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Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Austria (REAL) (REAL)

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ClinicalTrials.gov Identifier: NCT02582658
Recruitment Status : Completed
First Posted : October 21, 2015
Results First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO) and work productivity data of the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir +/- dasabuvir) +/- Ribavirin (RBV) in chronic hepatitis C virus (HCV) infected participants in Austria.

Condition or disease
Chronic Hepatitis C

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Study Type : Observational
Actual Enrollment : 173 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 Austria (REAL)
Study Start Date : October 6, 2015
Actual Primary Completion Date : January 12, 2017
Actual Study Completion Date : January 12, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Chronic infection of HCV GT1 or GT4
Participants with confirmed chronic hepatitis C genotype (GT) 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir +/- dasabuvir) ± Ribavirin (RBV) according to standard of care and in line with the current local label



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 ]
    SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels < 50 IU/mL 12 weeks after the last actual dose of study drug.


Secondary Outcome Measures :
  1. Percentage of Participants With Virological Response at End of Treatment (EoTR) [ Time Frame: Up to 24 weeks of treatment ]
    The percentage of participants with virological response (HCV RNA <50 IU/mL) at end of treatment (EoT, defined as last intake of ABBVIE REGIMEN or ribavirin [RBV]).

  2. Percentage of Participants With On-treatment Virologic Failure (Breakthrough) [ Time Frame: Up to approximately 24 weeks ]
    The percentage of participants with on-treatment virologic failure (breakthrough [defined as at least one documented HCV RNA <50 IU/mL followed by HCV RNA >= 50 IU/mL during treatment]).

  3. Percentage of Participants Achieving SVR12 (Core Population Sufficient Follow-up) [ Time Frame: 12 weeks after last dose of study drug ]
    SVR12 is defined as HCV RNA levels < 50 IU/mL 12 weeks after the last actual dose of study drug in the Core Population Sufficient Follow-up (CPSFU).

  4. Percentage of Participants With Post-treatment Relapse [ Time Frame: Up to 12 weeks after last dose of study drug ]
    The percentage of participants with relapse (defined as HCV RNA <50 IU/mL at EoT followed by HCV RNA ≥50 IU/mL)


Other Outcome Measures:
  1. Percentage of Planned Duration of Ribavirin (RBV) Taken [ Time Frame: Up to 24 weeks of treatment ]
    Adherence to RBV is defined as percentage of target dose (adherence=cumulated dose taken/ [initially prescribed dose x planned duration]).

  2. Total Score of Participant Activation According to the Patient Activation Measure (PAM-13) Questionnaire [ Time Frame: Day 0 and End of Treatment (EoT) ]
    The PAM-13 item scale is a measure used to assess the patient knowledge, skill, and confidence for self-management. 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). Responses are summed and averaged to come up with an overall score of level 1 through level 4. The responses to the 13 questions are summed and transformed into a PAM Score between 0 and 100; a higher score indicates more knowledge and confidence to take action for self-management.

  3. Percentage of Participants With Concomitant Medications [ Time Frame: Day 0 to end of treatment (up to 24 weeks) ]
    Percentage of participants taking at least 1 concomitant medication

  4. Percentage of Participants With Co-morbidities and/or Co-infections [ Time Frame: Day 0 ]
    Percentage of participants with co-morbidities and/or co-infections at baseline (Day 0).

  5. Quality of Life Measured With the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire [ Time Frame: Day 0 and post treatment week 12 ]
    The EQ-5D-5L is a health state utility instrument that evaluates preference for health status (utility). The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from -0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. The EQ-5D visual analogue scale (VAS) records the participant's self-rated health status on a vertical graduated scale from 0 to 100, with 0 indicating the worst imaginable health state and 100 indicating the best imaginable health state. An increase in EQ-5D-5L VAS score indicates improvement.

  6. Change in Mean Score From Baseline to 12 Weeks After End of Treatment (EOT) in Work Productivity and Activity Impairment (WPAI) Version 2: Hepatitis C Questionnaire [ Time Frame: Day 0 to post treatment week 12 ]
    The WPAI questionnaire was used to measure work absenteeism, work presenteeism, work productivity impairment and daily activity impairment. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity: Presenteeism - percentage of impairment while working due to health problem; Total work productivity impairment - percentage of overall work impairment due to health problem Absenteeism - percentage of work time missed due to health problem; Total activity impairment - percentage of general (non-work) activity impairment due to health problem

  7. Patient Support Program (PSP) Utilization and Satisfaction Assessment [ Time Frame: Up to 24 weeks of treatment ]
    The AbbVie PSP included educational and information material (including printed, online, pillbox), digital and mobile resource (web-portal), digital and mobile resources (reminders). The PSP utilization and satisfaction assessment evaluated the frequency of utilization (usually daily, several times per week, usually once weekly, less than once weekly) and patient's overall satisfaction (very good, good, satisfactory) with their respective PSP.

  8. Percentage of Participants With Adherence to Planned RBV Target Dose Taken [ Time Frame: Up to 24 weeks of treatment ]
    Adherence to RBV is defined as percentage of target dose (adherence=cumulated number of pills taken / [initially prescribed number of pills x planned duration]) and categorized as follows: >105%, >95% - <=105%, >80% - <=95%, >50% - <=80%, <=50%.

  9. Percentage of Participants Deviating From the Target ABBVIE Regimen Duration [ Time Frame: Up to 24 weeks of treatment ]
    Deviations from the target dose of the ABBVIE REGIMEN were defined as the actual duration is shortened/prolonged (exceedence) for more than 7 days.

  10. Percentage of Participants With Adherence to Planned ABBVIE Regimen Target Dose Taken [ Time Frame: Up to 24 weeks of treatment ]
    Adherence to the ABBVIE REGIMEN was defined as percentage of target dose (adherence=cumulated number of pills taken / [initially prescribed number of pills x planned duration]) and categorized as follows: >105%, >95% to <=105%, >80% to <=95%, >50% to <=80%, <=50%.



Information from the National Library of Medicine

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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
Patients with chronic infection of HCV Genotype 1 (GT1) or Genotype 4 (GT4)
Criteria

Inclusion Criteria:

Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C, genotype (GT)1 or GT4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± Ribavirin (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 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): NCT02582658


Sponsors and Collaborators
AbbVie
Investigators
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Study Director: Alexander P Dorr, PhD AbbVie Austria

Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02582658     History of Changes
Other Study ID Numbers: P15-695
First Posted: October 21, 2015    Key Record Dates
Results First Posted: June 5, 2019
Last Update Posted: June 5, 2019
Last Verified: October 2018

Keywords provided by AbbVie:
Paritaprevir
Dasabuvir
Ombitasvir
Chronic Hepatitis C
HCV

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
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents