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 Germany (LIFE-C) (NCT NCT02615145)
NCT ID: NCT02615145
Last Updated: 2019-10-07
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
472 participants
Primary outcome timeframe
12 weeks after the last dose of study drug (treatment period was 12 or 24 weeks)
Results posted on
2019-10-07
Participant Flow
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.
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.
Participant milestones
| Measure |
Genotype 1a Participants
Treatment-naïve or -experienced participants with confirmed chronic hepatitis C (CHC) genotype 1a (G1a, includes all GT1- participants except participants with GT1b or GT1b/4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) + ribavirin (RBV) according to standard of care and in line with the current local label.
|
Genotype 1b Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1b (G1b; includes G1b/G4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) according to standard of care and in line with the current local label.
|
Genotype 4 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 4 (G4; non-G1), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
|
Missing
Treatment-naïve or -experienced participants with confirmed CHC but no genotype information.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
145
|
278
|
48
|
1
|
|
Overall Study
2 DAA + Ribavirin (RBV)
|
0
|
0
|
45
|
0
|
|
Overall Study
3DAA
|
5
|
261
|
0
|
0
|
|
Overall Study
3DAA + RBV
|
140
|
17
|
2
|
0
|
|
Overall Study
COMPLETED
|
118
|
263
|
40
|
0
|
|
Overall Study
NOT COMPLETED
|
27
|
15
|
8
|
1
|
Reasons for withdrawal
| Measure |
Genotype 1a Participants
Treatment-naïve or -experienced participants with confirmed chronic hepatitis C (CHC) genotype 1a (G1a, includes all GT1- participants except participants with GT1b or GT1b/4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) + ribavirin (RBV) according to standard of care and in line with the current local label.
|
Genotype 1b Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1b (G1b; includes G1b/G4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) according to standard of care and in line with the current local label.
|
Genotype 4 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 4 (G4; non-G1), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
|
Missing
Treatment-naïve or -experienced participants with confirmed CHC but no genotype information.
|
|---|---|---|---|---|
|
Overall Study
Did Not Start Treatment
|
0
|
0
|
1
|
1
|
|
Overall Study
Failure to Return
|
20
|
10
|
7
|
0
|
|
Overall Study
Death
|
2
|
3
|
0
|
0
|
|
Overall Study
Other, Not Specified
|
5
|
2
|
0
|
0
|
Baseline Characteristics
participants with a Baseline assessment
Baseline characteristics by cohort
| Measure |
2 DAA+RBV
n=45 Participants
Two direct-acting antivirals (2DAA): paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) plus RBV
|
3DAA
n=266 Participants
Three direct-acting antivirals (3DAA): paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN)
|
3DAA+RBV
n=159 Participants
3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) plus RBV
|
Total
n=470 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 11.5 • n=45 Participants
|
55 years
STANDARD_DEVIATION 13.6 • n=266 Participants
|
49 years
STANDARD_DEVIATION 11.9 • n=159 Participants
|
52 years
STANDARD_DEVIATION 13.3 • n=470 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=45 Participants
|
124 Participants
n=266 Participants
|
38 Participants
n=159 Participants
|
172 Participants
n=470 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=45 Participants
|
142 Participants
n=266 Participants
|
121 Participants
n=159 Participants
|
298 Participants
n=470 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
41 Participants
n=45 Participants
|
255 Participants
n=266 Participants
|
152 Participants
n=159 Participants
|
448 Participants
n=470 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=45 Participants
|
2 Participants
n=266 Participants
|
1 Participants
n=159 Participants
|
3 Participants
n=470 Participants
|
|
Race/Ethnicity, Customized
Asian/Oriental
|
4 Participants
n=45 Participants
|
3 Participants
n=266 Participants
|
5 Participants
