ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With an... | NCT01464827 | Trialant
NCT01464827
Sponsor
AbbVie (prior sponsor, Abbott)
Status
Completed
Last Update Posted
Apr 22, 2015Estimated
Enrollment
580Actual
Phase
Phase 2
Conditions
Chronic Hepatitis C
Hepatitis C (HCV)
Hepatitis C Genotype 1
Interventions
ABT-450
ABT-333
ABT-267
Ribavirin
Ritonavir
Countries
United States
Australia
Canada
France
Germany
New Zealand
Puerto Rico
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01464827
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
M11-652
Secondary IDs
ID
Type
Description
Link
2010-022455-31
EudraCT Number
Brief Title
ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With and Without Ribavirin in Genotype 1 Hepatitis C Virus Infected Patients
Official Title
A Randomized, Open-Label, Multicenter Study to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics, of ABT-450 With Ritonavir (ABT-450/r) in Combination With ABT-267 and/or ABT-333 With and Without Ribavirin (RBV) for 8, 12 or 24 Weeks in Treatment-Naïve and Null Responder Subjects With Genotype 1 Chronic Hepatitis C Virus Infection
Acronym
Not provided
Organization
AbbVieINDUSTRY
Status Module
Record Verification Date
Apr 2015
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 2011
Primary Completion Date
Mar 2013Actual
Completion Date
Sep 2013Actual
First Submitted Date
Sep 28, 2011
First Submission Date that Met QC Criteria
Nov 3, 2011
First Posted Date
Nov 4, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 23, 2014
Results First Submitted that Met QC Criteria
Dec 23, 2014
Results First Posted Date
Jan 6, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Mar 25, 2014
Certification/Extension First Submitted that Passed QC Review
Mar 25, 2014
Certification/Extension First Posted Date
Apr 21, 2014Estimated
Last Update Submitted Date
Apr 2, 2015
Last Update Posted Date
Apr 22, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AbbVie (prior sponsor, Abbott)INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a study of combination direct-acting antiviral agents (DAA) with or without ribavirin (RBV) in patients with chronic Hepatitis C Virus (HCV).
Detailed Description
A study to evaluate the safety and effectiveness of experimental drugs ABT-450, ABT-267 (also known as ombitasvir), ABT-333 (also known as dasabuvir), ritonavir, and ribavirin in participants with HCV. The study will test the safety and effects of combinations of these drugs in treatments up to 24 weeks.
Conditions Module
Conditions
Chronic Hepatitis C
Hepatitis C (HCV)
Hepatitis C Genotype 1
Keywords
Hepatitis C Genotype 1
Hepatitis C
Interferon-Free
HCV
Chronic Hepatitis C
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
580Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group A
Experimental
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 8 weeks.
Drug: ABT-450
Drug: ABT-333
Drug: ABT-267
Drug: Ribavirin
Drug: Ritonavir
Group B
Experimental
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
Drug: ABT-450
Drug: ABT-333
Drug: Ribavirin
Drug: Ritonavir
Group C
Experimental
Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
Drug: ABT-450
Drug: ABT-267
Drug: Ribavirin
Drug: Ritonavir
Group D
Experimental
Treatment-naïve participants received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
Drug: ABT-450
Drug: ABT-267
Drug: Ribavirin
Drug: Ritonavir
Group E
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ABT-450
Drug
ABT-450 tablets
Group A
Group B
Group C
Group D
Group E
Group F
Group G
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Adverse Events (AEs)
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment.
The investigator assessed the relationship of each AE to the use of direct-acting antiviral agents (DAAs) and to ribavirin, and rated the severity of each event as either:
Mild: The AE was transient and easily tolerated by the participant; Moderate: The AE caused the participant discomfort and interrupted usual activities; Severe: The AE caused considerable interference with the participant's usual activities and could have been incapacitating or life-threatening.
A serious adverse event was any event that resulted in death, was life-threatening, resulted in or prolonged hospitalization, resulted in a congenital anomaly or persistent or significant disability or was any other important medical event requiring medical or surgical intervention.
From the time of study drug administration until 30 days following discontinuation of study drug administration (up to 28 weeks).
Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose for 8 Weeks Versus 12 Weeks of Treatment With 3 DAAs and Ribavirin
The percentage of participants achieving sustained virologic response 24 weeks after the last dose of study drug (SVR24), defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than the lower limit of quantitation (LLOQ), without any confirmed quantifiable (≥ LLOQ) post-treatment value before that time point. HCV RNA levels were measured from plasma by a central laboratory. The LLOQ for the assay was 25 IU/mL.
