Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin and Patient Support Program in Patients With Chronic Hepatitis C

Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. Participants with missing HCV RNA were counted as virological failure.

Time frame: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)

Population: The Core Population, defined as enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).

The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate visual analog scale (VAS). Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score by applying country-specific weights.The range for EQ-5D-5L index score is 0 to 1 where '0' is defined as a health state equivalent to being dead and '1' is full health.The higher the score the better the health status.

Time frame: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment

Population: The Core Population with available data at baseline and each time point.

The EQ-5D-5L is a health state utility instrument that evaluates preference for health status with a separate visual analog scale (VAS). The VAS assesses overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable).

Time frame: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment

Population: The Core Population with available data at baseline and each time point.

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. Absenteeism indicates the percentage of work time missed due to health problems.

Time frame: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment

Population: The Core Population who were employed and with available data at baseline and each time point.

Time frame: From first dose of study drug through 30 days after last dose (16 weeks).

Population: The Safety Population, defined as all enrolled participants who received at least one dose of the ABBVIE regimen.

Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL.

Time frame: End of treatment (week 12 or 24 depending on the treatment regimen)

Population: The Core Population defined as enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).

SVR12 non-response was categorized according to the following: * On-treatment virologic failure (breakthrough \[at least one documented HCV RNA \< 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment\] 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 patients who completed treatment (not more than 7 days shortened); * Premature treatment discontinuation with no on-treatment virologic failure; * Missing SVR12 data and/or none of the above criteria.

Time frame: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)

Population: The Core Population

Breakthrough was defined as at least one documented HCV RNA \< 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment.

Time frame: 12 or 24 weeks (depending on the treatment regimen)

Population: The Core Population with virological response on-treatment and with at least one on-treatment measurement thereafter (including EOT).

Relapse was defined as participants with a virologic response (VR; HCV RNA \< 50 IU/mL) at end of treatment (EOT) followed by HCV RNA ≥ 50 IU/mL at any time after the end of treatment.

Time frame: End of treatment (week 12 or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.

Population: The Core Population with VR at EOT and who completed treatment, and had ≥ 1 HCV RNA measurement ≥ 70 days post-treatment or were a treatment failure between EOT and day 70.

Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. The Core Population with sufficient follow-up data regarding SVR12 included all core population participants who * had evaluable HCV RNA data ≥ 70 days after the last actual dose of the ABBVIE REGIMEN * or a HCV RNA value ≥ 50 IU/mL at the last measurement post-baseline * or had HCV RNA \< 50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥ 70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to adverse event) or virologic failure.

Time frame: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)

Population: The Core Population with sufficient follow-up data regarding SVR12

Time frame: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.

Population: The Core Population who were prescribed ribavirin.

Adherence to study treatment was calculated as: Cumulative dose taken / (initial prescribed dose \* planned duration)

Time frame: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.

Population: The Core Population

Adherence to study treatment was calculated as: Cumulative dose taken / (initial prescribed dose \* planned duration)

Time frame: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen

Population: The Core Population who were prescribed ribavirin.