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| ID | Type | Description | Link |
|---|---|---|---|
| PLHCVRWE01 | Other Grant/Funding Number | Affiliate Study Tracking Number |
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| Name | Class |
|---|---|
| IST GmbH, Germany | INDUSTRY |
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This study seeks to provide evidence of the effectiveness and obtain patient reported outcomes (PRO) and work productivity data of the interferon-free regimen of paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), +/- dasabuvir (DSV), +/- ribavirin (RBV) in chronic hepatitis C virus infected patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Virological Response at End of Treatment | Virologic response is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL. | End of treatment (week 12 or 24 depending on the treatment regimen) |
| Percentage of Participants With Relapse |
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Inclusion Criteria:
Exclusion Criteria:
-None
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Chronic Hepatitis C (CHC)
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30739368 | Derived | Ferenci P, Bourgeois S, Buggisch P, Norris S, Curescu M, Larrey D, Marra F, Kleine H, Dorr P, Charafeddine M, Crown E, Bondin M, Back D, Flisiak R. Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir +/- dasabuvir +/- ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studies from 13 countries. J Viral Hepat. 2019 Jun;26(6):685-696. doi: 10.1111/jvh.13080. Epub 2019 Mar 5. |
| Label | URL |
|---|---|
| Related Info | View source |
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Effectiveness analyses of clinical outcomes are reported by HCV genotype. Safety variables were analyzed by treatment regimen.
In this prospective, multi-center observational study a total of 394 adult patients chronically infected with hepatitis C virus (HCV) were enrolled at 17 centers in Poland.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Enrolled participants who received adequate treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) according to standard of care and within local label recommendations for their specific disease characteristics. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen) |
|
From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 2 DAA + RBV | Participants received paritaprevir/ritonavir and ombitasvir plus ribavirin for either 12 or 24 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | medDRA 19.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | medDRA 19.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 9, 2016 | Feb 2, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 13, 2016 | Feb 2, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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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. |
| End of treatment (week 12 or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment. |
| Percentage 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. | 12 or 24 weeks (depending on the treatment regimen) |
| Percentage of Participants With a Rapid Virological Response at Week 4 | Rapid virological response at week 4 (RVR4) was defined as participants with HCV RNA < 50 IU/mL at week 4. Due to the non-interventional character of the study, many participants did not have an HCV RNA assessed at treatment week 4 since this is not generally recommended in the label. Participants with missing data at the RVR4 time point were considered as virological failures. | Week 4 |
| Percentage of Participants Achieving Sustained Virological Response 24 Weeks Post-treatment (SVR24) | Sustained virologic response is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 24 weeks after the last dose of study drug. | 24 weeks after the last dose of study drug (week 36 or 48 depending on the treatment regimen) |
| Percentage of Participants in the Core Population With Sufficient Follow-up Data for SVR12 Who Achieved 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. The core population with sufficient follow-up data regarding SVR12 included all core population participants who
| 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen) |
| Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment | SVR12 non-response was categorized according to the following:
| 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen) |
| Assigned Treatment Regimen | Treatment regimen was assigned by the physician according to local practice and label. Participants could receive two direct-acting antiviral (DAA) drugs (paritaprevir/ritonavir and ombitasvir) plus ribavirin (RBV) for either 12 or 24 weeks, or three DAAs (paritaprevir/ritonavir, ombitasvir, and dasabuvir) with or without RBV for 12 or 24 weeks. | Baseline |
| Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA | Adherence to study treatment was calculated as: Cumulative dose taken / (initial prescribed dose * planned duration) | From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen |
| Percentage of the Ribavirin (RBV) Dose Taken in Relation to the Target Dose of RBV | Adherence to study treatment was calculated as: Cumulative dose taken / (initial prescribed dose * planned duration) | From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen |
| Number of Participants With Comorbidities | Baseline |
| Number of Participants Who Received Concomitant Medications | Concomitant medication other than for chromic hepatitis C used from the time when the decision was made to initiate treatment with the ABBVIE REGIMEN until after the last dose. | From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen |
| Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies | From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days. |
| 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. | Baseline, end of treatment, and at 12 and 24 weeks after end of treatment |
| 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. with a separate visual analog scale (VAS). The VAS assesses overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable). | Baseline, end of treatment, and at 12 and 24 weeks after end of treatment |
| 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. | Baseline, end of treatment, and at 12 and 24 weeks post treatment |
