A Randomized Study to Evaluate the Safety, Tolerability a... | NCT01074008 | Trialant
NCT01074008
Sponsor
AbbVie (prior sponsor, Abbott)
Status
Completed
Last Update Posted
Jan 8, 2015Estimated
Enrollment
74Actual
Phase
Phase 2
Conditions
Hepatitis C
HCV
Chronic Hepatitis C Infection
Hepatitis C Genotype 1
Interventions
ABT-450
ABT-072
ABT-333
Ritonavir
Peginterferon alpha-2a
Ribavirin
Placebo
Countries
United States
Puerto Rico
Protocol Section
Identification Module
NCT ID
NCT01074008
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
M11-602
Secondary IDs
Not provided
Brief Title
A Randomized Study to Evaluate the Safety, Tolerability and Antiviral Activity of ABT-450, ABT-333 and ABT-072
Official Title
A Blinded, Randomized, Placebo-controlled, Dose Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-450 With Ritonavir (ABT-450/r), ABT-333 or ABT-072 Each Administered Alone and in Combination With Peginterferon α-2a and Ribavirin (PegIFN/RBV) in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Acronym
Champion2
Organization
AbbVieINDUSTRY
Status Module
Record Verification Date
Dec 2014
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
Mar 2010
Primary Completion Date
Jun 2011Actual
Completion Date
Jan 2012Actual
First Submitted Date
Feb 22, 2010
First Submission Date that Met QC Criteria
Feb 22, 2010
First Posted Date
Feb 24, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 29, 2014
Results First Submitted that Met QC Criteria
Dec 29, 2014
Results First Posted Date
Jan 8, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Jun 25, 2012
Certification/Extension First Submitted that Passed QC Review
Jun 25, 2012
Certification/Extension First Posted Date
Jul 2, 2012Estimated
Last Update Submitted Date
Dec 29, 2014
Last Update Posted Date
Jan 8, 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)
No
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 study assessed the safety, tolerability, pharmacokinetics, and antiviral activity of multiple oral doses of ABT-450/ritonavir (r), ABT-333 (also known as dasabuvir), or ABT-072 in hepatitis C virus (HCV), genotype 1-infected, treatment-naïve adults.
Detailed Description
This was a Phase 2a, randomized, blinded, placebo-controlled, dose-ranging study in chronically, hepatitis C virus (HCV) genotype 1-infected participants designed to explore the safety, tolerability, pharmacokinetics, antiviral activity, as well as the evolution and persistence to resistance of ABT-450/r, ABT-333, or ABT-072. Participants were treated with ABT-450/r, ABT-333, or ABT-072 monotherapy for 3 days, followed by 81 days (12 weeks minus 3 days of monotherapy) of ABT-450/r, ABT-333, or ABT-072 combined with pegylated interferon/ribavirin (pegIFN/RBV), followed by 36 weeks of pegIFN/RBV alone. Participants randomized to an ABT-450/r treatment group who achieved rapid virologic response (RVR) and had HCV ribonucleic acid (RNA) levels < 25 IU/mL at all subsequent visits were eligible to stop pegIFN/RBV therapy on or after Week 24.
Conditions Module
Conditions
Hepatitis C
HCV
Chronic Hepatitis C Infection
Hepatitis C Genotype 1
Keywords
Not provided
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
74Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
ABT-450/r (50/100 mg) once daily (QD) + pegIFN/RBV
Experimental
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Drug: ABT-450
Drug: Ritonavir
Drug: Peginterferon alpha-2a
Drug: Ribavirin
ABT-450/r (100/100 mg) once daily (QD) + pegIFN/RBV
Experimental
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Drug: ABT-450
Drug: Ritonavir
Drug: Peginterferon alpha-2a
Drug: Ribavirin
ABT-450/r (200/100 mg) once daily (QD) + pegIFN/RBV
Experimental
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Drug: ABT-450
Drug: Ritonavir
Drug: Peginterferon alpha-2a
Drug: Ribavirin
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ABT-450
Drug
50 mg capsules co-administered with ritonavir
ABT-450/r (100/100 mg) once daily (QD) + pegIFN/RBV
ABT-450/r (200/100 mg) once daily (QD) + pegIFN/RBV
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Maximal Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels During ABT-450/r, ABT-333, or ABT-072 Monotherapy Treatment
Plasma HCV RNA levels (reported as log10 IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay that had a lower limit of detection of 10 IU/mL and a lower limit of quantification of 25 IU/mL. The baseline value was the HCV RNA level before the first dose of study drug on Day 1. The maximal change during monotherapy was the difference from baseline to the lowest log10 HCV RNA level anytime after the first dose of study drug on Day 1 through the last log10 HCV RNA level before the first dose of study drug on Day 4. Data are reported as the mean ± standard deviation.
Prior to dosing on Day 1 to before the morning dose on Day 4
Maximum Plasma Concentration (Cmax) of ABT-450
Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-450 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ABT-450 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)
Time to Maximum Plasma Concentration (Tmax) of ABT-450
Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-450 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-450 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Rapid Virologic Response (RVR) at Week 4
Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay that had a lower limit of detection of 10 IU/mL and a lower limit of quantification (LLOQ) of 25 IU/mL. Rapid virologic response was defined as HCV RNA level < LLOQ (< 25 IU/mL) at Week 4. Data are reported as the percentage of participants with RVR.
Other Outcomes
Measure
Description
Time Frame
Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-450 in Non-structural Viral Protein 3 (NS3)
Baseline samples were analyzed for resistance-associated amino acid variants using population and clonal sequencing and were compared with the appropriate reference sequence (1a-H77 or 1b-Con1). Phenotypic resistance to ABT-450 at baseline was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Available samples at Day 4 with HCV RNA ≥ 1000 IU/mL were analyzed for resistance-associated variants using population and clonal sequencing and were compared with the baseline sequences to assess amino acid changes. Phenotypic resistance to ABT-450 at Day 4 was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding baseline sample. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance are presented.
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Chronic hepatitis C virus (HCV), genotype 1 infection (HCV ribonucleic acid level greater than or equal to 100,000 IU/mL) at screening
Liver biopsy within 3 years with histology consistent with HCV-induced liver damage, with no evidence of cirrhosis or liver pathology due to any cause other than chronic HCV
Treatment naïve male or female between the ages of 18 and 65
Females must be post-menopausal for more than 2 years or surgically sterile
Negative screen for drugs and alcohol
Negative hepatitis B surface antigen (HBsAg) and anti-human immunodeficiency virus antibodies (anti-HIV Ab)
No use of cytochrome P450 3A (CYP3A) and cytochrome P450 2C8 (CYP2C8) enzyme inducers or inhibitors within 1 month of dosing
Be in a condition of general good health, as perceived by the investigator, other than HCV infection
Exclusion Criteria:
Significant sensitivity to any drug
Use of herbal supplements within 2 weeks prior to study drug dosing
History of major depression within 2 years
Prior treatment with any investigational or commercially available anti-HCV agents
Pilot-Matias T, Tripathi R, Cohen D, Gaultier I, Dekhtyar T, Lu L, Reisch T, Irvin M, Hopkins T, Pithawalla R, Middleton T, Ng T, McDaniel K, Or YS, Menon R, Kempf D, Molla A, Collins C. In vitro and in vivo antiviral activity and resistance profile of the hepatitis C virus NS3/4A protease inhibitor ABT-450. Antimicrob Agents Chemother. 2015 Feb;59(2):988-97. doi: 10.1128/AAC.04227-14. Epub 2014 Dec 1.
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
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
0
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
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
ABT-072 (100 mg) once daily (QD) + pegIFN/RBV
Experimental
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Drug: ABT-072
Drug: Peginterferon alpha-2a
Drug: Ribavirin
ABT-072 (300 mg) once daily (QD) + pegIFN/RBV
Experimental
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Drug: ABT-072
Drug: Peginterferon alpha-2a
Drug: Ribavirin
ABT-072 (600 mg) once daily (QD) + pegIFN/RBV
Experimental
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Drug: ABT-072
Drug: Peginterferon alpha-2a
Drug: Ribavirin
ABT-333 (400 mg) twice a day (BID) + pegIFN/RBV
Experimental
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Drug: ABT-333
Drug: Peginterferon alpha-2a
Drug: Ribavirin
ABT-333 (800 mg) twice daily (BID) + pegIFN/RBV
Experimental
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Drug: ABT-333
Drug: Peginterferon alpha-2a
Drug: Ribavirin
Placebo + pegIFN/RBV
Placebo Comparator
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Drug: Peginterferon alpha-2a
Drug: Ribavirin
Other: Placebo
ABT-450/r (50/100 mg) once daily (QD) + pegIFN/RBV
ABT-072
Drug
50 mg tablet
ABT-072 (100 mg) once daily (QD) + pegIFN/RBV
ABT-072 (300 mg) once daily (QD) + pegIFN/RBV
ABT-072 (600 mg) once daily (QD) + pegIFN/RBV
ABT-333
Drug
400 mg tablet
ABT-333 (400 mg) twice a day (BID) + pegIFN/RBV
ABT-333 (800 mg) twice daily (BID) + pegIFN/RBV
Dasabuvir
Ritonavir
Drug
100 mg capsules co-administered with ABT-450
ABT-450/r (100/100 mg) once daily (QD) + pegIFN/RBV
ABT-450/r (200/100 mg) once daily (QD) + pegIFN/RBV
ABT-450/r (50/100 mg) once daily (QD) + pegIFN/RBV
ABT-538
Norvir
Peginterferon alpha-2a
Drug
Syringe, 180 µg/0.5 mL for subcutaneous injections
ABT-072 (100 mg) once daily (QD) + pegIFN/RBV
ABT-072 (300 mg) once daily (QD) + pegIFN/RBV
ABT-072 (600 mg) once daily (QD) + pegIFN/RBV
ABT-333 (400 mg) twice a day (BID) + pegIFN/RBV
ABT-333 (800 mg) twice daily (BID) + pegIFN/RBV
ABT-450/r (100/100 mg) once daily (QD) + pegIFN/RBV
ABT-450/r (200/100 mg) once daily (QD) + pegIFN/RBV
ABT-450/r (50/100 mg) once daily (QD) + pegIFN/RBV
Placebo + pegIFN/RBV
Ribavirin
Drug
200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day
ABT-072 (100 mg) once daily (QD) + pegIFN/RBV
ABT-072 (300 mg) once daily (QD) + pegIFN/RBV
ABT-072 (600 mg) once daily (QD) + pegIFN/RBV
ABT-333 (400 mg) twice a day (BID) + pegIFN/RBV
ABT-333 (800 mg) twice daily (BID) + pegIFN/RBV
ABT-450/r (100/100 mg) once daily (QD) + pegIFN/RBV
ABT-450/r (200/100 mg) once daily (QD) + pegIFN/RBV
ABT-450/r (50/100 mg) once daily (QD) + pegIFN/RBV
Placebo + pegIFN/RBV
Placebo
Other
Matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level
Placebo + pegIFN/RBV
Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)
Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-450
Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-450 using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ABT-450 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)
Maximum Plasma Concentration (Cmax) of Ritonavir
Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ritonavir using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ritonavir was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)
Time to Maximum Plasma Concentration (Tmax) of Ritonavir
Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ritonavir using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ritonavir was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)
Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of Ritonavir
Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ritonavir using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ritonavir was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)
Maximum Plasma Concentration (Cmax) of ABT-072
Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-072 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ABT-072 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)
Time to Maximum Plasma Concentration (Tmax) of ABT-072
Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-072 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-072 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)
Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-072
Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-072 using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ABT-072 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)
Maximum Plasma Concentration (Cmax) of ABT-333
Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)
Time to Maximum Plasma Concentration (Tmax) of ABT-333
Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)
Area Under the Plasma Concentration-time Curve From 0 to 12 Hours (AUC12) Post-dose of ABT-333
Blood samples were collected immediately prior to morning dose (time 0 hours) and at 2, 4, 8, and 12 hours after the morning dose on Day 1. The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC12 of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
Immediately prior to morning dose (time 0 hours) and at 2, 4, 8, and 12 hours after the morning dose on Day 1
Week 4
Percentage of Participants With Partial Early Virologic Response (EVR) at Week 12
Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay that had a lower limit of detection of 10 IU/mL and a lower limit of quantification of 25 IU/mL. Partial early virologic response (EVR) was defined as HCV RNA levels that decreased > 2 log10 IU/mL at Week 12 as compared to baseline. The baseline value was the last measurement before the first dose on Day 1. Data are reported as the percentage of participants with partial EVR.
Baseline and Week 12
Percentage of Participants With Complete Early Virologic Response (cEVR) at Week 12
Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay that had a lower limit of detection of 10 IU/mL and a lower limit of quantification (LLOQ) of 25 IU/mL. Complete EVR was defined as HCV RNA levels < LLOQ (< 25 IU/mL) at Week 12. Data are reported as the percentage of participants with cEVR.
Week 12
Baseline and Day 4
Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-072 in Non-structural Viral Protein 5B (NS5B)
Baseline samples were analyzed for resistance-associated amino acid variants using population and clonal sequencing and were compared with the appropriate reference sequence (1a-H77 or 1b-Con1). Phenotypic resistance to ABT-072 at baseline was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Available samples at Day 4 with HCV RNA ≥ 1000 IU/mL were analyzed for the presence of resistance-associated variants using population and clonal sequencing and were compared with the baseline sequences to assess amino acid changes. Phenotypic resistance to ABT-072 at Day 4 was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding baseline sample. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance are presented.
