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

Study Overview
=================
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.

Official Title
-----------------
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C -An Observational Study in Kuwait

Conditions
-----------------
Chronic Hepatitis C

Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants With Hepatitis C Virus (HCV) Genotype 1 or 4<br>Participants with HCV genotype 1 or 4 receiving paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV. The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice and label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study. | |

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Virological Response at End of Treatment (EoT) | Virological response defined as HCV RNA level less than 50 IU/mL. | 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. | 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. | 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). | 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. | 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. | 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. | Up to 48 weeks | 
| Adherence: Percentage of Planned Duration of RBV Taken by Participant |  | 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. | 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). | Up to EoT, maximum of 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Paritaprevir/r - Ombitasvir, ± Dasabuvir, Sustained Virological Response, Chronic Hepatitis C genotype 4, Observational Study, Chronic Hepatitis C genotype 1, Chronic Hepatitis C