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

AbbVie40 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Chronic Hepatitis C

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Secondary Outcomes

Percentage of Participants With Virological Response at End of Treatment (EoT)

Virological response defined as HCV RNA level less than 50 IU/mL.

Time frame: Up to EoT, maximum of 24 weeks

Percentage of Participants With Relapse at EoT

Relapse defined as HCV RNA less than 50 IU/mL at EoT followed by HCV RNA greater than or equal to 50 IU/mL.

Time frame: Up to EoT, maximum of 24 weeks

Percentage of Participants With Breakthrough.

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.

Time frame: Up to EoT, maximum of 24 weeks

Percentage of Participants Meeting the SVR Non-response Categories of On-treatment Virologic Failure or Relapse

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).

Time frame: 12 weeks (i.e. at least 70 days) after the last dose of study drug

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

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.

Time frame: 12 weeks (i.e. at least 70 days) after the last dose of study drug

Adherence to ABBVIE Regimen: Percentage of the Direct-acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA

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.

Time frame: Up to 48 weeks

Adherence to RBV: Percentage of RBV Dose Taken in Relation to the Target Dose of RBV

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.

Time frame: Up to 48 weeks

Adherence: Percentage of Planned Duration of RBV Taken by Participant

Time frame: Up to 48 weeks

Change From Baseline in the PAM-13 Questionnaire

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.

Time frame: Up to 48 weeks

Patient Support Program (PSP) Questionnaire: Utilization of PSP Components

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).

Time frame: Up to EoT, maximum of 24 weeks