Baseline and Day 4
Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-333 in Non-structural Viral Protein 5B (NS5B)
Baseline samples were analyzed for resistance-associated amino acid variants using population and clonal sequencing and were compared with the appropriate reference sequence (1a-H77 or 1b-Con1). Phenotypic resistance to ABT-333 at baseline was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Available samples at Day 4 with HCV RNA ≥ 1000 IU/mL were analyzed for the presence of resistance-associated variants using population and clonal sequencing and were compared with the baseline sequences to assess amino acid changes. Phenotypic resistance to ABT-333 at Day 4 was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding baseline sample. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance are presented.
Baseline and Day 4
Change From Baseline in Hepatitis C Virus Patient-reported Outcomes (HCV-PRO) Total Score
The Hepatitis C Virus Patient-report Outcomes (HCV-PRO, formerly known as HCV Quality of Life) survey was used to assess disease-specific function and well-being on a scale from 0 to 100; a higher score indicated relatively good function and well-being of treated participants. Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are reported as the group mean change from baseline ± standard deviation.
Baseline up to Post-treatment Week 24
Change From Baseline in ED-5D Visual Analog Scale (ED-5D VAS) Score
The ED-5D VAS was a self-rating survey used to capture the current health status of a participant and ranged from 0 (the worst imaginable health state) to 100 (best imaginable health state). Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are presented as the group mean change from baseline ± standard deviation.
Baseline and Post-treatment Week 24
Change From Baseline in EQ-5D (3 Level) Health Index Score
The EQ-5D was a health state questionnaire used to measure five health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The combination of responses from all five dimensions were derived into an index score ranging from 0 to 1; a higher score indicated a more preferable health utility value from the societal perspectives. Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are presented as the group mean change from baseline ± standard deviation.
Baseline and Post-treatment Week 24
Change From Baseline in SF-36 Physical Component Summary (PCS)
The Physical Component Summary (PCS) of the SF-36 was used to measure the overall physical health status of a participant. The aggregated score of the SF-36 PCS score was standardized using a linear T-score transformation with a mean of 50 and a standard deviation of 10; a higher score indicated better physical function and well-being. Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are presented as the group mean change from baseline ± standard deviation.
Baseline and Post-treatment Week 24
Change From Baseline in SF-36 Mental Component Summary (MCS)
The Mental Component Summary (MCS) of the SF-36 was used to measure the overall mental health status of participants. The aggregated score of the SF-36 MPS was standardized using a linear T-score transformation with a mean of 50 and a standard deviation of 10; a higher score indicated better mental function and well-being. Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are presented as the group mean change from baseline ± standard deviation.
Baseline and Post-treatment Week 24
Anaheim
California
92801
United States
Site Reference ID/Investigator# 23387
La Jolla
California
92037
United States
Site Reference ID/Investigator# 23388
Los Angeles
California
90048
United States
Site Reference ID/Investigator# 23371
Aurora
Colorado
80045
United States
Site Reference ID/Investigator# 23369
Orlando
Florida
32803
United States
Site Reference ID/Investigator# 26362
Orlando
Florida
32809
United States
Site Reference ID/Investigator# 23373
Chicago
Illinois
60611
United States
Site Reference ID/Investigator# 24908
Chicago
Illinois
60612
United States
Site Reference ID/Investigator# 23381
Indianapolis
Indiana
46202-5121
United States
Site Reference ID/Investigator# 23372
Baton Rouge
Louisiana
70810
United States
Site Reference ID/Investigator# 24710
New Orleans
Louisiana
70112
United States
Site Reference ID/Investigator# 23391
Baltimore
Maryland
21287
United States
Site Reference ID/Investigator# 23377
Detroit
Michigan
48202
United States
Site Reference ID/Investigator# 24909
Saint Paul
Minnesota
55114
United States
Site Reference ID/Investigator# 35842
New York
New York
10016
United States
Site Reference ID/Investigator# 23379
New York
New York
10021
United States
Site Reference ID/Investigator# 23375
Chapel Hill
North Carolina
27599-7584
United States
Site Reference ID/Investigator# 23385
Durham
North Carolina
27705
United States
Site Reference ID/Investigator# 23376
Dallas
Texas
75203
United States
Site Reference ID/Investigator# 24891
Houston
Texas
77030
United States
Site Reference ID/Investigator# 23382
San Antonio
Texas
78215
United States
Site Reference ID/Investigator# 24715
Salt Lake City
Utah
84132-2410
United States
Site Reference ID/Investigator# 25463
Seattle
Washington
98101
United States
Site Reference ID/Investigator# 23383
Madison
Wisconsin
53792
United States
Site Reference ID/Investigator# 23363
Ponce
00731
Puerto Rico
FG001
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
FG002
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
FG003
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
FG004
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
FG005
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
FG006
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
FG007
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
FG008
Placebo + pegIFN/RBV
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
FG0008 subjects
FG0018 subjects
FG0028 subjects
FG0038 subjects
FG0048 subjects
FG0057 subjects
FG0068 subjects
FG0078 subjects
FG00811 subjects
Completed Direct-acting Antiviral Agent
FG0008 subjects
FG0017 subjects
FG0027 subjects
FG0038 subjects
FG0048 subjects
FG0055 subjects
FG0068 subjects
FG0077 subjects
FG0085 subjects
COMPLETED
FG0007 subjects
FG0015 subjects
FG0026 subjects
FG0037 subjects
FG0046 subjects
FG0057 subjects
FG0067 subjects
FG0078 subjects
FG0087 subjects
NOT COMPLETED
FG0001 subjects
FG0013 subjects
FG0022 subjects
FG0031 subjects
FG0042 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0084 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG004
All participants who recieved at least one dose of study drug were included in the baseline characteristic analaysis.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
BG001
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
BG002
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
BG003
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
BG004
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
BG005
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
BG006
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
BG007
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
BG008
Placebo + pegIFN/RBV
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0008
BG0018
BG0028
BG0038
BG0048
BG0057
BG0068
BG0078
BG00811
BG00974
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
BG00048.4± 9.36
BG00150.9± 2.59
BG00250.6± 9.26
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0013
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
Maximal Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels During ABT-450/r, ABT-333, or ABT-072 Monotherapy Treatment
Plasma HCV RNA levels (reported as log10 IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay that had a lower limit of detection of 10 IU/mL and a lower limit of quantification of 25 IU/mL. The baseline value was the HCV RNA level before the first dose of study drug on Day 1. The maximal change during monotherapy was the difference from baseline to the lowest log10 HCV RNA level anytime after the first dose of study drug on Day 1 through the last log10 HCV RNA level before the first dose of study drug on Day 4. Data are reported as the mean ± standard deviation.
Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.
