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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 outcome (PRO) data for the interferon-free regimen of paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), + dasabuvir (DSV), +/- ribavirin (RBV) in participants with chronic hepatitis C (CHC) in a real life setting across clinical practice patient populations in Romania.
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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, and 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 was 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 in the Core Population With Sufficient Follow-up Data for SVR12 Who Achieved Sustained Virological Response 12 Weeks Post-treatment |
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Inclusion Criteria:
Treatment-naïve or -experienced adult male or female patients with confirmed CHC, genotype 1, receiving combination therapy with the interferon-free paritaprevir/ritonavir and ombitasvir with dasabuvir ± RBV according to standard of care and in line with the current local label
If RBV is co-administered with the paritaprevir/ritonavir and ombitasvir with dasabuvir, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)
Patients must voluntarily sign and date a patient authorization to use and/or disclose his/her anonymized health data prior to inclusion into the study
Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial
Exclusion Criteria:
None
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Clinical practice patient populations with chronic infection of HCV Genotype 1 (GT1)
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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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In this prospective, multi-center observational study a total of 522 adult patients chronically infected with hepatitis C virus (HCV) genotype 1 were enrolled by 22 centers in Romania.
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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, and 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, and 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 were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). Three participants with genotype 1 prescribed paritaprevir/r and ombitasvir instead of paritaprevir/r, ombitasvir and dasabuvir (3DAA) were excluded. | 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 (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.
The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.
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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 | Paritaprevir/Ritonavir + Ombitasvir With 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 (20.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (20.0) | 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 16, 2016 | Jul 16, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 28, 2017 | Jul 16, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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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 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. | 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 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 three direct-acting antiviral (DAA) drugs (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 Dose Taken in Relation to the Target Dose of Ribavirin | 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 Ribavirin (RBV) 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 With Comorbidities | Baseline |
| 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. | From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen |
| 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 (week 12 or 24 depending on the treatment regimen), 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 (week 12 or 24 depending on the treatment regimen), 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 (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of 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 (week 12 or 24 depending on the treatment regimen), 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 (week 12 or 24 depending on the treatment regimen), 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 (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment |
| 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 higher patient activation | Baseline and end of treatment (week 12 or 24 depending on the treatment regimen) |
| Change From Baseline in Beliefs Medication Questionnaire - (18-item BMQ) | The BMQ consists of 2 sections and 18 questions to screen for patients' beliefs, attitudes and concerns about their medication. The BMQ-Specific section comprises two 5-item subscales assessing the necessity of and concerns about the prescribed medication (Specific-Necessity and Specific-Concerns). The BMQ-General section comprises two 4-item subscales assessing beliefs that medicines are harmful and overused by doctors in general (General-Harm and General-Overuse). The 18 items are rated on a Likert scale from 1 (strongly disagree) to 5 (strongly agree). Each subscale score ranges from 1 to 5. High scores in the Specific-Concerns scale represent the notion that adverse reactions are potentially harmful when taking medication on a regular basis, and high scores in the Specific-Necessity scale indicate the patient's need to adhere to medication to maintain health. High scores in the General-Harm and General-Overuse scales represent an overall negative perception of medication. | Baseline and end of treatment (week 12 or 24 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 (16 or 28 weeks depending on the treatment regimen). The over all median (minimum, maximum) duration of treatment was 84 (28, 175) days. |
| years |
|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Years Since Diagnosis of HCV Infection | Mean | Standard Deviation | years |
|
| HCV Genotype | Count of Participants | Participants |
|
| Cirrhosis Status | Count of Participants | Participants |
|
| HCV RNA | 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). | Median | Full Range | log10 IU/mL |
|
|
|
| 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. | 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). | Posted | Number | 95% Confidence Interval | percentage of participants | End of treatment (week 12 or 24 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 | 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
| 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), and 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 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. | Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics, and with VR at EOT and who completed treatment, and had ≥ 1 HCV RNA measurement ≥ 70 days post-treatment and were a treatment failure between EOT and post-treatment 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. | 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) with virological response on-treatment and with at least one on-treatment measurement (including EOT) thereafter. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 or 24 weeks (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 were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). | 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 three direct-acting antiviral (DAA) drugs (paritaprevir/ritonavir, ombitasvir, and dasabuvir) with or without RBV for 12 or 24 weeks. | 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). | 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) | 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). | Posted | Count of Participants | Participants | From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen. |