The primary efficacy endpoint was the comparison between treatment-naïve participants following 8 weeks of treatment with 3 DAAs and ribavirin and those with 12 weeks of treatment with 3 DAAs and ribavirin (Group A versus Group G).
Post Treatment Week 24
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment of Different Durations With 3 Direct-acting Antiviral Agents (DAAs) and Ribavirin
This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks after the last dose of study drug (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 3 DAAs (ABT-450/ritonavir, ABT-267, and ABT-333) and ribavirin in both treatment naïve and null-responder participants for 8 weeks (Group A) versus 12 weeks (Groups F + G + K + L) versus 24 weeks (Groups H + I + M + N).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Males and females 18-70 years old, inclusive
Females must be post-menopausal for more than 2 years or surgically sterile or practicing specific forms of birth control
Chronic hepatitis C virus (HCV), genotype 1 infection
Treatment-naive OR null-responders to previous treatment with pegylated interferon (pegIFN) and ribavirin (at least 12 weeks of treatment and failure to achieve a 2 log10 HCV RNA decrease at Week 12)
No evidence of liver cirrhosis
Exclusion Criteria:
Significant liver disease with any cause other than HCV as the primary cause
Positive hepatitis B surface antigen and anti-human immunodeficiency virus antibody
Positive screen for drugs and alcohol
Significant sensitivity to any drug
Use of contraindicated or prohibited medications within 1 month of dosing
Krishnan P, Tripathi R, Schnell G, Reisch T, Beyer J, Irvin M, Xie W, Larsen L, Cohen D, Podsadecki T, Pilot-Matias T, Collins C. Resistance analysis of baseline and treatment-emergent variants in hepatitis C virus genotype 1 in the AVIATOR study with paritaprevir-ritonavir, ombitasvir, and dasabuvir. Antimicrob Agents Chemother. 2015 Sep;59(9):5445-54. doi: 10.1128/AAC.00998-15. Epub 2015 Jun 22.
This was a Phase 2, open-label, randomized, combination treatment study of multiple doses of ABT-450/ritonavir, and ABT-267 and/or ABT-333 with or without ribavirin in hepatitis C virus (HCV) genotype 1-infected treatment-naïve patients and previous null responders to pegylated interferon (pegIFN) and ribavirin treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Group A
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 8 weeks.
FG001
Group B
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Experimental
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
Drug: ABT-450
Drug: ABT-333
Drug: ABT-267
Drug: Ritonavir
Group F
Experimental
Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
Drug: ABT-450
Drug: ABT-333
Drug: ABT-267
Drug: Ribavirin
Drug: Ritonavir
Group G
Experimental
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
Drug: ABT-450
Drug: ABT-333
Drug: ABT-267
Drug: Ribavirin
Drug: Ritonavir
Group H
Experimental
Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
Drug: ABT-450
Drug: ABT-333
Drug: ABT-267
Drug: Ribavirin
Drug: Ritonavir
Group I
Experimental
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
Drug: ABT-450
Drug: ABT-333
Drug: ABT-267
Drug: Ribavirin
Drug: Ritonavir
Group J
Experimental
Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
Drug: ABT-450
Drug: ABT-267
Drug: Ribavirin
Drug: Ritonavir
Group K
Experimental
Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
Drug: ABT-450
Drug: ABT-333
Drug: ABT-267
Drug: Ribavirin
Drug: Ritonavir
Group L
Experimental
Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
Drug: ABT-450
Drug: ABT-333
Drug: ABT-267
Drug: Ribavirin
Drug: Ritonavir
Group M
Experimental
Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
Drug: ABT-450
Drug: ABT-333
Drug: ABT-267
Drug: Ribavirin
Drug: Ritonavir
Group N
Experimental
Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
Drug: ABT-450
Drug: ABT-333
Drug: ABT-267
Drug: Ribavirin
Drug: Ritonavir
Group H
Group I
Group J
Group K
Group L
Group M
Group N
ABT-333
Drug
ABT-333 tablets
Group A
Group B
Group E
Group F
Group G
Group H
Group I
Group K
Group L
Group M
Group N
Dasabuvir
ABT-267
Drug
ABT-267 tablets
Group A
Group C
Group D
Group E
Group F
Group G
Group H
Group I
Group J
Group K
Group L
Group M
Group N
Ombitasvir
Ribavirin
Drug
Ribavirin tablets administered at a weight-based dose, between 1,000 to 1,200 mg daily (divided).