Posted
Mean
Standard Deviation
log10 IU/mL
Prior to dosing on Day 1 to before the morning dose on Day 4
ID
Title
Description
OG000
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG001
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG002
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG003
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG004
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG005
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG006
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG007
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG008
Placebo + pegIFN/RBV
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG000-4.07± 0.53
OG001-3.91± 0.42
OG002-4.11± 0.32
OG003
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
OG008
Eight participants per ABT-450/r group and 11 participants in the placebo group would provide > 95% power to detect a 1.0 log10 difference with a common standard deviation of 0.5 log10 IU/mL using a two-sided, two-sample t-test with a significance level of 0.05.
ANCOVA
Treatment was the factor and baseline log10 HCV RNA level was the covariate.
<0.001
There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.
No
Superiority or Other
Secondary
Percentage of Participants With Rapid Virologic Response (RVR) at Week 4
Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay that had a lower limit of detection of 10 IU/mL and a lower limit of quantification (LLOQ) of 25 IU/mL. Rapid virologic response was defined as HCV RNA level < LLOQ (< 25 IU/mL) at Week 4. Data are reported as the percentage of participants with RVR.
All participants who received at least one dose of study drug and had at least one post-baseline HCV RNA value were included in this efficacy analysis.
Posted
Number
percentage of participants
Week 4
ID
Title
Description
OG000
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG001
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Secondary
Percentage of Participants With Partial Early Virologic Response (EVR) at Week 12
Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay that had a lower limit of detection of 10 IU/mL and a lower limit of quantification of 25 IU/mL. Partial early virologic response (EVR) was defined as HCV RNA levels that decreased > 2 log10 IU/mL at Week 12 as compared to baseline. The baseline value was the last measurement before the first dose on Day 1. Data are reported as the percentage of participants with partial EVR.
To be included in the efficacy analysis, participants received at least one dose of study drug (direct-acting antiviral agent) and at least one post-baseline measurement of HCV RNA levels.
Posted
Number
percentage of participants
Baseline and Week 12
ID
Title
Description
OG000
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG001
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Primary
Maximum Plasma Concentration (Cmax) of ABT-450
Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-450 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ABT-450 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.
Posted
Mean
Standard Deviation
ng/mL
Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)
ID
Title
Description
OG000
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG001
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
Primary
Time to Maximum Plasma Concentration (Tmax) of ABT-450
Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-450 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-450 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.
Posted
Mean
Standard Deviation
Hours
Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)
ID
Title
Description
OG000
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG001
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Primary
Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-450
Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-450 using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ABT-450 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.
Posted
Mean
Standard Deviation
ng*hr/mL
Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)
ID
Title
Description
OG000
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG001
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
Primary
Maximum Plasma Concentration (Cmax) of Ritonavir
Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ritonavir using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ritonavir was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.
Posted
Mean
Standard Deviation
ng/mL
Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)
ID
Title
Description
OG000
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG001
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
Primary
Time to Maximum Plasma Concentration (Tmax) of Ritonavir
Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ritonavir using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ritonavir was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.
Posted
Mean
Standard Deviation
Hours
Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)
ID
Title
Description
OG000
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG001
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
Primary
Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of Ritonavir
Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ritonavir using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ritonavir was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.
Posted
Mean
Standard Deviation
ng*hr/mL
Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)
ID
Title
Description
OG000
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG001
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
Primary
Maximum Plasma Concentration (Cmax) of ABT-072
Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-072 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ABT-072 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.
Posted
Mean
Standard Deviation
ng/mL
Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)
ID
Title
Description
OG000
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG001
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
Primary
Time to Maximum Plasma Concentration (Tmax) of ABT-072
Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-072 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-072 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.
Posted
Mean
Standard Deviation
Hours
Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)
ID
Title
Description
OG000
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG001
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Primary
Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-072
Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-072 using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ABT-072 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.
Posted
Mean
Standard Deviation
ng*hr/mL
Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)
ID
Title
Description
OG000
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG001
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
Primary
Maximum Plasma Concentration (Cmax) of ABT-333
Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.
Posted
Mean
Standard Deviation
ng/mL
Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)
ID
Title
Description
OG000
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG001
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
Primary
Time to Maximum Plasma Concentration (Tmax) of ABT-333
Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.
Posted
Mean
Standard Deviation
Hours
Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)
ID
Title
Description
OG000
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG001
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Primary
Area Under the Plasma Concentration-time Curve From 0 to 12 Hours (AUC12) Post-dose of ABT-333
Blood samples were collected immediately prior to morning dose (time 0 hours) and at 2, 4, 8, and 12 hours after the morning dose on Day 1. The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC12 of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.
Posted
Mean
Standard Deviation
ng*hr/mL
Immediately prior to morning dose (time 0 hours) and at 2, 4, 8, and 12 hours after the morning dose on Day 1
ID
Title
Description
OG000
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG001
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Secondary
Percentage of Participants With Complete Early Virologic Response (cEVR) at Week 12
Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay that had a lower limit of detection of 10 IU/mL and a lower limit of quantification (LLOQ) of 25 IU/mL. Complete EVR was defined as HCV RNA levels < LLOQ (< 25 IU/mL) at Week 12. Data are reported as the percentage of participants with cEVR.
To be included in the efficacy analysis, participants received at least one dose of study drug (direct-acting antiviral agent) and have at least one post-baseline measurement of HCV RNA levels.
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG001
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Other Pre-specified
Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-450 in Non-structural Viral Protein 3 (NS3)
Baseline samples were analyzed for resistance-associated amino acid variants using population and clonal sequencing and were compared with the appropriate reference sequence (1a-H77 or 1b-Con1). Phenotypic resistance to ABT-450 at baseline was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Available samples at Day 4 with HCV RNA ≥ 1000 IU/mL were analyzed for resistance-associated variants using population and clonal sequencing and were compared with the baseline sequences to assess amino acid changes. Phenotypic resistance to ABT-450 at Day 4 was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding baseline sample. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance are presented.
All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the analysis. When the number of participants used to analyze the data at a specific time point differs from the Number of Participants Analyzed, the n (number of participants) is denoted in the Category Title.
Posted
Number
participants
Baseline and Day 4
ID
Title
Description
OG000
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Other Pre-specified
Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-072 in Non-structural Viral Protein 5B (NS5B)
Baseline samples were analyzed for resistance-associated amino acid variants using population and clonal sequencing and were compared with the appropriate reference sequence (1a-H77 or 1b-Con1). Phenotypic resistance to ABT-072 at baseline was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Available samples at Day 4 with HCV RNA ≥ 1000 IU/mL were analyzed for the presence of resistance-associated variants using population and clonal sequencing and were compared with the baseline sequences to assess amino acid changes. Phenotypic resistance to ABT-072 at Day 4 was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding baseline sample. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance are presented.
All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the analysis. When the number of participants used to analyze the data at a specific time point differs from the Number of Participants Analyzed, the n (number of participants) is denoted in the Category Title.
Posted
Number
participants
Baseline and Day 4
ID
Title
Description
OG000
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Other Pre-specified
Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-333 in Non-structural Viral Protein 5B (NS5B)
Baseline samples were analyzed for resistance-associated amino acid variants using population and clonal sequencing and were compared with the appropriate reference sequence (1a-H77 or 1b-Con1). Phenotypic resistance to ABT-333 at baseline was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Available samples at Day 4 with HCV RNA ≥ 1000 IU/mL were analyzed for the presence of resistance-associated variants using population and clonal sequencing and were compared with the baseline sequences to assess amino acid changes. Phenotypic resistance to ABT-333 at Day 4 was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding baseline sample. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance are presented.
All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the analysis. When the number of participants used to analyze the data at a specific time point differs from the Number of Participants Analyzed, the n (number of participants) is denoted in the Category Title.
Posted
Number
participants
Baseline and Day 4
ID
Title
Description
OG000
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Other Pre-specified
Change From Baseline in Hepatitis C Virus Patient-reported Outcomes (HCV-PRO) Total Score
The Hepatitis C Virus Patient-report Outcomes (HCV-PRO, formerly known as HCV Quality of Life) survey was used to assess disease-specific function and well-being on a scale from 0 to 100; a higher score indicated relatively good function and well-being of treated participants. Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are reported as the group mean change from baseline ± standard deviation.
Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.
Posted
Mean
Standard Deviation
units on a scale
Baseline up to Post-treatment Week 24
ID
Title
Description
OG000
ABT-450/r (Regardless of Dose) + pegIFN/RBV
Participants received ABT-450 and ritonavir (r) monotherapy at each dose level once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG001
ABT-072 (Regardless of Dose) + pegIFN/RBV
Participants received ABT-072 monotherapy at each dose level once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Other Pre-specified
Change From Baseline in ED-5D Visual Analog Scale (ED-5D VAS) Score
The ED-5D VAS was a self-rating survey used to capture the current health status of a participant and ranged from 0 (the worst imaginable health state) to 100 (best imaginable health state). Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are presented as the group mean change from baseline ± standard deviation.
Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.
Posted
Mean
Standard Deviation
units on a scale
Baseline and Post-treatment Week 24
ID
Title
Description
OG000
ABT-450/r (Regardless of Dose) + pegIFN/RBV
Participants received ABT-450 and ritonavir (r) monotherapy at each dose level once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG001
ABT-072 (Regardless of Dose) + pegIFN/RBV
Participants received ABT-072 monotherapy at each dose level once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Other Pre-specified
Change From Baseline in EQ-5D (3 Level) Health Index Score
The EQ-5D was a health state questionnaire used to measure five health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The combination of responses from all five dimensions were derived into an index score ranging from 0 to 1; a higher score indicated a more preferable health utility value from the societal perspectives. Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are presented as the group mean change from baseline ± standard deviation.
Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.
Posted
Mean
Standard Deviation
units on a scale
Baseline and Post-treatment Week 24
ID
Title
Description
OG000
ABT-450/r (Regardless of Dose) + pegIFN/RBV
Participants received ABT-450 and ritonavir (r) monotherapy at each dose level once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG001
ABT-072 (Regardless of Dose) + pegIFN/RBV
Participants received ABT-072 monotherapy at each dose level once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Other Pre-specified
Change From Baseline in SF-36 Physical Component Summary (PCS)
The Physical Component Summary (PCS) of the SF-36 was used to measure the overall physical health status of a participant. The aggregated score of the SF-36 PCS score was standardized using a linear T-score transformation with a mean of 50 and a standard deviation of 10; a higher score indicated better physical function and well-being. Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are presented as the group mean change from baseline ± standard deviation.
Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.
Posted
Mean
Standard Deviation
units on a scale
Baseline and Post-treatment Week 24
ID
Title
Description
OG000
ABT-450/r (Regardless of Dose) + pegIFN/RBV
Participants received ABT-450 and ritonavir (r) monotherapy at each dose level once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG001
ABT-072 (Regardless of Dose) + pegIFN/RBV
Participants received ABT-072 monotherapy at each dose level once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Other Pre-specified
Change From Baseline in SF-36 Mental Component Summary (MCS)
The Mental Component Summary (MCS) of the SF-36 was used to measure the overall mental health status of participants. The aggregated score of the SF-36 MPS was standardized using a linear T-score transformation with a mean of 50 and a standard deviation of 10; a higher score indicated better mental function and well-being. Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are presented as the group mean change from baseline ± standard deviation.
Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.
Posted
Mean
Standard Deviation
units on a scale
Baseline and Post-treatment Week 24
ID
Title
Description
OG000
ABT-450/r (Regardless of Dose) + pegIFN/RBV
Participants received ABT-450 and ritonavir (r) monotherapy at each dose level once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG001
ABT-072 (Regardless of Dose) + pegIFN/RBV
Participants received ABT-072 monotherapy at each dose level once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Time Frame
Adverse events were collected from the time of study drug administration to 30 days after last dose of ABT-450/r, ABT-267, or ABT-333 (16 Weeks); Serious adverse events were also collected from the time that informed consent was obtained (76 weeks ).
