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)
Sponsor
AbbVie (Industry)
Overall Status
Completed
CT.gov ID
NCT02615145
Collaborator
(none)
472
27.7
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
472 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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)
Actual Study Start Date
:
Dec 3, 2015
Actual Primary Completion Date
:
Mar 26, 2018
Actual Study Completion Date
:
Mar 26, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Genotype 1a (G1a) 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. The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice and label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study. |
|
| Genotype 1b (G1b) Participants Treatment-naïve or -experienced participants with confirmed CHC genotype 1b (G1b; includes G1b/Genotype 4 [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. The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice and label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study. |
|
| Genotype 4 (G4) 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. The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice and label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study. |
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
- Number of Participants With On-Treatment Virological Failure or Relapse [Up to post-treatment Week 12 (treatment period was 12 or 24 weeks)]
The number of participants meeting the following SVR12 non-response categories: 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) 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 4]
RVR4 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 Time [Baseline, 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-Infection [up to post-treatment Week 48 (treatment period was 12 or 24 weeks)]
- Percentage of Participants Taking ≥ 1 Co-Medication [up to post-treatment Week 48 (treatment period was 12 or 24 weeks)]
- Mean Duration of of ABBVIE REGIMEN and RBV Taken [Up to Week 12 or Week 24]
Documented by participant interview and/or participant diary.
- Percentage of Planned Duration of ABBVIE REGIMEN and RBV Taken [Up to Week 12 or Week 24]
Planned duration of treatment was 12 or 24 weeks.
- Change From Baseline in FACIT-F Scale Over Time [Baseline, EoT (treatment period was 12 or 24 weeks), 12 and 48 weeks after EoT]
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.
- Change From Baseline to EoT in PAM-13 Questionnaire [Baseline, 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 Impairment [Baseline, EoT (treatment period was 12 or 24 weeks),12 and 24 weeks after EoT]
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.
- Change From Baseline Over Time in WPAI: Total Activity Impairment [Baseline, EoT (treatment period was 12 or 24 weeks),12 and 24 weeks after EoT]
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.
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies [up 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 99 Years
Sexes Eligible for Study:
All
Accepts 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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- AbbVie
Investigators
- Study Director: AbbVie Inc., AbbVie
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
AbbVie
ClinicalTrials.gov Identifier:
NCT02615145
Other Study ID Numbers:
- P15-398
First Posted:
Nov 26, 2015
Last Update Posted:
Oct 7, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by AbbVie
Additional relevant MeSH terms:
Study Results
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 Detail | 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. |
| Arm/Group Title | Genotype 1a Participants | Genotype 1b Participants | Genotype 4 Participants | Missing |
|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | Treatment-naïve or -experienced participants with confirmed CHC but no genotype information. |
| Period Title: Overall Study | ||||
| STARTED | 145 | 278 | 48 | 1 |
| 2 DAA + Ribavirin (RBV) | 0 | 0 | 45 | 0 |
| 3DAA | 5 | 261 | 0 | 0 |
| 3DAA + RBV | 140 | 17 | 2 | 0 |
| COMPLETED | 118 | 263 | 40 | 0 |
| NOT COMPLETED | 27 | 15 | 8 | 1 |
Baseline Characteristics
| Arm/Group Title | 2 DAA+RBV | 3DAA | 3DAA+RBV | Total |
|---|---|---|---|---|
| Arm/Group Description | Two direct-acting antivirals (2DAA): paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) plus RBV | Three direct-acting antivirals (3DAA): paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) | 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) plus RBV | Total of all reporting groups |
| Overall Participants | 45 | 266 | 159 | 470 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
47
(11.5)
|
55
(13.6)
|
49
(11.9)
|
52
(13.3)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
10
22.2%
|
124
46.6%
|
38
23.9%
|
172
36.6%
|
| Male |
35
77.8%
|
142
53.4%
|
121
76.1%
|
298
63.4%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||
| White/Caucasian |
41
91.1%
|
255
95.9%
|
152
95.6%
|
448
95.3%
|
| Black |
0
0%
|
2
0.8%
|
1
0.6%
|
3
0.6%
|
| Asian/Oriental |
4
8.9%
|
3
1.1%
|
5
3.1%
|
12
2.6%
|
| Other, Not Specified |
0
0%
|
6
2.3%
|
1
0.6%
|
7
1.5%
|
| Pictorial Representation of Illness and Self-Measure (PRISM) Tool (cm) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [cm] |
13.1
(9.16)
|
12.3
(8.78)
|
12.4
(8.89)
|
12.4
(8.84)
|
| Chronic Illness Therapy-Fatigue (FACIT-F) Scale (units on a scale) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [units on a scale] |
70.8
(22.1)
|
69.3
(23.1)
|
67.4
(23.1)
|
68.8
(23.0)
|
| Patient Activation Measure (PAM-13) Questionnaire (units on a scale) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [units on a scale] |
64.1
(11.8)
|
64.3
(10.1)
|
63.0
(9.49)
|
63.8
(10.1)
|
| Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (percentage of work productivity impairme) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [percentage of work productivity impairme] |
14.2
(17.9)
|
19.1
(28.0)
|
18.1
(23.3)
|
18.2
(25.5)
|
| WPAI: Total Activity Impairment (percentage of activity impairment) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [percentage of activity impairment] |
23.0
(25.8)
|
25.9
(27.3)
|
28.0
(28.9)
|
26.3
(27.7)
|
Outcome Measures
| Title | Percentage of Participants With Sustained Virologic Response (SVR12) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | All Participants | All Genotype 1 Participants | Genotype 1a Participants | Genotype 1b Participants | Genotype 4 Participants |
|---|---|---|---|---|---|
| Arm/Group Description | 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 | 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. | 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. | 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. | 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. |
| Measure Participants | 470 | 423 | 145 | 278 | 47 |
| Number [percentage of participants] |
88.1
195.8%
|
88.4
33.2%
|
77.9
49%
|
93.9
20%
|
85.1
NaN
|
| Title | Percentage of Participants With Virological Response at End of Treatment (EoTR) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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). |
| Arm/Group Title | All Participants | All Genotype 1 Participants | Genotype 1a Participants | Genotype 1b Participants | Genotype 4 Participants |
|---|---|---|---|---|---|
| Arm/Group Description | 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 | 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. | 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. | 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. | 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. |
| Measure Participants | 470 | 423 | 145 | 278 | 47 |
| Number [percentage of participants] |
93.4
207.6%
|
94.8
35.6%
|
89.0
56%
|
97.8
20.8%
|
80.9
NaN
|
| Title | Number of Participants With On-Treatment Virological Failure or Relapse |
|---|---|
| Description | The number of participants meeting the following SVR12 non-response categories: 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) 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | All Participants | All Genotype 1 Participants | Genotype 1a Participants | Genotype 1b Participants | Genotype 4 Participants |
|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 56 | 49 | 32 | 17 | 7 |
| On-Treatment Virological Failure |
6
13.3%
|
3
1.1%
|
3
1.9%
|
0
0%
|
3
NaN
|
| Relapse |
5
11.1%
|
5
1.9%
|
1
0.6%
|
4
0.9%
|
0
NaN
|
| Title | Percentage of Participants With Rapid Virological Response at Week 4 (RVR4) |
|---|---|
| Description | RVR4 is defined as participants with HCV RNA < 50 IU/mL at Week 4. |
| Time Frame | Week 4 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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). |
| Arm/Group Title | All Participants | All Genotype 1 Participants | Genotype 1a Participants | Genotype 1b Participants | Genotype 4 Participants |
|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 470 | 423 | 145 | 278 | 47 |
| Number [percentage of participants] |
57.0
126.7%
|
57.2
21.5%
|
62.1
39.1%
|
54.7
11.6%
|
55.3
NaN
|
| Title | Percentage of Participants With Sustained Virological Response 24 Weeks After EoT (SVR24) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | All Participants | All Genotype 1 Participants | Genotype 1a Participants | Genotype 1b Participants | Genotype 4 Participants |
|---|---|---|---|---|---|
| Arm/Group Description | 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 | 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. | 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. | 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. | 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. |
| Measure Participants | 362 | 325 | 97 | 228 | 37 |
| Number [percentage of participants] |
95.0
211.1%
|
95.4
35.9%
|
92.8
58.4%
|
96.5
20.5%
|
91.9
NaN
|
| Title | Percentage of Participants With Sustained Virological Response 48 Weeks After EoT (SVR48) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | All Participants | Genotype 1 Participants | Genotype 1a Participants | Genotype 1b Participants | Genotype 4 Participants |
|---|---|---|---|---|---|
| Arm/Group Description | Treatment-naïve or -experienced participants with confirmed chronic hepatitis C (CHC), genotype 1 or 4, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) according to standard of care and in line with the current local label | 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. | 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. | 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. | 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. |
| Measure Participants | 262 | 237 | 73 | 164 | 25 |
| Number [percentage of participants] |
92.7
206%
|
93.2
35%
|
89.0
56%
|
95.1
20.2%
|
88.0
NaN
|
| Title | Change From Baseline in PRISM Over Time |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | 2 DAA+RBV | 3DAA | 3DAA+RBV |
|---|---|---|---|
| Arm/Group Description | 2DAA: paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) plus RBV | 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) | 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) + RBV |
| Measure Participants | 30 | 222 | 115 |
| 12 Weeks EoT |
5.41
|
7.05
|
5.31
|
| 48 Weeks EoT |
10.2
|
10.1
|
10.3
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | All Participants, All Genotype 1 Participants, Genotype 1a Participants |
|---|---|---|
| Comments | Week 12 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1110 |
| Comments | Between group change comparison: overall. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline. | |
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | All Participants, All Genotype 1 Participants |
|---|---|---|
| Comments | Week 12 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2704 |
| Comments | Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | difference in LS means |
| Estimated Value | 1.64 | |
| Confidence Interval |
(2-Sided) 95% -1.28 to 4.56 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | All Participants, Genotype 1a Participants |
|---|---|---|
| Comments | Week 12 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9516 |
| Comments | Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | difference in LS means |
| Estimated Value | -0.09 | |
| Confidence Interval |
(2-Sided) 95% -3.17 to 2.98 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | All Genotype 1 Participants, Genotype 1a Participants |
|---|---|---|
| Comments | Week 12 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0489 |
| Comments | Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | difference in LS means |
| Estimated Value | -1.73 | |
| Confidence Interval |
(2-Sided) 95% -3.46 to -0.01 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | All Participants, All Genotype 1 Participants, Genotype 1a Participants |
|---|---|---|
| Comments | Week 48 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9785 |
| Comments | Between group change comparison: overall. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline. | |
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | All Participants, All Genotype 1 Participants |
|---|---|---|
| Comments | Week 48 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9379 |
| Comments | Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | difference in LS means |
| Estimated Value | -0.13 | |
| Confidence Interval |
(2-Sided) 95% -3.37 to 3.11 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | All Participants, Genotype 1a Participants |
|---|---|---|
| Comments | Week 48 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9678 |
| Comments | Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | difference in LS means |
| Estimated Value | 0.07 | |
| Confidence Interval |
(2-Sided) 95% -3.33 to 3.47 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | All Genotype 1 Participants, Genotype 1a Participants |
|---|---|---|
| Comments | Week 48 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8373 |
| Comments | Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | difference in LS means |
| Estimated Value | 0.20 | |
| Confidence Interval |
(2-Sided) 95% -1.70 to 2.10 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | All Participants, All Genotype 1 Participants, Genotype 1a Participants |
|---|---|---|
| Comments | Week 12 vs Baseline across all participants | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.0001 |
| Comments | ||
| Method | paired t-test | |
| Comments | paired t-test of whether difference in means is 0 | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 6.37 | |
| Confidence Interval |
(2-Sided) 95% 5.417 to 7.320 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | All Participants, All Genotype 1 Participants, Genotype 1a Participants |
|---|---|---|
| Comments | Week 48 vs Baseline across all participants | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.0001 |