n=159 Participants
|
12 Participants
n=470 Participants
|
|
Race/Ethnicity, Customized
Other, Not Specified
|
0 Participants
n=45 Participants
|
6 Participants
n=266 Participants
|
1 Participants
n=159 Participants
|
7 Participants
n=470 Participants
|
|
Pictorial Representation of Illness and Self-Measure (PRISM) Tool
|
13.1 cm
STANDARD_DEVIATION 9.16 • n=43 Participants • participants with a Baseline assessment
|
12.3 cm
STANDARD_DEVIATION 8.78 • n=263 Participants • participants with a Baseline assessment
|
12.4 cm
STANDARD_DEVIATION 8.89 • n=158 Participants • participants with a Baseline assessment
|
12.4 cm
STANDARD_DEVIATION 8.84 • n=464 Participants • participants with a Baseline assessment
|
|
Chronic Illness Therapy-Fatigue (FACIT-F) Scale
|
70.8 units on a scale
STANDARD_DEVIATION 22.1 • n=42 Participants • participants with a Baseline assessment
|
69.3 units on a scale
STANDARD_DEVIATION 23.1 • n=256 Participants • participants with a Baseline assessment
|
67.4 units on a scale
STANDARD_DEVIATION 23.1 • n=148 Participants • participants with a Baseline assessment
|
68.8 units on a scale
STANDARD_DEVIATION 23.0 • n=446 Participants • participants with a Baseline assessment
|
|
Patient Activation Measure (PAM-13) Questionnaire
|
64.1 units on a scale
STANDARD_DEVIATION 11.8 • n=41 Participants • participants with a Baseline assessment
|
64.3 units on a scale
STANDARD_DEVIATION 10.1 • n=207 Participants • participants with a Baseline assessment
|
63.0 units on a scale
STANDARD_DEVIATION 9.49 • n=139 Participants • participants with a Baseline assessment
|
63.8 units on a scale
STANDARD_DEVIATION 10.1 • n=387 Participants • participants with a Baseline assessment
|
|
Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment
|
14.2 percentage of work productivity impairme
STANDARD_DEVIATION 17.9 • n=22 Participants • participants with a Baseline assessment
|
19.1 percentage of work productivity impairme
STANDARD_DEVIATION 28.0 • n=105 Participants • participants with a Baseline assessment
|
18.1 percentage of work productivity impairme
STANDARD_DEVIATION 23.3 • n=58 Participants • participants with a Baseline assessment
|
18.2 percentage of work productivity impairme
STANDARD_DEVIATION 25.5 • n=185 Participants • participants with a Baseline assessment
|
|
WPAI: Total Activity Impairment
|
23.0 percentage of activity impairment
STANDARD_DEVIATION 25.8 • n=43 Participants • participants with a Baseline assessment
|
25.9 percentage of activity impairment
STANDARD_DEVIATION 27.3 • n=242 Participants • participants with a Baseline assessment
|
28.0 percentage of activity impairment
STANDARD_DEVIATION 28.9 • n=147 Participants • participants with a Baseline assessment
|
26.3 percentage of activity impairment
STANDARD_DEVIATION 27.7 • n=432 Participants • participants with a Baseline assessment
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
All Participants
n=470 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1 or 4, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label
|
All Genotype 1 Participants
n=423 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label.
|
Genotype 1a Participants
n=145 Participants
Treatment-naïve or -experienced participants with confirmed CHC G1a (includes all GT1-participants except participants with GT1b or GT1b/4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
|
Genotype 1b Participants
n=278 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1b (G1b; includes G1b/G4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) according to standard of care and in line with the current local label.
|
Genotype 4 Participants
n=47 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 4 (G4; non-G1), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR12)
|
88.1 percentage of participants
|
88.4 percentage of participants
|
77.9 percentage of participants
|
93.9 percentage of participants
|
85.1 percentage of participants
|
SECONDARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
All Participants
n=470 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1 or 4, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label
|
All Genotype 1 Participants
n=423 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label.
