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Real World Evidence of the Effectiveness of Paritaprevir/Ritonavir, Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C

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ClinicalTrials.gov Identifier: NCT02640547
Recruitment Status : Completed
First Posted : December 29, 2015
Results First Posted : October 17, 2018
Last Update Posted : October 17, 2018
Sponsor:
Collaborator:
IST GmbH, Germany
Information provided by (Responsible Party):
AbbVie

Brief Summary:
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.

Condition or disease
Chronic Hepatitis C

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Study Type : Observational
Actual Enrollment : 394 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real World Evidence (RWE) of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Poland (HCV RWE PMOS)
Actual Study Start Date : November 26, 2015
Actual Primary Completion Date : March 29, 2017
Actual Study Completion Date : March 29, 2017

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 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.




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 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.


Secondary Outcome Measures :
  1. Percentage of Participants Achieving Virological Response at End of Treatment [ Time Frame: End of treatment (week 12 or 24 depending on the treatment regimen) ]
    Virologic response is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL.

  2. Percentage of Participants With Relapse [ Time Frame: End of treatment (week 12 or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment. ]
    Relapse was defined as participants with a virologic response (VR; HCV RNA < 50 IU/mL) at end of treatment (EOT) followed by HCV RNA ≥ 50 IU/mL at any time after the end of treatment.

  3. Percentage of Participants With Breakthrough [ Time Frame: 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.

  4. Percentage of Participants With a Rapid Virological Response at Week 4 [ Time Frame: 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.


  5. Percentage of Participants Achieving Sustained Virological Response 24 Weeks Post-treatment (SVR24) [ Time Frame: 24 weeks after the last dose of study drug (week 36 or 48 depending on the treatment regimen) ]
    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.

  6. Percentage of Participants in the Core Population With Sufficient Follow-up Data for SVR12 Who Achieved Sustained Virological Response 12 Weeks Post-treatment (SVR12) [ Time Frame: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen) ]

    Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug.

    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.

  7. Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment [ Time Frame: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen) ]

    SVR12 non-response was categorized according to the following:

    • 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 virological failure;
    • Missing SVR12 data and/or none of the above criteria.

  8. Assigned Treatment Regimen [ Time Frame: Baseline ]
    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.

  9. Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA [ Time Frame: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen ]

    Adherence to study treatment was calculated as:

    Cumulative dose taken / (initial prescribed dose * planned duration)


  10. Percentage of the Ribavirin (RBV) Dose Taken in Relation to the Target Dose of RBV [ Time Frame: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen ]

    Adherence to study treatment was calculated as:

    Cumulative dose taken / (initial prescribed dose * planned duration)


  11. Number of Participants With Comorbidities [ Time Frame: Baseline ]
  12. Number of Participants Who Received Concomitant Medications [ Time Frame: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen ]
    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.

  13. 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. The median duration of treatment was 84 days. ]
  14. Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score [ Time Frame: Baseline, end of treatment, 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, 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, and at 12 and 24 weeks post 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, 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, 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, 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.




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 to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chronic Hepatitis C (CHC)
Criteria

Inclusion Criteria:

  • Treatment-naïve or -experienced adult male or female patients with confirmed CHC, genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± RBV according to standard of care and in line with the current local label.
  • If RBV is co-administered with the ABBVIE REGIMEN, 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


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): NCT02640547


Sponsors and Collaborators
AbbVie
IST GmbH, Germany
Investigators
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Study Director: AbbVie Inc. AbbVie
  Study Documents (Full-Text)

Documents provided by AbbVie:
Study Protocol  [PDF] March 9, 2016
Statistical Analysis Plan  [PDF] December 13, 2016


Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02640547    
Other Study ID Numbers: P15-767
PLHCVRWE01 ( Other Grant/Funding Number: Affiliate Study Tracking Number )
First Posted: December 29, 2015    Key Record Dates
Results First Posted: October 17, 2018
Last Update Posted: October 17, 2018
Last Verified: March 2018
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:
Chronic Hepatitis C
Dasabuvir
Paritaprevir/r/Ombitasvir
Observational Study
Quality of Life
Fibrosis
Cirrhosis
Work Ability
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, 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