| Comments | ||
| Method | paired t-test | |
| Comments | paired t-test of whether difference in means is 0 | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 10.15 | |
| Confidence Interval |
(2-Sided) 95% 8.936 to 11.362 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Participants With ≥ 1 Comorbidity and/or Co-Infection |
|---|---|
| Description | |
| Time Frame | up to post-treatment Week 48 (treatment period was 12 or 24 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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). |
| Arm/Group Title | All Participants | Genotype 1 Participants | Genotype 1a Participants | Genotype 1b Participants | Genotype 4 Participants |
|---|---|---|---|---|---|
| Arm/Group Description | Treatment-naïve or -experienced participants with confirmed chronic hepatitis C (CHC), genotype 1 or 4, receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) according to standard of care and in line with the current local label. | 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. | 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. | 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. | 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. |
| Measure Participants | 470 | 423 | 145 | 278 | 47 |
| Number [percentage of participants] |
70.0
155.6%
|
69.3
26.1%
|
71.0
44.7%
|
68.3
14.5%
|
76.6
NaN
|
| Title | Percentage of Participants Taking ≥ 1 Co-Medication |
|---|---|
| Description | |
| Time Frame | up to post-treatment Week 48 (treatment period was 12 or 24 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population: all enrolled participants who received at least one dose of the ABBVIE REGIMEN (the prescribed ABBVIE REGIMEN was known). |
| Arm/Group Title | Total | 2 DAA+RBV | 3DAA | 3DAA+RBV |
|---|---|---|---|---|
| Arm/Group Description | 2DAA: paritaprevir/ritonavir - ombitasvir [ABBVIE REGIMEN]) plus RBV 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir [ABBVIE REGIMEN]) 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) plus RBV | 2DAA: paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) plus RBV | 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) | 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) plus RBV |
| Measure Participants | 470 | 45 | 266 | 159 |
| Number [percentage of participants] |
59.1
131.3%
|
64.4
24.2%
|
54.1
34%
|
66.0
14%
|
| Title | Mean Duration of of ABBVIE REGIMEN and RBV Taken |
|---|---|
| Description | Documented by participant interview and/or participant diary. |
| Time Frame | Up to Week 12 or Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Total | 2 DAA+RBV | 3DAA | 3DAA+RBV |
|---|---|---|---|---|
| Arm/Group Description | 2DAA: paritaprevir/ritonavir - ombitasvir [ABBVIE REGIMEN]) plus RBV 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir [ABBVIE REGIMEN]) 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) plus RBV | 2DAA: paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) plus RBV | 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) | 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) plus RBV |
| Measure Participants | 468 | 45 | 265 | 158 |
| ABBVIE REGIMEN |
83
(11.7)
|
84
(3.4)
|
83
(9.7)
|
84
(15.6)
|
| RBV |
81
(18.1)
|
84
(3.4)
|
81
(20.5)
|
| Title | Percentage of Planned Duration of ABBVIE REGIMEN and RBV Taken |
|---|---|
| Description | Planned duration of treatment was 12 or 24 weeks. |
| Time Frame | Up to Week 12 or Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | All Participants | All Genotype 1 Participants | Genotype 1a Participants | Genotype 1b Participants | Genotype 4 Participants |
|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 468 | 421 | 144 | 277 | 47 |
| ABBVIE REGIMEN |
98.7
(9.74)
|
98.6
(10.18)
|
97.7
(12.94)
|
99.1
(8.39)
|
99.8
(3.91)
|
| RBV |
95.4
(17.55)
|
94.1
(19.72)
|
95.3
(17.68)
|
83.5
(30.68)
|
99.8
(3.91)
|
| Title | Change From Baseline in FACIT-F Scale Over Time |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | 2 DAA+RBV | 3DAA | 3DAA+RBV |
|---|---|---|---|
| Arm/Group Description | 2DAA: paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) plus RBV | 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) | 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) plus RBV |
| Measure Participants | 29 | 213 | 112 |
| EoT |
4.17
|
6.45
|
4.49
|
| 12 Weeks EoT |
12.5
|
9.92
|
10.2
|
| 48 Weeks EoT |
13.3
|
9.68
|
10.3
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | All Participants, All Genotype 1 Participants, Genotype 1a Participants |
|---|---|---|
| Comments | EOT | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5751 |
| Comments | Between group change comparison: overall. The dependent variable in the change of FACIT-F [0-100] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline. | |
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | All Participants, All Genotype 1 Participants |
|---|---|---|
