A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection

• Sponsor: AbbVie (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02243293
• Collaborator: (none)
• Enrollment: 694
• Arms: 22
• Duration (Months): 29.2

Study Details

Study Description

Brief Summary

The purpose of this phase 2/3, open-label, multipart, multicenter study was to evaluate the efficacy, and safety of co-administration of ABT-493 and ABT-530 with and without ribavirin (RBV) in chronic HCV genotype 2 (GT2-), genotype 3 (GT3-), genotype 4 (GT4), genotype 5 (GT5-), or genotype 6 (GT6-) infected participants with or without cirrhosis.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis C; Hepatitis C Virus	Drug: ABT-493; Drug: ABT-530; Drug: ribavirin (RBV); Drug: ABT-493/ABT-530	Phase 2/Phase 3

Detailed Description

The study consisted of four independent parts with treatment and post-treatment periods of enrollment. Parts 1 and 2 were the supportive/ exploratory parts (phase 2) of the study and part 3 and 4 were the confirmatory/ registrational parts (phase 3) of the study. In parts 1 and 2 of the study, ABT-493 and ABT-530 were co-administered as separate tablets. However, in parts 3 and 4 of the study, the ABT-493/ABT-530 co-formulated tablets were administered.

Study Design

• Study Type: Interventional
• Actual Enrollment: 694 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection (SURVEYOR-II)
• Study Start Date: Sep 19, 2014
• Actual Primary Completion Date: Oct 25, 2016
• Actual Study Completion Date: Feb 23, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.	Drug: ABT-493; Tablet; Other Names: glecaprevir ; Drug: ABT-530; Tablet; Other Names: pibrentasvir
Experimental: Arm B ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.	Drug: ABT-493; Tablet; Other Names: glecaprevir ; Drug: ABT-530; Tablet; Other Names: pibrentasvir
Experimental: Arm C ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.	Drug: ABT-493; Tablet; Other Names: glecaprevir ; Drug: ABT-530; Tablet; Other Names: pibrentasvir ; Drug: ribavirin (RBV); Tablet
Experimental: Arm D ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.	Drug: ABT-493; Tablet; Other Names: glecaprevir ; Drug: ABT-530; Tablet; Other Names: pibrentasvir
Experimental: Arm E ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.	Drug: ABT-493; Tablet; Other Names: glecaprevir ; Drug: ABT-530; Tablet; Other Names: pibrentasvir
Experimental: Arm F ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.	Drug: ABT-493; Tablet; Other Names: glecaprevir ; Drug: ABT-530; Tablet; Other Names: pibrentasvir ; Drug: ribavirin (RBV); Tablet
Experimental: Arm G ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.	Drug: ABT-493; Tablet; Other Names: glecaprevir ; Drug: ABT-530; Tablet; Other Names: pibrentasvir
Experimental: Arm H ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.	Drug: ABT-493; Tablet; Other Names: glecaprevir ; Drug: ABT-530; Tablet; Other Names: pibrentasvir
Experimental: Arm I ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.	Drug: ABT-493; Tablet; Other Names: glecaprevir ; Drug: ABT-530; Tablet; Other Names: pibrentasvir
Experimental: Arm J ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.	Drug: ABT-493; Tablet; Other Names: glecaprevir ; Drug: ABT-530; Tablet; Other Names: pibrentasvir
Experimental: Arm K ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.	Drug: ABT-493; Tablet; Other Names: glecaprevir ; Drug: ABT-530; Tablet; Other Names: pibrentasvir
Experimental: Arm L ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.	Drug: ABT-493; Tablet; Other Names: glecaprevir ; Drug: ABT-530; Tablet; Other Names: pibrentasvir
Experimental: Arm M ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis.	Drug: ABT-493; Tablet; Other Names: glecaprevir ; Drug: ABT-530; Tablet; Other Names: pibrentasvir
Experimental: Arm N ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD and ribavirin (RBV) (800 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis.	Drug: ABT-493; Tablet; Other Names: glecaprevir ; Drug: ABT-530; Tablet; Other Names: pibrentasvir ; Drug: ribavirin (RBV); Tablet
Experimental: Arm O ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.	Drug: ABT-493; Tablet; Other Names: glecaprevir ; Drug: ABT-530; Tablet; Other Names: pibrentasvir
Experimental: Arm P ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.	Drug: ABT-493; Tablet; Other Names: glecaprevir ; Drug: ABT-530; Tablet; Other Names: pibrentasvir ; Drug: ribavirin (RBV); Tablet
Experimental: Arm Q1 ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.	Drug: ABT-493/ABT-530; Tablet; ABT-493 co-formulated ABT-530; Other Names: ABT-493 also known as glecaprevir ABT-530 also known as pibrentasvir MAVYRET
Experimental: Arm Q2 ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.	Drug: ABT-493/ABT-530; Tablet; ABT-493 co-formulated ABT-530; Other Names: ABT-493 also known as glecaprevir ABT-530 also known as pibrentasvir MAVYRET
Experimental: Arm R1 ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.	Drug: ABT-493/ABT-530; Tablet; ABT-493 co-formulated ABT-530; Other Names: ABT-493 also known as glecaprevir ABT-530 also known as pibrentasvir MAVYRET
Experimental: Arm R2 ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.	Drug: ABT-493/ABT-530; Tablet; ABT-493 co-formulated ABT-530; Other Names: ABT-493 also known as glecaprevir ABT-530 also known as pibrentasvir MAVYRET
Experimental: Arm S1 ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.	Drug: ABT-493/ABT-530; Tablet; ABT-493 co-formulated ABT-530; Other Names: ABT-493 also known as glecaprevir ABT-530 also known as pibrentasvir MAVYRET
Experimental: Arm S2 ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.	Drug: ABT-493/ABT-530; Tablet; ABT-493 co-formulated ABT-530; Other Names: ABT-493 also known as glecaprevir ABT-530 also known as pibrentasvir MAVYRET

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [12 weeks after the last actual dose of study drug]

   SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.