Description
Not provided
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
ABT-450/r (50/100 mg) Once Daily (QD) + (pegIFN/RBV)
Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
1
8
8
8
EG001
ABT-450/r (100/100 mg) Once Daily (QD) + (pegIFN/RBV)
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
0
8
8
8
EG002
ABT-450/r (200/100 mg) Once Daily (QD) + (pegIFN/RBV)
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
0
8
8
8
EG003
ABT-072 (100 mg) Once Daily (QD) + (pegIFN/RBV)
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
1
8
8
8
EG004
ABT-072 (300 mg) Once Daily (QD) + (pegIFN/RBV)
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
0
8
8
8
EG005
ABT-072 (600 mg) Once Daily (QD) + (pegIFN/RBV
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
0
7
7
7
EG006
ABT-333 (400 mg) Twice a Day (BID) + (pegIFN/RBV)
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
0
8
8
8
EG007
ABT-333 (800 mg) Twice Daily (BID) + (pegIFN/RBV)
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
0
8
8
8
EG008
Placebo + (pegIFN/RBV)
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
0
11
10
11
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
HAEMORRHOIDS
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected8 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected8 at risk
EG0070 affected8 at risk
EG0080 affected11 at risk
MALIGNANT MELANOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected8 at risk
EG0012 affected8 at risk
EG0021 affected8 at risk
EG0032 affected8 at risk
EG0042 affected8 at risk
EG0050 affected7 at risk
EG0062 affected8 at risk
EG0072 affected8 at risk
EG0081 affected11 at risk
LEUKOPENIA
Blood and lymphatic system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
LYMPHADENOPATHY
Blood and lymphatic system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected8 at risk
EG0025 affected8 at risk
EG003
THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
CERUMEN IMPACTION
Ear and labyrinth disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
TINNITUS
Ear and labyrinth disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
CONJUNCTIVITIS
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
LACRIMATION INCREASED
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
MACULAR OEDEMA
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
RETINAL DETACHMENT
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
RETINAL EXUDATES
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
VISION BLURRED
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
VISUAL ACUITY REDUCED
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
ABDOMINAL DISCOMFORT
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
ABDOMINAL DISTENSION
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
APHTHOUS STOMATITIS
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected8 at risk
EG0012 affected8 at risk
EG0021 affected8 at risk
EG003
DRY MOUTH
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected8 at risk
EG0021 affected8 at risk
EG003
FLATULENCE
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
GASTROOESOPHAGEAL REFLUX DISEASE
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
GINGIVITIS
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
GLOSSODYNIA
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
HAEMORRHOIDS
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
LIP DRY
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
LOOSE TOOTH
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
MOUTH ULCERATION
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0003 affected8 at risk
EG0012 affected8 at risk
EG0022 affected8 at risk
EG003
PROCTALGIA
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
PROCTITIS
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
RECTAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
STOMATITIS
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0012 affected8 at risk
EG0020 affected8 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected8 at risk
EG0010 affected8 at risk
EG0022 affected8 at risk
EG003
APPLICATION SITE RASH
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
ASTHENIA
General disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
CHILLS
General disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected8 at risk
EG0011 affected8 at risk
EG0021 affected8 at risk
EG003
FATIGUE
General disorders
MedDRA 14.1
Systematic Assessment
EG0003 affected8 at risk
EG0014 affected8 at risk
EG0023 affected8 at risk
EG003
INFLUENZA LIKE ILLNESS
General disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected8 at risk
EG0012 affected8 at risk
EG0022 affected8 at risk
EG003
INFUSION SITE INFLAMMATION
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
INJECTION SITE ERYTHEMA
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
INJECTION SITE HAEMATOMA
General disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
INJECTION SITE RASH
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
INJECTION SITE REACTION
General disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
IRRITABILITY
General disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
MALAISE
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
NON-CARDIAC CHEST PAIN
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
PAIN
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
PYREXIA
General disorders
MedDRA 14.1
Systematic Assessment
EG0003 affected8 at risk
EG0011 affected8 at risk
EG0021 affected8 at risk
EG003
TEMPERATURE INTOLERANCE
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
THIRST
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
HEPATOMEGALY
Hepatobiliary disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
ANAL ABSCESS
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
CANDIDIASIS
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
CELLULITIS
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
EAR INFECTION
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
HERPES SIMPLEX
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
LOCALISED INFECTION
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
ORAL CANDIDIASIS
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
PERITONSILLAR ABSCESS
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
PHARYNGITIS
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
SKIN INFECTION
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
TOOTH ABSCESS
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
TOOTH INFECTION
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
BURNS THIRD DEGREE
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
EXCORIATION
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
THERMAL BURN
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
BLOOD BILIRUBIN INCREASED
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
BLOOD CREATININE INCREASED
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
BLOOD GLUCOSE INCREASED
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
BLOOD PHOSPHORUS DECREASED
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
BLOOD POTASSIUM DECREASED
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
BLOOD TRIGLYCERIDES INCREASED
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
CREATININE RENAL CLEARANCE DECREASED
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
GAMMA-GLUTAMYLTRANSFERASE INCREASED
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
HAEMOGLOBIN DECREASED
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
LYMPHOCYTE COUNT DECREASED
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
NEUTROPHIL COUNT DECREASED
Investigations
MedDRA 14.1
Systematic Assessment
EG0002 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
PLATELET COUNT DECREASED
Investigations
MedDRA 14.1
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
WEIGHT DECREASED
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
WHITE BLOOD CELL COUNT DECREASED
Investigations
MedDRA 14.1
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
HYPOPHOSPHATAEMIA
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
INCREASED APPETITE
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected8 at risk
EG0012 affected8 at risk
EG0021 affected8 at risk
EG003
AXILLARY MASS
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
COSTOCHONDRITIS
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
FLANK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
JOINT STIFFNESS
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
MUSCLE TIGHTNESS
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
MUSCULOSKELETAL CHEST PAIN
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
MUSCULOSKELETAL PAIN
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected8 at risk
EG0013 affected8 at risk
EG0023 affected8 at risk
EG003
NECK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
DISTURBANCE IN ATTENTION
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0022 affected8 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
DYSGEUSIA
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0006 affected8 at risk
EG0014 affected8 at risk
EG0025 affected8 at risk
EG003
HYPOAESTHESIA
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
MEMORY IMPAIRMENT
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
RESTLESS LEGS SYNDROME
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
SINUS HEADACHE
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
SOMNOLENCE
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
ABNORMAL DREAMS
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
AFFECT LABILITY
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
AGITATION
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
ANGER
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
ANXIETY
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected8 at risk
EG0023 affected8 at risk
EG003
CONFUSIONAL STATE
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
DEPRESSED MOOD
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0003 affected8 at risk
EG0012 affected8 at risk
EG0024 affected8 at risk
EG003
IMPATIENCE
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0003 affected8 at risk
EG0015 affected8 at risk
EG0021 affected8 at risk
EG003
MOOD SWINGS
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
RESTLESSNESS
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
DYSURIA
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
POLLAKIURIA
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0021 affected8 at risk
EG003
URINE ODOUR ABNORMAL
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
VULVOVAGINAL PRURITUS
Reproductive system and breast disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0022 affected8 at risk
EG003
DYSPHONIA
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
DYSPNOEA EXERTIONAL
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
EPISTAXIS
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0021 affected8 at risk
EG003
PRODUCTIVE COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
RHINORRHOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
SINUS CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
UPPER-AIRWAY COUGH SYNDROME
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
ALOPECIA
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
DERMATITIS
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0022 affected8 at risk
EG003
DRY SKIN
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
ERYTHEMA
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
HYPERHIDROSIS
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected8 at risk
EG0010 affected8 at risk
EG0022 affected8 at risk
EG003
PRURITUS GENERALISED
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected8 at risk
EG0012 affected8 at risk
EG0023 affected8 at risk
EG003
RASH GENERALISED
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
RASH MACULO-PAPULAR
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
RASH PAPULAR
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
SKIN LESION
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
URTICARIA
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
HOT FLUSH
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 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 Information
AbbVie (prior sponsor, Abbott)
800-633-9110
ID
Term
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
D006505
Hepatitis
D008107
Liver Diseases
D004066
Digestive System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C585405
paritaprevir
C000625346
ABT-072
C588260
dasabuvir
D019438
Ritonavir
D012254
Ribavirin
Ancestor Terms
ID
Term
D013844
Thiazoles
D013457
Sulfur Compounds
D009930
Organic Chemicals
D001393
Azoles
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D012263
Ribonucleosides
D009705
Nucleosides
D009706
Nucleic Acids, Nucleotides, and Nucleosides
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
1 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0084 subjects
53.5
± 5.40
BG00451.3± 7.76
BG00540.9± 11.25
BG00649.6± 8.37
BG00753.5± 6.46
BG00851.5± 6.36
BG00950.2± 8.01
4
BG0033
BG0041
BG0050
BG0062
BG0070
BG0082
BG00916
Male
BG0007
BG0015
BG0024
BG0035
BG0047
BG0057
BG0066
BG0078
BG0089
BG00958
8
OG0048
OG0057
OG0068
OG0078
OG00811
-1.14
± 0.99
OG004-1.07± 0.41
OG005-1.57± 0.94
OG006-1.08± 0.68
OG007-0.95± 0.68
OG008-0.36± 0.13
OG001
OG008
Eight participants per ABT-450/r group and 11 participants in the placebo group would provide > 95% power to detect a 1.0 log10 difference with a common standard deviation of 0.5 log10 IU/mL using a two-sided, two-sample t-test with a significance level of 0.05.