Group A
Group B
Group C
Group D
Group F
Group G
Group H
Group I
Group J
Group K
Group L
Group M
Group N
Ritonavir
Drug
Ritonavir capsules
Group A
Group B
Group C
Group D
Group E
Group F
Group G
Group H
Group I
Group J
Group K
Group L
Group M
Group N
Norvir
Post-Treatment Week 24
Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment for 12 Weeks With 2 DAAs and Ribavirin Versus 3 DAAs and Ribavirin
This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks post-dose (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 2 DAAs (ABT-450/ritonavir plus ABT-333 [Group B] or ABT-450/ritonavir plus ABT-267 [Groups C + D + J]) and ribavirin versus 3 DAAs (ABT-450/ritonavir plus ABT-333 and ABT-267) and ribavirin (Groups F + G + K + L).
Post-Treatment Week 24
Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment for 12 Weeks With 3 DAAs With Versus Without Ribavirin
This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks post-dose (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 3 DAAs with or without ribavirin (Group E versus Groups F + G + K + L).
Post-Treatment Week 24
Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose in Treatment-naïve Versus Null-responders
This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks post-dose (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 3 DAAs and ribavirin in participants who were treatment-naïve versus those who were null-responders to previous HCV therapy (Groups F + G + H + I versus Groups K + L + M + N).
Kowdley KV, Lawitz E, Poordad F, Cohen DE, Nelson DR, Zeuzem S, Everson GT, Kwo P, Foster GR, Sulkowski MS, Xie W, Pilot-Matias T, Liossis G, Larsen L, Khatri A, Podsadecki T, Bernstein B. Phase 2b trial of interferon-free therapy for hepatitis C virus genotype 1. N Engl J Med. 2014 Jan 16;370(3):222-32. doi: 10.1056/NEJMoa1306227.
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
FG002
Group C
Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
FG003
Group D
Treatment-naïve participants received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
FG004
Group E
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
FG005
Group F
Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
FG006
Group G
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
FG007
Group H
Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
FG008
Group I
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
FG009
Group J
Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
FG010
Group K
Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
FG011
Group L
Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
FG012
Group M
Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
FG013
Group N
Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
FG00080 subjects
FG00143 subjects
FG00239 subjects
FG00340 subjects
FG00480 subjects
FG00539 subjects
FG00641 subjects
FG00740 subjects
FG00840 subjects
FG00947 subjects
FG01023 subjects
FG01123 subjects
FG01223 subjects
FG01322 subjects
Treated
FG00080 subjects
FG00141 subjects
FG00239 subjects
FG00340 subjects
FG00479 subjects
FG00539 subjects
FG00640 subjects
FG00740 subjects
FG00840 subjects
FG00945 subjects
FG01023 subjects
FG01122 subjects
FG01223 subjects
FG01320 subjects
COMPLETED
FG00077 subjects
FG00136 subjects
FG00239 subjects
FG00336 subjects
FG00472 subjects
FG00538 subjects
FG00637 subjects
FG00737 subjects
FG00837 subjects
FG00944 subjects
FG01021 subjects
FG01121 subjects
FG01221 subjects
FG01319 subjects
NOT COMPLETED
FG0003 subjects
FG0017 subjects
FG0020 subjects
FG0034 subjects
FG0048 subjects
FG0051 subjects
FG0064 subjects
FG0073 subjects
FG0083 subjects
FG0093 subjects
FG0102 subjects
FG0112 subjects
FG0122 subjects
FG0133 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0121 subjects
FG0130 subjects
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0032 subjects
FG004
Other
FG0002 subjects
FG0013 subjects
FG0020 subjects
FG0032 subjects
FG004
Not Treated
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Safety population (participants who received at least 1 dose of direct-acting antiviral agent)
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Group A
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 8 weeks.
BG001
Group B
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
BG002
Group C
Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
BG003
Group D
Treatment-naïve participants received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
BG004
Group E
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
BG005
Group F
Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
BG006
Group G
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
BG007
Group H
Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
BG008
Group I
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
BG009
Group J
Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
BG010
Group K
Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
BG011
Group L
Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
BG012
Group M
Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
BG013
Group N
Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
BG014
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00080
BG00141
BG00239
BG00340
BG00479
BG00539
BG00640
BG00740
BG00840
BG00945
BG01023
BG01122
BG01223
BG01320
BG014571
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00050.1± 9.99
BG00150.8± 9.84
BG00251.1± 8.07
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00034
BG00123
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Adverse Events (AEs)
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment.