| Comments | EoT | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5176 |
| Comments | Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable in the change of FACIT-F [0-100] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | difference in LS means |
| Estimated Value | 2.29 | |
| Confidence Interval |
(2-Sided) 95% -4.66 to 9.23 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | All Participants, Genotype 1a Participants |
|---|---|---|
| Comments | EoT | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9308 |
| Comments | Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable in the change of FACIT-F [0-100] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | difference in LS means |
| Estimated Value | 0.324 | |
| Confidence Interval |
(2-Sided) 95% -7.00 to 7.64 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | All Genotype 1 Participants, Genotype 1a Participants |
|---|---|---|
| Comments | EoT | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3462 |
| Comments | Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable in the change of FACIT-F [0-100] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | difference in LS means |
| Estimated Value | -1.96 | |
| Confidence Interval |
(2-Sided) 95% -6.06 to 2.13 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | All Participants, All Genotype 1 Participants, Genotype 1a Participants |
|---|---|---|
| Comments | 12 Weeks after EoT | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7016 |
| Comments | Between group change comparison: overall. The dependent variable in the change of FACIT-F [0-100] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline. | |
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | All Participants, All Genotype 1 Participants |
|---|---|---|
| Comments | 12 weeks after EoT | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4002 |
| Comments | Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable in the change of FACIT-F [0-100] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | difference in LS means |
| Estimated Value | -2.61 | |
| Confidence Interval |
(2-Sided) 95% -8.71 to 3.49 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | All Participants, Genotype 1a Participants |
|---|---|---|
| Comments | 12 weeks after EoT | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4750 |
| Comments | Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable in the change of FACIT-F [0-100] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | difference in LS means |
| Estimated Value | -2.33 | |
| Confidence Interval |
(2-Sided) 95% -8.74 to 4.08 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | All Genotype 1 Participants, Genotype 1a Participants |
|---|---|---|
| Comments | 12 weeks after EoT | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8740 |
| Comments | Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable in the change of FACIT-F [0-100] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | difference in LS means |
| Estimated Value | 0.282 | |
| Confidence Interval |
(2-Sided) 95% -3.21 to 3.77 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | All Participants, All Genotype 1 Participants, Genotype 1a Participants |
|---|---|---|
| Comments | 48 weeks after EoT | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7211 |
| Comments | Between group change comparison: overall. The dependent variable in the change of FACIT-F [0-100] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline. | |
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | All Participants, All Genotype 1 Participants |
|---|---|---|
| Comments | 48 weeks after EoT | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4256 |
| Comments | Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable in the change of FACIT-F [0-100] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | difference in LS means |
| Estimated Value | -3.67 | |
| Confidence Interval |
(2-Sided) 95% -12.7 to 5.39 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | All Participants, Genotype 1a Participants |
|---|---|---|
| Comments | 48 weeks after EoT | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5347 |
| Comments | Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable in the change of FACIT-F [0-100] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | difference in LS means |
| Estimated Value | -3.01 | |
| Confidence Interval |
(2-Sided) 95% -12.6 to 6.54 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | All Genotype 1 Participants, Genotype 1a Participants |
|---|---|---|
| Comments | 48 weeks after EoT | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7920 |
| Comments | Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable in the change of FACIT-F [0-100] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | difference in LS means |
| Estimated Value | 0.654 | |
| Confidence Interval |
(2-Sided) 95% -4.23 to 5.54 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | All Participants, All Genotype 1 Participants, Genotype 1a Participants |