2. Percentage of Genotype 2 (GT2) Direct-acting Antiviral Agents (DAA)-Naive Participants (in Part 4, Arm S1) With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) as Compared to Historical Control [12 weeks after the last actual dose of study drug]

   SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.

Secondary Outcome Measures

1. Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4) [4 weeks after the last actual dose of study drug]

   SVR4 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 4 weeks after the last dose of study drug.

2. Percentage of Participants With On-treatment Virologic Failure [Up to end of treatment (treatment week 8, 12 or 16 depending on arm) or premature discontinuation from treatment]

   On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.

3. Percentage of Participants With Post-treatment Relapse [From the end of treatment through 12 weeks after the last dose of study drug]

   Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Screening laboratory result indicating HCV Genotype 2, 3, 4, 5, or 6 infection.

• Chronic HCV infection.

• Participant had to be either HCV treatment-naïve or treatment-experienced.

• Participant had to be documented as non-cirrhotic or as having compensated cirrhosis (GT3 only).

Exclusion Criteria:

• History of severe, life-threatening or other significant sensitivity to any drug.

• Female who was pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner was pregnant or planning to become pregnant during the study.

• Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.

• Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).

• HCV genotype performed during screening indicating co-infection with more than one HCV genotype.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• AbbVie

Investigators

• Study Director: AbbVie Inc., AbbVie

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

• Kwo PY, Poordad F, Asatryan A, Wang S, Wyles DL, Hassanein T, Felizarta F, Sulkowski MS, Gane E, Maliakkal B, Overcash JS, Gordon SC, Muir AJ, Aguilar H, Agarwal K, Dore GJ, Lin CW, Liu R, Lovell SS, Ng TI, Kort J, Mensa FJ. Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1-6 without cirrhosis. J Hepatol. 2017 Aug;67(2):263-271. doi: 10.1016/j.jhep.2017.03.039. Epub 2017 Apr 13.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT02243293
• Other Study ID Numbers: M14-868; 2014-002927-90
• First Posted: Sep 17, 2014
• Last Update Posted: Jul 30, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by AbbVie: Hepatitis C Virus (HCV); Hepatitis C; Chronic Hepatitis C; interferon free; Hepatitis C Genotype 2; Hepatitis C Genotype 3; Hepatitis C Genotype 4; Hepatitis C Genotype 5; Hepatitis C Genotype 6
• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Ribavirin

Study Results

Participant Flow

Recruitment Details	Enrollment into arms H, I, K, M and N was not opened by AbbVie.
Pre-assignment Detail	Intent-to-treat population: all participants who received at least 1 dose of study drug

Arm/Group Title	Arm A	Arm B	Arm C	Arm D	Arm E	Arm F	Arm G	Arm H	Arm I	Arm J	Arm K	Arm L	Arm M	Arm N	Arm O	Arm P	Arm Q1	Arm Q2	Arm R1	Arm R2	Arm S1	Arm S2
Arm/Group Description	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.	ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis.	ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD and ribavirin (RBV) (800 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.
Period Title: Overall Study
STARTED	25	24	25	30	31	31	30	0	0	55	0	53	0	0	28	27	40	22	22	48	145	58
COMPLETED	23	23	24	29	30	31	27	0	0	53	0	50	0	0	27	26	37	21	22	47	143	55
NOT COMPLETED	2	1	1	1	1	0	3	0	0	2	0	3	0	0	1	1	3	1	0	1	2	3

Baseline Characteristics

Arm/Group Title	Arm A	Arm B	Arm C	Arm D	Arm E	Arm F	Arm G	Arm J	Arm L	Arm O	Arm P	Arm Q1	Arm Q2	Arm R1	Arm R2	Arm S1	Arm S2	Total
Arm/Group Description	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.	Total of all reporting groups
Overall Participants	25	24	25	30	30	31	30	54	53	28	27	40	22	22	47	145	58	691
Age, Customized (participants) [Number]
< 65 years	21 84%	21 87.5%	22 88%	28 93.3%	29 96.7%	30 96.8%	28 93.3%	44 81.5%	52 98.1%	26 92.9%	24 88.9%	38 95%	18 81.8%	19 86.4%	39 83%	128 88.3%	49 84.5%	616 89.1%
>= 65 years	4 16%	3 12.5%	3 12%	2 6.7%	1 3.3%	1 3.2%	2 6.7%	10 18.5%	1 1.9%	2 7.1%	3 11.1%	2 5%	4 18.2%	3 13.6%	8 17%	17 11.7%	9 15.5%	75 10.9%
Sex: Female, Male (Count of Participants)
Female	9 36%	11 45.8%	7 28%	11 36.7%	16 53.3%	12 38.7%	15 50%	21 38.9%	21 39.6%	13 46.4%	9 33.3%	16 40%	8 36.4%	8 36.4%	11 23.4%	84 57.9%	21 36.2%	293 42.4%
Male	16 64%	13 54.2%	18 72%	19 63.3%	14 46.7%	19 61.3%	15 50%	33 61.1%	32 60.4%	15 53.6%	18 66.7%	24 60%	14 63.6%	14 63.6%	36 76.6%	61 42.1%	37 63.8%	398 57.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 4%	2 8.3%	4 16%	4 13.3%	3 10%	5 16.1%	5 16.7%	6 11.1%	2 3.8%	4 14.3%	2 7.4%	9 22.5%	1 4.5%	0 0%	4 8.5%	11 7.6%	2 3.4%	65 9.4%
Not Hispanic or Latino	24 96%	22 91.7%	21 84%	26 86.7%	27 90%	26 83.9%	25 83.3%	48 88.9%	51 96.2%	24 85.7%	25 92.6%	31 77.5%	21 95.5%	22 100%	43 91.5%	134 92.4%	56 96.6%	626 90.6%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Description	SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.
Time Frame	12 weeks after the last actual dose of study drug

Outcome Measure Data

Analysis Population Description

All participants who received at least 1 dose of study drug (ITT population) with evaluable data; participants with missing data after backwards imputation were imputed as nonresponders.