The investigator assessed the relationship of each AE to the use of direct-acting antiviral agents (DAAs) and to ribavirin, and rated the severity of each event as either:
Mild: The AE was transient and easily tolerated by the participant; Moderate: The AE caused the participant discomfort and interrupted usual activities; Severe: The AE caused considerable interference with the participant's usual activities and could have been incapacitating or life-threatening.
A serious adverse event was any event that resulted in death, was life-threatening, resulted in or prolonged hospitalization, resulted in a congenital anomaly or persistent or significant disability or was any other important medical event requiring medical or surgical intervention.
Safety population. Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
Posted
Number
participants
From the time of study drug administration until 30 days following discontinuation of study drug administration (up to 28 weeks).
ID
Title
Description
OG000
Group A
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 8 weeks.
OG001
Group B
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
OG002
Group C + D
Treatment-naïve participants received ABT-450 (100 mg or 200 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
OG003
Group E
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
OG004
Group F + G
Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
OG005
Group H + I
Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
OG006
Group J
Units
Counts
Participants
OG00080
OG00141
OG00279
OG003
Title
Denominators
Categories
Any adverse event
Title
Measurements
OG00067
OG00136
OG00271
OG003
Primary
Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose for 8 Weeks Versus 12 Weeks of Treatment With 3 DAAs and Ribavirin
The percentage of participants achieving sustained virologic response 24 weeks after the last dose of study drug (SVR24), defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than the lower limit of quantitation (LLOQ), without any confirmed quantifiable (≥ LLOQ) post-treatment value before that time point. HCV RNA levels were measured from plasma by a central laboratory. The LLOQ for the assay was 25 IU/mL.
The primary efficacy endpoint was the comparison between treatment-naïve participants following 8 weeks of treatment with 3 DAAs and ribavirin and those with 12 weeks of treatment with 3 DAAs and ribavirin (Group A versus Group G).
Intent-to-treat population (all participants who received at least 1 dose of direct-acting antiviral agent); participants with missing data were counted as non-responders.
Posted
Number
percentage of participants
Post Treatment Week 24
ID
Title
Description
OG000
Group A
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 8 weeks.
OG001
Group B
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
Secondary
Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment of Different Durations With 3 Direct-acting Antiviral Agents (DAAs) and Ribavirin
This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks after the last dose of study drug (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 3 DAAs (ABT-450/ritonavir, ABT-267, and ABT-333) and ribavirin in both treatment naïve and null-responder participants for 8 weeks (Group A) versus 12 weeks (Groups F + G + K + L) versus 24 weeks (Groups H + I + M + N).
Intent-to-treat population; participants with missing data were counted as non-responders.
Posted
Number
percentage of participants
Post-Treatment Week 24
ID
Title
Description
OG000
Group A
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 8 weeks.
OG001
Groups F + G + K + L
Participants (treatment-naïve and null-responders) received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
OG002
Groups H + I + M + N
Secondary
Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment for 12 Weeks With 2 DAAs and Ribavirin Versus 3 DAAs and Ribavirin
This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks post-dose (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 2 DAAs (ABT-450/ritonavir plus ABT-333 [Group B] or ABT-450/ritonavir plus ABT-267 [Groups C + D + J]) and ribavirin versus 3 DAAs (ABT-450/ritonavir plus ABT-333 and ABT-267) and ribavirin (Groups F + G + K + L).
Intent-to-treat population; participants with missing data were counted as non-responders.
Posted
Number
percentage of participants
Post-Treatment Week 24
ID
Title
Description
OG000
Group B
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
OG001
Groups C + D + J
Participants (treatment-naïve and null-responders) received ABT-450 (100 mg or 200 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
OG002
Groups F + G + K + L
Secondary
Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment for 12 Weeks With 3 DAAs With Versus Without Ribavirin
This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks post-dose (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 3 DAAs with or without ribavirin (Group E versus Groups F + G + K + L).
Intent-to-treat population; participants with missing data were counted as non-responders.
Posted
Number
percentage of participants
Post-Treatment Week 24
ID
Title
Description
OG000
Group E
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily, for 12 weeks.
OG001
Groups F + G + K + L
Participants (treatment-naïve and null-responders) received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
Units
Counts
Participants
Secondary
Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose in Treatment-naïve Versus Null-responders
This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks post-dose (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 3 DAAs and ribavirin in participants who were treatment-naïve versus those who were null-responders to previous HCV therapy (Groups F + G + H + I versus Groups K + L + M + N).
Intent-to-treat population; participants with missing data were counted as non-responders.
Posted
Number
percentage of participants
Post-Treatment Week 24
ID
Title
Description
OG000
Groups F + G + H + I
Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 or 24 weeks.