|---|---|---|
| Comments | Baseline to EOT across all participants | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.0001 |
| Comments | ||
| Method | paired t-test | |
| Comments | paired t-test of mean difference from 0 | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 5.64 | |
| Confidence Interval |
(2-Sided) 95% 3.355 to 7.935 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | All Participants, All Genotype 1 Participants, Genotype 1a Participants |
|---|---|---|
| Comments | Baseline vs 12 weeks after EOT across all participants | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.0001 |
| Comments | ||
| Method | paired t-test | |
| Comments | paired t-test of mean difference versus 0 | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 10.21 | |
| Confidence Interval |
(2-Sided) 95% 8.113 to 12.299 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | All Participants, All Genotype 1 Participants, Genotype 1a Participants |
|---|---|---|
| Comments | baseline vs 48 weeks after EOT across all participants | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.0001 |
| Comments | ||
| Method | paired t-test | |
| Comments | paired t-test of mean difference versus 0 | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 10.13 | |
| Confidence Interval |
(2-Sided) 95% 7.259 to 12.992 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline to EoT in PAM-13 Questionnaire |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | 2 DAA+RBV | 3DAA | 3DAA+RBV |
|---|---|---|---|
| Arm/Group Description | 2DAA: paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) plus RBV | 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) | 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) plus RBV |
| Measure Participants | 23 | 150 | 93 |
| Least Squares Mean (95% Confidence Interval) [score on a scale] |
1.91
|
0.01
|
-0.74
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | All Participants, All Genotype 1 Participants, Genotype 1a Participants |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3869 |
| Comments | Between group change comparison: overall. The dependent variable in the change of PAM-13 from Baseline (Visit-Baseline). The analysis is adjusted for Baseline. | |
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | All Participants, All Genotype 1 Participants |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3125 |
| Comments | Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable in the change of PAM-13 from Baseline (Visit-Baseline). The analysis is adjusted for Baseline. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | difference in LS means |
| Estimated Value | -1.89 | |
| Confidence Interval |
(2-Sided) 95% -5.57 to 1.79 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | All Participants, Genotype 1a Participants |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1741 |
| Comments | Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable in the change of PAM-13 from Baseline (Visit-Baseline). The analysis is adjusted for Baseline. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | difference in LS means |
| Estimated Value | -2.65 | |
| Confidence Interval |
(2-Sided) 95% -6.48 to 1.18 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | All Genotype 1 Participants, Genotype 1a Participants |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4941 |
| Comments | Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable in the change of PAM-13 from Baseline (Visit-Baseline). The analysis is adjusted for Baseline. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | difference in LS means |
| Estimated Value | -0.76 | |
| Confidence Interval |
(2-Sided) 95% -2.94 to 1.42 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | All Participants, All Genotype 1 Participants, Genotype 1a Participants |
|---|---|---|
| Comments | Change from Baseline to Final visit across all participants | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8842 |
| Comments | ||
| Method | paired t-test | |
| Comments | paired t-test of mean difference vs 0 | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.09 | |
| Confidence Interval |
(2-Sided) 95% -1.271 to 1.096 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline Over Time in WPAI: Total Work Productivity Impairment |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Total | 2 DAA+RBV | 3DAA | 3DAA+RBV |
|---|---|---|---|---|
| Arm/Group Description | 2DAA: paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) plus RBV or 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir [ABBVIE REGIMEN]) or 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) + RBV | 2DAA: paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) plus RBV | 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) | 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) plus RBV |
| Measure Participants | 185 | 22 | 105 | 58 |
| EoT |
5.5
(31.4)
|
5.0
(36.4)
|
4.4
(27.1)
