Chronic Hepatitis C
Conditions
Keywords
Chronic Hepatitis C, Dasabuvir, Paritaprevir/r/Ombitasvir, Observational Study, Quality of Life, Fibrosis, Cirrhosis, Work Ability
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.
Interventions
None listed
Sponsors
IST GmbH, Germany
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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): 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. |
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 243 |
| Total | 243 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Did Not Receive Treatment | 1 |
| Overall Study | Failure to Return | 4 |
| Overall Study | Insufficient Virological Response | 1 |
| Overall Study | Other | 2 |
Baseline characteristics
| Characteristic | Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin |
|---|---|
| Age, Continuous | 60 years STANDARD_DEVIATION 10.1 |
| Age, Customized 18-65 years | 178 Participants |
| Age, Customized 66-84 years | 65 Participants |
| Assigned Treatment 3 DAA without RBV for 12 weeks | 133 Participants |
| Assigned Treatment 3 DAA without RBV for 24 weeks | 5 Participants |
| Assigned Treatment 3 DAA with RBV for 12 weeks | 96 Participants |
| Assigned Treatment 3 DAA with RBV for 24 weeks | 9 Participants |
| Cirrhosis Status Cirrhosis | 172 Participants |
| Cirrhosis Status No cirrhosis | 42 Participants |
| Cirrhosis Status Transition to cirrhosis | 29 Participants |
| Co-morbidities Any co-morbidity or co-infection | 197 Participants |
| Co-morbidities Co-infections | 1 Participants |
| Co-morbidities Hepatitis B | 1 Participants |
| Co-morbidities Liver and/or CHC related co-morbidities | 47 Participants |
| HCV Ribonucleic Acid (RNA) Level | 5.79 log10 IU/mL STANDARD_DEVIATION 0.889 |
| Hepatitis C Virus Genotype Genotype 1a | 9 Participants |
| Hepatitis C Virus Genotype Genotype 1a/1b | 5 Participants |
| Hepatitis C Virus Genotype Genotype 1b | 227 Participants |
| Hepatitis C Virus Genotype Genotype 1b/4 unknown | 1 Participants |
| Hepatitis C Virus Genotype Genotype 1 unknown | 1 Participants |
| Pretreatment Status Experienced | 160 Participants |
| Pretreatment Status Naive | 83 Participants |
| Race/Ethnicity, Customized White | 243 Participants |
| Sex: Female, Male Female | 141 Participants |
| Sex: Female, Male Male | 102 Participants |
| Years Since Diagnosis of HCV Infection | 9.2 years STANDARD_DEVIATION 7.66 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 138 | 3 / 105 |
| other Total, other adverse events | 0 / 138 | 16 / 105 |
| serious Total, serious adverse events | 3 / 138 | 4 / 105 |
Outcome results
Primary
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
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)
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) | 94.5 percentage of participants |
Secondary
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score
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
Population: Core population with available data at baseline and each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | End of treatment | 0.02 units on a scale |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | 12 weeks after end of treatment | 0.03 units on a scale |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | 24 weeks after end of treatment | 0.04 units on a scale |
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | End of treatment | 0.02 units on a scale |
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | 12 weeks after end of treatment | 0.04 units on a scale |
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | 24 weeks after end of treatment | 0.04 units on a scale |
Secondary
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score
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
Population: Core population with available data at baseline and each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score | End of treatment | 5.70 units on a scale |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score | 12 weeks after end of treatment | 9.18 units on a scale |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score | 24 weeks after end of treatment | 10.5 units on a scale |
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score | End of treatment | 2.77 units on a scale |
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score | 12 weeks after end of treatment | 5.98 units on a scale |
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score | 24 weeks after end of treatment | 6.07 units on a scale |
Secondary
Change From Baseline in Patient Activation Measure 13 (PAM-13)
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)
Population: The Core population with available data at baseline and end of treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in Patient Activation Measure 13 (PAM-13) | 0.85 units on a scale |
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV | Change From Baseline in Patient Activation Measure 13 (PAM-13) | 0.22 units on a scale |
Secondary
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism
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
Population: The Core population who were employed and with available data at baseline and each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism | End of treatment | -2.1 percent impairment | Standard Deviation 21.6 |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism | 12 weeks after end of treatment | -1.7 percent impairment | Standard Deviation 22.2 |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism | 24 weeks after end of treatment | 1.0 percent impairment | Standard Deviation 19.6 |
Secondary
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism
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
