A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects With HCV Genotype 1, 4, 5, and 6 Infection

• Sponsor: AbbVie (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02243280
• Collaborator: (none)
• Enrollment: 174
• Arms: 11
• Duration (Months): 18

Study Details

Study Description

Brief Summary

The purpose of this Phase 2, open-label, 2-part, multicenter study was to evaluate the efficacy, safety, and pharmacokinetics of co-administration of ABT-493 and ABT-530 with and without ribavirin (RBV) at different doses in chronic Hepatitis C virus (HCV) Genotype 1 (GT1), Genotype 4 (GT4), Genotype 5 (GT5), and Genotype 6 (GT6) infection with compensated cirrhosis (GT1 only) or without cirrhosis (GT1, GT4, GT5, or GT6). Although RBV was initially planned in the protocol, it was not administered in any of the study arms.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis C; Hepatitis C Virus; HCV	Drug: ABT-493; Drug: ABT-530	Phase 2

Detailed Description

This study consisted of two independent parts: Part 1 was conducted first followed by Part 2. Part 1 enrolled participants who received ABT-493 and ABT-530 for 12 weeks; Part 2 enrolled participants who received ABT-493 and ABT-530 for 8 or 12 weeks. Participants who completed or prematurely discontinued the treatment period were followed for 24 weeks to monitor HCV RNA to evaluate efficacy and the emergence and persistence of viral variants.

Study Design

• Study Type: Interventional
• Actual Enrollment: 174 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects With Chronic Hepatitis C Virus (HCV) Genotype 1, 4, 5, and 6 Infection (SURVEYOR-I)
• Study Start Date: Aug 1, 2014
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected 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) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected 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) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)	Drug: ABT-493; Tablet; Other Names: glecaprevir ; Drug: ABT-530; Tablet; Other Names: pibrentasvir
Experimental: Arm D ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)	Drug: ABT-493; Tablet; Other Names: glecaprevir ; Drug: ABT-530; Tablet; Other Names: pibrentasvir
Experimental: Arm E ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	Drug: ABT-493; Tablet; Other Names: glecaprevir ; Drug: ABT-530; Tablet; Other Names: pibrentasvir
Experimental: Arm F ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis	Drug: ABT-493; Tablet; Other Names: glecaprevir ; Drug: ABT-530; Tablet; Other Names: pibrentasvir
Experimental: Arm G ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	Drug: ABT-493; Tablet; Other Names: glecaprevir ; Drug: ABT-530; Tablet; Other Names: pibrentasvir
Experimental: Arm H ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	Drug: ABT-493; Tablet; Other Names: glecaprevir ; Drug: ABT-530; Tablet; Other Names: pibrentasvir
Experimental: Arm I ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis	Drug: ABT-493; Tablet; Other Names: glecaprevir ; Drug: ABT-530; Tablet; Other Names: pibrentasvir
Experimental: Arm J ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened - Sponsor decision)	Drug: ABT-493; Tablet; Other Names: glecaprevir ; Drug: ABT-530; Tablet; Other Names: pibrentasvir
Experimental: Arm K ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis	Drug: ABT-493; Tablet; Other Names: glecaprevir ; Drug: ABT-530; Tablet; Other Names: pibrentasvir

Outcome Measures

Primary Outcome Measures

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

   The percentage of participants with sustained virologic response (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 (SVR) 4 Weeks Post-treatment [4 weeks after the last actual dose of study drug]

   The percentage of participants with sustained virologic response (plasma hepatitis C virus ribonucleic acid [HCV RNA] 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 [Screening, Day 1, Day 3, treatment weeks 1, 2, 4, 6, 8, 10, and 12 or premature discontinuation from treatment]

   The percentage of participants with on-treatment virologic failure (defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantitation [≥ 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 hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantitation (≥ 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male or female between 18 and 70 years of age, inclusive, at time of screening

2. Screening laboratory result indicating hepatitis C virus (HCV) GT1 (Study Parts 1 and

1. or GT4, GT5, or GT6 (Study Part 2) infection

1. Chronic HCV infection defined as one of the following:

• Positive for anti-HCV antibody (Ab) or HCV RNA at least 6 months before screening, and positive for HCV RNA and anti-HCV Ab at the time of screening or