| 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. | Baseline, end of treatment, and at 12 and 24 weeks after end of treatment |
| 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. | Baseline, end of treatment, and at 12 and 24 weeks after end of treatment |
| 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. | Baseline, end of treatment, and at 12 and 24 weeks after end of treatment |
| Miscellaneous |
|
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Years Since Diagnosis of HCV Infection | Mean | Standard Deviation | years |
|
| HCV Genotype | Count of Participants | Participants |
|
| Cirrhosis Status | Count of Participants | Participants |
|
| OG001 | Genotype 1a | Participants with genotype 1a HCV 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. |
| OG002 | Genotype 1b | Participants with genotype 1b HCV 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. |
| OG003 | Genotype 4 | Participants with genotype 4 HCV 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. |
|
|
| Secondary | Percentage of Participants Achieving Virological Response at End of Treatment | Virologic response is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL. | Enrolled participants who received adequate treatment with paritaprevir/r and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin according to standard of care and within local label recommendations for their specific disease characteristics. | Posted | Number | 95% Confidence Interval | percentage of participants | End of treatment (week 12 or 24 depending on the treatment regimen) |
|
|
|
| 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. | Participants who received adequate treatment with the ABBVIE REGIMEN ± RBV according to standard of care and within local label recommendations for their specific disease characteristics, and with VR at actual EOT and who completed treatment, and had ≥ 1 HCV RNA measurement ≥ 70 days post-treatment or were a treatment failure between EOT and day 70 | Posted | Number | 95% Confidence Interval | percentage of participants | End of treatment (week 12 or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment. |
|
|
|
| Secondary | Percentage 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. | Participants who received adequate treatment with the ABBVIE REGIMEN ± RBV according to standard of care and within local label recommendations for their specific disease characteristics, who had at least one undetectable HCV RNA measurement on-treatment and at least one measurement on-treatment thereafter | Posted | Number | 95% Confidence Interval | percentage of participants | 12 or 24 weeks (depending on the treatment regimen) |
|
|
|
| Secondary | Percentage of Participants With a Rapid Virological Response at Week 4 | Rapid virological response at week 4 (RVR4) was defined as participants with HCV RNA < 50 IU/mL at week 4. Due to the non-interventional character of the study, many participants did not have an HCV RNA assessed at treatment week 4 since this is not generally recommended in the label. Participants with missing data at the RVR4 time point were considered as virological failures. | Enrolled participants who received adequate treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) according to standard of care and within local label recommendations for their specific disease characteristics. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 4 |
|
|
|
| Secondary | Percentage of Participants Achieving Sustained Virological Response 24 Weeks Post-treatment (SVR24) | Sustained virologic response is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 24 weeks after the last dose of study drug. | Enrolled participants who received adequate treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) according to standard of care and within local label recommendations for their specific disease characteristics. | Posted | Number | 95% Confidence Interval | percentage of participants | 24 weeks after the last dose of study drug (week 36 or 48 depending on the treatment regimen) |
|
|
|
| Secondary | Percentage of Participants in the Core Population With Sufficient Follow-up Data for SVR12 Who Achieved 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. The core population with sufficient follow-up data regarding SVR12 included all core population participants who
| The core population with sufficient follow-up data regarding SVR12 | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen) |
|
|
|
| Secondary | Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment | SVR12 non-response was categorized according to the following:
| Enrolled participants who received adequate treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) according to standard of care and within local label recommendations for their specific disease characteristics. | Posted | Number | percentage of participants | 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen) |
|
|
|
| Secondary | Assigned Treatment Regimen | Treatment regimen was assigned by the physician according to local practice and label. Participants could receive two direct-acting antiviral (DAA) drugs (paritaprevir/ritonavir and ombitasvir) plus ribavirin (RBV) for either 12 or 24 weeks, or three DAAs (paritaprevir/ritonavir, ombitasvir, and dasabuvir) with or without RBV for 12 or 24 weeks. | Enrolled participants who received adequate treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) according to standard of care and within local label recommendations for their specific disease characteristics. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA | Adherence to study treatment was calculated as: Cumulative dose taken / (initial prescribed dose * planned duration) | All enrolled participants who received at least one dose of the ABBVIE REGIMEN. | Posted | Count of Participants | Participants | From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen |
|
|
|
| Secondary | Percentage of the Ribavirin (RBV) Dose Taken in Relation to the Target Dose of RBV | Adherence to study treatment was calculated as: Cumulative dose taken / (initial prescribed dose * planned duration) | All enrolled participants who received at least one dose of the ABBVIE REGIMEN that included ribavirin | Posted | Count of Participants | Participants | From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen |
|
|
|