Arm/Group Title	Arm A	Arm B	Arm C	Arm D	Arm E	Arm F	Arm G	Arm J	Arm L	Arm O	Arm P	Arm Q1	Arm Q2	Arm R1	Arm R2	Arm S1	Arm S2
Arm/Group Description	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.
Measure Participants	25	24	25	30	30	31	30	54	53	28	27	40	22	22	47	145	58
Number (95% Confidence Interval) [percentage of participants]	96.0 384%	100.0 416.7%	100.0 400%	93.3 311%	93.3 311%	93.5 301.6%	83.3 277.7%	98.1 181.7%	94.3 177.9%	96.4 344.3%	100.0 370.4%	97.5 243.8%	90.9 413.2%	95.5 434.1%	95.7 203.6%	97.9 67.5%	93.1 160.5%

2. Primary Outcome

Title	Percentage of Genotype 2 (GT2) Direct-acting Antiviral Agents (DAA)-Naive Participants (in Part 4, Arm S1) With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) as Compared to Historical Control
Description	SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.
Time Frame	12 weeks after the last actual dose of study drug

Outcome Measure Data

Analysis Population Description

All participants who received at least 1 dose of study drug (ITT population) with evaluable data; participants with missing data after backwards imputation were imputed as nonresponders.

Arm/Group Title	Arm S1
Arm/Group Description	ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.
Measure Participants	137
Number (95% Confidence Interval) [percentage of participants]	98.5 394%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm A
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	The non-inferiority of the rate of sustained virologic response at 12 weeks after treatment as compared to historical control (in genotype 2 (GT2) DAA-naive participants in Part 4, arm S) was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 89% to achieve noninferiority.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage of Participants
	Estimated Value	98.5
	Confidence Interval	(2-Sided) 95%; 96.5 to 100.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	95% CI was calculated using the normal approximation to the binomial distribution.

3. Secondary Outcome

Title	Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4)
Description	SVR4 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 4 weeks after the last dose of study drug.
Time Frame	4 weeks after the last actual dose of study drug

Outcome Measure Data

Analysis Population Description

All participants who received at least 1 dose of study drug (ITT population) with evaluable data; participants with missing data after backwards imputation were imputed as nonresponders.

Arm/Group Title	Arm A	Arm B	Arm C	Arm D	Arm E	Arm F	Arm G	Arm J	Arm L	Arm O	Arm P	Arm Q1	Arm Q2	Arm R1	Arm R2	Arm S1	Arm S2
Arm/Group Description	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.
Measure Participants	25	24	25	30	30	31	30	54	53	28	27	40	22	22	47	145	58
Number (95% Confidence Interval) [percentage of participants]	96.0 384%	100.0 416.7%	100.0 400%	93.3 311%	93.3 311%	93.5 301.6%	93.3 311%	98.1 181.7%	96.2 181.5%	96.4 344.3%	100.0 370.4%	97.5 243.8%	95.5 434.1%	95.5 434.1%	95.7 203.6%	97.9 67.5%	98.3 169.5%

4. Secondary Outcome

Title	Percentage of Participants With On-treatment Virologic Failure
Description	On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.
Time Frame	Up to end of treatment (treatment week 8, 12 or 16 depending on arm) or premature discontinuation from treatment

Outcome Measure Data

Analysis Population Description

All participants who received at least 1 dose of study drug (ITT population) with evaluable data.

Arm/Group Title	Arm A	Arm B	Arm C	Arm D	Arm E	Arm F	Arm G	Arm J	Arm L	Arm O	Arm P	Arm Q1	Arm Q2	Arm R1	Arm R2	Arm S1	Arm S2
Arm/Group Description	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.
Measure Participants	25	24	25	30	30	31	30	54	53	28	27	40	22	22	47	145	58
Number (95% Confidence Interval) [percentage of participants]	0 0%	0 0%	0 0%	0 0%	0 0%	3.2 10.3%	3.3 11%	0 0%	1.9 3.6%	0 0%	0 0%	0 0%	0 0%	0 0%	2.1 4.5%	0 0%	0 0%

5. Secondary Outcome

Title	Percentage of Participants With Post-treatment Relapse
Description	Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.
Time Frame	From the end of treatment through 12 weeks after the last dose of study drug

Outcome Measure Data

Analysis Population Description

All participants who received at least 1 dose of study drug (ITT population) with evaluable data, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.

Arm/Group Title	Arm A	Arm B	Arm C	Arm D	Arm E	Arm F	Arm G	Arm J	Arm L	Arm O	Arm P	Arm Q1	Arm Q2	Arm R1	Arm R2	Arm S1	Arm S2
Arm/Group Description	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.	ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.
Measure Participants	24	24	25	29	30	28	28	53	51	28	27	39	22	22	46	144	57
Number (95% Confidence Interval) [percentage of participants]	0.0 0%	0.0 0%	0.0 0%	3.4 11.3%	6.7 22.3%	0.0 0%	7.1 23.7%	0.0 0%	2.0 3.8%	3.6 12.9%	0.0 0%	0 0%	9.1 41.4%	4.5 20.5%	2.2 4.7%	1.4 1%	0 0%

