A Study to Evaluate the Efficacy, Safety, and Pharmacokin... | NCT01306617

Label	Type	Description	Intervention Names
ABT-450/r (250/100 mg) and ABT-333 plus RBV in treatment-naïve	Experimental	ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	Drug: ABT-450 Drug: ABT-333 Drug: ribavirin Drug: ritonavir
ABT-450/r (150/100 mg) and ABT-333 plus RBV in treatment-naïve	Experimental	ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	Drug: ABT-450 Drug: ABT-333 Drug: ribavirin Drug: ritonavir
ABT-450/r (150/100 mg) and ABT-333 plus RBV in non-responders	Experimental	ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.	Drug: ABT-450 Drug: ABT-333 Drug: ribavirin Drug: ritonavir

Name	Type	Description	Arm Group Labels	Other Names
ABT-450	Drug	tablets	ABT-450/r (150/100 mg) and ABT-333 plus RBV in non-responders ABT-450/r (150/100 mg) and ABT-333 plus RBV in treatment-naïve ABT-450/r (250/100 mg) and ABT-333 plus RBV in treatment-naïve

Measure	Description	Time Frame
Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Detection (LLOD) From Week 4 Through Week 12	Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of detection (< 15 IU/mL).	Week 4 through Week 12

Measure	Description	Time Frame
Percentage of Participants With HCV RNA < 1000 International Units Per Milliliter (IU/mL)	Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2.	Week 2
Percentage of Participants With HCV RNA Below the Lower Limit of Quantitation (LLOQ; <25 IU/mL) at Week 4

Name	Affiliation	Role
Daniel Cohen, MD	AbbVie	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Site Reference ID/Investigator# 48263		Los Angeles	California	90048	United States
Site Reference ID/Investigator# 48264

PubMed Identifier	Type	Citation	Retractions
23281975	Derived	Poordad F, Lawitz E, Kowdley KV, Cohen DE, Podsadecki T, Siggelkow S, Heckaman M, Larsen L, Menon R, Koev G, Tripathi R, Pilot-Matias T, Bernstein B. Exploratory study of oral combination antiviral therapy for hepatitis C. N Engl J Med. 2013 Jan 3;368(1):45-53. doi: 10.1056/NEJMoa1208809.

Label	URL
Related Info	View source

ID	Title	Description
FG000	ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve	ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
FG001	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve

ID	Title	Description
BG000	ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve	ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
BG001	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve	ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
BG002	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders	ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00019 BG00114 BG00217 BG00350

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

Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Detection (LLOD) From Week 4 Through Week 12

Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of detection (< 15 IU/mL).

Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.

Posted

Number

percentage of participants

Week 4 through Week 12

ID	Title	Description
OG000	ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve	ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
OG001	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve	ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
OG002	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders	ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.

Units	Counts
Participants	OG00019 OG00114 OG00217

Title

Denominators

Categories

Title	Measurements
	OG00089.5 OG00178.6 OG00258.8

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	For the percentage of subjects with HCV RNA suppressed below the LLOD from Week 4 through Week 12, if it was assumed that 60% of subjects would be successfully suppressed from Week 4 through Week 12, then 20 subjects in arm 1 would give a 95% 2-sided confidence interval (CI) of (38.5%, 81.5%), 10 subjects in arm 2 would give a 95% CI of (29.6%, 90.4%), and 15 subjects in arm 3 would give a 95% CI of (35.2%, 84.8%) for the percentage of subjects suppressed using the binomial exact method.	Regression, Logistic	Arm, baseline log10 HCV RNA level (<=800,000, >800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.	0.547						2-Sided							No

Secondary

Percentage of Participants With HCV RNA < 1000 International Units Per Milliliter (IU/mL)

Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2.

Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.

Posted

Number

percentage of participants

Week 2

ID	Title	Description
OG000	ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve	ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
OG001	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve	ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
OG002	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders	ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.

Secondary

Percentage of Participants With HCV RNA Below the Lower Limit of Quantitation (LLOQ; <25 IU/mL) at Week 4

Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL).

Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.

Posted

Number

percentage of participants

Week 4

ID	Title	Description
OG000	ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve	ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
OG001	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve	ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
OG002	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders	ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.

Secondary

Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment

Sustained virologic response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug.

Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.

Posted

Number

percentage of participants

Post-treatment Day 1 to Post-treatment Week 12

ID	Title	Description
OG000	ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve	ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
OG001	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve	ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
OG002	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders	ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.

