A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Subjects With Genotype 1 Infection

• Sponsor: AbbVie (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02604017
• Collaborator: (none)
• Enrollment: 703
• Arms: 2
• Duration (Months): 15

Study Details

Study Description

Brief Summary

This study seeks to evaluate the efficacy and safety of ABT-493/ABT-530 in participants with Genotype 1 hepatitis C virus infection without cirrhosis

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis C; Hepatitis C Virus; HCV	Drug: ABT-493/ABT-530	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 703 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 and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1 Infection (ENDURANCE-1)
• Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: Jan 1, 2017
• Actual Study Completion Date: Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ABT-493/ABT-530 for 12 weeks ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.	Drug: ABT-493/ABT-530; Tablet; ABT-493 coformulated with ABT-530; Other Names: ABT-493 also known as glecaprevir ABT-530 also known as pibrentasvir MAVYRET
Experimental: ABT-493/ABT-530 for 8 weeks ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.	Drug: ABT-493/ABT-530; Tablet; ABT-493 coformulated with 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) in Mono-infected Hepatitis C Virus Genotype 1 (HCV GT1), Direct-acting Antiviral Agent (DAA) Naïve Participants in the 12-Week Treatment Arm [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. The primary efficacy endpoint was noninferiority of the percentage of participants who achieved SVR12 in the 12-week treatment group compared with the historical control rate for HCV GT1 subjects who are treatment-naïve or treated with pegylated-interferon alfa-2a or alfa-2b and ribavirin (pegIFN/RBV).

2. Percentage of Participants With SVR12: Noninferiority of 8-Week Arm to 12-Week Arm in Mono-infected HCV GT1, DAA-Naïve Participants, Excluding Those Who Discontinued/Experienced Virologic Failure by Week 8 or Had No HCV RNA Value at Week 12 or Later [12 weeks after last actual dose of study drug]

   SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of mono-infected HCV GT1, DAA-naïve participants (excluding those who discontinued/experienced virologic failure by Week 8 or had no HCV RNA value at Week 12 or later) who achieved SVR12 in the 8-week treatment arm compared with the 12-week treatment arm.

3. Percentage of Participants With SVR12: Noninferiority of 8-Week Treatment Arm to 12-Week Treatment Arm in Mono-infected HCV GT1, DAA-Naïve Participants [12 weeks after the last actual dose of study drug]

   SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of mono-infected HCV GT1, DAA-naïve participants who achieved SVR12 in the 8-week treatment arm compared with the 12-week treatment arm.

Secondary Outcome Measures

1. Percentage of Participants With SVR12 in Mono-infected HCV GT1 Participants [12 weeks after last actual dose of study drug]

   SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug.

2. Percentage of Participants With SVR12 [12 weeks after last actual dose of study drug]

   SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug.

3. Percentage of Participants With SVR12 in Co-infected HCV GT1/Human Immunodeficiency Virus Type 1 (HIV-1) Participants [12 weeks after last actual dose of study drug]

   SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug.

4. Percentage of Participants With SVR12 in HCV GT1-infected, Prior Sofosbuvir (SOF) Treatment-Experienced Participants [12 weeks after last actual dose of study drug]

   SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug.

5. Percentage of Participants With On-treatment Virologic Failure [Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment]

   On-treatment virologic failure was defined as confirmed increase of >1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥100 IU/mL after HCV RNA <LLOQ during treatment, or HCV RNA ≥LLOQ at end of treatment with at least 6 weeks of treatment.

6. Percentage of Participants With On-treatment Virologic Failure in Mono-infected HCV GT1, DAA-Naïve Participants [Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment]

   On-treatment virologic failure was defined as confirmed increase of >1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥100 IU/mL after HCV RNA <LLOQ during treatment, or HCV RNA ≥LLOQ at end of treatment with at least 6 weeks of treatment.

7. 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.

8. Percentage of Participants With Post-treatment Relapse in Mono-infected HCV GT1, DAA-Naïve Participants [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:

• Male or female, at least 18 years of age at time of screening.

• Screening laboratory result indicating hepatitis C virus (HCV) genotype 1 (GT1) infection.

• Chronic HCV infection.

• Subject must be HCV treatment-naïve (i.e., patient has never received a single dose of any approved or investigational regimen) or treatment-experienced (has failed prior interferon [IFN] or pegylated IFN (pegIFN) with or without ribivarin (RBV), or sofosbuvir (SOF) plus RBV with or without pegIFN therapy).

• Subjects must be non-cirrhotic.

Additional Inclusion Criteria for HCV GT1/human immununovirus type 1 (HIV-1) co-infected patients:

• HIV-1 antiretroviral treatment (ART) naïve with CD4 ≥ 500 cells/mm3 (or CD4+ % ≥ 29%) at Screening and plasma HIV-1 RNA <1,000 copies/mL at Screening and at least once during the 12 months prior to Screening.

OR

• On a stable, qualifying HIV-1 ART regimen for at least 8 weeks prior to screening, with CD4 ≥ 200 cells/mm3 (or CD4+ % ≥14%) at Screening and plasma HIV-1 RNA < LLOQ at Screening and at least once during the 12 months prior to Screening.

Exclusion Criteria:

• History of severe, life-threatening or other significant sensitivity to any excipients of the study drugs.

• 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.

• 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).

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

• Chronic HIV type 2 (HIV-2) infection.

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

• Zeuzem S, Foster GR, Wang S, Asatryan A, Gane E, Feld JJ, Asselah T, Bourlière M, Ruane PJ, Wedemeyer H, Pol S, Flisiak R, Poordad F, Chuang WL, Stedman CA, Flamm S, Kwo P, Dore GJ, Sepulveda-Arzola G, Roberts SK, Soto-Malave R, Kaita K, Puoti M, Vierling J, Tam E, Vargas HE, Bruck R, Fuster F, Paik SW, Felizarta F, Kort J, Fu B, Liu R, Ng TI, Pilot-Matias T, Lin CW, Trinh R, Mensa FJ. Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection. N Engl J Med. 2018 Jan 25;378(4):354-369. doi: 10.1056/NEJMoa1702417.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT02604017
• Other Study ID Numbers: M13-590; 2015-002087-17
• First Posted: Nov 13, 2015
• Last Update Posted: Jul 13, 2021
• Last Verified: Jul 1, 2021

• Keywords provided by AbbVie: HCV GT1; Non-cirrhotic; RBV Free; Without cirrhosis; Chronic Hepatitis C; Hepatitis C Genotype 1 (GT1); IFN free; Hepatitis C; Ribavirin Free; Interferon (IFN) Free; HCV; Hepatitis C virus; DAA
• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic

Study Results

Participant Flow

Pre-assignment Detail	This study included a 35-day screening period.

Arm/Group Title	ABT-493/ABT-530 for 12 Weeks	ABT-493/ABT-530 for 8 Weeks
Arm/Group Description	ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.	ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
Period Title: Overall Study
STARTED	352	351
COMPLETED	346	343
NOT COMPLETED	6	8

Baseline Characteristics

Arm/Group Title	ABT-493/ABT-530 for 12 Weeks	ABT-493/ABT-530 for 8 Weeks	Total
Arm/Group Description	ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.	ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.	Total of all reporting groups
Overall Participants	352	351	703
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.27 (11.62)	51.58 (11.90)	50.93 (11.77)
Sex: Female, Male (Count of Participants)
Female	176 50%	184 52.4%	360 51.2%
Male	176 50%	167 47.6%	343 48.8%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Mono-infected Hepatitis C Virus Genotype 1 (HCV GT1), Direct-acting Antiviral Agent (DAA) Naïve Participants in the 12-Week Treatment Arm
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. The primary efficacy endpoint was noninferiority of the percentage of participants who achieved SVR12 in the 12-week treatment group compared with the historical control rate for HCV GT1 subjects who are treatment-naïve or treated with pegylated-interferon alfa-2a or alfa-2b and ribavirin (pegIFN/RBV).
Time Frame	12 weeks after the last actual dose of study drug

Outcome Measure Data

Analysis Population Description

All participants in the ITT population who were mono-infected HCV GT1, DAA-naïve; participants with missing data after backwards imputation were imputed as nonresponders.