Adverse Events

Time Frame	Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 20 weeks).
Adverse Event Reporting Description	TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Arm/Group Title	ARM A		ARM B		ARM C		ARM D		ARM E		ARM F		ARM G		ARM J		ARM L		ARM O		ARM P		ARM Q1		ARM Q2		ARM R1		ARM R2		ARM S1		ARM S2
Arm/Group Description	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.		ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.		ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.		ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.		ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.		ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.		ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.		ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.		ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.		ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.		ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.		ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.		ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.		ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.		ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.		ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.		ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.
All Cause Mortality
	ARM A		ARM B		ARM C		ARM D		ARM E		ARM F		ARM G		ARM J		ARM L		ARM O		ARM P		ARM Q1		ARM Q2		ARM R1		ARM R2		ARM S1		ARM S2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/25 (4%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		0/30 (0%)		0/31 (0%)		0/30 (0%)		0/54 (0%)		0/53 (0%)		0/28 (0%)		1/27 (3.7%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		1/145 (0.7%)		0/58 (0%)
Serious Adverse Events
	ARM A		ARM B		ARM C		ARM D		ARM E		ARM F		ARM G		ARM J		ARM L		ARM O		ARM P		ARM Q1		ARM Q2		ARM R1		ARM R2		ARM S1		ARM S2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/24 (0%)		1/25 (4%)		0/30 (0%)		0/30 (0%)		2/31 (6.5%)		0/30 (0%)		1/54 (1.9%)		1/53 (1.9%)		2/28 (7.1%)		2/27 (7.4%)		1/40 (2.5%)		1/22 (4.5%)		1/22 (4.5%)		3/47 (6.4%)		1/145 (0.7%)		1/58 (1.7%)
Blood and lymphatic system disorders
Anaemia	0/25 (0%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		0/30 (0%)		0/31 (0%)		0/30 (0%)		0/54 (0%)		0/53 (0%)		0/28 (0%)		1/27 (3.7%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		0/145 (0%)		0/58 (0%)
Cardiac disorders
Angina pectoris	0/25 (0%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		0/30 (0%)		0/31 (0%)		0/30 (0%)		0/54 (0%)		0/53 (0%)		0/28 (0%)		0/27 (0%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		1/47 (2.1%)		0/145 (0%)		0/58 (0%)
Atrial fibrillation	0/25 (0%)		0/24 (0%)		1/25 (4%)		0/30 (0%)		0/30 (0%)		0/31 (0%)		0/30 (0%)		0/54 (0%)		0/53 (0%)		0/28 (0%)		0/27 (0%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		0/145 (0%)		0/58 (0%)
Gastrointestinal disorders
Umbilical hernia	0/25 (0%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		0/30 (0%)		0/31 (0%)		0/30 (0%)		0/54 (0%)		0/53 (0%)		0/28 (0%)		0/27 (0%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		1/47 (2.1%)		0/145 (0%)		0/58 (0%)
Hepatobiliary disorders
Cholecystitis	0/25 (0%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		0/30 (0%)		0/31 (0%)		0/30 (0%)		0/54 (0%)		0/53 (0%)		0/28 (0%)		0/27 (0%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		1/145 (0.7%)		0/58 (0%)
Infections and infestations
Appendicitis	0/25 (0%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		0/30 (0%)		0/31 (0%)		0/30 (0%)		0/54 (0%)		1/53 (1.9%)		0/28 (0%)		0/27 (0%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		0/145 (0%)		0/58 (0%)
Cellulitis	0/25 (0%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		0/30 (0%)		0/31 (0%)		0/30 (0%)		1/54 (1.9%)		0/53 (0%)		0/28 (0%)		0/27 (0%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		0/145 (0%)		0/58 (0%)
Pneumonia	0/25 (0%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		0/30 (0%)		1/31 (3.2%)		0/30 (0%)		0/54 (0%)		0/53 (0%)		0/28 (0%)		0/27 (0%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		0/145 (0%)		0/58 (0%)
Urosepsis	0/25 (0%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		0/30 (0%)		0/31 (0%)		0/30 (0%)		0/54 (0%)		0/53 (0%)		0/28 (0%)		0/27 (0%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		0/145 (0%)		1/58 (1.7%)
Injury, poisoning and procedural complications
