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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)

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)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02615145
Acronym
LIFE-C
Enrollment
472
Registered
2015-11-26
Start date
2015-12-03
Completion date
2018-03-26
Last updated
2019-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Keywords

Chronic Hepatitis C, Dasabuvir, Ombitasvir+Paritaprevir+Ritonavir, Observational Study, Quality of life, Work-ability, Fibrosis, Cirrhosis

Brief summary

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.

Interventions

None listed

Sponsors

AbbVie
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* Treatment-naïve or -experienced patients with confirmed CHC, genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± RBV according to standard of care and in line with local label. * If RBV is co-administered with the ABBVIE REGIMEN, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy) * Patients must voluntarily sign and date a patient authorization to use and/or disclose his/her pseudonymized health data prior to inclusion into the study * Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial

Exclusion criteria

• Adolescents; people not treated according to label

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants With Sustained Virologic Response (SVR12)12 weeks after the last dose of study drug (treatment period was 12 or 24 weeks)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.

Secondary

MeasureTime frameDescription
Number of Participants With On-Treatment Virological Failure or RelapseUp to post-treatment Week 12 (treatment period was 12 or 24 weeks)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).
Percentage of Participants With Rapid Virological Response at Week 4 (RVR4)Week 4RVR4 is defined as participants with HCV RNA \< 50 IU/mL at Week 4.
Percentage of Participants With Sustained Virological Response 24 Weeks After EoT (SVR24)24 Weeks After EoT (treatment period was 12 or 24 weeks)SVR24 is defined as HCV RNA \< 50 IU/mL 24 Weeks After EoT.
Percentage of Participants With Sustained Virological Response 48 Weeks After EoT (SVR48)48 Weeks After EoT (treatment period was 12 or 24 weeks)SVR48 is defined as participants with HCV RNA \< 50 IU/mL 48 weeks after EoT.
Change From Baseline in PRISM Over TimeBaseline, 12 and 48 weeks after EoT (treatment period was 12 or 24 weeks)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.
Percentage of Participants With ≥ 1 Comorbidity and/or Co-Infectionup to post-treatment Week 48 (treatment period was 12 or 24 weeks)
Percentage of Participants Taking ≥ 1 Co-Medicationup to post-treatment Week 48 (treatment period was 12 or 24 weeks)
Percentage of Participants With Virological Response at End of Treatment (EoTR)EoT, (treatment period was 12 weeks or 24 weeks)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.
Percentage of Planned Duration of ABBVIE REGIMEN and RBV TakenUp to Week 12 or Week 24Planned duration of treatment was 12 or 24 weeks.
Change From Baseline in FACIT-F Scale Over TimeBaseline, EoT (treatment period was 12 or 24 weeks), 12 and 48 weeks after EoTThe 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.
Change From Baseline to EoT in PAM-13 QuestionnaireBaseline, EoT (treatment period was 12 or 24 weeks)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.
Change From Baseline Over Time in WPAI: Total Work Productivity ImpairmentBaseline, EoT (treatment period was 12 or 24 weeks),12 and 24 weeks after EoTThe 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.
Change From Baseline Over Time in WPAI: Total Activity ImpairmentBaseline, EoT (treatment period was 12 or 24 weeks),12 and 24 weeks after EoTThe 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.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnanciesup to 30 days post treatment (treatment period was 12 weeks or 24 weeks)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.
Mean Duration of of ABBVIE REGIMEN and RBV TakenUp to Week 12 or Week 24Documented by participant interview and/or participant diary.

Participant flow

Recruitment details

In this prospective, multi-center observational study, adult patients chronic hepatitis C (CHC) virus receiving the interferon-free ABBVIE REGIMEN (paritaprevir/r - ombitasvir with or without dasabuvir) with or without ribavirin (RBV) were offered the opportunity to participate in this study during a routine clinical visit at participating sites.

Pre-assignment details

Per protocol, the Enrolled Population is used to present Participant Flow. Enrolled Population analysis groups are defined according to the participant's HCV genotype/subtype, regardless of ABBVIE Regimen prescribed.

