Trial Outcomes & Findings for Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Hungary (NCT NCT02636608)

NCT ID: NCT02636608

Last Updated: 2019-07-26

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 244 participants
• Primary outcome timeframe: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)
• Results posted on: 2019-07-26

Participant Flow

This observational study was conducted in 14 medical centers in Hungary experienced in the treatment of chronic hepatitis C (CHC). The first participant entered the study on November 27, 2015 and last patient last visit was on 23 May 2018.

Participant milestones

Measure	Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease. The prescription of treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer the patient the opportunity to participate in this study.
Overall Study STARTED	244
Overall Study Received Treatment	243
Overall Study COMPLETED	233
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Measure	Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease. The prescription of treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer the patient the opportunity to participate in this study.
Overall Study Failure to Return	4
Overall Study Insufficient Virological Response	1
Overall Study Death	3
Overall Study Other	2
Overall Study Did Not Receive Treatment	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin n=243 Participants Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
Age, Continuous	60 years STANDARD_DEVIATION 10.1 • n=5 Participants
Age, Customized 18-65 years	178 Participants n=5 Participants
Age, Customized 66-84 years	65 Participants n=5 Participants
Sex: Female, Male Female	141 Participants n=5 Participants
Sex: Female, Male Male	102 Participants n=5 Participants
Race/Ethnicity, Customized White	243 Participants n=5 Participants
Years Since Diagnosis of HCV Infection	9.2 years STANDARD_DEVIATION 7.66 • n=5 Participants
Hepatitis C Virus Genotype Genotype 1a	9 Participants n=5 Participants
Hepatitis C Virus Genotype Genotype 1a/1b	5 Participants n=5 Participants
Hepatitis C Virus Genotype Genotype 1b	227 Participants n=5 Participants
Hepatitis C Virus Genotype Genotype 1b/4 unknown	1 Participants n=5 Participants
Hepatitis C Virus Genotype Genotype 1 unknown	1 Participants n=5 Participants
Cirrhosis Status No cirrhosis	42 Participants n=5 Participants
Cirrhosis Status Transition to cirrhosis	29 Participants n=5 Participants
Cirrhosis Status Cirrhosis	172 Participants n=5 Participants
Pretreatment Status Naive	83 Participants n=5 Participants
Pretreatment Status Experienced	160 Participants n=5 Participants
HCV Ribonucleic Acid (RNA) Level	5.79 log10 IU/mL STANDARD_DEVIATION 0.889 • n=5 Participants
Assigned Treatment 3 DAA without RBV for 12 weeks	133 Participants n=5 Participants
Assigned Treatment 3 DAA without RBV for 24 weeks	5 Participants n=5 Participants
Assigned Treatment 3 DAA with RBV for 12 weeks	96 Participants n=5 Participants
Assigned Treatment 3 DAA with RBV for 24 weeks	9 Participants n=5 Participants
Co-morbidities Any co-morbidity or co-infection	197 Participants n=5 Participants
Co-morbidities Co-infections	1 Participants n=5 Participants
Co-morbidities Hepatitis B	1 Participants n=5 Participants
Co-morbidities Liver and/or CHC related co-morbidities	47 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin n=238 Participants Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)	94.5 percentage of participants Interval 90.9 to 96.8	—

SECONDARY outcome

Timeframe: 24 weeks after the last dose of study drug (week 36 or 48 depending on the treatment regimen)

Population: The Core population with sufficient follow-up data regarding SVR24

Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 24 weeks after the last dose of study drug.

The Core population with sufficient follow-up data regarding SVR24 included all core population participants who

• had evaluable HCV RNA data ≥ 126 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 ≥ 126 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.

Outcome measures

Measure	Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin n=232 Participants Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 24 Weeks Post-treatment (SVR24)	96.6 percentage of participants Interval 93.3 to 98.2	—

SECONDARY outcome

Timeframe: 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).

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

Outcome measures

Measure	Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin n=238 Participants Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
Percentage of Participants Achieving Virological Response at End of Treatment	97.1 percentage of participants Interval 94.1 to 98.6	—

SECONDARY outcome

Timeframe: 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, who completed treatment, and had ≥ 1 HCV RNA measurement ≥ 70 days post-treatment or were a treatment failure between EOT and day 70.

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.

Outcome measures

Measure	Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin n=225 Participants Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
Percentage of Participants With Relapse	1.3 percentage of participants Interval 0.5 to 3.8	—

SECONDARY outcome

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

Population: The Core population with at least one documented HCV RNA \< 50 IU/mL while on treatment and at least one on-treatment or EOT measurement thereafter.