Population: The Core population who were employed and with available data at baseline and each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism | End of treatment | 0.6 percent impairment | Standard Deviation 28.8 |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism | 12 weeks after end of treatment | -5.7 percent impairment | Standard Deviation 25.1 |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism | 24 weeks after end of treatment | -7.3 percent impairment | Standard Deviation 23.3 |
Secondary
Change From Baseline in Work Productivity and Activity Impairment (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 (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
Population: The Core population with available data at baseline and each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment | End of treatment | -0.5 percent impairment | Standard Deviation 29.4 |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment | 12 weeks after end of treatment | -6.7 percent impairment | Standard Deviation 28.4 |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment | 24 weeks after end of treatment | -8.5 percent impairment | Standard Deviation 26.6 |
Secondary
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP)
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
Population: The Core population who were employed and with available data at baseline and each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP) | End of treatment | -2.3 percent impairment | Standard Deviation 34.5 |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP) | 12 weeks after end of treatment | -8.1 percent impairment | Standard Deviation 30.5 |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP) | 24 weeks after end of treatment | -7.3 percent impairment | Standard Deviation 27.3 |
Secondary
Number of Participants Who Participated in the AbbVie Patient Support Program (PSP)
Time frame: Up to post treatment week 24
Population: Core population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants Who Participated in the AbbVie Patient Support Program (PSP) | 179 Participants |
Secondary
Number of Participants Who Received Concomitant Medications
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
Population: All treated participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants Who Received Concomitant Medications | Any concomitant medication | 169 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants Who Received Concomitant Medications | Beta blocking agents | 78 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants Who Received Concomitant Medications | ACE inhibitors | 53 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants Who Received Concomitant Medications | Diuretics | 42 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants Who Received Concomitant Medications | Peptic ulcer / gastro-oesophageal reflux disease | 42 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants Who Received Concomitant Medications | Calcium channel blockers | 34 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants Who Received Concomitant Medications | Blood glucose-lowering drugs | 27 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants Who Received Concomitant Medications | Mineral supplements | 25 Participants |
Secondary
Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies
Time frame: From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen)
Population: All treated participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies | Adverse events | 29 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies | Serious adverse events | 6 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies | Pregnancies | 0 Participants |
Secondary
Number of Participants With Breakthrough
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)
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants With Breakthrough | 0 Participants |
Secondary
Percentage of Participants Achieving Virological Response at End of Treatment
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)
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants Achieving Virological Response at End of Treatment | 97.1 percentage of participants |
Secondary
Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment
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)
Population: The Core population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment | On-treatment virologic failure | 2 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment | Relapse | 3 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment | Death | 3 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment | Premature treatment discontinuation | 2 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment | None of the above criteria | 3 Participants |
Secondary
Percentage of Participants With Adherence to Ribavirin by Adherence Category
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
Population: Core population who were prescribed ribavirin
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants With Adherence to Ribavirin by Adherence Category | > 105% | 1.0 percentage of participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants With Adherence to Ribavirin by Adherence Category | > 95% to ≤ 105% | 78.1 percentage of participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants With Adherence to Ribavirin by Adherence Category | > 80% to ≤ 95% | 5.7 percentage of participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants With Adherence to Ribavirin by Adherence Category | > 50% to ≤ 80% | 6.7 percentage of participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants With Adherence to Ribavirin by Adherence Category | ≤ 50% | 8.6 percentage of participants |
Secondary
Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category
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.