Participants by arm

ArmCount
2 DAA+RBV
Two direct-acting antivirals (2DAA): paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) plus RBV
45
3DAA
Three direct-acting antivirals (3DAA): paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN)
266
3DAA+RBV
3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) plus RBV
159
Total470

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyDeath2300
Overall StudyDid Not Start Treatment0011
Overall StudyFailure to Return201070
Overall StudyOther, Not Specified5200

Baseline characteristics

Characteristic2 DAA+RBV3DAA3DAA+RBVTotal
Age, Continuous47 years
STANDARD_DEVIATION 11.5
55 years
STANDARD_DEVIATION 13.6
49 years
STANDARD_DEVIATION 11.9
52 years
STANDARD_DEVIATION 13.3
Chronic Illness Therapy-Fatigue (FACIT-F) Scale70.8 units on a scale
STANDARD_DEVIATION 22.1
69.3 units on a scale
STANDARD_DEVIATION 23.1
67.4 units on a scale
STANDARD_DEVIATION 23.1
68.8 units on a scale
STANDARD_DEVIATION 23
Patient Activation Measure (PAM-13) Questionnaire64.1 units on a scale
STANDARD_DEVIATION 11.8
64.3 units on a scale
STANDARD_DEVIATION 10.1
63.0 units on a scale
STANDARD_DEVIATION 9.49
63.8 units on a scale
STANDARD_DEVIATION 10.1
Pictorial Representation of Illness and Self-Measure (PRISM) Tool13.1 cm
STANDARD_DEVIATION 9.16
12.3 cm
STANDARD_DEVIATION 8.78
12.4 cm
STANDARD_DEVIATION 8.89
12.4 cm
STANDARD_DEVIATION 8.84
Race/Ethnicity, Customized
Asian/Oriental
4 Participants3 Participants5 Participants12 Participants
Race/Ethnicity, Customized
Black
0 Participants2 Participants1 Participants3 Participants
Race/Ethnicity, Customized
Other, Not Specified
0 Participants6 Participants1 Participants7 Participants
Race/Ethnicity, Customized
White/Caucasian
41 Participants255 Participants152 Participants448 Participants
Sex: Female, Male
Female
10 Participants124 Participants38 Participants172 Participants
Sex: Female, Male
Male
35 Participants142 Participants121 Participants298 Participants
Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment14.2 percentage of work productivity impairme
STANDARD_DEVIATION 17.9
19.1 percentage of work productivity impairme
STANDARD_DEVIATION 28
18.1 percentage of work productivity impairme
STANDARD_DEVIATION 23.3
18.2 percentage of work productivity impairme
STANDARD_DEVIATION 25.5
WPAI: Total Activity Impairment23.0 percentage of activity impairment
STANDARD_DEVIATION 25.8
25.9 percentage of activity impairment
STANDARD_DEVIATION 27.3
28.0 percentage of activity impairment
STANDARD_DEVIATION 28.9
26.3 percentage of activity impairment
STANDARD_DEVIATION 27.7

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 454 / 2661 / 159
other
Total, other adverse events
7 / 4533 / 26623 / 159
serious
Total, serious adverse events
1 / 457 / 2665 / 159

Outcome results

Primary

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)

Population: Core Population: 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 prescribed ABBVIE REGIMEN was known) with sufficient follow-up data regarding SVR12.

ArmMeasureValue (NUMBER)
All ParticipantsPercentage of Participants With Sustained Virologic Response (SVR12)88.1 percentage of participants
All Genotype 1 ParticipantsPercentage of Participants With Sustained Virologic Response (SVR12)88.4 percentage of participants
Genotype 1a ParticipantsPercentage of Participants With Sustained Virologic Response (SVR12)77.9 percentage of participants
Genotype 1b ParticipantsPercentage of Participants With Sustained Virologic Response (SVR12)93.9 percentage of participants
Genotype 4 ParticipantsPercentage of Participants With Sustained Virologic Response (SVR12)85.1 percentage of participants
Secondary