• Positive for anti-HCV Ab and HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed prior to enrollment with evidence of chronic HCV infection)

1. Participant had to meet one of the following criteria:

• Treatment-naïve: participant had never received treatment for HCV infection

• Treatment-experienced: pegylated-interferon alpha-2a or alpha-2b and ribavirin (PR)-null responder (for Study Part 1) or PR-experienced (on-treatment failure or prior relapse) (for Study Part 2)

1. Documented absence of cirrhosis (in Study Part 1 and in corresponding arms of Study Part 2), or compensated cirrhosis (in corresponding arms of Study Part 2, GT1 only), per local standard

Exclusion Criteria:

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

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

3. 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

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

5. Hepatitis C virus (HCV) genotype performed during screening indicating co-infection with more than one HCV genotype

6. Any cause of liver disease other than chronic HCV infection

7. Participants with plasma HCV RNA load ≤ 10,000 international units (IU)/mL or unquantifiable or undetectable HCV RNA at screening

8. Previous use of an HCV direct-acting antiviral agent (DAA)

9. Consideration by the investigator, for any reason, that the participant was an unsuitable candidate to receive ABT-493, ABT-530, or RBV (RBV for cirrhotic subjects only)

10. For participants in Study Part 2 who were enrolling with compensated cirrhosis: past clinical evidence of Child-Pugh B or C Classification (score of > 6) or clinical history of liver decompensation, including ascites (noted on physical exam), bleeding varices, use of beta-blockers for portal hypertension or ascites, or hepatic encephalopathy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• AbbVie

Investigators

• Study Director: Armen Asatryan, MD, AbbVie

Study Documents (Full-Text)

None provided.

More Information

Publications

• Gane E, Poordad F, Wang S, Asatryan A, Kwo PY, Lalezari J, Wyles DL, Hassanein T, Aguilar H, Maliakkal B, Liu R, Lin CW, Ng TI, Kort J, Mensa FJ. High Efficacy of ABT-493 and ABT-530 Treatment in Patients With HCV Genotype 1 or 3 Infection and Compensated Cirrhosis. Gastroenterology. 2016 Oct;151(4):651-659.e1. doi: 10.1053/j.gastro.2016.07.020. Epub 2016 Jul 25.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT02243280
• Other Study ID Numbers: M14-867; 2014-002925-36
• First Posted: Sep 17, 2014
• Last Update Posted: Jul 13, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by AbbVie: HCV GT4; Hepatitis C virus; HCV GT1; HCV; Compensated Cirrhosis; HCV GT6; Hepatitis C Genotype 4 (GT 4); Hepatitis C Genotype 1 (GT1); RBV; Cirrhotic; Hepatitis C; Interferon (IFN) Free; IFN free; HCV GT5; Chronic Hepatitis C; Ribavirin; Child Pugh A; Hepatitis C Genotype 5 (GT 5); Hepatitis C Genotype 6 (GT 6); ABT-493; ABT-530; glecaprevir; pibrentasvir
• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic

Study Results

Participant Flow

Pre-assignment Detail	Safety population: all participants who received at least 1 dose of study drug. Two participants assigned to Arm I received the incorrect dose of study drug throughout their participation in the study (ABT-493 200 mg QD instead of 300 mg) and are therefore included in Arm A instead of Arm I in the safety population.

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/Group Description	ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis	ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis	ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)	ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)	ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis	ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis	ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened - Sponsor decision)	ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
Period Title: Enrolled
STARTED	40	39	0	0	0	27	0	0	34	0	34
COMPLETED	40	39	0	0	0	27	0	0	34	0	34
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0
Period Title: Enrolled
STARTED	42	39	0	0	0	27	0	0	32	0	34
Completed Treatment	42	38	0	0	0	27	0	0	32	0	33
COMPLETED	41	39	0	0	0	27	0	0	31	0	31
NOT COMPLETED	1	0	0	0	0	0	0	0	1	0	3

