Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Germany (LIFE-C)

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.

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.

The number of participants meeting the following SVR12 non-response categories:

• 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)
• 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).

RVR4 is defined as participants with HCV RNA < 50 IU/mL at Week 4.

SVR24 is defined as HCV RNA < 50 IU/mL 24 Weeks After EoT.

SVR48 is defined as participants with HCV RNA < 50 IU/mL 48 weeks after EoT.

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.

Documented by participant interview and/or participant diary.

Planned duration of treatment was 12 or 24 weeks.

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.

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.

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.

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.

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.