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

Population: Core Population: 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 prescribed ABBVIE REGIMEN was known). Participants with a measurement at given time point.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
All ParticipantsChange From Baseline in FACIT-F Scale Over Time12 Weeks EoT12.5 score on a scale
All ParticipantsChange From Baseline in FACIT-F Scale Over TimeEoT4.17 score on a scale
All ParticipantsChange From Baseline in FACIT-F Scale Over Time48 Weeks EoT13.3 score on a scale
All Genotype 1 ParticipantsChange From Baseline in FACIT-F Scale Over Time12 Weeks EoT9.92 score on a scale
All Genotype 1 ParticipantsChange From Baseline in FACIT-F Scale Over TimeEoT6.45 score on a scale
All Genotype 1 ParticipantsChange From Baseline in FACIT-F Scale Over Time48 Weeks EoT9.68 score on a scale
Genotype 1a ParticipantsChange From Baseline in FACIT-F Scale Over TimeEoT4.49 score on a scale
Genotype 1a ParticipantsChange From Baseline in FACIT-F Scale Over Time48 Weeks EoT10.3 score on a scale
Genotype 1a ParticipantsChange From Baseline in FACIT-F Scale Over Time12 Weeks EoT10.2 score on a scale
Comparison: EOTp-value: 0.5751ANCOVA
Comparison: EoTp-value: 0.517695% CI: [-4.66, 9.23]ANCOVA
Comparison: EoTp-value: 0.930895% CI: [-7, 7.64]ANCOVA
Comparison: EoTp-value: 0.346295% CI: [-6.06, 2.13]ANCOVA
Comparison: 12 Weeks after EoTp-value: 0.7016ANCOVA
Comparison: 12 weeks after EoTp-value: 0.400295% CI: [-8.71, 3.49]ANCOVA
Comparison: 12 weeks after EoTp-value: 0.47595% CI: [-8.74, 4.08]ANCOVA
Comparison: 12 weeks after EoTp-value: 0.87495% CI: [-3.21, 3.77]ANCOVA
Comparison: 48 weeks after EoTp-value: 0.7211ANCOVA
Comparison: 48 weeks after EoTp-value: 0.425695% CI: [-12.7, 5.39]ANCOVA
Comparison: 48 weeks after EoTp-value: 0.534795% CI: [-12.6, 6.54]ANCOVA
Comparison: 48 weeks after EoTp-value: 0.79295% CI: [-4.23, 5.54]ANCOVA
Comparison: Baseline to EOT across all participantsp-value: <0.000195% CI: [3.355, 7.935]paired t-test
Comparison: Baseline vs 12 weeks after EOT across all participantsp-value: <0.000195% CI: [8.113, 12.299]paired t-test
Comparison: baseline vs 48 weeks after EOT across all participantsp-value: <0.000195% CI: [7.259, 12.992]paired t-test
Secondary

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)

Population: Core Population: 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 prescribed ABBVIE REGIMEN was known). Participants with a measurement at given time point.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
All ParticipantsChange From Baseline in PRISM Over Time48 Weeks EoT10.2 cm
All ParticipantsChange From Baseline in PRISM Over Time12 Weeks EoT5.41 cm
All Genotype 1 ParticipantsChange From Baseline in PRISM Over Time48 Weeks EoT10.1 cm
All Genotype 1 ParticipantsChange From Baseline in PRISM Over Time12 Weeks EoT7.05 cm
Genotype 1a ParticipantsChange From Baseline in PRISM Over Time12 Weeks EoT5.31 cm
Genotype 1a ParticipantsChange From Baseline in PRISM Over Time48 Weeks EoT10.3 cm
Comparison: Week 12p-value: 0.111ANCOVA
Comparison: Week 12p-value: 0.270495% CI: [-1.28, 4.56]ANCOVA
Comparison: Week 12p-value: 0.951695% CI: [-3.17, 2.98]ANCOVA
Comparison: Week 12p-value: 0.048995% CI: [-3.46, -0.01]ANCOVA
Comparison: Week 48p-value: 0.9785ANCOVA
Comparison: Week 48p-value: 0.937995% CI: [-3.37, 3.11]ANCOVA
Comparison: Week 48p-value: 0.967895% CI: [-3.33, 3.47]ANCOVA
Comparison: Week 48p-value: 0.837395% CI: [-1.7, 2.1]ANCOVA
Comparison: Week 12 vs Baseline across all participantsp-value: <0.000195% CI: [5.417, 7.32]paired t-test
Comparison: Week 48 vs Baseline across all participantsp-value: <0.000195% CI: [8.936, 11.362]paired t-test
Secondary

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

Population: Core Population: Participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (the prescribed ABBVIE REGIMEN was known). Overall: participants with a measurement at Baseline; data rows = participants with a measurement at Baseline and given time point.