Baseline Characteristics

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	Total
Arm/Group Description	ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis	ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis	ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)	ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)	ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis	ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis	ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened - Sponsor decision)	ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis	Total of all reporting groups
Overall Participants	42	39	0	0	0	27	0	0	32	0	34	174
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.4 (10.01)	52.5 (10.41)	58.9 (5.47)	55.0 (11.13)	53.5 (10.34)	54.1 (9.98)
Sex: Female, Male (Count of Participants)
Female	17 40.5%	21 53.8%	0 NaN	0 NaN	0 NaN	7 25.9%	0 NaN	0 NaN	16 50%	0 NaN	15 44.1%	76 43.7%
Male	25 59.5%	18 46.2%	0 NaN	0 NaN	0 NaN	20 74.1%	0 NaN	0 NaN	16 50%	0 NaN	19 55.9%	98 56.3%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks Post-treatment
Description	The percentage of participants with sustained virologic response (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

Intention-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/Group Description	ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis	ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis	ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)	ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)	ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis	ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis	ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened - Sponsor decision)	ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
Measure Participants	40	39	0	0	0	27	0	0	34	0	34
Number (95% Confidence Interval) [percentage of participants]	100 238.1%	97.4 249.7%	96.3 Infinity	100 Infinity	97.1 Infinity

2. Secondary Outcome

Title	Percentage of Participants With Sustained Virologic Response (SVR) 4 Weeks Post-treatment
Description	The percentage of participants with sustained virologic response (plasma hepatitis C virus ribonucleic acid [HCV RNA] 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

Intention-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/Group Description	ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis	ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis	ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)	ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)	ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis	ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis	ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened - Sponsor decision)	ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
Measure Participants	40	39	0	0	0	27	0	0	34	0	34
Number (95% Confidence Interval) [percentage of participants]	100 238.1%	97.4 249.7%	96.3 Infinity	100 Infinity	100 Infinity

3. Secondary Outcome

Title	Percentage of Participants With On-treatment Virologic Failure
Description	The percentage of participants with on-treatment virologic failure (defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantitation [≥ 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	Screening, Day 1, Day 3, treatment weeks 1, 2, 4, 6, 8, 10, and 12 or premature discontinuation from treatment

Outcome Measure Data

Analysis Population Description

Intention-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/Group Description	ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis	ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis	ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)	ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)	ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis	ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis	ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened - Sponsor decision)	ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
Measure Participants	40	39	0	0	0	27	0	0	34	0	34
Number (95% Confidence Interval) [percentage of participants]	0 0%	0 0%	0 NaN	0 NaN	0 NaN

4. Secondary Outcome

Title	Percentage of Participants With Post-treatment Relapse
Description	Post-treatment relapse was defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantitation (≥ 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.
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, 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 H	Arm I	Arm J	Arm K
Arm/Group Description	ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis	ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis	ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)	ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)	ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis	ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)	ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis	ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened - Sponsor decision)	ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
Measure Participants	40	38	0	0	0	27	0	0	34	0	33
Number (95% Confidence Interval) [percentage of participants]	0 0%	2.6 6.7%	3.7 Infinity	0 NaN	0 NaN