Tibia fracture	0/25 (0%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		0/30 (0%)		0/31 (0%)		0/30 (0%)		0/54 (0%)		0/53 (0%)		1/28 (3.6%)		0/27 (0%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		0/145 (0%)		0/58 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma	0/25 (0%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		0/30 (0%)		1/31 (3.2%)		0/30 (0%)		0/54 (0%)		0/53 (0%)		0/28 (0%)		0/27 (0%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		0/145 (0%)		0/58 (0%)
Colon cancer	0/25 (0%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		0/30 (0%)		0/31 (0%)		0/30 (0%)		0/54 (0%)		0/53 (0%)		0/28 (0%)		0/27 (0%)		1/40 (2.5%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		0/145 (0%)		0/58 (0%)
Hepatic neoplasm	0/25 (0%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		0/30 (0%)		0/31 (0%)		0/30 (0%)		0/54 (0%)		0/53 (0%)		1/28 (3.6%)		0/27 (0%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		0/145 (0%)		0/58 (0%)
Squamous cell carcinoma of skin	0/25 (0%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		0/30 (0%)		0/31 (0%)		0/30 (0%)		0/54 (0%)		0/53 (0%)		0/28 (0%)		0/27 (0%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		1/47 (2.1%)		0/145 (0%)		0/58 (0%)
Psychiatric disorders
Delusional disorder, unspecified type	0/25 (0%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		0/30 (0%)		0/31 (0%)		0/30 (0%)		0/54 (0%)		0/53 (0%)		0/28 (0%)		1/27 (3.7%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		0/145 (0%)		0/58 (0%)
Schizophrenia	0/25 (0%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		0/30 (0%)		0/31 (0%)		0/30 (0%)		0/54 (0%)		0/53 (0%)		0/28 (0%)		0/27 (0%)		0/40 (0%)		1/22 (4.5%)		0/22 (0%)		0/47 (0%)		0/145 (0%)		0/58 (0%)
Respiratory, thoracic and mediastinal disorders
Pleural effusion	0/25 (0%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		0/30 (0%)		0/31 (0%)		0/30 (0%)		0/54 (0%)		0/53 (0%)		0/28 (0%)		0/27 (0%)		0/40 (0%)		0/22 (0%)		1/22 (4.5%)		0/47 (0%)		0/145 (0%)		0/58 (0%)
Other (Not Including Serious) Adverse Events
	ARM A		ARM B		ARM C		ARM D		ARM E		ARM F		ARM G		ARM J		ARM L		ARM O		ARM P		ARM Q1		ARM Q2		ARM R1		ARM R2		ARM S1		ARM S2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/25 (48%)		11/24 (45.8%)		22/25 (88%)		19/30 (63.3%)		20/30 (66.7%)		23/31 (74.2%)		18/30 (60%)		26/54 (48.1%)		40/53 (75.5%)		20/28 (71.4%)		21/27 (77.8%)		30/40 (75%)		12/22 (54.5%)		13/22 (59.1%)		31/47 (66%)		78/145 (53.8%)		32/58 (55.2%)
Blood and lymphatic system disorders
Anaemia	0/25 (0%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		0/30 (0%)		2/31 (6.5%)		0/30 (0%)		0/54 (0%)		0/53 (0%)		0/28 (0%)		0/27 (0%)		0/40 (0%)		0/22 (0%)		1/22 (4.5%)		0/47 (0%)		0/145 (0%)		1/58 (1.7%)
Ear and labyrinth disorders
Ear pain	0/25 (0%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		0/30 (0%)		0/31 (0%)		0/30 (0%)		0/54 (0%)		0/53 (0%)		0/28 (0%)		0/27 (0%)		2/40 (5%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		0/145 (0%)		0/58 (0%)
Gastrointestinal disorders
Abdominal discomfort	0/25 (0%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		0/30 (0%)		0/31 (0%)		0/30 (0%)		0/54 (0%)		4/53 (7.5%)		0/28 (0%)		2/27 (7.4%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		0/145 (0%)		0/58 (0%)
Abdominal distension	0/25 (0%)		1/24 (4.2%)		0/25 (0%)		0/30 (0%)		0/30 (0%)		0/31 (0%)		0/30 (0%)		2/54 (3.7%)		3/53 (5.7%)		2/28 (7.1%)		1/27 (3.7%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		1/145 (0.7%)		0/58 (0%)
Abdominal pain	0/25 (0%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		0/30 (0%)		2/31 (6.5%)		0/30 (0%)		2/54 (3.7%)		3/53 (5.7%)		0/28 (0%)		2/27 (7.4%)		2/40 (5%)		2/22 (9.1%)		1/22 (4.5%)		2/47 (4.3%)		3/145 (2.1%)		2/58 (3.4%)
Abdominal pain lower	0/25 (0%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		0/30 (0%)		0/31 (0%)		0/30 (0%)		0/54 (0%)		0/53 (0%)		0/28 (0%)		0/27 (0%)		2/40 (5%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		1/145 (0.7%)		1/58 (1.7%)
Abdominal pain upper	1/25 (4%)		0/24 (0%)		0/25 (0%)		1/30 (3.3%)		0/30 (0%)		1/31 (3.2%)		0/30 (0%)		1/54 (1.9%)		1/53 (1.9%)		1/28 (3.6%)		0/27 (0%)		2/40 (5%)		0/22 (0%)		1/22 (4.5%)		1/47 (2.1%)		0/145 (0%)		1/58 (1.7%)
Constipation	1/25 (4%)		1/24 (4.2%)		1/25 (4%)		0/30 (0%)		0/30 (0%)		2/31 (6.5%)		1/30 (3.3%)		3/54 (5.6%)		3/53 (5.7%)		0/28 (0%)		0/27 (0%)		1/40 (2.5%)		2/22 (9.1%)		0/22 (0%)		1/47 (2.1%)		4/145 (2.8%)		0/58 (0%)