ArmMeasureGroupValue (MEAN)Dispersion
All ParticipantsChange From Baseline Over Time in WPAI: Total Activity ImpairmentEoT-2.1 percentage impairment of activityStandard Deviation 30.9
All ParticipantsChange From Baseline Over Time in WPAI: Total Activity Impairment12 Weeks EoT-11.9 percentage impairment of activityStandard Deviation 27
All ParticipantsChange From Baseline Over Time in WPAI: Total Activity Impairment24 Weeks EoT-13.4 percentage impairment of activityStandard Deviation 25.9
All Genotype 1 ParticipantsChange From Baseline Over Time in WPAI: Total Activity ImpairmentEoT7.0 percentage impairment of activityStandard Deviation 25.2
All Genotype 1 ParticipantsChange From Baseline Over Time in WPAI: Total Activity Impairment12 Weeks EoT-7.7 percentage impairment of activityStandard Deviation 22
All Genotype 1 ParticipantsChange From Baseline Over Time in WPAI: Total Activity Impairment24 Weeks EoT-11.3 percentage impairment of activityStandard Deviation 22.8
Genotype 1a ParticipantsChange From Baseline Over Time in WPAI: Total Activity Impairment24 Weeks EoT-12.3 percentage impairment of activityStandard Deviation 24
Genotype 1a ParticipantsChange From Baseline Over Time in WPAI: Total Activity ImpairmentEoT-3.0 percentage impairment of activityStandard Deviation 28.9
Genotype 1a ParticipantsChange From Baseline Over Time in WPAI: Total Activity Impairment12 Weeks EoT-13.3 percentage impairment of activityStandard Deviation 24.8
Genotype 1b ParticipantsChange From Baseline Over Time in WPAI: Total Activity Impairment24 Weeks EoT-16.3 percentage impairment of activityStandard Deviation 30.3
Genotype 1b ParticipantsChange From Baseline Over Time in WPAI: Total Activity ImpairmentEoT-2.8 percentage impairment of activityStandard Deviation 35.5
Genotype 1b ParticipantsChange From Baseline Over Time in WPAI: Total Activity Impairment12 Weeks EoT-10.5 percentage impairment of activityStandard Deviation 31.6
Secondary

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

Population: Core Population: Participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (the prescribed ABBVIE REGIMEN was known). Overall: participants with a measurement at Baseline; data rows = participants with a measurement at Baseline and given time point.

ArmMeasureGroupValue (MEAN)Dispersion
All ParticipantsChange From Baseline Over Time in WPAI: Total Work Productivity ImpairmentEoT5.5 percentage of overall work impairmentStandard Deviation 31.4
All ParticipantsChange From Baseline Over Time in WPAI: Total Work Productivity Impairment24 Weeks EoT-7.4 percentage of overall work impairmentStandard Deviation 22.1
All ParticipantsChange From Baseline Over Time in WPAI: Total Work Productivity Impairment12 Weeks EoT-4.3 percentage of overall work impairmentStandard Deviation 23.4
All Genotype 1 ParticipantsChange From Baseline Over Time in WPAI: Total Work Productivity ImpairmentEoT5.0 percentage of overall work impairmentStandard Deviation 36.4
All Genotype 1 ParticipantsChange From Baseline Over Time in WPAI: Total Work Productivity Impairment24 Weeks EoT-3.2 percentage of overall work impairmentStandard Deviation 33.6
All Genotype 1 ParticipantsChange From Baseline Over Time in WPAI: Total Work Productivity Impairment12 Weeks EoT-4.2 percentage of overall work impairmentStandard Deviation 11.9
Genotype 1a ParticipantsChange From Baseline Over Time in WPAI: Total Work Productivity Impairment12 Weeks EoT-3.8 percentage of overall work impairmentStandard Deviation 21.5
Genotype 1a ParticipantsChange From Baseline Over Time in WPAI: Total Work Productivity ImpairmentEoT4.4 percentage of overall work impairmentStandard Deviation 27.1
Genotype 1a ParticipantsChange From Baseline Over Time in WPAI: Total Work Productivity Impairment24 Weeks EoT-7.2 percentage of overall work impairmentStandard Deviation 22.1
Genotype 1b ParticipantsChange From Baseline Over Time in WPAI: Total Work Productivity ImpairmentEoT7.5 percentage of overall work impairmentStandard Deviation 36.3
Genotype 1b ParticipantsChange From Baseline Over Time in WPAI: Total Work Productivity Impairment24 Weeks EoT-9.7 percentage of overall work impairmentStandard Deviation 15.6
Genotype 1b ParticipantsChange From Baseline Over Time in WPAI: Total Work Productivity Impairment12 Weeks EoT-5.4 percentage of overall work impairmentStandard Deviation 29.6
Secondary