|
Genotype 1a Participants
n=145 Participants
Treatment-naïve or -experienced participants with confirmed CHC G1a (includes all GT1-participants except participants with GT1b or GT1b/4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
|
Genotype 1b Participants
n=278 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1b (G1b; includes G1b/G4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) according to standard of care and in line with the current local label.
|
Genotype 4 Participants
n=47 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 4 (G4; non-G1), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Virological Response at End of Treatment (EoTR)
|
93.4 percentage of participants
|
94.8 percentage of participants
|
89.0 percentage of participants
|
97.8 percentage of participants
|
80.9 percentage of participants
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
All Participants
n=56 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1 or 4, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label
|
All Genotype 1 Participants
n=49 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label.
|
Genotype 1a Participants
n=32 Participants
Treatment-naïve or -experienced participants with confirmed CHC G1a (includes all GT1-participants except participants with GT1b or GT1b/4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
|
Genotype 1b Participants
n=17 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1b (G1b; includes G1b/G4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) according to standard of care and in line with the current local label.
|
Genotype 4 Participants
n=7 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 4 (G4; non-G1), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
|
|---|---|---|---|---|---|
|
Number of Participants With On-Treatment Virological Failure or Relapse
On-Treatment Virological Failure
|
6 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With On-Treatment Virological Failure or Relapse
Relapse
|
5 Participants
|
5 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 4Population: 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).
RVR4 is defined as participants with HCV RNA \< 50 IU/mL at Week 4.
Outcome measures
| Measure |
All Participants
n=470 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1 or 4, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label
|
All Genotype 1 Participants
n=423 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label.
|
Genotype 1a Participants
n=145 Participants
Treatment-naïve or -experienced participants with confirmed CHC G1a (includes all GT1-participants except participants with GT1b or GT1b/4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
|
Genotype 1b Participants
n=278 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1b (G1b; includes G1b/G4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) according to standard of care and in line with the current local label.
|
Genotype 4 Participants
n=47 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 4 (G4; non-G1), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Rapid Virological Response at Week 4 (RVR4)
|
57.0 percentage of participants
|
57.2 percentage of participants
|
62.1 percentage of participants
|
54.7 percentage of participants
|
55.3 percentage of participants
|
SECONDARY outcome
Timeframe: 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.
SVR24 is defined as HCV RNA \< 50 IU/mL 24 Weeks After EoT.
Outcome measures
| Measure |
All Participants
n=362 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1 or 4, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label
|
All Genotype 1 Participants
n=325 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label.
|
Genotype 1a Participants
n=97 Participants
Treatment-naïve or -experienced participants with confirmed CHC G1a (includes all GT1-participants except participants with GT1b or GT1b/4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
|
Genotype 1b Participants
n=228 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1b (G1b; includes G1b/G4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) according to standard of care and in line with the current local label.
|
Genotype 4 Participants
n=37 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 4 (G4; non-G1), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virological Response 24 Weeks After EoT (SVR24)
|
95.0 percentage of participants
|
95.4 percentage of participants
|
92.8 percentage of participants
|
96.5 percentage of participants
|
91.9 percentage of participants
|
SECONDARY outcome
Timeframe: 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.
SVR48 is defined as participants with HCV RNA \< 50 IU/mL 48 weeks after EoT.
Outcome measures
| Measure |
All Participants
n=262 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1 or 4, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label
|
All Genotype 1 Participants
n=237 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label.
|
Genotype 1a Participants
n=73 Participants
Treatment-naïve or -experienced participants with confirmed CHC G1a (includes all GT1-participants except participants with GT1b or GT1b/4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
|
Genotype 1b Participants
n=164 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1b (G1b; includes G1b/G4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) according to standard of care and in line with the current local label.
|
Genotype 4 Participants
n=25 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 4 (G4; non-G1), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virological Response 48 Weeks After EoT (SVR48)
|
92.7 percentage of participants
|
93.2 percentage of participants
|
89.0 percentage of participants
|
95.1 percentage of participants
|
88.0 percentage of participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
All Participants
n=30 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1 or 4, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label
|
All Genotype 1 Participants
n=222 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label.