OG001
Groups K + L + M + N
Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 or 24 weeks.
Units
Time Frame
Up to 28 weeks
Description
Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Group A
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 8 weeks.
0
80
64
80
EG001
Group B
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
0
41
33
41
EG002
Group C + D
Treatment-naïve participants received ABT-450 (100 mg or 200 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
2
79
66
79
EG003
Group E
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
2
79
59
79
EG004
Group F + G
Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
1
79
66
79
EG005
Group H + I
Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
1
80
74
80
EG006
Group J
Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
0
45
40
45
EG007
Group K + L
Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
0
45
36
45
EG008
Group M + N
Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
2
43
34
43
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
CHOLECYSTITIS ACUTE
Hepatobiliary disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected41 at risk
EG0020 affected79 at risk
EG0030 affected79 at risk
EG0040 affected79 at risk
EG0050 affected80 at risk
EG0060 affected45 at risk
EG0070 affected45 at risk
EG0081 affected43 at risk
BRONCHITIS
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected41 at risk
EG0021 affected79 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected41 at risk
EG0020 affected79 at risk
EG003
ANIMAL BITE
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected41 at risk
EG0020 affected79 at risk
EG003
BLOOD CREATININE INCREASED
Investigations
MedDRA 16.0
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected41 at risk
EG0021 affected79 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected41 at risk
EG0020 affected79 at risk
EG003
NECK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected41 at risk
EG0020 affected79 at risk
EG003
SPINAL OSTEOARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected41 at risk
EG0020 affected79 at risk
EG003
CERVICOBRACHIAL SYNDROME
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected41 at risk
EG0020 affected79 at risk
EG003
FACIAL PARESIS
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected41 at risk
EG0021 affected79 at risk
EG003
AFFECTIVE DISORDER
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected41 at risk
EG0020 affected79 at risk
EG003
LUNG DISORDER
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected41 at risk
EG0020 affected79 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 16.0
Systematic Assessment
EG0005 affected80 at risk
EG0011 affected41 at risk
EG0023 affected79 at risk
EG0031 affected79 at risk
EG0047 affected79 at risk
EG0056 affected80 at risk
EG0063 affected45 at risk
EG0073 affected45 at risk
EG0082 affected43 at risk
TINNITUS
Ear and labyrinth disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected80 at risk
EG0013 affected41 at risk
EG0020 affected79 at risk
EG003
ABDOMINAL DISTENSION
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected80 at risk
EG0011 affected41 at risk
EG0021 affected79 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected80 at risk
EG0013 affected41 at risk
EG0024 affected79 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected80 at risk
EG0012 affected41 at risk
EG0025 affected79 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0003 affected80 at risk
EG0011 affected41 at risk
EG0025 affected79 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0008 affected80 at risk
EG00110 affected41 at risk
EG0028 affected79 at risk
EG003
DRY MOUTH
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0004 affected80 at risk
EG0010 affected41 at risk
EG0022 affected79 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0007 affected80 at risk
EG0011 affected41 at risk
EG0029 affected79 at risk
EG003
FLATULENCE
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected80 at risk
EG0011 affected41 at risk
EG0024 affected79 at risk
EG003
GASTROOESOPHAGEAL REFLUX DISEASE
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected80 at risk
EG0010 affected41 at risk
EG0022 affected79 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG00012 affected80 at risk
EG0017 affected41 at risk
EG00216 affected79 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0007 affected80 at risk
EG0014 affected41 at risk
EG0024 affected79 at risk
EG003
ASTHENIA
General disorders
MedDRA 16.0
Systematic Assessment
EG0007 affected80 at risk
EG0011 affected41 at risk
EG0028 affected79 at risk
EG003
CHEST PAIN
General disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected80 at risk
EG0011 affected41 at risk
EG0022 affected79 at risk
EG003
CHILLS
General disorders
MedDRA 16.0
Systematic Assessment
EG0004 affected80 at risk
EG0011 affected41 at risk
EG0021 affected79 at risk
EG003
FATIGUE
General disorders
MedDRA 16.0
Systematic Assessment
EG00029 affected80 at risk
EG00113 affected41 at risk