|
|
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| Secondary | Percentage of the Ribavirin Dose Taken in Relation to the Target Dose of Ribavirin | Adherence to study treatment was calculated as: Cumulative dose taken / (initial prescribed dose * planned duration) | 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), who were prescribed ribavirin, and with available data. | Posted | Count of Participants | Participants | From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen |
|
|
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| Secondary | Percentage of Ribavirin (RBV) Treatment Days in Relation to the Target Number of Ribavirin Treatment Days | 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), who were prescribed ribavirin. | Posted | Mean | Standard Deviation | percentage of days | From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen. |
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| Secondary | Number of Participants With Comorbidities | 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). | Posted | Count of Participants | Participants | Baseline |
|
|
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| 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. | Enrolled patients who received at least one dose of paritaprevir/ritonavir and ombitasvir with or without dasabuvir. | Posted | Count of Participants | Participants | From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen |
|
|
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| 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 were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype) and with available data at baseline and each time point. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment |
|
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| 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 were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype) and with available data at baseline and each time point. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment |
|
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| 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 were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). Participants who were employed with available data at baseline and each time point are included. | Posted | Mean | Standard Deviation | percent impairment | Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment |
|
|
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| 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 were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). Participants who were employed with available data at baseline and each time point are included. | Posted | Mean | Standard Deviation | percent impairment | Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment |
|
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| 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 were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). Participants who were employed with available data at baseline and each time point are included. | Posted | Mean | Standard Deviation | percent impairment | Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment |
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| 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 were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype) with available data at baseline and each time point. | Posted | Mean | Standard Deviation | percent impairment | Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment |
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| 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 higher patient activation | 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) with available data at baseline and end of treatment. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline and end of treatment (week 12 or 24 depending on the treatment regimen) |
|
|
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| Secondary | Change From Baseline in Beliefs Medication Questionnaire - (18-item BMQ) | The BMQ consists of 2 sections and 18 questions to screen for patients' beliefs, attitudes and concerns about their medication. The BMQ-Specific section comprises two 5-item subscales assessing the necessity of and concerns about the prescribed medication (Specific-Necessity and Specific-Concerns). The BMQ-General section comprises two 4-item subscales assessing beliefs that medicines are harmful and overused by doctors in general (General-Harm and General-Overuse). The 18 items are rated on a Likert scale from 1 (strongly disagree) to 5 (strongly agree). Each subscale score ranges from 1 to 5. High scores in the Specific-Concerns scale represent the notion that adverse reactions are potentially harmful when taking medication on a regular basis, and high scores in the Specific-Necessity scale indicate the patient's need to adhere to medication to maintain health. High scores in the General-Harm and General-Overuse scales represent an overall negative perception of medication. | 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) with available data at baseline and end of treatment. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline and end of treatment (week 12 or 24 depending on the treatment regimen) |
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|
|
| Secondary | Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies | All enrolled participants who received at least one dose of paritaprevir/ritonavir and ombitasvir with or without dasabuvir. | Posted | Count of Participants | Participants | From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The over all median (minimum, maximum) duration of treatment was 84 (28, 175) days. |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV | Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir without ribavirin for 12 weeks. | 0 | 73 | 3 | 73 | 0 | 73 |
| EG002 | Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With R+ RBV | Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks. | 3 | 446 | 17 | 446 | 44 | 446 |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| ENTEROCOLITIS | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| GASTRIC VARICES HAEMORRHAGE | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
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| GASTRITIS | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
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| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| CHOLANGITIS | Hepatobiliary disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| HEPATIC FAILURE | Hepatobiliary disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| JAUNDICE | Hepatobiliary disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| ESCHERICHIA URINARY TRACT INFECTION | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| PYELONEPHRITIS ACUTE | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| PYONEPHROSIS | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| BLADDER CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Non-systematic Assessment |
|
| HAEMATURIA | Renal and urinary disorders | MedDRA (20.0) | Non-systematic Assessment |
|
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 |
| Title | Measurements |
|---|---|
|
| Premature treatment discontinuation |
|
| None of the above criteria |
|
| > 50% to ≤ 80% |
|
| ≤ 50% |
|
| > 50% to ≤ 80% |
|
| ≤ 50% |
|
| Title | Measurements |
|---|---|
|
| Coinfection with hepatitis B virus |
|
| 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 |
|
|
| Specific Necessity |
|
|
| General Overuse |
|
|
| General Harm |
|
|
|
| Pregnancies |
|