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)

Population: Core Population: 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 prescribed ABBVIE REGIMEN was known). Participants with a measurement at given time point.

ArmMeasureValue (LEAST_SQUARES_MEAN)
All ParticipantsChange From Baseline to EoT in PAM-13 Questionnaire1.91 score on a scale
All Genotype 1 ParticipantsChange From Baseline to EoT in PAM-13 Questionnaire0.01 score on a scale
Genotype 1a ParticipantsChange From Baseline to EoT in PAM-13 Questionnaire-0.74 score on a scale
p-value: 0.3869ANCOVA
p-value: 0.312595% CI: [-5.57, 1.79]ANCOVA
p-value: 0.174195% CI: [-6.48, 1.18]ANCOVA
p-value: 0.494195% CI: [-2.94, 1.42]ANCOVA
Comparison: Change from Baseline to Final visit across all participantsp-value: 0.884295% CI: [-1.271, 1.096]paired t-test
Secondary

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

Population: Safety Population: all enrolled participants who received at least one dose of the ABBVIE REGIMEN (the prescribed ABBVIE REGIMEN was known) and had an assessment.

ArmMeasureGroupValue (MEAN)Dispersion
All ParticipantsMean Duration of of ABBVIE REGIMEN and RBV TakenABBVIE REGIMEN83 daysStandard Deviation 11.7
All ParticipantsMean Duration of of ABBVIE REGIMEN and RBV TakenRBV81 daysStandard Deviation 18.1
All Genotype 1 ParticipantsMean Duration of of ABBVIE REGIMEN and RBV TakenRBV84 daysStandard Deviation 3.4
All Genotype 1 ParticipantsMean Duration of of ABBVIE REGIMEN and RBV TakenABBVIE REGIMEN84 daysStandard Deviation 3.4
Genotype 1a ParticipantsMean Duration of of ABBVIE REGIMEN and RBV TakenABBVIE REGIMEN83 daysStandard Deviation 9.7
Genotype 1b ParticipantsMean Duration of of ABBVIE REGIMEN and RBV TakenABBVIE REGIMEN84 daysStandard Deviation 15.6
Genotype 1b ParticipantsMean Duration of of ABBVIE REGIMEN and RBV TakenRBV81 daysStandard Deviation 20.5
Secondary

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)

Population: Core Population: 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 prescribed ABBVIE REGIMEN was known). Participants with non-response 12 weeks after EoT.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
All ParticipantsNumber of Participants With On-Treatment Virological Failure or RelapseRelapse5 Participants
All ParticipantsNumber of Participants With On-Treatment Virological Failure or RelapseOn-Treatment Virological Failure6 Participants
All Genotype 1 ParticipantsNumber of Participants With On-Treatment Virological Failure or RelapseRelapse5 Participants
All Genotype 1 ParticipantsNumber of Participants With On-Treatment Virological Failure or RelapseOn-Treatment Virological Failure3 Participants
Genotype 1a ParticipantsNumber of Participants With On-Treatment Virological Failure or RelapseRelapse1 Participants
Genotype 1a ParticipantsNumber of Participants With On-Treatment Virological Failure or RelapseOn-Treatment Virological Failure3 Participants
Genotype 1b ParticipantsNumber of Participants With On-Treatment Virological Failure or RelapseOn-Treatment Virological Failure0 Participants
Genotype 1b ParticipantsNumber of Participants With On-Treatment Virological Failure or RelapseRelapse4 Participants
Genotype 4 ParticipantsNumber of Participants With On-Treatment Virological Failure or RelapseRelapse0 Participants
Genotype 4 ParticipantsNumber of Participants With On-Treatment Virological Failure or RelapseOn-Treatment Virological Failure3 Participants
Secondary