EG00222 affected79 at risk
EG003
IRRITABILITY
General disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected80 at risk
EG0014 affected41 at risk
EG0025 affected79 at risk
EG003
JAUNDICE
Hepatobiliary disorders
MedDRA 16.0
Systematic Assessment
EG0003 affected80 at risk
EG0010 affected41 at risk
EG0021 affected79 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0001 affected80 at risk
EG0010 affected41 at risk
EG0021 affected79 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0004 affected80 at risk
EG0013 affected41 at risk
EG0024 affected79 at risk
EG003
ORAL HERPES
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0002 affected80 at risk
EG0010 affected41 at risk
EG0022 affected79 at risk
EG003
RHINITIS
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0001 affected80 at risk
EG0010 affected41 at risk
EG0025 affected79 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0004 affected80 at risk
EG0010 affected41 at risk
EG0027 affected79 at risk
EG003
TOOTH INFECTION
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0002 affected80 at risk
EG0010 affected41 at risk
EG0020 affected79 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0005 affected80 at risk
EG0011 affected41 at risk
EG0025 affected79 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0004 affected80 at risk
EG0013 affected41 at risk
EG0022 affected79 at risk
EG003
HAEMOGLOBIN DECREASED
Investigations
MedDRA 16.0
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected41 at risk
EG0020 affected79 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA 16.0
Systematic Assessment
EG0008 affected80 at risk
EG0011 affected41 at risk
EG0025 affected79 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0002 affected80 at risk
EG0012 affected41 at risk
EG0026 affected79 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0002 affected80 at risk
EG0011 affected41 at risk
EG0023 affected79 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0002 affected80 at risk
EG0011 affected41 at risk
EG0022 affected79 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0004 affected80 at risk
EG0013 affected41 at risk
EG0025 affected79 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0002 affected80 at risk
EG0011 affected41 at risk
EG0021 affected79 at risk
EG003
DISTURBANCE IN ATTENTION
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0002 affected80 at risk
EG0011 affected41 at risk
EG0022 affected79 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0005 affected80 at risk
EG0017 affected41 at risk
EG0022 affected79 at risk
EG003
DYSGEUSIA
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0002 affected80 at risk
EG0011 affected41 at risk
EG0023 affected79 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG00028 affected80 at risk
EG00113 affected41 at risk
EG00223 affected79 at risk
EG003
LETHARGY
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected41 at risk
EG0022 affected79 at risk
EG003
MEMORY IMPAIRMENT
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected41 at risk
EG0021 affected79 at risk
EG003
PARAESTHESIA
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected41 at risk
EG0023 affected79 at risk
EG003
ABNORMAL DREAMS
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected80 at risk
EG0012 affected41 at risk
EG0022 affected79 at risk
EG003
ANXIETY
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
EG0002 affected80 at risk
EG0012 affected41 at risk
EG0020 affected79 at risk
EG003
DEPRESSED MOOD
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected80 at risk
EG0013 affected41 at risk
EG0021 affected79 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
EG0003 affected80 at risk
EG0013 affected41 at risk
EG0023 affected79 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
EG00010 affected80 at risk
EG0018 affected41 at risk
EG0029 affected79 at risk
EG003
SLEEP DISORDER
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected80 at risk
EG0010 affected41 at risk
EG0020 affected79 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG00012 affected80 at risk
EG0015 affected41 at risk
EG00211 affected79 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0008 affected80 at risk
EG0013 affected41 at risk
EG0024 affected79 at risk
EG003
DYSPNOEA EXERTIONAL
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0002 affected80 at risk
EG0010 affected41 at risk
EG0023 affected79 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0003 affected80 at risk
EG0010 affected41 at risk
EG0024 affected79 at risk
EG003
SINUS CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0004 affected80 at risk
EG0010 affected41 at risk
EG0020 affected79 at risk
EG003
ALOPECIA
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected41 at risk
EG0020 affected79 at risk
EG003
DRY SKIN
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0004 affected80 at risk
EG0013 affected41 at risk
EG0023 affected79 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG00012 affected80 at risk
