vascular disorders | ||||
| HYPERTENSION | 1/138 (0.7%) | 1 | 0/105 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV | Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/138 (0%) | 16/105 (15.2%) | ||
| Blood and lymphatic system disorders | ||||
| ANAEMIA | /138 (NaN) | 16/105 (15.2%) | 16 | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Global Medical Services |
|---|---|
| Organization | AbbVie |
| Phone | 800-633-9110 |
| abbvieclinicaltrials@abbvie.com |
- P15-709
- HU15-01