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)

Population: Safety Population: all enrolled participants who received at least one dose of the ABBVIE REGIMEN (the prescribed ABBVIE REGIMEN was known). Pregnancy data presented for female participants only.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
All ParticipantsNumber of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies≥ 1 TEAE124 Participants
All ParticipantsNumber of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or PregnanciesPregnancy0 Participants
All ParticipantsNumber of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies≥ 1 Serious TEAE13 Participants
All Genotype 1 ParticipantsNumber of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies≥ 1 TEAE16 Participants
All Genotype 1 ParticipantsNumber of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or PregnanciesPregnancy0 Participants
All Genotype 1 ParticipantsNumber of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies≥ 1 Serious TEAE1 Participants
Genotype 1a ParticipantsNumber of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies≥ 1 Serious TEAE7 Participants
Genotype 1a ParticipantsNumber of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies≥ 1 TEAE65 Participants
Genotype 1a ParticipantsNumber of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or PregnanciesPregnancy0 Participants
Genotype 1b ParticipantsNumber of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies≥ 1 TEAE43 Participants
Genotype 1b ParticipantsNumber of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or PregnanciesPregnancy0 Participants
Genotype 1b ParticipantsNumber of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies≥ 1 Serious TEAE5 Participants
Secondary

Percentage of Participants Taking ≥ 1 Co-Medication

Time frame: up to post-treatment Week 48 (treatment period was 12 or 24 weeks)

Population: Safety Population: all enrolled participants who received at least one dose of the ABBVIE REGIMEN (the prescribed ABBVIE REGIMEN was known).

ArmMeasureValue (NUMBER)
All ParticipantsPercentage of Participants Taking ≥ 1 Co-Medication59.1 percentage of participants
All Genotype 1 ParticipantsPercentage of Participants Taking ≥ 1 Co-Medication64.4 percentage of participants
Genotype 1a ParticipantsPercentage of Participants Taking ≥ 1 Co-Medication54.1 percentage of participants
Genotype 1b ParticipantsPercentage of Participants Taking ≥ 1 Co-Medication66.0 percentage of participants
Secondary

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)

Population: Core Population: 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 prescribed ABBVIE REGIMEN was known).

ArmMeasureValue (NUMBER)
All ParticipantsPercentage of Participants With ≥ 1 Comorbidity and/or Co-Infection70.0 percentage of participants
All Genotype 1 ParticipantsPercentage of Participants With ≥ 1 Comorbidity and/or Co-Infection69.3 percentage of participants
Genotype 1a ParticipantsPercentage of Participants With ≥ 1 Comorbidity and/or Co-Infection71.0 percentage of participants
Genotype 1b ParticipantsPercentage of Participants With ≥ 1 Comorbidity and/or Co-Infection68.3 percentage of participants
Genotype 4 ParticipantsPercentage of Participants With ≥ 1 Comorbidity and/or Co-Infection76.6 percentage of participants
Secondary

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

Population: Core Population: 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 prescribed ABBVIE REGIMEN was known).

ArmMeasureValue (NUMBER)
All ParticipantsPercentage of Participants With Rapid Virological Response at Week 4 (RVR4)57.0 percentage of participants
All Genotype 1 ParticipantsPercentage of Participants With Rapid Virological Response at Week 4 (RVR4)57.2 percentage of participants
Genotype 1a ParticipantsPercentage of Participants With Rapid Virological Response at Week 4 (RVR4)62.1 percentage of participants
Genotype 1b ParticipantsPercentage of Participants With Rapid Virological Response at Week 4 (RVR4)54.7 percentage of participants
Genotype 4 ParticipantsPercentage of Participants With Rapid Virological Response at Week 4 (RVR4)55.3 percentage of participants
Secondary

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)

Population: Core Population: 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 prescribed ABBVIE REGIMEN was known) with sufficient follow-up data regarding SVR24.

