Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study

Completed

• Conditions: Chronic Hepatitis C

• Registration Number: NCT02798315
• Lead Sponsor: AbbVie

Brief Summary

The interferon-free combination regimen of paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well controlled conditions.

This observational study is the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in Kuwait in a clinical practice patient population.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-25
• Study First Submitted: 2016-06-09
• Study First Submitted QC: 2016-06-09
• Study First Posted: 2016-06-14
• Status Verified: 2017-06
• Primary Completion: 2017-06-12
• Study Completion: 2017-06-12
• Results First Submitted: 2018-06-11
• Results First Submitted QC: 2018-06-11
• Last Update Submitted: 2018-06-11
• Results First Posted: 2018-12-31
• Last Update Posted: 2018-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Treatment-naïve or -experienced adult male or female participants 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).
• Participant must not be participating or intending to participate in a concurrent interventional therapeutic trial.

Exclusion Criteria

• Participant must not be participating or attending in a concurrent interventional therapeutic trial.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)	12 weeks (i.e. at least 70 days) after the last dose of study drug	SVR12 defined as the HCV ribonucleic acid (RNA) level less than 50 IU/mL 12 weeks after the last dose of study drug

Secondary Outcome Measures

Name	Time	Method
Adherence: Percentage of Planned Duration of RBV Taken by Participant	Up to 48 weeks
Change From Baseline in the PAM-13 Questionnaire	Up to 48 weeks	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). Based on responses to the 13-item measure, the score is calculated by adding up the raw scores (range of the sum: 13 - 52) and mapping up the value onto a scale of 0-100 indicating strength of agreement with the 13 items. A higher score indicates that the patient is likely to participate more actively in health care processes and takes more responsibility for his or her health.
Percentage of Participants With Breakthrough.	Up to EoT, maximum of 24 weeks	Breakthrough defined as at least 1 documented HCV RNA less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment.
Percentage of Participants Meeting the SVR Non-response Categories of On-treatment Virologic Failure or Relapse	12 weeks (i.e. at least 70 days) after the last dose of study drug	On-treatment virologic failure defined as breakthrough (at least 1 documented HCV RNA less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value greater than or equal to 50 IU/mL). Relapse (defined as HCV RNA \<50 IU/mL at EoT or at the last on-treatment HCV RNA measurement followed by HCV RNA ≥50 IU/mL post-treatment).
Percentage of Participants With Virological Response at End of Treatment (EoT)	Up to EoT, maximum of 24 weeks	Virological response defined as HCV RNA level less than 50 IU/mL.
Percentage of Participants With Relapse at EoT	Up to EoT, maximum of 24 weeks	Relapse defined as HCV RNA less than 50 IU/mL at EoT followed by HCV RNA greater than or equal to 50 IU/mL.
Percentage of Participants Meeting the SVR Non-response Categories of Premature Study Drug Discontinuation or Missing SVR12 Data and/or None of the Above Criteria	12 weeks (i.e. at least 70 days) after the last dose of study drug	Premature study drug discontinuation category is defined as participants who prematurely discontinued study drug and who experienced no on-treatment virologic failure. The final SVR non-response category was defined as missing SVR12 data and/or none of the above criteria.
Patient Support Program (PSP) Questionnaire: Utilization of PSP Components	Up to EoT, maximum of 24 weeks	Percentage of participants using each component of the PSP, including personal support, educational and information material (printed, online) and additional digital and mobile resources (web-portal, app, and reminders).
Adherence to ABBVIE Regimen: Percentage of the Direct-acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA	Up to 48 weeks	Percentage of the DAA dose taken in relation to the target dose of DAA (cumulative dose taken divided by target dose in percent), presented as the number of participants taking \> 95% to ≤ 105% of the target dose and those taking \> 80% to ≤ 95% of the target dose.
Adherence to RBV: Percentage of RBV Dose Taken in Relation to the Target Dose of RBV	Up to 48 weeks	Percentage of the RBV dose taken in relation to the target dose of RBV (cumulative dose taken divided by target dose in percent), presented as the number of participants taking \> 95% to ≤ 105% of the target dose and those taking \> 80% to ≤ 95% of the target dose.