EG0013 affected41 at risk
EG0028 affected79 at risk
EG003
PRURITUS GENERALISED
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0002 affected80 at risk
EG0015 affected41 at risk
EG0020 affected79 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG00010 affected80 at risk
EG0012 affected41 at risk
EG0026 affected79 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Point of Contact
Title
Organization
Phone
Extension
Email
Global Medical Services
AbbVie (prior sponsor, Abbott)
800-633-9110
ID
Term
D019698
Hepatitis C, Chronic
D006526
Hepatitis C
Ancestor Terms
ID
Term
D000086982
Blood-Borne Infections
D003141
Communicable Diseases
D007239
Infections
D006525
Hepatitis, Viral, Human
D014777
Virus Diseases
D018178
Flaviviridae Infections
D012327
RNA Virus Infections
D006521
Hepatitis, Chronic
D006505
Hepatitis
D008107
Liver Diseases
D004066
Digestive System Diseases
D002908
Chronic Disease
D020969
Disease Attributes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C585405
paritaprevir
C588260
dasabuvir
C586094
ombitasvir
D012254
Ribavirin
D019438
Ritonavir
Ancestor Terms
ID
Term
D012263
Ribonucleosides
D009705
Nucleosides
D009706
Nucleic Acids, Nucleotides, and Nucleosides
D013844
Thiazoles
D013457
Sulfur Compounds
D009930
Organic Chemicals
D001393
Azoles
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
3 subjects
FG0051 subjects
FG0062 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
FG0120 subjects
FG0131 subjects
3 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0083 subjects
FG0091 subjects
FG0102 subjects
FG0110 subjects
FG0121 subjects
FG0130 subjects
1 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0092 subjects
FG0100 subjects
FG0111 subjects
FG0120 subjects
FG0132 subjects
49.0
± 10.59
BG00448.3± 10.53
BG00549.4± 9.72
BG00651.0± 11.08
BG00751.5± 11.95
BG00851.5± 9.78
BG00950.6± 11.19
BG01048.5± 12.91
BG01151.2± 12.07
BG01251.5± 9.06
BG01354.6± 11.78
BG01450.3± 10.49
14
BG00320
BG00434
BG00519
BG00616
BG00722
BG00824
BG00918
BG0107
BG01110
BG0128
BG0138
BG014257
Male
BG00046
BG00118
BG00225
BG00320
BG00445
BG00520
BG00624
BG00718
BG00816
BG00927
BG01016
BG01112
BG01215
BG01312
BG014314
Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
OG007
Group K + L
Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
OG008
Group M + N
Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
79
OG00479
OG00580
OG00645
OG00745
OG00845
68
OG00471
OG00577
OG00642
OG00739
OG00837
Any adverse event at least possibly DAA-related
Title
Measurements
OG00058
OG00129
OG00253
OG00351
OG00457
OG00568
OG00635
OG00730
OG00828
Any severe adverse event
Title
Measurements
OG0003
OG0010
OG0023
OG0035
OG0043
OG0053
OG0061
OG0071
OG0081
Any serious adverse event
Title
Measurements
OG0000
OG0010
OG0022
OG0032
OG0041
OG0051
OG0060
OG0070
OG0082
Any AE leading to discontinuation of study drug
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0043
OG0053
OG0061
OG0070
OG0081
Any AE leading to interruption of study drug
Title
Measurements
OG0000
OG0011
OG0022
OG0031
OG0040
OG0051
OG0060
OG0070
OG0080
Any AE leading to ribavirin dose modification
Title
Measurements
OG0002
OG0012
OG0024
OG0030
OG0049
OG00510
OG0063
OG0071
OG0083
Any fatal adverse events
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG002
Group C
Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
OG003
Group D
Treatment-naïve participants received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
OG004
Group E
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
OG005
Group F
Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
OG006
Group G
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
OG007
Group H
Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
OG008
Group I
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
OG009
Group J
Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
OG010
Group K
Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
OG011
Group L
Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
OG012
Group M
Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
OG013
Group N
Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
Units
Counts
Participants
OG00080
OG00141
OG00239
OG00340
OG00479
OG00539
OG00640
OG00740
OG00840
OG00945
OG01023
OG01122
OG01223
OG01320
Title
Denominators
Categories
Title
Measurements
OG00087.5
OG00182.9
OG00284.6
OG00392.5
OG00488.6
OG00597.4
OG00695.0
OG00792.5
OG00890.0
OG00988.9
OG01091.3
OG01195.5
OG01291.3
OG013100.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG006
The primary efficacy endpoint was the comparison of the percentage of treatment-naïve participants with SVR24 after treatment with 3 DAAs (at the 150 mg ABT-450 dose) and ribavirin for 8 weeks (Group A) versus 12 weeks (Group G).
Logistic regression with baseline log10 HCV RNA level, treatment group, Interleukin 28B genotype (CC or non-CC), HCV subgenotype (1a or non-1a), and geographic region (US or non-US) as predictors.
Regression, Logistic
0.406
No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.
