Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Austria (REAL)

SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels \< 50 IU/mL 12 weeks after the last actual dose of study drug.

Time frame: 12 Weeks after the last dose of study drug

Population: The Core Population (CP) was defined as all patients in the safety population (SP; all enrolled subjects who received at least 1 dose of study drug) who met eligibility criteria and were adequately treated according to the standard of care and within local label recommendations.

SVR12 is defined as HCV RNA levels \< 50 IU/mL 12 weeks after the last actual dose of study drug in the Core Population Sufficient Follow-up (CPSFU).

Time frame: 12 weeks after last dose of study drug

Population: CP subjects with evaluable HCV RNA data ≥70 days after last dose AbbVie Regimen, or HCV RNA value ≥50IU/mL at last measurement postbaseline, or HCV RNA \<50IU /mL at last measurement postbaseline, but no HCV RNA value ≥70 days after last dose AbbVie Regimen due to safety or virologic failure (relapse reported but date/value of HCV RNA test missing).

The percentage of participants with on-treatment virologic failure (breakthrough \[defined as at least one documented HCV RNA \<50 IU/mL followed by HCV RNA \>= 50 IU/mL during treatment\]).

Time frame: Up to approximately 24 weeks

Population: Core Population (CP)

The percentage of participants with relapse (defined as HCV RNA \<50 IU/mL at EoT followed by HCV RNA ≥50 IU/mL)

Time frame: Up to 12 weeks after last dose of study drug

Population: Core Population (CP)

The percentage of participants with virological response (HCV RNA \<50 IU/mL) at end of treatment (EoT, defined as last intake of ABBVIE REGIMEN or ribavirin \[RBV\]).

Time frame: Up to 24 weeks of treatment

Population: Core Population (CP)

The WPAI questionnaire was used to measure work absenteeism, work presenteeism, work productivity impairment and daily activity impairment. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity: Presenteeism - percentage of impairment while working due to health problem; Total work productivity impairment - percentage of overall work impairment due to health problem Absenteeism - percentage of work time missed due to health problem; Total activity impairment - percentage of general (non-work) activity impairment due to health problem

Time frame: Day 0 to post treatment week 12

Population: Core Population (CP)

The AbbVie PSP included educational and information material (including printed, online, pillbox), digital and mobile resource (web-portal), digital and mobile resources (reminders). The PSP utilization and satisfaction assessment evaluated the frequency of utilization (usually daily, several times per week, usually once weekly, less than once weekly) and patient's overall satisfaction (very good, good, satisfactory) with their respective PSP.

Time frame: Up to 24 weeks of treatment

Population: Core Population (CP)

Deviations from the target dose of the ABBVIE REGIMEN were defined as the actual duration is shortened/prolonged (exceedence) for more than 7 days.

Time frame: Up to 24 weeks of treatment

Population: Core Population (CP)

Adherence to the ABBVIE REGIMEN was defined as percentage of target dose (adherence=cumulated number of pills taken / \[initially prescribed number of pills x planned duration\]) and categorized as follows: \>105%, \>95% to \<=105%, \>80% to \<=95%, \>50% to \<=80%, \<=50%.

Time frame: Up to 24 weeks of treatment

Population: Core Population (CP)

Adherence to RBV is defined as percentage of target dose (adherence=cumulated number of pills taken / \[initially prescribed number of pills x planned duration\]) and categorized as follows: \>105%, \>95% - \<=105%, \>80% - \<=95%, \>50% - \<=80%, \<=50%.

Time frame: Up to 24 weeks of treatment

Population: All participants in the Core Population (CP) who received RBV

Percentage of participants with co-morbidities and/or co-infections at baseline (Day 0).

Time frame: Day 0

Population: Core Population (CP)

Percentage of participants taking at least 1 concomitant medication

Time frame: Day 0 to end of treatment (up to 24 weeks)

Population: The safety population (SP) was defined as enrolled patients who received at least 1 dose of ABBVIE REGIMEN.

Adherence to RBV is defined as percentage of target dose (adherence=cumulated dose taken/ \[initially prescribed dose x planned duration\]).

Time frame: Up to 24 weeks of treatment

Population: All participants in the Core Population (CP) who received RBV

The EQ-5D-5L is a health state utility instrument that evaluates preference for health status (utility). The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from -0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. The EQ-5D visual analogue scale (VAS) records the participant's self-rated health status on a vertical graduated scale from 0 to 100, with 0 indicating the worst imaginable health state and 100 indicating the best imaginable health state. An increase in EQ-5D-5L VAS score indicates improvement.

Time frame: Day 0 and post treatment week 12

Population: Core Population (CP)

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). Responses are summed and averaged to come up with an overall score of level 1 through level 4. The responses to the 13 questions are summed and transformed into a PAM Score between 0 and 100; a higher score indicates more knowledge and confidence to take action for self-management.

Time frame: Day 0 and End of Treatment (EoT)

Population: Core Population (CP)