Secondary

Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment

Sustained virologic response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 24 weeks after the last dose of study drug.

Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.

Posted

Number

percentage of participants

Post-treatment Day 1 to Post-treatment Week 24

ID	Title	Description
OG000	ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve	ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
OG001	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve	ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
OG002	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders	ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.

Secondary

Time to Failure to Suppress or Rebound During Treatment

Time to failure to achieve a 2 log10 IU/mL HCV RNA decrease at Week 1, failure to achieve HCV RNA < Lower Limit of Detection (LLOD) at Week 6, or a confirmed increase of at least 0.5 log10 IU/mL above nadir (local minimum value) or confirmed HCV RNA > lower limit of quantitation (LLOQ) for participants who previously achieved HCV RNA < LLOQ.

Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).

Posted

Mean

Standard Error

days

Day 1 through Week 12

ID	Title	Description
OG000	ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve	ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
OG001	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve	ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
OG002	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders	ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.

Secondary

Time to Virologic Relapse Post-treatment

Time to the first of 2 consecutive measurements of confirmed HCV RNA ≥ lower limit of quantitation (LLOQ) at any point in the post-treatment period among participants with HCV RNA < LLOQ at the end of treatment.

All randomized participants who received at least 1 dose of study drug with HCV RNA < LLOQ at the final treatment visit who completed treatment.

Posted

Mean

Standard Error

days

Post-treatment Day 1 to post-treatment week 48

ID	Title	Description
OG000	ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve	ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
OG001	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve	ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
OG002	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders	ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.

Secondary

Resistance-Associated Variants and Phenotypic Resistance

Baseline samples were analyzed for resistance-associated amino acid variants using population sequencing. Phenotypic resistance to ABT-450 or 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). Participants not achieving SVR12 were analyzed for resistance-associated variants at the time of failure using population sequencing and were compared with the baseline and appropriate reference sequences to assess amino acid changes. Phenotypic resistance to ABT-450 or ABT-333 at the time of failure 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 at baseline and at the time of failure are presented.

Resistance analyses included all participants who receive at least one dose of study drug (intent-to-treat [ITT] population).

Posted

Number

participants

Day 1 to post-treatment week 48

ID	Title	Description
OG000	ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve	ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
OG001	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve

Secondary

Pharmacokinetics (C Trough) of ABT 450 in HCV Infected Participants

Trough concentration (C trough) is the concentration 24 hours after once daily (QD) dose and 12 hours after twice daily (BID) dose.

Pharmacokinetic analyses included all participants who received at least 1 dose of the study drug (ITT) and for whom concentration data was available to characterize C trough.

Posted

Geometric Mean

Full Range

nanograms (ng) per milliliter (mL)

Day 1 to Week 12

ID	Title	Description
OG000	ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve	ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
OG001	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve	ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
OG002	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders	ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.

Secondary

Pharmacokinetics (C Trough) of ABT-333 in HCV Infected Participants

Trough concentration (C trough) is the concentration 24 hours after once daily (QD) dose and 12 hours after twice daily (BID) dose.

Pharmacokinetic analyses included all participants who received at least 1 dose of the study drug (ITT) and for whom concentration data was available to characterize C trough.

Posted

Geometric Mean

Full Range

nanograms (ng) per milliliter (mL)

Day 1 to Week 12

ID	Title	Description
OG000	ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve	ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
OG001	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve	ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
OG002	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders	ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.

Secondary

Pharmacokinetics (C Trough) of Ritonavir in HCV Infected Participants

Trough concentration (C trough) is the concentration 24 hours after once daily (QD) dose and 12 hours after twice daily (BID) dose.

Pharmacokinetic analyses included all participants who received at least 1 dose of the study drug (ITT) and for whom concentration data was available to characterize C trough.

Posted

Geometric Mean

Full Range

nanograms (ng) per milliliter (mL)

Day 1 to Week 12

ID	Title	Description
OG000	ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve	ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
OG001	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve	ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
OG002	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders	ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.

Secondary

Pharmacokinetics (C Trough) of Ribavirin in HCV Infected Participants

Trough concentration (C trough) is the concentration 24 hours after once daily (QD) dose and 12 hours after twice daily (BID) dose.

Pharmacokinetic analyses included all participants who received at least 1 dose of the study drug (ITT) and for whom concentration data was available to characterize C trough.