Odds Ratio (OR)
0.49
2-Sided
95
0.09
2.61
Odds ratio: Group A : Group G
No
Superiority or Other
Participants (treatment-naïve and null-responders) received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
Units
Counts
Participants
OG00080
OG001124
OG002123
Title
Denominators
Categories
Title
Measurements
OG00087.5
OG00195.2
OG00292.7
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
The percentage of participants with SVR24 after treatment for 8 weeks versus 12 weeks was compared using logistic regression with treatment group, baseline log10 HCV RNA level, HCV subgenotype (1a or non-1a), geographic region (US or non-US), Interleukin 28B genotype (CC or non-CC), and ABT-450/ritonavir dose and population (treatment-naïve or null-responders) as predictors.
Regression, Logistic
0.266
No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.
Odds Ratio (OR)
0.40
2-Sided
95
0.08
2.02
Odds ratio: Group A : Groups [F + G + K + L]
No
Superiority or Other
OG000
OG002
The percentage of participants with SVR24 after treatment for 8 weeks versus 24 weeks was compared using logistic regression with treatment group, baseline log10 HCV RNA level, HCV subgenotype (1a or non-1a), geographic region (US or non-US), Interleukin 28B genotype (CC or non-CC), ABT-450/ritonavir dose and population (treatment-naïve or null-responders) as predictors.
Regression, Logistic
0.525
No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.
Odds Ratio (OR)
0.66
2-Sided
95
0.18
2.40
Odds ratio: Group A : Groups [H + I + M + N]
No
Superiority or Other
OG001
OG002
The percentage of participants with SVR24 after treatment for 12 weeks versus 24 weeks was compared using logistic regression with treatment group, baseline log10 HCV RNA level, HCV subgenotype (1a or non-1a), geographic region (US or non-US), Interleukin 28B genotype (CC or non-CC), ABT-450/ritonavir dose and population (treatment-naïve or null-responders) as predictors.
Regression, Logistic
0.375
No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.
Odds Ratio (OR)
1.64
2-Sided
95
0.55
4.92
Odds ratio: Groups [F + G + K + L] : Groups [H + I + M + N]
No
Superiority or Other
Participants (treatment-naïve and null-responders) received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
Units
Counts
Participants
OG00041
OG001124
OG002124
Title
Denominators
Categories
Title
Measurements
OG00082.9
OG00188.7
OG00295.2
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
The percentage of participants with SVR24 after treatment with 2 DAAs and ribavirin versus 3 DAAs and ribavirin was compared using stratum-adjusted Mantel-Haenszel (MH) method with Interleukin 28B genotype (CC or non-CC) and HCV subgenotype (1a or non-1a).
Mantel Haenszel
The Mantel-Haenszel method was used because logistic regression failed due to separation or quasi-separation.
0.068
No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.
Difference
-12.16
2-Sided
95
-25.20
0.88
Difference = Group B - Groups [F + G + K + L]
No
Superiority or Other
OG001
OG002
The percentage of participants with SVR24 after treatment with 2 DAAs and ribavirin versus 3 DAAs and ribavirin was compared using stratum-adjusted Mantel-Haenszel (MH) method with Interleukin 28B genotype (CC or non-CC) and HCV subgenotype (1a or non-1a).
Mantel Haenszel
The Mantel-Haenszel method was used because logistic regression failed due to separation or quasi-separation.
0.065
No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.
Difference
-6.75
2-Sided
95
-13.93
0.43
Difference = Groups [C + D + J] - Groups [F + G + K + L]
No
Superiority or Other
OG00079
OG001124
Title
Denominators
Categories
Title
Measurements
OG00088.6
OG00195.2
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
The percentage of participants with SVR24 after treatment with 3 DAAs with and without ribavirin was compared using a stratum-adjusted Mantel-Haenszel (MH) method with Interleukin 28B genotype (CC or non-CC) and HCV subgenotype (1a or non-1a).
Mantel Haenszel
The Mantel-Haenszel method was used because logistic regression failed due to separation or quasi-separation.
0.106
No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.
Difference
-7.13
2-Sided
95
-15.77
1.51
Difference = Group E - Groups [F + G + K + L]
No
Superiority or Other
Counts
Participants
OG000159
OG00188
Title
Denominators
Categories
Title
Measurements
OG00093.7
OG00194.3
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
The percentage of participants with SVR24 after treatment with 3 DAAs and ribavirin in treatment-naïve versus null-responders was compared using logistic regression with treatment group, baseline log10 HCV RNA level, HCV subgenotype (1a or non-1a), geographic region (US or non-US), Interleukin 28B genotype (CC or non-CC), and ABT-450/ritonavir dose as predictors.
Regression, Logistic
0.616
No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.
Odds Ratio (OR)
1.41
2-Sided
95
0.37
5.34
Odds ratio: Groups [F + G + H + I] : Groups [K + L + M + N]