|
7.5
(36.3)
|
| 12 Weeks EoT |
-4.3
(23.4)
|
-4.2
(11.9)
|
-3.8
(21.5)
|
-5.4
(29.6)
|
| 24 Weeks EoT |
-7.4
(22.1)
|
-3.2
(33.6)
|
-7.2
(22.1)
|
-9.7
(15.6)
|
| Title | Change From Baseline Over Time in WPAI: Total Activity Impairment |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Total | 2 DAA+RBV | 3DAA | 3DAA+RBV |
|---|---|---|---|---|
| Arm/Group Description | 2DAA: paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) plus RBV or 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir [ABBVIE REGIMEN]) or 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) + RBV | 2DAA: paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) plus RBV | 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) | 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) plus RBV |
| Measure Participants | 432 | 43 | 242 | 147 |
| EoT |
-2.1
(30.9)
|
7.0
(25.2)
|
-3.0
(28.9)
|
-2.8
(35.5)
|
| 12 Weeks EoT |
-11.9
(27.0)
|
-7.7
(22.0)
|
-13.3
(24.8)
|
-10.5
(31.6)
|
| 24 Weeks EoT |
-13.4
(25.9)
|
-11.3
(22.8)
|
-12.3
(24.0)
|
-16.3
(30.3)
|
| Title | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Total | 2 DAA+RBV | 3DAA | 3DAA+RBV |
|---|---|---|---|---|
| Arm/Group Description | 2DAA: paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) plus RBV or 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir [ABBVIE REGIMEN]) or 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) + RBV | Two direct-acting antivirals (2DAA): paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) plus RBV | Three direct-acting antivirals (3DAA): paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) | 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) + RBV |
| Measure Participants | 470 | 45 | 266 | 159 |
| ≥ 1 TEAE |
124
275.6%
|
16
6%
|
65
40.9%
|
43
9.1%
|
| ≥ 1 Serious TEAE |
13
28.9%
|
1
0.4%
|
7
4.4%
|
5
1.1%
|
| Pregnancy |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Adverse Events
| Time Frame | up to 30 days post treatment (treatment period was 12 weeks or 24 weeks) | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | 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. | |||||
| Arm/Group Title | 2 DAA+RBV | 3DAA | 3DAA+RBV | |||
| Arm/Group Description | 2DAA: paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) plus RBV | 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) | 3DAA: paritaprevir/ritonavir - ombitasvir + dasabuvir (ABBVIE REGIMEN) plus RBV | |||
All Cause Mortality |
||||||
| 2 DAA+RBV | 3DAA | 3DAA+RBV | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/45 (0%) | 4/266 (1.5%) | 1/159 (0.6%) | |||
Serious Adverse Events |
||||||
| 2 DAA+RBV | 3DAA | 3DAA+RBV | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/45 (2.2%) | 7/266 (2.6%) | 5/159 (3.1%) | |||
| Blood and lymphatic system disorders | ||||||
| ANAEMIA | 0/45 (0%) | 0 | 0/266 (0%) | 0 | 2/159 (1.3%) | 2 |
| Gastrointestinal disorders | ||||||
| GASTRIC PERFORATION | 0/45 (0%) | 0 | 1/266 (0.4%) | 1 | 0/159 (0%) | 0 |
| General disorders | ||||||
| DEATH | 0/45 (0%) | 0 | 1/266 (0.4%) | 1 | 0/159 (0%) | 0 |
| Hepatobiliary disorders | ||||||
| HEPATIC CIRRHOSIS | 0/45 (0%) | 0 | 1/266 (0.4%) | 1 | 0/159 (0%) | 0 |
| Infections and infestations | ||||||
| OROPHARYNGEAL CANDIDIASIS | 0/45 (0%) | 0 | 1/266 (0.4%) | 1 | 0/159 (0%) | 0 |
| SEPTIC SHOCK | 0/45 (0%) | 0 | 1/266 (0.4%) | 1 | 0/159 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||
| OVERDOSE | 0/45 (0%) | 0 | 0/266 (0%) | 0 | 1/159 (0.6%) | 1 |
| TOXICITY TO VARIOUS AGENTS | 1/45 (2.2%) | 1 | 0/266 (0%) | 0 | 0/159 (0%) | 0 |
| Investigations | ||||||
| BLOOD POTASSIUM DECREASED | 0/45 (0%) | 0 | 1/266 (0.4%) | 1 | 0/159 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| PSEUDARTHROSIS | 0/45 (0%) | 0 | 0/266 (0%) | 0 | 1/159 (0.6%) | 1 |
| Nervous system disorders | ||||||
| CEREBROVASCULAR ACCIDENT | 0/45 (0%) | 0 | 1/266 (0.4%) | 1 | 0/159 (0%) | 0 |
| Renal and urinary disorders | ||||||
| ACUTE KIDNEY INJURY | 0/45 (0%) | 0 | 0/266 (0%) | 0 | 1/159 (0.6%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||
| 2 DAA+RBV | 3DAA | 3DAA+RBV | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 7/45 (15.6%) | 33/266 (12.4%) | 23/159 (14.5%) | |||
| Blood and lymphatic system disorders | ||||||
| ANAEMIA | 2/45 (4.4%) | 2 | 0/266 (0%) | 0 | 8/159 (5%) | 8 |
| General disorders | ||||||
| FATIGUE | 2/45 (4.4%) | 2 | 21/266 (7.9%) | 21 | 9/159 (5.7%) | 9 |
| Nervous system disorders | ||||||
| HEADACHE | 0/45 (0%) | 0 | 15/266 (5.6%) | 15 | 4/159 (2.5%) | 4 |
| Skin and subcutaneous tissue disorders | ||||||
| RASH | 4/45 (8.9%) | 4 | 2/266 (0.8%) | 2 | 4/159 (2.5%) | 4 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Global Medical Services |
|---|---|
| Organization | AbbVie |
| Phone | 800-633-9110 |
| abbvieclinicaltrials@abbvie.com |
Responsible Party:
AbbVie
ClinicalTrials.gov Identifier:
NCT02615145
Other Study ID Numbers:
- P15-398
First Posted:
Nov 26, 2015
Last Update Posted:
Oct 7, 2019
Last Verified:
Jan 1, 2019