Population: Core population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category | > 80% to ≤ 95% | 0.8 percentage of participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category | > 105% | 3.4 percentage of participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category | > 95% to ≤ 105% | 93.7 percentage of participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category | > 50% to ≤ 80% | 0.8 percentage of participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category | ≤ 50% | 1.3 percentage of participants |
Secondary
Percentage of Participants With Relapse
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.
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants With Relapse | 1.3 percentage of participants |
Secondary
Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 24 Weeks Post-treatment (SVR24)
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)
Population: The Core population with sufficient follow-up data regarding SVR24
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 24 Weeks Post-treatment (SVR24) | 96.6 percentage of participants |
Secondary
Percentage of Ribavirin Treatment Days in Relation to the Target Number of Ribavirin Treatment Days
Time frame: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.
Population: Core population who were prescribed ribavirin
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Ribavirin Treatment Days in Relation to the Target Number of Ribavirin Treatment Days | 93.1 percentage of days | Standard Deviation 22.2 |
Secondary
Satisfaction With the AbbVie Patient Support Program (PSP) Components
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)
Population: Core population who participated in the PSP with available data
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Satisfaction With the AbbVie Patient Support Program (PSP) Components | Personal support | Very good | 95 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Satisfaction With the AbbVie Patient Support Program (PSP) Components | Personal support | Good | 33 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Satisfaction With the AbbVie Patient Support Program (PSP) Components | Personal support | Satisfactory | 6 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Satisfaction With the AbbVie Patient Support Program (PSP) Components | Personal support | Poor | 0 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Satisfaction With the AbbVie Patient Support Program (PSP) Components | Printed educational material | Very good | 50 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Satisfaction With the AbbVie Patient Support Program (PSP) Components | Printed educational material | Good | 42 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Satisfaction With the AbbVie Patient Support Program (PSP) Components | Printed educational material | Satisfactory | 11 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Satisfaction With the AbbVie Patient Support Program (PSP) Components | Printed educational material | Poor | 1 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Satisfaction With the AbbVie Patient Support Program (PSP) Components | Online educational material | Very good | 21 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Satisfaction With the AbbVie Patient Support Program (PSP) Components | Online educational material | Good | 27 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Satisfaction With the AbbVie Patient Support Program (PSP) Components | Online educational material | Satisfactory | 8 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Satisfaction With the AbbVie Patient Support Program (PSP) Components | Online educational material | Poor | 0 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Satisfaction With the AbbVie Patient Support Program (PSP) Components | Web-portal | Very good | 24 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Satisfaction With the AbbVie Patient Support Program (PSP) Components | Web-portal | Good | 23 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Satisfaction With the AbbVie Patient Support Program (PSP) Components | Web-portal | Satisfactory | 8 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Satisfaction With the AbbVie Patient Support Program (PSP) Components | Web-portal | Poor | 1 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Satisfaction With the AbbVie Patient Support Program (PSP) Components | App | Very good | 14 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Satisfaction With the AbbVie Patient Support Program (PSP) Components | App | Good | 31 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Satisfaction With the AbbVie Patient Support Program (PSP) Components | App | Satisfactory | 2 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Satisfaction With the AbbVie Patient Support Program (PSP) Components | App | Poor | 0 Participants |
Secondary
Utilization of the AbbVie Patient Support Program (PSP) Components
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)
Population: Core population who participated in the PSP
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Utilization of the AbbVie Patient Support Program (PSP) Components | Any | 141 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Utilization of the AbbVie Patient Support Program (PSP) Components | Personal support | 134 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Utilization of the AbbVie Patient Support Program (PSP) Components | Printed educational material | 128 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Utilization of the AbbVie Patient Support Program (PSP) Components | Online educational material | 58 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Utilization of the AbbVie Patient Support Program (PSP) Components | Web-portal | 65 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Utilization of the AbbVie Patient Support Program (PSP) Components | App | 54 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Utilization of the AbbVie Patient Support Program (PSP) Components | None/missing | 38 Participants |