Arm/Group Title	ABT-493/ABT-530 for 12 Weeks
Arm/Group Description	ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
Measure Participants	332
Number [percentage of participants]	99.7 28.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ABT-493/ABT-530 for 12 Weeks
	Comments	Based on a 2-sided significance level of 0.05 and an underlying rate of ≥97% in the 12-week arm, 270 participants provides >90% power to demonstrate noninferiority of the 12-week arm to the historical control rate for HCV GT1 subjects who are treatment-naïve or treated with pegIFN/RBV (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).
	Type of Statistical Test	Non-Inferiority
	Comments	The noninferiority of the rate of SVR12 for the 12-week treatment group as compared with the historical rate was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with SVR12 must exceed 91% to achieve noninferiority.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage of Participants
	Estimated Value	99.7
	Confidence Interval	(2-Sided) 95%; 99.1 to 100.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Percentage of Participants With SVR12: Noninferiority of 8-Week Arm to 12-Week Arm in Mono-infected HCV GT1, DAA-Naïve Participants, Excluding Those Who Discontinued/Experienced Virologic Failure by Week 8 or Had No HCV RNA Value at Week 12 or Later
Description	SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of mono-infected HCV GT1, DAA-naïve participants (excluding those who discontinued/experienced virologic failure by Week 8 or had no HCV RNA value at Week 12 or later) who achieved SVR12 in the 8-week treatment arm compared with the 12-week treatment arm.
Time Frame	12 weeks after last actual dose of study drug

Outcome Measure Data

Analysis Population Description

All participants in the ITT population who were mono-infected HCV GT1 DAA-naïve (excluding those who discontinued/experienced virologic failure by Week 8 or had no HCV RNA value at Week 12 or later); participants with missing data after backwards imputation were imputed as nonresponders.

Arm/Group Title	ABT-493/ABT-530 for 12 Weeks	ABT-493/ABT-530 for 8 Weeks
Arm/Group Description	ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.	ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
Measure Participants	331	332
Number (95% Confidence Interval) [percentage of participants]	100.0 28.4%	100 28.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ABT-493/ABT-530 for 12 Weeks, ABT-493/ABT-530 for 8 Weeks
	Comments	Based on a 2-sided significance level of 0.05 and an -5% noninferiority margin and an underlying rate of ≥97% in the 8-week arm (270 participants) and ≥97% in the 12-week arm (270 participants) provides >90% power to demonstrate noninferiority of the 8-week arm to the 12-week arm.
	Type of Statistical Test	Non-Inferiority
	Comments	The noninferiority of the rate of SVR12 for the 8-week treatment group as compared with the 12-week treatment group was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the difference in percentage of participants with SVR12 (8-week group minus 12-week group) must be above -5% to achieve noninferiority.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage of Participants
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; -1.1 to 1.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Percentage of Participants With SVR12: Noninferiority of 8-Week Treatment Arm to 12-Week Treatment Arm in Mono-infected HCV GT1, DAA-Naïve Participants
Description	SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of mono-infected HCV GT1, DAA-naïve participants who achieved SVR12 in the 8-week treatment arm compared with the 12-week treatment arm.
Time Frame	12 weeks after the last actual dose of study drug

Outcome Measure Data

Analysis Population Description

All participants in the ITT population who were mono-infected HCV GT1, DAA-naïve; participants with missing data after backwards imputation were imputed as nonresponders.