|
Genotype 1a Participants
n=115 Participants
Treatment-naïve or -experienced participants with confirmed CHC G1a (includes all GT1-participants except participants with GT1b or GT1b/4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
|
Genotype 1b Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1b (G1b; includes G1b/G4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) according to standard of care and in line with the current local label.
|
Genotype 4 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 4 (G4; non-G1), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
|
|---|---|---|---|---|---|
|
Change From Baseline in PRISM Over Time
12 Weeks EoT
|
5.41 cm
Interval 2.67 to 8.15
|
7.05 cm
Interval 6.04 to 8.05
|
5.31 cm
Interval 3.91 to 6.71
|
—
|
—
|
|
Change From Baseline in PRISM Over Time
48 Weeks EoT
|
10.2 cm
Interval 7.16 to 13.2
|
10.1 cm
Interval 8.93 to 11.2
|
10.3 cm
Interval 8.75 to 11.8
|
—
|
—
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
All Participants
n=470 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1 or 4, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label
|
All Genotype 1 Participants
n=423 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label.
|
Genotype 1a Participants
n=145 Participants
Treatment-naïve or -experienced participants with confirmed CHC G1a (includes all GT1-participants except participants with GT1b or GT1b/4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
|
Genotype 1b Participants
n=278 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1b (G1b; includes G1b/G4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) according to standard of care and in line with the current local label.
|
Genotype 4 Participants
n=47 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 4 (G4; non-G1), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
|
|---|---|---|---|---|---|
|
Percentage of Participants With ≥ 1 Comorbidity and/or Co-Infection
|
70.0 percentage of participants
|
69.3 percentage of participants
|
71.0 percentage of participants
|
68.3 percentage of participants
|
76.6 percentage of participants
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
All Participants
n=470 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1 or 4, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label
|
All Genotype 1 Participants
n=45 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label.
|
Genotype 1a Participants
n=266 Participants
Treatment-naïve or -experienced participants with confirmed CHC G1a (includes all GT1-participants except participants with GT1b or GT1b/4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
|
Genotype 1b Participants
n=159 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1b (G1b; includes G1b/G4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) according to standard of care and in line with the current local label.
|
Genotype 4 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 4 (G4; non-G1), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
|
|---|---|---|---|---|---|
|
Percentage of Participants Taking ≥ 1 Co-Medication
|
59.1 percentage of participants
|
64.4 percentage of participants
|
54.1 percentage of participants
|
66.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Up to Week 12 or Week 24Population: 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.
Documented by participant interview and/or participant diary.
Outcome measures
| Measure |
All Participants
n=468 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1 or 4, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label
|
All Genotype 1 Participants
n=45 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label.
|
Genotype 1a Participants
n=265 Participants
Treatment-naïve or -experienced participants with confirmed CHC G1a (includes all GT1-participants except participants with GT1b or GT1b/4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
|
Genotype 1b Participants
n=158 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1b (G1b; includes G1b/G4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) according to standard of care and in line with the current local label.
|
Genotype 4 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 4 (G4; non-G1), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
|
|---|---|---|---|---|---|
|
Mean Duration of of ABBVIE REGIMEN and RBV Taken
ABBVIE REGIMEN
|
83 days
Standard Deviation 11.7
|
84 days
Standard Deviation 3.4
|
83 days
Standard Deviation 9.7
|
84 days
Standard Deviation 15.6
|
—
|
|
Mean Duration of of ABBVIE REGIMEN and RBV Taken
RBV
|
81 days
Standard Deviation 18.1
|
84 days
Standard Deviation 3.4
|
—
|
81 days
Standard Deviation 20.5
|
—
|
SECONDARY outcome
Timeframe: Up to Week 12 or Week 24Population: 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.
Planned duration of treatment was 12 or 24 weeks.