ANCOVA
Treatment was the factor and baseline log10 HCV RNA level was the covariate.
<0.001
There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.
No
Superiority or Other
OG002
OG008
Eight participants per ABT-450/r group and 11 participants in the placebo group would provide > 95% power to detect a 1.0 log10 difference with a common standard deviation of 0.5 log10 IU/mL using a two-sided, two-sample t-test with a significance level of 0.05.
ANCOVA
Treatment was the factor and baseline log10 HCV RNA level was the covariate.
<0.001
There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.
No
Superiority or Other
OG003
OG008
Eight participants per ABT-072 and 11 participants in the placebo group would provide 92% power to detect a 1.0 log10 difference with a standard deviation of 0.6 log10 IU/mL and a two-sided, two-sample t-test with a significance level of 0.05.
ANCOVA
Treatment was the factor and baseline log10 HCV RNA level was the covariate.
0.009
There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.
No
Superiority or Other
OG004
OG008
Eight participants per ABT-072 and 11 participants in the placebo group would provide 92% power to detect a 1.0 log10 difference with a standard deviation of 0.6 log10 IU/mL and a two-sided, two-sample t-test with a significance level of 0.05.
ANCOVA
Treatment was the factor and baseline log10 HCV RNA level was the covariate.
0.012
There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.
No
Superiority or Other
OG005
OG008
Eight participants per ABT-072 and 11 participants in the placebo group would provide 92% power to detect a 1.0 log10 difference with a standard deviation of 0.6 log10 IU/mL and a two-sided, two-sample t-test with a significance level of 0.05.
ANCOVA
Treatment was the factor and baseline log10 HCV RNA level was the covariate.
<0.001
There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.
No
Superiority or Other
OG006
OG008
Eight subjects per ABT-333 group and 11 subjects in the placebo group would provide 82% power to detect a 1.0 log10 IU/mL difference with a standard deviation of 0.7 log10 IU/mL and a 2-sided 2-sample t-test with a significance level of 0.05.
ANCOVA
Treatment was the factor and baseline log10 HCV RNA level was the covariate.
0.032
There was no adjustment for multiple comparisons and the pre-specified, 2-sided significance level was ≤ 0.05.
No
Superiority or Other
OG007
OG008
Eight participants per ABT-333 group and 11 participants in the placebo group would provide 82% power to detect a 1.0 log10 IU/mL difference with a standard deviation of 0.7 log10 IU/mL and a two-sided, two-sample t-test with a significance level of 0.05.
ANCOVA
Treatment was the factor and baseline log10 HCV RNA level was the covariate.
0.053
There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.
No
Superiority or Other
OG002
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG003
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG004
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG005
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG006
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG007
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG008
Placebo + pegIFN/RBV
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG0038
OG0048
OG0057
OG0068
OG0078
OG00811
Title
Denominators
Categories
Title
Measurements
OG00087.5
OG00175.0
OG002100.0
OG00337.5
OG00412.5
OG00542.9
OG00650.0
OG00750.0
OG0089.1
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
OG008
Fisher Exact
0.001
There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.
2-Sided
No
Superiority or Other
OG001
OG008
Fisher Exact
0.006
There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.
2-Sided
No
Superiority or Other
OG002
OG008
Fisher Exact
<0.001
There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.
2-Sided
No
Superiority or Other
OG003
OG008
Fisher Exact
0.262
There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.
2-Sided
No
Superiority or Other
OG004
OG008
Fisher Exact
1.000
There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.
2-Sided
No
Superiority or Other
OG005
OG008
Fisher Exact
0.245
There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.
2-Sided
No
Superiority or Other
OG006
OG008
Fisher Exact
0.111
There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.
2-Sided
No
Superiority or Other
OG007
OG008
Fisher Exact
0.111
There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.
2-Sided
No
Superiority or Other
OG002
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG003
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG004
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG005
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG006
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG007
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG008
Placebo + pegIFN/RBV
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG0038
OG0048
OG0057
OG0068
OG0078
OG00811
Title
Denominators
Categories
Title
Measurements
OG000100.0
OG00187.5
OG002100.0
OG003100.0
OG00462.5
OG005100.0
OG006100.0
OG007100.0
OG00836.4
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
OG008
Fisher Exact
0.013
There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.
2-Sided
No
Superiority or Other
OG001
OG008
Fisher Exact
0.059
There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.
2-Sided
No
Superiority or Other
OG002
OG008
Fisher Exact
0.013
There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.
2-Sided
No
Superiority or Other
OG003
OG008
Fisher Exact
0.013
There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.
2-Sided
No
Superiority or Other
OG004
OG008
Fisher Exact
0.370
There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.
2-Sided
No
Superiority or Other
OG005
OG008
Fisher Exact
0.013
There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.
2-Sided
No
Superiority or Other
OG006
OG008
Fisher Exact
0.013
There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.
2-Sided
No
Superiority or Other
OG007
OG008
Fisher Exact
0.013
There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.