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

Outcome measures

Measure	Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin n=8 Participants Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
Number of Participants With Breakthrough	0 Participants	—

SECONDARY outcome

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

Population: The Core population

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);
• Death;
• Premature treatment discontinuation with no on-treatment virologic failure;
• None of the above criteria or missing SVR12 data

Outcome measures

Measure	Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin n=238 Participants Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment On-treatment virologic failure	2 Participants	—
Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment Relapse	3 Participants	—
Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment Death	3 Participants	—
Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment Premature treatment discontinuation	2 Participants	—
Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment None of the above criteria	3 Participants	—

SECONDARY outcome

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

Population: Core population

Adherence to the ABBVIE treatment regimen is expressed as a percentage of the target dose and was calculated as:

Cumulative dose taken / (initial prescribed dose * planned duration) * 100

The ABBVIE regimen consists of paritaprevir/r and ombitasvir with or without dasabuvir.

Outcome measures

Measure	Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin n=238 Participants Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category > 105%	3.4 percentage of participants	—
Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category > 95% to ≤ 105%	93.7 percentage of participants	—
Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category > 80% to ≤ 95%	0.8 percentage of participants	—
Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category > 50% to ≤ 80%	0.8 percentage of participants	—
Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category ≤ 50%	1.3 percentage of participants	—

SECONDARY outcome

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

Population: Core population who were prescribed ribavirin

Adherence to ribavirin is expressed as a percentage of the target dose, and was calculated as:

Cumulative dose taken / (initial prescribed dose * planned duration) * 100

Outcome measures

Measure	Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin n=105 Participants Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
Percentage of Participants With Adherence to Ribavirin by Adherence Category > 105%	1.0 percentage of participants	—
Percentage of Participants With Adherence to Ribavirin by Adherence Category > 95% to ≤ 105%	78.1 percentage of participants	—
Percentage of Participants With Adherence to Ribavirin by Adherence Category > 80% to ≤ 95%	5.7 percentage of participants	—
Percentage of Participants With Adherence to Ribavirin by Adherence Category > 50% to ≤ 80%	6.7 percentage of participants	—
Percentage of Participants With Adherence to Ribavirin by Adherence Category ≤ 50%	8.6 percentage of participants	—

SECONDARY outcome

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

Population: Core population who were prescribed ribavirin

Outcome measures

Measure	Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin n=105 Participants Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
Percentage of Ribavirin Treatment Days in Relation to the Target Number of Ribavirin Treatment Days	93.1 percentage of days Standard Deviation 22.20	—

SECONDARY outcome

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

Population: All treated participants

Concomitant medication other than for chronic hepatitis C used from the time when the decision was made to initiate treatment with paritaprevir/ritonavir and ombitasvir with or without dasabuvir until after the last dose.

Outcome measures

Measure	Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin n=243 Participants Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
Number of Participants Who Received Concomitant Medications ACE inhibitors	53 Participants	—
Number of Participants Who Received Concomitant Medications Any concomitant medication	169 Participants	—
Number of Participants Who Received Concomitant Medications Beta blocking agents	78 Participants	—
Number of Participants Who Received Concomitant Medications Diuretics	42 Participants	—
Number of Participants Who Received Concomitant Medications Peptic ulcer / gastro-oesophageal reflux disease	42 Participants	—
Number of Participants Who Received Concomitant Medications Calcium channel blockers	34 Participants	—
Number of Participants Who Received Concomitant Medications Blood glucose-lowering drugs	27 Participants	—
Number of Participants Who Received Concomitant Medications Mineral supplements	25 Participants	—

SECONDARY outcome

Timeframe: From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen)

Population: All treated participants

Outcome measures

Measure	Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin n=243 Participants Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies Adverse events	29 Participants	—
Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies Serious adverse events	6 Participants	—
Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies Pregnancies	0 Participants	—

SECONDARY outcome

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

Population: 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. 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).

The VAS assesses overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable). The higher the score the better the health status.

Outcome measures

Measure	Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin n=128 Participants Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV n=102 Participants Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score End of treatment	5.70 units on a scale Interval 3.19 to 8.21	2.77 units on a scale Interval -0.03 to 5.57
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score 12 weeks after end of treatment	9.18 units on a scale Interval 6.83 to 11.5	5.98 units on a scale Interval 3.29 to 8.67
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score 24 weeks after end of treatment	10.5 units on a scale Interval 8.04 to 13.0	6.07 units on a scale Interval 3.26 to 8.87

SECONDARY outcome

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

Population: 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. 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.

Outcome measures

Measure	Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin n=124 Participants Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV n=103 Participants Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score End of treatment	0.02 units on a scale Interval 0.0 to 0.03	0.02 units on a scale Interval 0.0 to 0.04
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score 12 weeks after end of treatment	0.03 units on a scale Interval 0.01 to 0.05	0.04 units on a scale Interval 0.02 to 0.06
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score 24 weeks after end of treatment	0.04 units on a scale Interval 0.02 to 0.06	0.04 units on a scale Interval 0.02 to 0.06

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin n=68 Participants Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism End of treatment	-2.1 percent impairment Standard Deviation 21.6	—
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism 12 weeks after end of treatment	-1.7 percent impairment Standard Deviation 22.2	—
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism 24 weeks after end of treatment	1.0 percent impairment Standard Deviation 19.6	—

SECONDARY outcome

Timeframe: 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.