Outcome measures
| Measure |
All Participants
n=468 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1 or 4, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label
|
All Genotype 1 Participants
n=421 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label.
|
Genotype 1a Participants
n=144 Participants
Treatment-naïve or -experienced participants with confirmed CHC G1a (includes all GT1-participants except participants with GT1b or GT1b/4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
|
Genotype 1b Participants
n=277 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1b (G1b; includes G1b/G4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) according to standard of care and in line with the current local label.
|
Genotype 4 Participants
n=47 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 4 (G4; non-G1), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
|
|---|---|---|---|---|---|
|
Percentage of Planned Duration of ABBVIE REGIMEN and RBV Taken
ABBVIE REGIMEN
|
98.7 percentage of planned treatment duration
Standard Deviation 9.74
|
98.6 percentage of planned treatment duration
Standard Deviation 10.18
|
97.7 percentage of planned treatment duration
Standard Deviation 12.94
|
99.1 percentage of planned treatment duration
Standard Deviation 8.39
|
99.8 percentage of planned treatment duration
Standard Deviation 3.91
|
|
Percentage of Planned Duration of ABBVIE REGIMEN and RBV Taken
RBV
|
95.4 percentage of planned treatment duration
Standard Deviation 17.55
|
94.1 percentage of planned treatment duration
Standard Deviation 19.72
|
95.3 percentage of planned treatment duration
Standard Deviation 17.68
|
83.5 percentage of planned treatment duration
Standard Deviation 30.68
|
99.8 percentage of planned treatment duration
Standard Deviation 3.91
|
SECONDARY outcome
Timeframe: Baseline, EoT (treatment period was 12 or 24 weeks), 12 and 48 weeks after EoTPopulation: 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.
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.
Outcome measures
| Measure |
All Participants
n=29 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1 or 4, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label
|
All Genotype 1 Participants
n=213 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label.
|
Genotype 1a Participants
n=112 Participants
Treatment-naïve or -experienced participants with confirmed CHC G1a (includes all GT1-participants except participants with GT1b or GT1b/4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
|
Genotype 1b Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1b (G1b; includes G1b/G4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) according to standard of care and in line with the current local label.
|
Genotype 4 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 4 (G4; non-G1), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
|
|---|---|---|---|---|---|
|
Change From Baseline in FACIT-F Scale Over Time
EoT
|
4.17 score on a scale
Interval -2.35 to 10.7
|
6.45 score on a scale
Interval 4.05 to 8.86
|
4.49 score on a scale
Interval 1.17 to 7.81
|
—
|
—
|
|
Change From Baseline in FACIT-F Scale Over Time
12 Weeks EoT
|
12.5 score on a scale
Interval 6.78 to 18.3
|
9.92 score on a scale
Interval 7.87 to 12.0
|
10.2 score on a scale
Interval 7.37 to 13.0
|
—
|
—
|
|
Change From Baseline in FACIT-F Scale Over Time
48 Weeks EoT
|
13.3 score on a scale
Interval 4.71 to 22.0
|
9.68 score on a scale
Interval 6.87 to 12.5
|
10.3 score on a scale
Interval 6.37 to 14.3
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
All Participants
n=23 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1 or 4, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label
|
All Genotype 1 Participants
n=150 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label.
|
Genotype 1a Participants
n=93 Participants
Treatment-naïve or -experienced participants with confirmed CHC G1a (includes all GT1-participants except participants with GT1b or GT1b/4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
|
Genotype 1b Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1b (G1b; includes G1b/G4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) according to standard of care and in line with the current local label.
|
Genotype 4 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 4 (G4; non-G1), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
|
|---|---|---|---|---|---|
|
Change From Baseline to EoT in PAM-13 Questionnaire
|
1.91 score on a scale
Interval -1.52 to 5.33
|
0.01 score on a scale
Interval -1.33 to 1.36
|
-0.74 score on a scale
Interval -2.45 to 0.96
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, EoT (treatment period was 12 or 24 weeks),12 and 24 weeks after EoTPopulation: 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.