Diarrhoea	4/25 (16%)		1/24 (4.2%)		6/25 (24%)		2/30 (6.7%)		1/30 (3.3%)		2/31 (6.5%)		2/30 (6.7%)		4/54 (7.4%)		8/53 (15.1%)		6/28 (21.4%)		1/27 (3.7%)		4/40 (10%)		1/22 (4.5%)		2/22 (9.1%)		1/47 (2.1%)		4/145 (2.8%)		2/58 (3.4%)
Dyspepsia	0/25 (0%)		0/24 (0%)		3/25 (12%)		0/30 (0%)		0/30 (0%)		2/31 (6.5%)		0/30 (0%)		0/54 (0%)		2/53 (3.8%)		1/28 (3.6%)		1/27 (3.7%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		3/47 (6.4%)		4/145 (2.8%)		2/58 (3.4%)
Gastrooesophageal reflux disease	0/25 (0%)		0/24 (0%)		2/25 (8%)		0/30 (0%)		0/30 (0%)		1/31 (3.2%)		0/30 (0%)		1/54 (1.9%)		1/53 (1.9%)		1/28 (3.6%)		0/27 (0%)		0/40 (0%)		1/22 (4.5%)		0/22 (0%)		1/47 (2.1%)		2/145 (1.4%)		0/58 (0%)
Nausea	3/25 (12%)		1/24 (4.2%)		8/25 (32%)		2/30 (6.7%)		6/30 (20%)		11/31 (35.5%)		0/30 (0%)		5/54 (9.3%)		4/53 (7.5%)		3/28 (10.7%)		7/27 (25.9%)		4/40 (10%)		2/22 (9.1%)		2/22 (9.1%)		5/47 (10.6%)		18/145 (12.4%)		5/58 (8.6%)
Toothache	0/25 (0%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		0/30 (0%)		1/31 (3.2%)		0/30 (0%)		0/54 (0%)		4/53 (7.5%)		0/28 (0%)		1/27 (3.7%)		1/40 (2.5%)		0/22 (0%)		2/22 (9.1%)		0/47 (0%)		1/145 (0.7%)		0/58 (0%)
Vomiting	0/25 (0%)		1/24 (4.2%)		3/25 (12%)		0/30 (0%)		1/30 (3.3%)		4/31 (12.9%)		2/30 (6.7%)		3/54 (5.6%)		2/53 (3.8%)		2/28 (7.1%)		1/27 (3.7%)		2/40 (5%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		2/145 (1.4%)		1/58 (1.7%)
General disorders
Energy increased	0/25 (0%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		0/30 (0%)		2/31 (6.5%)		0/30 (0%)		2/54 (3.7%)		0/53 (0%)		0/28 (0%)		0/27 (0%)		0/40 (0%)		1/22 (4.5%)		0/22 (0%)		0/47 (0%)		0/145 (0%)		0/58 (0%)
Fatigue	2/25 (8%)		3/24 (12.5%)		10/25 (40%)		6/30 (20%)		5/30 (16.7%)		12/31 (38.7%)		2/30 (6.7%)		7/54 (13%)		15/53 (28.3%)		3/28 (10.7%)		8/27 (29.6%)		5/40 (12.5%)		4/22 (18.2%)		4/22 (18.2%)		16/47 (34%)		24/145 (16.6%)		13/58 (22.4%)
Feeling hot	0/25 (0%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		0/30 (0%)		2/31 (6.5%)		0/30 (0%)		0/54 (0%)		0/53 (0%)		0/28 (0%)		0/27 (0%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		1/47 (2.1%)		0/145 (0%)		0/58 (0%)
Pyrexia	0/25 (0%)		0/24 (0%)		0/25 (0%)		1/30 (3.3%)		0/30 (0%)		1/31 (3.2%)		2/30 (6.7%)		0/54 (0%)		0/53 (0%)		0/28 (0%)		1/27 (3.7%)		0/40 (0%)		0/22 (0%)		1/22 (4.5%)		0/47 (0%)		0/145 (0%)		1/58 (1.7%)
Infections and infestations
Bronchitis	2/25 (8%)		0/24 (0%)		1/25 (4%)		0/30 (0%)		2/30 (6.7%)		1/31 (3.2%)		0/30 (0%)		0/54 (0%)		0/53 (0%)		1/28 (3.6%)		1/27 (3.7%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		1/145 (0.7%)		0/58 (0%)
Gastroenteritis	0/25 (0%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		0/30 (0%)		0/31 (0%)		0/30 (0%)		1/54 (1.9%)		0/53 (0%)		1/28 (3.6%)		2/27 (7.4%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		0/145 (0%)		0/58 (0%)
Gastroenteritis viral	0/25 (0%)		0/24 (0%)		0/25 (0%)		1/30 (3.3%)		0/30 (0%)		0/31 (0%)		0/30 (0%)		0/54 (0%)		0/53 (0%)		0/28 (0%)		0/27 (0%)		2/40 (5%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		1/145 (0.7%)		0/58 (0%)
Lower respiratory tract infection	0/25 (0%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		0/30 (0%)		0/31 (0%)		0/30 (0%)		0/54 (0%)		0/53 (0%)		0/28 (0%)		1/27 (3.7%)		3/40 (7.5%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		0/145 (0%)		0/58 (0%)
Nasopharyngitis	2/25 (8%)		0/24 (0%)		0/25 (0%)		1/30 (3.3%)		2/30 (6.7%)		0/31 (0%)		2/30 (6.7%)		1/54 (1.9%)		3/53 (5.7%)		0/28 (0%)		1/27 (3.7%)		2/40 (5%)		1/22 (4.5%)		1/22 (4.5%)		3/47 (6.4%)		6/145 (4.1%)		1/58 (1.7%)
Pharyngitis	0/25 (0%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		1/30 (3.3%)		0/31 (0%)		0/30 (0%)		0/54 (0%)		0/53 (0%)		0/28 (0%)		2/27 (7.4%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		0/145 (0%)		0/58 (0%)
Sinusitis	1/25 (4%)		0/24 (0%)		4/25 (16%)		1/30 (3.3%)		2/30 (6.7%)		1/31 (3.2%)		0/30 (0%)		0/54 (0%)		1/53 (1.9%)		1/28 (3.6%)		1/27 (3.7%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		3/145 (2.1%)		0/58 (0%)
Tooth abscess	0/25 (0%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		0/30 (0%)		1/31 (3.2%)		2/30 (6.7%)		0/54 (0%)		1/53 (1.9%)		0/28 (0%)		0/27 (0%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		1/145 (0.7%)		0/58 (0%)
Upper respiratory tract infection	1/25 (4%)		1/24 (4.2%)		5/25 (20%)		4/30 (13.3%)		1/30 (3.3%)		1/31 (3.2%)		1/30 (3.3%)		1/54 (1.9%)		4/53 (7.5%)		5/28 (17.9%)		2/27 (7.4%)		3/40 (7.5%)		1/22 (4.5%)		0/22 (0%)		2/47 (4.3%)		10/145 (6.9%)		3/58 (5.2%)
Urinary tract infection	0/25 (0%)		2/24 (8.3%)		0/25 (0%)		0/30 (0%)		1/30 (3.3%)		0/31 (0%)		1/30 (3.3%)		1/54 (1.9%)		0/53 (0%)		1/28 (3.6%)		1/27 (3.7%)		2/40 (5%)		0/22 (0%)		1/22 (4.5%)		1/47 (2.1%)		7/145 (4.8%)		0/58 (0%)
Investigations
Blood bilirubin increased	0/25 (0%)		0/24 (0%)		1/25 (4%)		0/30 (0%)		0/30 (0%)		2/31 (6.5%)		0/30 (0%)		0/54 (0%)		0/53 (0%)		1/28 (3.6%)		1/27 (3.7%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		1/47 (2.1%)		0/145 (0%)		0/58 (0%)
Blood bilirubin unconjugated increased	0/25 (0%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		0/30 (0%)		2/31 (6.5%)		0/30 (0%)		0/54 (0%)		0/53 (0%)		0/28 (0%)		0/27 (0%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		0/145 (0%)		0/58 (0%)
Haematocrit decreased	0/25 (0%)		0/24 (0%)		2/25 (8%)		1/30 (3.3%)		0/30 (0%)		0/31 (0%)		0/30 (0%)		0/54 (0%)		0/53 (0%)		0/28 (0%)		0/27 (0%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		0/145 (0%)		0/58 (0%)
Haemoglobin decreased	0/25 (0%)		0/24 (0%)		4/25 (16%)		0/30 (0%)		0/30 (0%)		4/31 (12.9%)		0/30 (0%)		0/54 (0%)		0/53 (0%)		0/28 (0%)		2/27 (7.4%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		0/145 (0%)		0/58 (0%)
Weight decreased	0/25 (0%)		0/24 (0%)		2/25 (8%)		0/30 (0%)		0/30 (0%)		0/31 (0%)		0/30 (0%)		0/54 (0%)		1/53 (1.9%)		0/28 (0%)		0/27 (0%)		0/40 (0%)		1/22 (4.5%)		0/22 (0%)		0/47 (0%)		0/145 (0%)		0/58 (0%)
Metabolism and nutrition disorders
Decreased appetite	1/25 (4%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		0/30 (0%)		1/31 (3.2%)		1/30 (3.3%)		1/54 (1.9%)		0/53 (0%)		2/28 (7.1%)		0/27 (0%)		1/40 (2.5%)		0/22 (0%)		1/22 (4.5%)		2/47 (4.3%)		3/145 (2.1%)		3/58 (5.2%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/25 (4%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		0/30 (0%)		1/31 (3.2%)		2/30 (6.7%)		2/54 (3.7%)		2/53 (3.8%)		0/28 (0%)		2/27 (7.4%)		1/40 (2.5%)		0/22 (0%)		2/22 (9.1%)		1/47 (2.1%)		2/145 (1.4%)		1/58 (1.7%)
Back pain	1/25 (4%)		0/24 (0%)		0/25 (0%)		1/30 (3.3%)		1/30 (3.3%)		0/31 (0%)		2/30 (6.7%)		3/54 (5.6%)		1/53 (1.9%)		0/28 (0%)		3/27 (11.1%)		4/40 (10%)		0/22 (0%)		4/22 (18.2%)		0/47 (0%)		6/145 (4.1%)		2/58 (3.4%)
Muscle spasms	1/25 (4%)		0/24 (0%)		1/25 (4%)		1/30 (3.3%)		0/30 (0%)		1/31 (3.2%)		0/30 (0%)		0/54 (0%)		1/53 (1.9%)		0/28 (0%)		3/27 (11.1%)		1/40 (2.5%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		2/145 (1.4%)		0/58 (0%)
Musculoskeletal pain	0/25 (0%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		0/30 (0%)		0/31 (0%)		1/30 (3.3%)		0/54 (0%)		1/53 (1.9%)		2/28 (7.1%)		0/27 (0%)		1/40 (2.5%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		1/145 (0.7%)		0/58 (0%)
Myalgia	0/25 (0%)		1/24 (4.2%)		1/25 (4%)		0/30 (0%)		0/30 (0%)		2/31 (6.5%)		1/30 (3.3%)		0/54 (0%)		4/53 (7.5%)		0/28 (0%)		0/27 (0%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		1/47 (2.1%)		3/145 (2.1%)		2/58 (3.4%)
Neck pain	0/25 (0%)		0/24 (0%)		0/25 (0%)		2/30 (6.7%)		0/30 (0%)		0/31 (0%)		0/30 (0%)		0/54 (0%)		1/53 (1.9%)		0/28 (0%)		0/27 (0%)		2/40 (5%)		0/22 (0%)		1/22 (4.5%)		0/47 (0%)		0/145 (0%)		0/58 (0%)
Nervous system disorders
Dizziness	2/25 (8%)		0/24 (0%)		0/25 (0%)		1/30 (3.3%)		1/30 (3.3%)		5/31 (16.1%)		0/30 (0%)		0/54 (0%)		1/53 (1.9%)		2/28 (7.1%)		4/27 (14.8%)		4/40 (10%)		1/22 (4.5%)		0/22 (0%)		1/47 (2.1%)		7/145 (4.8%)		2/58 (3.4%)
Dysgeusia	1/25 (4%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		0/30 (0%)		2/31 (6.5%)		0/30 (0%)		0/54 (0%)		1/53 (1.9%)		0/28 (0%)		1/27 (3.7%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		3/145 (2.1%)		0/58 (0%)
Headache	1/25 (4%)		3/24 (12.5%)		6/25 (24%)		4/30 (13.3%)		3/30 (10%)		6/31 (19.4%)		5/30 (16.7%)		6/54 (11.1%)		17/53 (32.1%)		5/28 (17.9%)		9/27 (33.3%)		10/40 (25%)		5/22 (22.7%)		4/22 (18.2%)		6/47 (12.8%)		17/145 (11.7%)		11/58 (19%)
Hypoaesthesia	0/25 (0%)		0/24 (0%)		2/25 (8%)		0/30 (0%)		0/30 (0%)		0/31 (0%)		0/30 (0%)		0/54 (0%)		0/53 (0%)		0/28 (0%)		1/27 (3.7%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		1/47 (2.1%)		0/145 (0%)		0/58 (0%)
Migraine	0/25 (0%)		0/24 (0%)		2/25 (8%)		0/30 (0%)		0/30 (0%)		0/31 (0%)		0/30 (0%)		2/54 (3.7%)		0/53 (0%)		1/28 (3.6%)		0/27 (0%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		1/145 (0.7%)		0/58 (0%)