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.

Presenteeism indicates the percentage of impairment while working due to health problems.

Outcome measures

Measure	Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin n=81 Participants Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism End of treatment	0.6 percent impairment Standard Deviation 28.8	—
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism 12 weeks after end of treatment	-5.7 percent impairment Standard Deviation 25.1	—
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism 24 weeks after end of treatment	-7.3 percent impairment Standard Deviation 23.3	—

SECONDARY outcome

Timeframe: 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.

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 (TWP) indicates the percentage of overall work impairment due to health problems.

Outcome measures

Measure	Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin n=78 Participants Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP) End of treatment	-2.3 percent impairment Standard Deviation 34.5	—
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP) 12 weeks after end of treatment	-8.1 percent impairment Standard Deviation 30.5	—
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP) 24 weeks after end of treatment	-7.3 percent impairment Standard Deviation 27.3	—

SECONDARY outcome

Timeframe: 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.

Total activity impairment (TAI) indicates the percentage of general (non-work) activity impairment due to health problems.

Outcome measures

Measure	Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin n=194 Participants Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment End of treatment	-0.5 percent impairment Standard Deviation 29.4	—
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment 12 weeks after end of treatment	-6.7 percent impairment Standard Deviation 28.4	—
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment 24 weeks after end of treatment	-8.5 percent impairment Standard Deviation 26.6	—

SECONDARY outcome

Timeframe: Baseline and end of treatment (week 12 or 24 depending on the treatment regimen)

Population: The Core population with available data at baseline and end of treatment.

PAM-13 is a measure used to assess the patient knowledge, skill, and confidence for self-management, consisting of 13 questions. 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). Scores were summed to calculate the overall raw score, then transformed to a scale with a theoretical range 0 to 100, based on calibration tables, with higher PAM scores indicating that the participant is likely to participate more actively in health care processes and takes more responsibility for his or her health.

Outcome measures

Measure	Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin n=98 Participants Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV n=90 Participants Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
Change From Baseline in Patient Activation Measure 13 (PAM-13)	0.85 units on a scale Interval -1.04 to 2.73	0.22 units on a scale Interval -1.75 to 2.19

SECONDARY outcome

Timeframe: Up to post treatment week 24

Population: Core population

Outcome measures

Measure	Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin n=238 Participants Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
Number of Participants Who Participated in the AbbVie Patient Support Program (PSP)	179 Participants	—

SECONDARY outcome

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

Population: Core population who participated in the PSP

At the end of treatment visit participants were asked to indicate which of the following PSP services they had used:

• Personal support (e.g., Care Coach)
• Printed educational material
• Online educational materials
• Web-portal
• App

Outcome measures

Measure	Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin n=179 Participants Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
Utilization of the AbbVie Patient Support Program (PSP) Components Any	141 Participants	—
Utilization of the AbbVie Patient Support Program (PSP) Components Personal support	134 Participants	—
Utilization of the AbbVie Patient Support Program (PSP) Components Printed educational material	128 Participants	—
Utilization of the AbbVie Patient Support Program (PSP) Components Online educational material	58 Participants	—
Utilization of the AbbVie Patient Support Program (PSP) Components Web-portal	65 Participants	—
Utilization of the AbbVie Patient Support Program (PSP) Components App	54 Participants	—
Utilization of the AbbVie Patient Support Program (PSP) Components None/missing	38 Participants	—

SECONDARY outcome

Timeframe: End of treatment (weeks 12 or 24 depending on treatment regimen)

Population: Core population who participated in the PSP with available data

At the end of treatment visit participants were asked to indicate their level of satisfaction with each of the PSP services they had used.