Arm/Group Title	ABT-493/ABT-530 for 12 Weeks	ABT-493/ABT-530 for 8 Weeks
Arm/Group Description	ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.	ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
Measure Participants	332	335
Number (95% Confidence Interval) [percentage of participants]	99.7 28.3%	99.1 28.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ABT-493/ABT-530 for 12 Weeks, ABT-493/ABT-530 for 8 Weeks
	Comments	Based on a 2-sided significance level of 0.05 and a -5% noninferiority margin, and an underlying rate of ≥97% in the 8-week arm (270 participants) and ≥97% in the 12-week arm (270 participants) provides >90% power to demonstrate noninferiority of the 8-week arm to the 12-week arm.
	Type of Statistical Test	Non-Inferiority
	Comments	The noninferiority of the rate of SVR12 for the 8-week treatment group as compared with the 12-week treatment group was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the difference in percentage of participants with SVR12 must be above -5% to achieve noninferiority.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage of Participants
	Estimated Value	-0.6
	Confidence Interval	(2-Sided) 95%; -1.8 to 0.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Percentage of Participants With SVR12 in Mono-infected HCV GT1 Participants
Description	SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug.
Time Frame	12 weeks after last actual dose of study drug

Outcome Measure Data

Analysis Population Description

All participants in the ITT population who were mono-infected HCV GT1; participants with missing data after backwards imputation were imputed as nonresponders.

Arm/Group Title	ABT-493/ABT-530 for 12 Weeks	ABT-493/ABT-530 for 8 Weeks
Arm/Group Description	ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.	ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
Measure Participants	334	336
Number (95% Confidence Interval) [percentage of participants]	99.7 28.3%	99.1 28.2%

5. Secondary Outcome

Title	Percentage of Participants With SVR12
Description	SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug.
Time Frame	12 weeks after last actual dose of study drug

Outcome Measure Data

Analysis Population Description

All participants in the ITT population; participants with missing data after backwards imputation were imputed as nonresponders.

Arm/Group Title	ABT-493/ABT-530 for 12 Weeks	ABT-493/ABT-530 for 8 Weeks
Arm/Group Description	ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.	ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
Measure Participants	352	351
Number (95% Confidence Interval) [percentage of participants]	99.7 28.3%	99.1 28.2%

6. Secondary Outcome

Title	Percentage of Participants With SVR12 in Co-infected HCV GT1/Human Immunodeficiency Virus Type 1 (HIV-1) Participants
Description	SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug.
Time Frame	12 weeks after last actual dose of study drug

Outcome Measure Data

Analysis Population Description

All participants in the ITT population who were co-infected HCV GT1/HIV-1; participants with missing data after backwards imputation were imputed as nonresponders.

Arm/Group Title	ABT-493/ABT-530 for 12 Weeks	ABT-493/ABT-530 for 8 Weeks
Arm/Group Description	ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.	ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
Measure Participants	18	15
Number (95% Confidence Interval) [percentage of participants]	100.0 28.4%	100.0 28.5%

7. Secondary Outcome

Title	Percentage of Participants With SVR12 in HCV GT1-infected, Prior Sofosbuvir (SOF) Treatment-Experienced Participants
Description	SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug.
Time Frame	12 weeks after last actual dose of study drug

Outcome Measure Data

Analysis Population Description

All participants in the ITT population who were HCV GT1-infected, prior SOF-treatment experienced; participants with missing data after backwards imputation were imputed as nonresponders.

Arm/Group Title	ABT-493/ABT-530 for 12 Weeks	ABT-493/ABT-530 for 8 Weeks
Arm/Group Description	ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.	ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
Measure Participants	2	1
Number (95% Confidence Interval) [percentage of participants]	100.0 28.4%	100.0 28.5%

8. Secondary Outcome

Title	Percentage of Participants With On-treatment Virologic Failure
Description	On-treatment virologic failure was defined as confirmed increase of >1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥100 IU/mL after HCV RNA <LLOQ during treatment, or HCV RNA ≥LLOQ at end of treatment with at least 6 weeks of treatment.
Time Frame	Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment 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).