Posted

Geometric Mean

Full Range

nanograms (ng) per milliliter (mL)

Day 1 to Week 12

ID	Title	Description
OG000	ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve	ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
OG001	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve	ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
OG002	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders	ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected19 at risk EG0011 affected14 at risk EG0021 affected17 at risk
LEUKOCYTOSIS	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected14 at risk EG0020 affected17 at risk
LYMPHADENOPATHY	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected14 at risk EG0020 affected17 at risk
TACHYCARDIA	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected14 at risk EG0020 affected17 at risk
EAR PAIN	Ear and labyrinth disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected14 at risk EG0021 affected17 at risk
EYE HAEMORRHAGE	Eye disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected14 at risk EG0021 affected17 at risk
LACRIMATION INCREASED	Eye disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
PHOTOPHOBIA	Eye disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected14 at risk EG0020 affected17 at risk
ABDOMINAL DISCOMFORT	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0021 affected17 at risk
ABDOMINAL DISTENSION	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected14 at risk EG0020 affected17 at risk
CHEILITIS	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected14 at risk EG0021 affected17 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
DENTAL CARIES	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected14 at risk EG0020 affected17 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected19 at risk EG0011 affected14 at risk EG0022 affected17 at risk
DYSPEPSIA	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected14 at risk EG0020 affected17 at risk
EPIGASTRIC DISCOMFORT	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected14 at risk EG0021 affected17 at risk
FLATULENCE	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected14 at risk EG0021 affected17 at risk
FREQUENT BOWEL MOVEMENTS	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
GASTRITIS	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0004 affected19 at risk EG0013 affected14 at risk EG0024 affected17 at risk
VOMITING	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0013 affected14 at risk EG0020 affected17 at risk
ASTHENIA	General disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
CHEST PAIN	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected14 at risk EG0020 affected17 at risk
CHILLS	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected14 at risk EG0021 affected17 at risk
ENERGY INCREASED	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected14 at risk EG0020 affected17 at risk
FATIGUE	General disorders	MedDRA 15.0	Systematic Assessment	EG0009 affected19 at risk EG0016 affected14 at risk EG0026 affected17 at risk
FEELING ABNORMAL	General disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
HUNGER	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected14 at risk EG0021 affected17 at risk
INFLUENZA LIKE ILLNESS	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected14 at risk EG0020 affected17 at risk
INJECTION SITE REACTION	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected14 at risk EG0021 affected17 at risk
IRRITABILITY	General disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0012 affected14 at risk EG0021 affected17 at risk
NON-CARDIAC CHEST PAIN	General disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA 15.0	Systematic Assessment	EG0003 affected19 at risk EG0011 affected14 at risk EG0020 affected17 at risk
PAIN	General disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
PYREXIA	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected14 at risk EG0021 affected17 at risk
HYPERBILIRUBINAEMIA	Hepatobiliary disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
SEASONAL ALLERGY	Immune system disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
BODY TINEA	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
BRONCHITIS	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
CELLULITIS	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
FOLLICULITIS	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected14 at risk EG0020 affected17 at risk
GASTROENTERITIS	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected14 at risk EG0021 affected17 at risk
HORDEOLUM	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected14 at risk EG0021 affected17 at risk
INFLUENZA	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected14 at risk EG0021 affected17 at risk
PNEUMONIA	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected14 at risk EG0021 affected17 at risk
SINUSITIS	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected14 at risk EG0020 affected17 at risk
TINEA PEDIS	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected14 at risk EG0020 affected17 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0002 affected19 at risk EG0010 affected14 at risk EG0021 affected17 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
VIRAL UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected14 at risk EG0020 affected17 at risk
LACERATION	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected14 at risk EG0020 affected17 at risk
MUSCLE STRAIN	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected14 at risk EG0020 affected17 at risk
PROCEDURAL PAIN	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected14 at risk EG0020 affected17 at risk
SUNBURN	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected14 at risk EG0020 affected17 at risk
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0021 affected17 at risk
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
BLOOD CREATININE INCREASED	Investigations	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
BLOOD OESTROGEN INCREASED	Investigations	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected14 at risk EG0021 affected17 at risk
CREATININE RENAL CLEARANCE DECREASED	Investigations	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
ELECTROCARDIOGRAM QT PROLONGED	Investigations	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
HEART RATE INCREASED	Investigations	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected14 at risk EG0021 affected17 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected19 at risk EG0012 affected14 at risk EG0020 affected17 at risk
DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected14 at risk EG0021 affected17 at risk
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected14 at risk EG0021 affected17 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0012 affected14 at risk EG0020 affected17 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected19 at risk EG0011 affected14 at risk EG0021 affected17 at risk
FLANK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0021 affected17 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected14 at risk EG0021 affected17 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected14 at risk EG0020 affected17 at risk
COGNITIVE DISORDER	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected14 at risk EG0020 affected17 at risk
COORDINATION ABNORMAL	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected14 at risk EG0021 affected17 at risk
DIZZINESS	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0014 affected14 at risk EG0024 affected17 at risk
DYSGEUSIA	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0011 affected14 at risk EG0021 affected17 at risk
HEADACHE	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0005 affected19 at risk EG0012 affected14 at risk EG0023 affected17 at risk
HYPOAESTHESIA	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
LETHARGY	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected14 at risk EG0021 affected17 at risk
MEMORY IMPAIRMENT	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
MIGRAINE	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected14 at risk EG0021 affected17 at risk
PARAESTHESIA	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected19 at risk EG0012 affected14 at risk EG0020 affected17 at risk
POOR QUALITY SLEEP	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0012 affected14 at risk EG0020 affected17 at risk
SINUS HEADACHE	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected14 at risk EG0021 affected17 at risk
TREMOR	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
ABNORMAL DREAMS	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected14 at risk EG0020 affected17 at risk
AFFECT LABILITY	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
AGITATION	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0011 affected14 at risk EG0020 affected17 at risk
ANXIETY	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected14 at risk EG0021 affected17 at risk
CONFUSIONAL STATE	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected14 at risk EG0021 affected17 at risk
DEPRESSED MOOD	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected14 at risk EG0020 affected17 at risk
DEPRESSION	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
DISORIENTATION	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected14 at risk EG0020 affected17 at risk
HYPERVIGILANCE	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected14 at risk EG0020 affected17 at risk
INSOMNIA	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0005 affected19 at risk EG0013 affected14 at risk EG0020 affected17 at risk
LIBIDO DECREASED	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
NERVOUSNESS	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected14 at risk EG0021 affected17 at risk
SLEEP DISORDER	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected14 at risk EG0020 affected17 at risk
DYSURIA	Renal and urinary disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected19 at risk EG0011 affected14 at risk EG0020 affected17 at risk
MICTURITION URGENCY	Renal and urinary disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
POLLAKIURIA	Renal and urinary disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
RENAL FAILURE ACUTE	Renal and urinary disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
DYSPAREUNIA	Reproductive system and breast disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected14 at risk EG0021 affected17 at risk
VULVOVAGINAL DRYNESS	Reproductive system and breast disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected19 at risk EG0010 affected14 at risk EG0021 affected17 at risk
DYSPNOEA EXERTIONAL	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0021 affected17 at risk
HAEMOPTYSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
NASAL CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected14 at risk EG0020 affected17 at risk
PARANASAL SINUS HYPERSECRETION	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
PRODUCTIVE COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
RESPIRATORY TRACT CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0021 affected17 at risk
SINUS CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected14 at risk EG0021 affected17 at risk
ALOPECIA	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected14 at risk EG0021 affected17 at risk
COLD SWEAT	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected14 at risk EG0020 affected17 at risk
DERMATITIS CONTACT	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected14 at risk EG0020 affected17 at risk
DRY SKIN	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
DYSHIDROSIS	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0004 affected19 at risk EG0010 affected14 at risk EG0022 affected17 at risk
PRURITUS GENERALISED	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0003 affected19 at risk EG0011 affected14 at risk EG0020 affected17 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0004 affected19 at risk EG0011 affected14 at risk EG0021 affected17 at risk
SKIN ODOUR ABNORMAL	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0011 affected14 at risk EG0020 affected17 at risk
URTICARIA	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
FLUSHING	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected14 at risk EG0020 affected17 at risk
HOT FLUSH	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected19 at risk EG0011 affected14 at risk EG0020 affected17 at risk
HYPERTENSION	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected19 at risk EG0010 affected14 at risk EG0021 affected17 at risk

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

ID	Term
C585405	paritaprevir
C588260	dasabuvir
D012254	Ribavirin
D019438	Ritonavir

ID	Term
D012263	Ribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Title	Description	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naive	ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	19	17	19
EG001	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naive	ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.	14	13	14
EG002	ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders	ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.	17	13	17