Psychiatric disorders
Anxiety	0/25 (0%)		0/24 (0%)		2/25 (8%)		1/30 (3.3%)		2/30 (6.7%)		0/31 (0%)		1/30 (3.3%)		4/54 (7.4%)		1/53 (1.9%)		0/28 (0%)		1/27 (3.7%)		0/40 (0%)		1/22 (4.5%)		0/22 (0%)		3/47 (6.4%)		6/145 (4.1%)		2/58 (3.4%)
Depression	0/25 (0%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		2/30 (6.7%)		0/31 (0%)		2/30 (6.7%)		0/54 (0%)		0/53 (0%)		0/28 (0%)		2/27 (7.4%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		1/47 (2.1%)		4/145 (2.8%)		1/58 (1.7%)
Emotional disorder	0/25 (0%)		0/24 (0%)		0/25 (0%)		0/30 (0%)		0/30 (0%)		0/31 (0%)		0/30 (0%)		0/54 (0%)		0/53 (0%)		0/28 (0%)		2/27 (7.4%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		0/145 (0%)		0/58 (0%)
Insomnia	0/25 (0%)		0/24 (0%)		2/25 (8%)		1/30 (3.3%)		2/30 (6.7%)		3/31 (9.7%)		1/30 (3.3%)		3/54 (5.6%)		5/53 (9.4%)		0/28 (0%)		5/27 (18.5%)		1/40 (2.5%)		0/22 (0%)		0/22 (0%)		3/47 (6.4%)		1/145 (0.7%)		2/58 (3.4%)
Irritability	0/25 (0%)		1/24 (4.2%)		1/25 (4%)		0/30 (0%)		0/30 (0%)		4/31 (12.9%)		0/30 (0%)		2/54 (3.7%)		0/53 (0%)		0/28 (0%)		4/27 (14.8%)		1/40 (2.5%)		0/22 (0%)		1/22 (4.5%)		1/47 (2.1%)		2/145 (1.4%)		0/58 (0%)
Mood swings	0/25 (0%)		0/24 (0%)		1/25 (4%)		0/30 (0%)		0/30 (0%)		0/31 (0%)		1/30 (3.3%)		0/54 (0%)		3/53 (5.7%)		0/28 (0%)		0/27 (0%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		0/145 (0%)		1/58 (1.7%)
Renal and urinary disorders
Pollakiuria	0/25 (0%)		0/24 (0%)		1/25 (4%)		0/30 (0%)		0/30 (0%)		0/31 (0%)		0/30 (0%)		1/54 (1.9%)		0/53 (0%)		2/28 (7.1%)		0/27 (0%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		0/145 (0%)		0/58 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	0/25 (0%)		1/24 (4.2%)		1/25 (4%)		1/30 (3.3%)		2/30 (6.7%)		4/31 (12.9%)		0/30 (0%)		1/54 (1.9%)		2/53 (3.8%)		0/28 (0%)		3/27 (11.1%)		1/40 (2.5%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		3/145 (2.1%)		5/58 (8.6%)
Dyspnoea	0/25 (0%)		0/24 (0%)		1/25 (4%)		2/30 (6.7%)		0/30 (0%)		3/31 (9.7%)		0/30 (0%)		0/54 (0%)		0/53 (0%)		0/28 (0%)		1/27 (3.7%)		0/40 (0%)		1/22 (4.5%)		0/22 (0%)		0/47 (0%)		0/145 (0%)		0/58 (0%)
Dyspnoea exertional	0/25 (0%)		0/24 (0%)		3/25 (12%)		0/30 (0%)		0/30 (0%)		2/31 (6.5%)		1/30 (3.3%)		0/54 (0%)		1/53 (1.9%)		0/28 (0%)		0/27 (0%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		0/145 (0%)		0/58 (0%)
Nasal congestion	0/25 (0%)		0/24 (0%)		2/25 (8%)		0/30 (0%)		1/30 (3.3%)		0/31 (0%)		0/30 (0%)		0/54 (0%)		1/53 (1.9%)		0/28 (0%)		0/27 (0%)		0/40 (0%)		1/22 (4.5%)		0/22 (0%)		1/47 (2.1%)		1/145 (0.7%)		0/58 (0%)
Oropharyngeal pain	0/25 (0%)		0/24 (0%)		1/25 (4%)		1/30 (3.3%)		2/30 (6.7%)		0/31 (0%)		1/30 (3.3%)		0/54 (0%)		4/53 (7.5%)		1/28 (3.6%)		0/27 (0%)		0/40 (0%)		2/22 (9.1%)		1/22 (4.5%)		0/47 (0%)		2/145 (1.4%)		1/58 (1.7%)
Respiratory tract congestion	0/25 (0%)		0/24 (0%)		2/25 (8%)		0/30 (0%)		0/30 (0%)		0/31 (0%)		0/30 (0%)		0/54 (0%)		1/53 (1.9%)		0/28 (0%)		0/27 (0%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		0/145 (0%)		0/58 (0%)
Rhinorrhoea	0/25 (0%)		1/24 (4.2%)		2/25 (8%)		0/30 (0%)		0/30 (0%)		1/31 (3.2%)		1/30 (3.3%)		0/54 (0%)		1/53 (1.9%)		0/28 (0%)		0/27 (0%)		0/40 (0%)		1/22 (4.5%)		0/22 (0%)		0/47 (0%)		0/145 (0%)		1/58 (1.7%)
Skin and subcutaneous tissue disorders
Dry skin	0/25 (0%)		0/24 (0%)		1/25 (4%)		0/30 (0%)		0/30 (0%)		0/31 (0%)		0/30 (0%)		0/54 (0%)		0/53 (0%)		0/28 (0%)		2/27 (7.4%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		1/47 (2.1%)		0/145 (0%)		1/58 (1.7%)
Pruritus	1/25 (4%)		0/24 (0%)		1/25 (4%)		0/30 (0%)		0/30 (0%)		3/31 (9.7%)		1/30 (3.3%)		1/54 (1.9%)		4/53 (7.5%)		1/28 (3.6%)		2/27 (7.4%)		1/40 (2.5%)		2/22 (9.1%)		0/22 (0%)		1/47 (2.1%)		3/145 (2.1%)		1/58 (1.7%)
Rash	0/25 (0%)		0/24 (0%)		2/25 (8%)		1/30 (3.3%)		1/30 (3.3%)		0/31 (0%)		1/30 (3.3%)		0/54 (0%)		3/53 (5.7%)		2/28 (7.1%)		0/27 (0%)		1/40 (2.5%)		0/22 (0%)		0/22 (0%)		1/47 (2.1%)		0/145 (0%)		1/58 (1.7%)
Vascular disorders
Hypertension	0/25 (0%)		1/24 (4.2%)		3/25 (12%)		0/30 (0%)		0/30 (0%)		0/31 (0%)		0/30 (0%)		1/54 (1.9%)		2/53 (3.8%)		0/28 (0%)		0/27 (0%)		0/40 (0%)		0/22 (0%)		0/22 (0%)		0/47 (0%)		2/145 (1.4%)		0/58 (0%)

Limitations/Caveats

[Not Specified]

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Principal Investigators are NOT employed by the organization sponsoring the study.

AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.