ArmMeasureValue (NUMBER)
All ParticipantsPercentage of Participants With Sustained Virological Response 24 Weeks After EoT (SVR24)95.0 percentage of participants
All Genotype 1 ParticipantsPercentage of Participants With Sustained Virological Response 24 Weeks After EoT (SVR24)95.4 percentage of participants
Genotype 1a ParticipantsPercentage of Participants With Sustained Virological Response 24 Weeks After EoT (SVR24)92.8 percentage of participants
Genotype 1b ParticipantsPercentage of Participants With Sustained Virological Response 24 Weeks After EoT (SVR24)96.5 percentage of participants
Genotype 4 ParticipantsPercentage of Participants With Sustained Virological Response 24 Weeks After EoT (SVR24)91.9 percentage of participants
Secondary

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)

Population: Core Population: 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 prescribed ABBVIE REGIMEN was known) with sufficient follow-up data regarding SVR48.

ArmMeasureValue (NUMBER)
All ParticipantsPercentage of Participants With Sustained Virological Response 48 Weeks After EoT (SVR48)92.7 percentage of participants
All Genotype 1 ParticipantsPercentage of Participants With Sustained Virological Response 48 Weeks After EoT (SVR48)93.2 percentage of participants
Genotype 1a ParticipantsPercentage of Participants With Sustained Virological Response 48 Weeks After EoT (SVR48)89.0 percentage of participants
Genotype 1b ParticipantsPercentage of Participants With Sustained Virological Response 48 Weeks After EoT (SVR48)95.1 percentage of participants
Genotype 4 ParticipantsPercentage of Participants With Sustained Virological Response 48 Weeks After EoT (SVR48)88.0 percentage of participants
Secondary

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)

Population: Core Population: 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 prescribed ABBVIE REGIMEN was known).

ArmMeasureValue (NUMBER)
All ParticipantsPercentage of Participants With Virological Response at End of Treatment (EoTR)93.4 percentage of participants
All Genotype 1 ParticipantsPercentage of Participants With Virological Response at End of Treatment (EoTR)94.8 percentage of participants
Genotype 1a ParticipantsPercentage of Participants With Virological Response at End of Treatment (EoTR)89.0 percentage of participants
Genotype 1b ParticipantsPercentage of Participants With Virological Response at End of Treatment (EoTR)97.8 percentage of participants
Genotype 4 ParticipantsPercentage of Participants With Virological Response at End of Treatment (EoTR)80.9 percentage of participants
Secondary

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

Population: Core Population: 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 prescribed ABBVIE REGIMEN was known). Participants taking specified study drug with non-missing data.

ArmMeasureGroupValue (MEAN)Dispersion
All ParticipantsPercentage of Planned Duration of ABBVIE REGIMEN and RBV TakenRBV95.4 percentage of planned treatment durationStandard Deviation 17.55
All ParticipantsPercentage of Planned Duration of ABBVIE REGIMEN and RBV TakenABBVIE REGIMEN98.7 percentage of planned treatment durationStandard Deviation 9.74
All Genotype 1 ParticipantsPercentage of Planned Duration of ABBVIE REGIMEN and RBV TakenABBVIE REGIMEN98.6 percentage of planned treatment durationStandard Deviation 10.18
All Genotype 1 ParticipantsPercentage of Planned Duration of ABBVIE REGIMEN and RBV TakenRBV94.1 percentage of planned treatment durationStandard Deviation 19.72
Genotype 1a ParticipantsPercentage of Planned Duration of ABBVIE REGIMEN and RBV TakenRBV95.3 percentage of planned treatment durationStandard Deviation 17.68
Genotype 1a ParticipantsPercentage of Planned Duration of ABBVIE REGIMEN and RBV TakenABBVIE REGIMEN97.7 percentage of planned treatment durationStandard Deviation 12.94
Genotype 1b ParticipantsPercentage of Planned Duration of ABBVIE REGIMEN and RBV TakenABBVIE REGIMEN99.1 percentage of planned treatment durationStandard Deviation 8.39
Genotype 1b ParticipantsPercentage of Planned Duration of ABBVIE REGIMEN and RBV TakenRBV83.5 percentage of planned treatment durationStandard Deviation 30.68
Genotype 4 ParticipantsPercentage of Planned Duration of ABBVIE REGIMEN and RBV TakenABBVIE REGIMEN99.8 percentage of planned treatment durationStandard Deviation 3.91
Genotype 4 ParticipantsPercentage of Planned Duration of ABBVIE REGIMEN and RBV TakenRBV99.8 percentage of planned treatment durationStandard Deviation 3.91

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026