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Trial record 4 of 8 for:    Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study

The Effectiveness of Paritaprevir/Ritonavir - Ombitasvir, ± Dasabuvir, ± Ribavirin in France (OPALE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02618928
Recruitment Status : Completed
First Posted : December 2, 2015
Results First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This study seeks to determine the effectiveness of the interferon-free ABBVIE REGIMEN ± ribavirin (RBV) in participants with chronic hepatitis C (CHC) virus in clinical practices across France.

Condition or disease
Chronic Hepatitis C

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Study Type : Observational
Actual Enrollment : 735 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in France
Actual Study Start Date : December 15, 2015
Actual Primary Completion Date : March 29, 2018
Actual Study Completion Date : March 29, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
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 8, 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.




Primary Outcome Measures :
  1. Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) [ Time Frame: 12 weeks after the last dose of study drug (week 20, 24, or 36 depending on the treatment regimen) ]
    Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. Participants with missing HCV RNA were counted as virological failure.


Secondary Outcome Measures :
  1. Percentage of Participants Achieving Virological Response at End of Treatment [ Time Frame: End of treatment (week 8, 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.

  2. Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Post-treatment [ Time Frame: 12 weeks after the last dose of study drug (week 20, 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.

    The Core Population with sufficient follow-up data regarding SVR12 included all core population participants who

    • had evaluable HCV RNA data ≥ 70 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 ≥ 70 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.

  3. Percentage of Participants With Relapse [ Time Frame: End of treatment (week 8, 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.

  4. Percentage of Participants With Breakthrough [ Time Frame: 8, 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.

  5. Percentage of Participants With Rapid Virological Response at Week 4 (RVR4) [ Time Frame: Week 4 ]
    RVR 4 was defined as participants with HCV RNA < 50 IU/mL at week 4.

  6. Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 24 Weeks Post-treatment (SVR24) [ Time Frame: 24 weeks after the last dose of study drug (week 32, 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.

  7. Number of Participants in Each Non-response Category 12 Weeks Post-treatment [ Time Frame: 12 weeks after the last dose of study drug (week 20, 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;
    • Insufficient virological response reported or HCV RNA ≥ 50 IU/mL post-EOT and none of the above criteria
    • Missing SVR12 data and/or none of the above criteria.

  8. Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category [ Time Frame: From first dose of study drug to end of treatment, 8 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.


  9. Percentage of Participants With Adherence to Ribavirin by Adherence Category [ Time Frame: From first dose of study drug to end of treatment, 8 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


  10. 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, 8 to 24 weeks depending on the treatment regimen. ]
  11. Number of Participants Who Received Concomitant Medications [ Time Frame: From first dose of study drug to end of treatment, 8 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.

  12. 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 (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days. ]
  13. Change From Baseline in Fatigue Impact Scale Total Score [ Time Frame: Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment ]

    The Fatigue Impact Scale (FIS) questionnaire was used to assess the impact of fatigue on the quality of life of patients.

    The FIS consists of 40 items, each of which is scored 0 (no problem) to 4 (extreme problem), providing a total score from of 0 to 160, where a lower score = less fatigue impact


  14. Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score [ Time Frame: Baseline, end of treatment (week 8, 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.


  15. Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score [ Time Frame: Baseline, end of treatment (week 8, 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 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).


  16. Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism [ Time Frame: Baseline, end of treatment (week 8, 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.


  17. Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism [ Time Frame: Baseline, end of treatment (week 8, 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.


  18. Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP) [ Time Frame: Baseline, end of treatment (week 8, 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.


  19. Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment [ Time Frame: Baseline, end of treatment (week 8, 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.


  20. Change From Baseline in Beliefs Medication Questionnaire - (18-item BMQ) [ Time Frame: Baseline and end of treatment (week 8, 12, or 24 depending on the treatment regimen) ]
    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.

  21. Change From Baseline in Patient Activation Measure 13 (PAM-13) [ Time Frame: Baseline and end of treatment (week 8, 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 higher patient activation.

  22. Number of Participants With Outpatient Consultations Due to Liver Disease by Category [ Time Frame: From first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days. ]
  23. Number of Participants With Hospitalizations Due to Liver Disease by Category [ Time Frame: From first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days. ]
  24. Change From Baseline in Percent Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline and end of treatment (week 8, 12, or 24 depending on the treatment regimen) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients chronically infected with HCV, receiving the interferon-free ABBVIE REGIMEN, were offered the opportunity to participate in this study during a routine clinical visit at the participating sites.
Criteria

Inclusion Criteria:

  • Treatment-naïve or -experienced participants with confirmed CHC, genotype 1 or 4
  • Participants receiving or who will receive the interferon-free ABBVIE REGIMEN ± RBV according to product label
  • RBV prescribed in line with the current local label

Exclusion Criteria:

  • Participant is not participating or intending to participate in a concurrent interventional therapeutic trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02618928


  Show 70 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
  Study Documents (Full-Text)

Documents provided by AbbVie:
Study Protocol  [PDF] January 10, 2018
Statistical Analysis Plan  [PDF] February 15, 2018


Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02618928     History of Changes
Other Study ID Numbers: P15-405
First Posted: December 2, 2015    Key Record Dates
Results First Posted: June 17, 2019
Last Update Posted: June 17, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
HCV
Chronic Hepatitis C

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Ritonavir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors