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 Germany in a clinical practice patient population.
Study Type
OBSERVATIONAL
Enrollment
472
Percentage of Participants With Sustained Virologic Response (SVR12)
SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (\< 50 IU/mL) 12 weeks after the last actual dose of the ABBVIE REGIMEN.
Time frame: 12 weeks after the last dose of study drug (treatment period was 12 or 24 weeks)
Percentage of Participants With Virological Response at End of Treatment (EoTR)
Virological response is defined as HCV RNA \< 50 IU/mL. End of Treatment (EoT) is defined as the last intake of ABBVIE REGIMEN or RBV.
Time frame: EoT, (treatment period was 12 weeks or 24 weeks)
Number of Participants With On-Treatment Virological Failure or Relapse
The number of participants meeting the following SVR12 non-response categories: 1. On-treatment virological failure (breakthrough) defined \>= 1 documented HCV RNA \< 50 IU/mL followed by HCV RNA \>= 50 IU/mL during treatment or failure to suppress (each measured on-treatment HCV RNA value \>= 50 IU/mL) 2. Relapse defined as HCV RNA \< 50 IU/mL at EoT followed by HCV RNA \>= 50 IU/mL post-treatment in participants who completed treatment (\<= 7 days shortened).
Time frame: Up to post-treatment Week 12 (treatment period was 12 or 24 weeks)
Percentage of Participants With Rapid Virological Response at Week 4 (RVR4)
RVR4 is defined as participants with HCV RNA \< 50 IU/mL at Week 4.
Time frame: Week 4
Percentage of Participants With Sustained Virological Response 24 Weeks After EoT (SVR24)
SVR24 is defined as HCV RNA \< 50 IU/mL 24 Weeks After EoT.
Time frame: 24 Weeks After EoT (treatment period was 12 or 24 weeks)
Percentage of Participants With Sustained Virological Response 48 Weeks After EoT (SVR48)
SVR48 is defined as participants with HCV RNA \< 50 IU/mL 48 weeks after EoT.
Time frame: 48 Weeks After EoT (treatment period was 12 or 24 weeks)
Change From Baseline in PRISM Over Time
PRISM is a visual quantitative method to assess the perceived burden of suffering due to illness. The distance between the center of the "self" (yellow disk) and the illness disk (red disk) is called "self-illness separation" (SIS) and is measured in cm (range is 0 - 27). The smaller the distance, the higher the burden of suffering.
Time frame: Baseline, 12 and 48 weeks after EoT (treatment period was 12 or 24 weeks)
Percentage of Participants With ≥ 1 Comorbidity and/or Co-Infection
Time frame: up to post-treatment Week 48 (treatment period was 12 or 24 weeks)
Percentage of Participants Taking ≥ 1 Co-Medication
Time frame: up to post-treatment Week 48 (treatment period was 12 or 24 weeks)
Mean Duration of of ABBVIE REGIMEN and RBV Taken
Documented by participant interview and/or participant diary.
Time frame: Up to Week 12 or Week 24
Percentage of Planned Duration of ABBVIE REGIMEN and RBV Taken
Planned duration of treatment was 12 or 24 weeks.
Time frame: Up to Week 12 or Week 24
Change From Baseline in FACIT-F Scale Over Time
The FACIT-F Scale is a 13-item questionnaire that assesses self-reported fatigue during the past 7 days and its impact upon daily activities and function. Scores range from 0 - 100, with higher scores indicating a lesser degree of fatigue.
Time frame: Baseline, EoT (treatment period was 12 or 24 weeks), 12 and 48 weeks after EoT
Change From Baseline to EoT in PAM-13 Questionnaire
The PAM-13 item scale is a measure used to assess the patient knowledge, skill, and confidence for self-management. Scores range from 0 to 100. Higher scores indicate a higher level of knowledge, skill and confidence.
Time frame: Baseline, EoT (treatment period was 12 or 24 weeks)
Change From Baseline Over Time in WPAI: Total Work Productivity Impairment
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 indicates the percentage of overall work impairment due to health problems.
Time frame: Baseline, EoT (treatment period was 12 or 24 weeks),12 and 24 weeks after EoT
Change From Baseline Over Time in WPAI: Total Activity Impairment
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 indicates the percentage of general (non-work) activity impairment due to health problems.
Time frame: Baseline, EoT (treatment period was 12 or 24 weeks),12 and 24 weeks after EoT
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies
An adverse event (AE) is defined as any untoward medical occurrence. If an AE meets any of the following criteria, it is considered serious: results in death, is life threatening, results in hospitalization or prolongation of hospitalization, is a congenital anomaly, results in significant disability/incapacity, or is an important medical event. TEAEs are defined as any reported event that begins or worsens in severity after initiation of study drug through 30 days post-study drug dosing.
Time frame: up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
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