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.
Outcome measures
| Measure |
All Participants
n=185 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1 or 4, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label
|
All Genotype 1 Participants
n=22 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label.
|
Genotype 1a Participants
n=105 Participants
Treatment-naïve or -experienced participants with confirmed CHC G1a (includes all GT1-participants except participants with GT1b or GT1b/4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
|
Genotype 1b Participants
n=58 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1b (G1b; includes G1b/G4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) according to standard of care and in line with the current local label.
|
Genotype 4 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 4 (G4; non-G1), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
|
|---|---|---|---|---|---|
|
Change From Baseline Over Time in WPAI: Total Work Productivity Impairment
EoT
|
5.5 percentage of overall work impairment
Standard Deviation 31.4
|
5.0 percentage of overall work impairment
Standard Deviation 36.4
|
4.4 percentage of overall work impairment
Standard Deviation 27.1
|
7.5 percentage of overall work impairment
Standard Deviation 36.3
|
—
|
|
Change From Baseline Over Time in WPAI: Total Work Productivity Impairment
12 Weeks EoT
|
-4.3 percentage of overall work impairment
Standard Deviation 23.4
|
-4.2 percentage of overall work impairment
Standard Deviation 11.9
|
-3.8 percentage of overall work impairment
Standard Deviation 21.5
|
-5.4 percentage of overall work impairment
Standard Deviation 29.6
|
—
|
|
Change From Baseline Over Time in WPAI: Total Work Productivity Impairment
24 Weeks EoT
|
-7.4 percentage of overall work impairment
Standard Deviation 22.1
|
-3.2 percentage of overall work impairment
Standard Deviation 33.6
|
-7.2 percentage of overall work impairment
Standard Deviation 22.1
|
-9.7 percentage of overall work impairment
Standard Deviation 15.6
|
—
|
SECONDARY outcome
Timeframe: Baseline, EoT (treatment period was 12 or 24 weeks),12 and 24 weeks after EoTPopulation: 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.
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.
Outcome measures
| Measure |
All Participants
n=432 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1 or 4, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label
|
All Genotype 1 Participants
n=43 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label.
|
Genotype 1a Participants
n=242 Participants
Treatment-naïve or -experienced participants with confirmed CHC G1a (includes all GT1-participants except participants with GT1b or GT1b/4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
|
Genotype 1b Participants
n=147 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1b (G1b; includes G1b/G4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) according to standard of care and in line with the current local label.
|
Genotype 4 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 4 (G4; non-G1), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
|
|---|---|---|---|---|---|
|
Change From Baseline Over Time in WPAI: Total Activity Impairment
EoT
|
-2.1 percentage impairment of activity
Standard Deviation 30.9
|
7.0 percentage impairment of activity
Standard Deviation 25.2
|
-3.0 percentage impairment of activity
Standard Deviation 28.9
|
-2.8 percentage impairment of activity
Standard Deviation 35.5
|
—
|
|
Change From Baseline Over Time in WPAI: Total Activity Impairment
12 Weeks EoT
|
-11.9 percentage impairment of activity
Standard Deviation 27.0
|
-7.7 percentage impairment of activity
Standard Deviation 22.0
|
-13.3 percentage impairment of activity
Standard Deviation 24.8
|
-10.5 percentage impairment of activity
Standard Deviation 31.6
|
—
|
|
Change From Baseline Over Time in WPAI: Total Activity Impairment
24 Weeks EoT
|
-13.4 percentage impairment of activity
Standard Deviation 25.9
|
-11.3 percentage impairment of activity
Standard Deviation 22.8
|
-12.3 percentage impairment of activity
Standard Deviation 24.0
|
-16.3 percentage impairment of activity
Standard Deviation 30.3
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
All Participants
n=470 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1 or 4, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label
|
All Genotype 1 Participants
n=45 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and in line with the current local label.