Arm/Group Title	ABT-493/ABT-530 for 12 Weeks	ABT-493/ABT-530 for 8 Weeks
Arm/Group Description	ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.	ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
Measure Participants	352	351
Number (95% Confidence Interval) [percentage of particpants]	0.0	0.3

9. Secondary Outcome

Title	Percentage of Participants With On-treatment Virologic Failure in Mono-infected HCV GT1, DAA-Naïve Participants
Description	On-treatment virologic failure was defined as confirmed increase of >1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥100 IU/mL after HCV RNA <LLOQ during treatment, or HCV RNA ≥LLOQ at end of treatment with at least 6 weeks of treatment.
Time Frame	Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment

Outcome Measure Data

Analysis Population Description

All participants in the ITT population who were mono-infected HCV GT1, DAA-naïve.

Arm/Group Title	ABT-493/ABT-530 for 12 Weeks	ABT-493/ABT-530 for 8 Weeks
Arm/Group Description	ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.	ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
Measure Participants	332	335
Number (95% Confidence Interval) [percentage of participants]	0.0 0%	0.3 0.1%

10. 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, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.

Arm/Group Title	ABT-493/ABT-530 for 12 Weeks	ABT-493/ABT-530 for 8 Weeks
Arm/Group Description	ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.	ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
Measure Participants	352	349
Number (95% Confidence Interval) [percentage of participants]	0.0 0%	0.0 0%

11. Secondary Outcome

Title	Percentage of Participants With Post-treatment Relapse in Mono-infected HCV GT1, DAA-Naïve Participants
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 in the ITT population who were mono-infected HCV GT1, DAA-naïve, received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.

Arm/Group Title	ABT-493/ABT-530 for 12 Weeks	ABT-493/ABT-530 for 8 Weeks
Arm/Group Description	ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.	ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
Measure Participants	332	333
Number (95% Confidence Interval) [percentage of participants]	0.0 0%	0.0 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 16 weeks).
Adverse Event Reporting Description	TEAEs and TESAEs are defined as any AE or SAE with an onset or worsening 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	ABT-493/ABT-530 for 12 Weeks		ABT-493/ABT-530 for 8 Weeks
Arm/Group Description	ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.		ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
All Cause Mortality
	ABT-493/ABT-530 for 12 Weeks		ABT-493/ABT-530 for 8 Weeks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	ABT-493/ABT-530 for 12 Weeks		ABT-493/ABT-530 for 8 Weeks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/352 (1.1%)		5/351 (1.4%)
Cardiac disorders
ANGINA UNSTABLE	0/352 (0%)		1/351 (0.3%)
ATRIAL FIBRILLATION	1/352 (0.3%)		0/351 (0%)
Gastrointestinal disorders
IRRITABLE BOWEL SYNDROME	1/352 (0.3%)		0/351 (0%)
Infections and infestations
BRONCHITIS	1/352 (0.3%)		0/351 (0%)
Injury, poisoning and procedural complications
ALCOHOL POISONING	1/352 (0.3%)		0/351 (0%)
ARTERIAL INJURY	0/352 (0%)		1/351 (0.3%)
RADIUS FRACTURE	0/352 (0%)		1/351 (0.3%)
TOXICITY TO VARIOUS AGENTS	1/352 (0.3%)		0/351 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE LEIOMYOMA	0/352 (0%)		1/351 (0.3%)
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK	0/352 (0%)		1/351 (0.3%)
Psychiatric disorders
SUICIDE ATTEMPT	0/352 (0%)		1/351 (0.3%)
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION	1/352 (0.3%)		0/351 (0%)
Other (Not Including Serious) Adverse Events
	ABT-493/ABT-530 for 12 Weeks		ABT-493/ABT-530 for 8 Weeks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	130/352 (36.9%)		133/351 (37.9%)
Gastrointestinal disorders
NAUSEA	29/352 (8.2%)		19/351 (5.4%)
General disorders
FATIGUE	43/352 (12.2%)		31/351 (8.8%)
Infections and infestations
NASOPHARYNGITIS	31/352 (8.8%)		22/351 (6.3%)
Nervous system disorders
HEADACHE	62/352 (17.6%)		68/351 (19.4%)
Psychiatric disorders
INSOMNIA	15/352 (4.3%)		21/351 (6%)
Skin and subcutaneous tissue disorders
PRURITUS	17/352 (4.8%)		20/351 (5.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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.