| Secondary | Number of Participants With Comorbidities | Enrolled participants who received adequate treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) according to standard of care and within local label recommendations for their specific disease characteristics. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Number of Participants Who Received Concomitant Medications | Concomitant medication other than for chromic hepatitis C used from the time when the decision was made to initiate treatment with the ABBVIE REGIMEN until after the last dose. | All enrolled participants who received at least one dose of the ABBVIE REGIMEN. | Posted | Count of Participants | Participants | From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen |
|
|
|
| Secondary | Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies | All enrolled participants who received at least one dose of the ABBVIE REGIMEN. | Posted | Count of Participants | Participants | From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days. |
|
|
|
| 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. | Enrolled participants who received adequate treatment with paritaprevir/r and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) according to standard of care and within local label recommendations for their specific disease characteristics. Participants with available data at baseline and each time point are included. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, end of treatment, and at 12 and 24 weeks after end of treatment |
|
|
|
| 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. with a separate visual analog scale (VAS). The VAS assesses overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable). | Enrolled participants who received adequate treatment with paritaprevir/r and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and within local label recommendations for their specific disease characteristics. Participants with available data at baseline and each time point are included. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, end of treatment, and at 12 and 24 weeks after end of treatment |
|
|
|
| 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. | Enrolled participants who received adequate treatment with paritaprevir/r and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and within local label recommendations for their specific disease characteristics. Participants who were employed with available data at baseline and each time point are included. | Posted | Median | Inter-Quartile Range | percent impairment | Baseline, end of treatment, and at 12 and 24 weeks post treatment |
|
|
|
| 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. | Enrolled participants who received adequate treatment with paritaprevir/r and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and within local label recommendations for their specific disease characteristics. Participants who were employed with available data at baseline and each time point are included. | Posted | Median | Inter-Quartile Range | percent impairment | Baseline, end of treatment, and at 12 and 24 weeks after end of treatment |
|
|
|
| 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. | Enrolled participants who received adequate treatment with paritaprevir/r and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and within local label recommendations for their specific disease characteristics. Participants who were employed with available data at baseline and each time point are included. | Posted | Median | Inter-Quartile Range | percent impairment | Baseline, end of treatment, and at 12 and 24 weeks after end of treatment |
|
|
|
| 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. | Enrolled participants who received adequate treatment with paritaprevir/r and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and within local label recommendations for their specific disease characteristics. Participants with available data at baseline and each time point are included. | Posted | Median | Inter-Quartile Range | percent impairment | Baseline, end of treatment, and at 12 and 24 weeks after end of treatment |
|
|
|
| 0 |
| 19 |
| 3 |
| 19 |
| 8 |
| 19 |
| EG001 | 3 DAA Without RBV | Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir without RBV for 12 weeks. | 0 | 229 | 3 | 229 | 2 | 229 |
| EG002 | 3 DAA + RBV | Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks. | 2 | 146 | 8 | 146 | 26 | 146 |
| Diarrhoea | Gastrointestinal disorders | medDRA 19.1 | Non-systematic Assessment |
|
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | medDRA 19.1 | Non-systematic Assessment |
|
| Oesophageal Varices Haemorrhage | Gastrointestinal disorders | medDRA 19.1 | Non-systematic Assessment |
|
| Hepatic Failure | Hepatobiliary disorders | medDRA 19.1 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | medDRA 19.1 | Non-systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | medDRA 19.1 | Non-systematic Assessment |
|
| Hepatocellullar Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | medDRA 19.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | medDRA 19.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | medDRA 19.1 | Non-systematic Assessment |
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| Hyperbilirubinaemia | Hepatobiliary disorders | medDRA 19.1 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | medDRA 19.1 | Non-systematic Assessment |
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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.
| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Death |
|
| Premature treatment discontinuation |
|
| Missing SVR12 data/None of the above |
|
| 2 DAA + RBV (24 weeks) |
|
| 3 DAA without RBV (12 weeks) |
|
| 3 DAA + RBV (12 weeks) |
|
| 3 DAA + RBV (24 weeks) |
|
| > 50% to ≤ 80% |
|
| ≤ 50% |
|
| > 50% to ≤ 80% |
|
| ≤ 50% |
|
| Any coinfection |
|
| Coinfection with human immunodeficiency virus (HIV |
|
| Coinfection with hepatitis B virus |
|
|
| Pregnancies |
|
| 12 weeks post treatment |
|
|
| 24 weeks post treatment |
|
|
| 12 weeks post treatment |
|
|
| 24 weeks post treatment |
|
|
| 12 weeks post treatment |
|
|
| 24 weeks post treatment |
|
|
| 12 weeks post treatment |
|
|
| 24 weeks post treatment |
|
|
| 12 weeks post treatment |
|
|
| 24 weeks post treatment |
|
|
| 12 weeks post treatment |
|
|
| 24 weeks post treatment |
|
|