|
Genotype 1a Participants
n=266 Participants
Treatment-naïve or -experienced participants with confirmed CHC G1a (includes all GT1-participants except participants with GT1b or GT1b/4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
|
Genotype 1b Participants
n=159 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 1b (G1b; includes G1b/G4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) according to standard of care and in line with the current local label.
|
Genotype 4 Participants
Treatment-naïve or -experienced participants with confirmed CHC genotype 4 (G4; non-G1), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies
≥ 1 TEAE
|
124 Participants
|
16 Participants
|
65 Participants
|
43 Participants
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies
≥ 1 Serious TEAE
|
13 Participants
|
1 Participants
|
7 Participants
|
5 Participants
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies
Pregnancy
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
Adverse Events
2 DAA+RBV
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
3DAA
Serious events: 7 serious events
Other events: 33 other events
Deaths: 4 deaths
3DAA+RBV
Serious events: 5 serious events
Other events: 23 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
2 DAA+RBV
n=45 participants at risk
2DAA: paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) plus RBV
|
3DAA
n=266 participants at risk
3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN)
|
3DAA+RBV
n=159 participants at risk
3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) plus RBV
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/45 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
0.00%
0/266 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
1.3%
2/159 • Number of events 2 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
|
Gastrointestinal disorders
GASTRIC PERFORATION
|
0.00%
0/45 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
0.38%
1/266 • Number of events 1 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
0.00%
0/159 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
|
General disorders
DEATH
|
0.00%
0/45 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
0.38%
1/266 • Number of events 1 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
0.00%
0/159 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
|
Hepatobiliary disorders
HEPATIC CIRRHOSIS
|
0.00%
0/45 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
0.38%
1/266 • Number of events 1 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
0.00%
0/159 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
|
Infections and infestations
OROPHARYNGEAL CANDIDIASIS
|
0.00%
0/45 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
0.38%
1/266 • Number of events 1 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
0.00%
0/159 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/45 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
0.38%
1/266 • Number of events 1 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
0.00%
0/159 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
|
Investigations
BLOOD POTASSIUM DECREASED
|
0.00%
0/45 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
0.38%
1/266 • Number of events 1 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
0.00%
0/159 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
|
Musculoskeletal and connective tissue disorders
PSEUDARTHROSIS
|
0.00%
0/45 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
0.00%
0/266 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
0.63%
1/159 • Number of events 1 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/45 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
0.38%
1/266 • Number of events 1 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
0.00%
0/159 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/45 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
0.00%
0/266 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
0.63%
1/159 • Number of events 1 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.00%
0/45 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
0.00%
0/266 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
0.63%
1/159 • Number of events 1 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
|
Injury, poisoning and procedural complications
TOXICITY TO VARIOUS AGENTS
|
2.2%
1/45 • Number of events 1 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
0.00%
0/266 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
0.00%
0/159 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
Other adverse events
| Measure |
2 DAA+RBV
n=45 participants at risk
2DAA: paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) plus RBV
|
3DAA
n=266 participants at risk
3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN)
|
3DAA+RBV
n=159 participants at risk
3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) plus RBV
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
4.4%
2/45 • Number of events 2 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
0.00%
0/266 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
5.0%
8/159 • Number of events 8 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
|
General disorders
FATIGUE
|
4.4%
2/45 • Number of events 2 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
7.9%
21/266 • Number of events 21 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
5.7%
9/159 • Number of events 9 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/45 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
5.6%
15/266 • Number of events 15 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
2.5%
4/159 • Number of events 4 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
|
Skin and subcutaneous tissue disorders
RASH
|
8.9%
4/45 • Number of events 4 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
0.75%
2/266 • Number of events 2 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
2.5%
4/159 • Number of events 4 • up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Treatment-emergent AEs are presented. Treatment-emergent AEs are defined as any reported AE that begins or worsens in severity after initiation of study drug through 30 days after last study drug intake. Treatment duration was not a factor for assignment to reporting groups.
|
Additional Information
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