Adverse Events

Time Frame	Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.
Arm/Group Title	Arm A		Arm B		Arm F		Arm I		Arm K
Arm/Group Description	ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis		ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis		ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis		ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6- infected participants without cirrhosis		ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis
All Cause Mortality
	Arm A		Arm B		Arm F		Arm I		Arm K
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm A		Arm B		Arm F		Arm I		Arm K
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/42 (2.4%)		0/39 (0%)		1/27 (3.7%)		0/32 (0%)		1/34 (2.9%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA	0/42 (0%)		0/39 (0%)		0/27 (0%)		0/32 (0%)		1/34 (2.9%)
PROSTATE CANCER METASTATIC	1/42 (2.4%)		0/39 (0%)		0/27 (0%)		0/32 (0%)		0/34 (0%)
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM	0/42 (0%)		0/39 (0%)		1/27 (3.7%)		0/32 (0%)		0/34 (0%)
Other (Not Including Serious) Adverse Events
	Arm A		Arm B		Arm F		Arm I		Arm K
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	22/42 (52.4%)		22/39 (56.4%)		9/27 (33.3%)		20/32 (62.5%)		19/34 (55.9%)
Eye disorders
VISION BLURRED	0/42 (0%)		1/39 (2.6%)		0/27 (0%)		2/32 (6.3%)		0/34 (0%)
Gastrointestinal disorders
CONSTIPATION	0/42 (0%)		0/39 (0%)		0/27 (0%)		1/32 (3.1%)		2/34 (5.9%)
DIARRHOEA	3/42 (7.1%)		3/39 (7.7%)		1/27 (3.7%)		5/32 (15.6%)		3/34 (8.8%)
DRY MOUTH	0/42 (0%)		0/39 (0%)		0/27 (0%)		2/32 (6.3%)		0/34 (0%)
FLATULENCE	3/42 (7.1%)		0/39 (0%)		0/27 (0%)		2/32 (6.3%)		0/34 (0%)
NAUSEA	5/42 (11.9%)		8/39 (20.5%)		0/27 (0%)		3/32 (9.4%)		3/34 (8.8%)
General disorders
FATIGUE	10/42 (23.8%)		5/39 (12.8%)		3/27 (11.1%)		3/32 (9.4%)		6/34 (17.6%)
PAIN	1/42 (2.4%)		1/39 (2.6%)		0/27 (0%)		1/32 (3.1%)		2/34 (5.9%)
PYREXIA	3/42 (7.1%)		1/39 (2.6%)		0/27 (0%)		0/32 (0%)		0/34 (0%)
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION	2/42 (4.8%)		1/39 (2.6%)		2/27 (7.4%)		1/32 (3.1%)		1/34 (2.9%)
URINARY TRACT INFECTION	1/42 (2.4%)		1/39 (2.6%)		0/27 (0%)		0/32 (0%)		3/34 (8.8%)
Injury, poisoning and procedural complications
MUSCLE STRAIN	0/42 (0%)		0/39 (0%)		2/27 (7.4%)		1/32 (3.1%)		2/34 (5.9%)
Metabolism and nutrition disorders
DECREASED APPETITE	0/42 (0%)		0/39 (0%)		1/27 (3.7%)		1/32 (3.1%)		2/34 (5.9%)
Musculoskeletal and connective tissue disorders
ARTHRALGIA	0/42 (0%)		1/39 (2.6%)		0/27 (0%)		3/32 (9.4%)		1/34 (2.9%)
BACK PAIN	1/42 (2.4%)		1/39 (2.6%)		1/27 (3.7%)		0/32 (0%)		2/34 (5.9%)
Nervous system disorders
DIZZINESS	2/42 (4.8%)		2/39 (5.1%)		0/27 (0%)		2/32 (6.3%)		1/34 (2.9%)
HEADACHE	5/42 (11.9%)		8/39 (20.5%)		3/27 (11.1%)		8/32 (25%)		1/34 (2.9%)
MEMORY IMPAIRMENT	0/42 (0%)		2/39 (5.1%)		0/27 (0%)		0/32 (0%)		0/34 (0%)
PARAESTHESIA	1/42 (2.4%)		2/39 (5.1%)		0/27 (0%)		0/32 (0%)		0/34 (0%)
Psychiatric disorders
ANXIETY	2/42 (4.8%)		3/39 (7.7%)		0/27 (0%)		0/32 (0%)		1/34 (2.9%)
DEPRESSION	2/42 (4.8%)		0/39 (0%)		1/27 (3.7%)		2/32 (6.3%)		0/34 (0%)
INSOMNIA	1/42 (2.4%)		3/39 (7.7%)		0/27 (0%)		1/32 (3.1%)		2/34 (5.9%)
Respiratory, thoracic and mediastinal disorders
COUGH	2/42 (4.8%)		0/39 (0%)		0/27 (0%)		1/32 (3.1%)		3/34 (8.8%)
PARANASAL SINUS DISCOMFORT	0/42 (0%)		0/39 (0%)		0/27 (0%)		0/32 (0%)		2/34 (5.9%)
Skin and subcutaneous tissue disorders
HYPERHIDROSIS	1/42 (2.4%)		0/39 (0%)		0/27 (0%)		0/32 (0%)		2/34 (5.9%)
PRURITUS	0/42 (0%)		1/39 (2.6%)		2/27 (7.4%)		1/32 (3.1%)		1/34 (2.9%)

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.