Outcome measures

Measure	Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin n=179 Participants Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
Satisfaction With the AbbVie Patient Support Program (PSP) Components Personal support · Very good	95 Participants	—
Satisfaction With the AbbVie Patient Support Program (PSP) Components Personal support · Good	33 Participants	—
Satisfaction With the AbbVie Patient Support Program (PSP) Components Personal support · Satisfactory	6 Participants	—
Satisfaction With the AbbVie Patient Support Program (PSP) Components Personal support · Poor	0 Participants	—
Satisfaction With the AbbVie Patient Support Program (PSP) Components Printed educational material · Very good	50 Participants	—
Satisfaction With the AbbVie Patient Support Program (PSP) Components Printed educational material · Good	42 Participants	—
Satisfaction With the AbbVie Patient Support Program (PSP) Components Printed educational material · Satisfactory	11 Participants	—
Satisfaction With the AbbVie Patient Support Program (PSP) Components Printed educational material · Poor	1 Participants	—
Satisfaction With the AbbVie Patient Support Program (PSP) Components Online educational material · Very good	21 Participants	—
Satisfaction With the AbbVie Patient Support Program (PSP) Components Online educational material · Good	27 Participants	—
Satisfaction With the AbbVie Patient Support Program (PSP) Components Online educational material · Satisfactory	8 Participants	—
Satisfaction With the AbbVie Patient Support Program (PSP) Components Online educational material · Poor	0 Participants	—
Satisfaction With the AbbVie Patient Support Program (PSP) Components Web-portal · Very good	24 Participants	—
Satisfaction With the AbbVie Patient Support Program (PSP) Components Web-portal · Good	23 Participants	—
Satisfaction With the AbbVie Patient Support Program (PSP) Components Web-portal · Satisfactory	8 Participants	—
Satisfaction With the AbbVie Patient Support Program (PSP) Components Web-portal · Poor	1 Participants	—
Satisfaction With the AbbVie Patient Support Program (PSP) Components App · Very good	14 Participants	—
Satisfaction With the AbbVie Patient Support Program (PSP) Components App · Good	31 Participants	—
Satisfaction With the AbbVie Patient Support Program (PSP) Components App · Satisfactory	2 Participants	—
Satisfaction With the AbbVie Patient Support Program (PSP) Components App · Poor	0 Participants	—

Adverse Events

Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV

Serious events: 4 serious events

Other events: 16 other events

Deaths: 3 deaths

Serious adverse events

Measure	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV n=138 participants at risk Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir without ribavirin for12 or 24 weeks.	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV n=105 participants at risk Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
Blood and lymphatic system disorders ANAEMIA	0.00% 0/138 • From first dose of study drug to 30 days after last dose (16 to 28 weeks depending on treatment regimen)	0.95% 1/105 • Number of events 1 • From first dose of study drug to 30 days after last dose (16 to 28 weeks depending on treatment regimen)
Cardiac disorders CARDIAC FAILURE	0.00% 0/138 • From first dose of study drug to 30 days after last dose (16 to 28 weeks depending on treatment regimen)	0.95% 1/105 • Number of events 1 • From first dose of study drug to 30 days after last dose (16 to 28 weeks depending on treatment regimen)
General disorders GENERAL PHYSICAL HEALTH DETERIORATION	0.00% 0/138 • From first dose of study drug to 30 days after last dose (16 to 28 weeks depending on treatment regimen)	0.95% 1/105 • Number of events 1 • From first dose of study drug to 30 days after last dose (16 to 28 weeks depending on treatment regimen)
General disorders OEDEMA PERIPHERAL	0.72% 1/138 • Number of events 1 • From first dose of study drug to 30 days after last dose (16 to 28 weeks depending on treatment regimen)	0.00% 0/105 • From first dose of study drug to 30 days after last dose (16 to 28 weeks depending on treatment regimen)
Infections and infestations SEPSIS	0.00% 0/138 • From first dose of study drug to 30 days after last dose (16 to 28 weeks depending on treatment regimen)	0.95% 1/105 • Number of events 1 • From first dose of study drug to 30 days after last dose (16 to 28 weeks depending on treatment regimen)
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC DISORDER	0.72% 1/138 • Number of events 1 • From first dose of study drug to 30 days after last dose (16 to 28 weeks depending on treatment regimen)	0.00% 0/105 • From first dose of study drug to 30 days after last dose (16 to 28 weeks depending on treatment regimen)
Surgical and medical procedures HOSPITALISATION	0.72% 1/138 • Number of events 1 • From first dose of study drug to 30 days after last dose (16 to 28 weeks depending on treatment regimen)	0.00% 0/105 • From first dose of study drug to 30 days after last dose (16 to 28 weeks depending on treatment regimen)
Vascular disorders HYPERTENSION	0.72% 1/138 • Number of events 1 • From first dose of study drug to 30 days after last dose (16 to 28 weeks depending on treatment regimen)	0.00% 0/105 • From first dose of study drug to 30 days after last dose (16 to 28 weeks depending on treatment regimen)

Other adverse events

Measure	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV n=138 participants at risk Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir without ribavirin for12 or 24 weeks.	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV n=105 participants at risk Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.
Blood and lymphatic system disorders ANAEMIA	0.00% 0/138 • From first dose of study drug to 30 days after last dose (16 to 28 weeks depending on treatment regimen)	15.2% 16/105 • Number of events 16 • From first dose of study drug to 30 days after last dose (16 to 28 weeks depending on treatment regimen)

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Email: abbvieclinicaltrials@abbvie.com

Results disclosure agreements

• Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
• Publication restrictions are in place

Restriction type: OTHER