2-Sided
No
Superiority or Other
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG002
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Units
Counts
Participants
OG0008
OG0018
OG0028
Title
Denominators
Categories
Title
Measurements
OG00034.4± 31.7
OG001165± 221
OG0022923± 2026
OG002
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Units
Counts
Participants
OG0008
OG0018
OG0028
Title
Denominators
Categories
Title
Measurements
OG0002.5± 0.9
OG0014.8± 3.5
OG0023.0± 1.1
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG002
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Units
Counts
Participants
OG0008
OG0018
OG0028
Title
Denominators
Categories
Title
Measurements
OG000250± 245
OG0011122± 992
OG00217351± 15841
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG002
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Units
Counts
Participants
OG0008
OG0018
OG0028
Title
Denominators
Categories
Title
Measurements
OG000563± 674
OG001851± 638
OG0021098± 619
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG002
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Units
Counts
Participants
OG0008
OG0018
OG0028
Title
Denominators
Categories
Title
Measurements
OG0004.8± 2.8
OG0015.3± 3.2
OG0024.5± 1.4
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG002
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Units
Counts
Participants
OG0008
OG0018
OG0028
Title
Denominators
Categories
Title
Measurements
OG0004518± 5063
OG0017638± 6284
OG0028663± 5006
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG002
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Units
Counts
Participants
OG0008
OG0018
OG0027
Title
Denominators
Categories
Title
Measurements
OG000390± 153
OG0011218± 382
OG0021748± 707
OG002
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Units
Counts
Participants
OG0008
OG0018
OG0027
Title
Denominators
Categories
Title
Measurements
OG0004.5± 1.4
OG0012.8± 1.0
OG0023.1± 1.1
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG002
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Units
Counts
Participants
OG0008
OG0018
OG0027
Title
Denominators
Categories
Title
Measurements
OG0003678± 1742
OG0019413± 3125
OG00214126± 6102
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Units
Counts
Participants
OG0008
OG0016
Title
Denominators
Categories
Title
Measurements
OG000800± 382
OG0011201± 419
Units
Counts
Participants
OG0008
OG0016
Title
Denominators
Categories
Title
Measurements
OG0004.5± 5.2
OG0017.0± 8.4
Units
Counts
Participants
OG0008
OG0016
Title
Denominators
Categories
Title
Measurements
OG0004315± 2176
OG0016431± 1914
OG002
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG003
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG004
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG005
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG006
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV
Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG007
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG008
Placebo + pegIFN/RBV
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG0038
OG0048
OG0057
OG0068
OG0078
OG00811
Title
Denominators
Categories
Title
Measurements
OG00087.5
OG00187.5
OG002100.0
OG00375.0
OG00450.0
OG00585.7
OG00687.5
OG00762.5
OG00818.2
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
OG008
Fisher Exact
0.005
There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.
2-Sided
No
Superiority or Other
OG001
OG008
Fisher Exact
0.005
There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.
2-Sided
No
Superiority or Other
OG002
OG008
Fisher Exact
<0.001
There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.
2-Sided
No
Superiority or Other
OG003
OG008
Fisher Exact
0.024
There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.
2-Sided
No
Superiority or Other
OG004
OG008
Fisher Exact
0.319
There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.
2-Sided
No
Superiority or Other
OG005
OG008
Fisher Exact
0.013
There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.
2-Sided
No
Superiority or Other
OG006
OG008
Fisher Exact
0.005
There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.
2-Sided
No
Superiority or Other
OG007
OG008
Fisher Exact
0.074
There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.
2-Sided
No
Superiority or Other
OG001
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG002
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV
Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Units
Counts
Participants
OG0008
OG0018
OG0028
Title
Denominators
Categories
Baseline Variants in NS3
Title
Measurements
OG0000
OG0010
OG0020
Baseline Resistance to ABT-450 >10-fold
Title
Measurements
OG0000
OG0010
OG0020
Day 4 Variants in NS3 (n=3, 2, 3)
Title
Measurements
OG0002
OG0012
OG0021
Day 4: Resistance to ABT-450 >10-fold (n=3, 2, 3)
Title
Measurements
OG0001
OG0011
OG0020
OG001
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV
Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG002
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV
Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Units
Counts
Participants
OG0008
OG0018
OG0027
Title
Denominators
Categories
Baseline Variants in NS5B
Title
Measurements
OG0000
OG0011
OG0020
Baseline Resistance to ABT-072 >10-fold
Title
Measurements
OG0000
OG0011
OG0020
Day 4: Variants in NS5B (n=6, 7, 6)
Title
Measurements
OG0001
OG0012
OG0021
Day 4: Resistance to ABT-072 >10-fold (n=6, 7, 6)
Title
Measurements
OG0000
OG0010
OG0021
OG001
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV
Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Units
Counts
Participants
OG0008
OG0018
Title
Denominators
Categories
Baseline Variants in NS5B
Title
Measurements
OG0001
OG0012
Baseline Resistance to ABT-333 >10-fold NS5B
Title
Measurements
OG0000
OG0011
Day 4: Variants in NS5B (n=7, 8)
Title
Measurements
OG0003
OG0013
Day 4: Resistance to ABT-333 >10-fold (n=7, 8)
Title
Measurements
OG0000
OG0010
OG002
ABT-333 (Regardless of Dose) + pegIFN/RBV
Participants received ABT-333 monotherapy at each dose level twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG003
Placebo (Regardless of Dose) + pegIFN/RBV
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Units
Counts
Participants
OG00012
OG00113
OG00210
OG0034
Title
Denominators
Categories
Title
Measurements
OG000-0.78± 15.53
OG001-0.37± 13.97
OG002-3.25± 14.72
OG003-9.04± 12.41
OG002
ABT-333 (Regardless of Dose) + pegIFN/RBV
Participants received ABT-333 monotherapy at each dose level twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG003
Placebo (Regardless of Dose) + pegIFN/RBV
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Units
Counts
Participants
OG00011
OG00113
OG00211
OG0034
Title
Denominators
Categories
Title
Measurements
OG000-5.91± 31.92
OG001-2.38± 29.86
OG00211.18± 27.19
OG003-9.00± 22.23
OG002
ABT-333 (Regardless of Dose) + pegIFN/RBV
Participants received ABT-333 monotherapy at each dose level twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG003
Placebo (Regardless of Dose) + pegIFN/RBV
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Units
Counts
Participants
OG00012
OG00113
OG00211
OG0034
Title
Denominators
Categories
Title
Measurements
OG000-0.06± 0.22
OG001-0.06± 0.15
OG002-0.02± 0.17
OG003-0.09± 0.09
OG002
ABT-333 (Regardless of Dose) + pegIFN/RBV
Participants received ABT-333 monotherapy at each dose level twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG003
Placebo (Regardless of Dose) + pegIFN/RBV
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Units
Counts
Participants
OG00011
OG00113
OG00211
OG0034
Title
Denominators
Categories
Title
Measurements
OG0003.01± 6.15
OG001-1.92± 5.89
OG0024.08± 5.76
OG003-2.84± 7.92
OG002
ABT-333 (Regardless of Dose) + pegIFN/RBV
Participants received ABT-333 monotherapy at each dose level twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
OG003
Placebo (Regardless of Dose) + pegIFN/RBV
Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.