CERTAIN-1: A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Chronic Hepatitis C Virus Infection

• Sponsor: AbbVie (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02707952
• Collaborator: (none)
• Enrollment: 295
• Arms: 4
• Actual Duration (Months): 11.6

Study Details

Study Description

Brief Summary

The purpose of this phase 3, multicenter study is to evaluate the efficacy and safety of ABT-493/ABT-530 in Japanese adults with chronic Hepatitis C Virus (HCV)-infected, HCV direct-acting antiviral agent (DAA) treatment-naïve, and DAA treatment-experienced Japanese adult subjects.

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

Detailed Description

The study consisted of two sub-studies that enrolled in parallel. Substudy 1 was randomized, open-label, and active-controlled, wherein HCV treatment-naïve or interferon (IFN)-experienced (i.e., DAA treatment-naïve), genotype (GT)1-infected participants without cirrhosis were enrolled. Substudy 2 was non-randomized, open label, and enrolled special populations of HCV-infected participants [GT1- or GT2-infected subjects with compensated cirrhosis, HCV GT3-, 4-, 5- and 6-infected subjects (with compensated cirrhosis or without cirrhosis), HCV GT1- and GT2-infected subjects who had failed prior DAA treatments (with compensated cirrhosis or without cirrhosis), HCV GT1- or GT2-infected subjects with severe renal impairment (with compensated cirrhosis or without cirrhosis)].

Study Design

• Study Type: Interventional
• Actual Enrollment: 295 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 Japanese Adults With Chronic Hepatitis C Virus Infection (CERTAIN-1)
• Actual Study Start Date: Feb 22, 2016
• Actual Primary Completion Date: Nov 14, 2016
• Actual Study Completion Date: Feb 9, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) for 8 weeks in HCV genotype(GT)1 -infected, DAA treatment-naïve participants without cirrhosis.	Drug: ABT-493/ABT-530; Co-formulated tablet; Other Names: Glecaprevir/Pibrentasvir glecaprevir (ABT-493) pibrentasvir (ABT-530)
Active Comparator: Arm B Ombitasvir (25 mg)/paritaprevir (150 mg)/ritonavir (100mg) (OBV/PTV/r) QD for 12 weeks in HCV GT1 infected, DAA treatment-naïve participants without cirrhosis.	Drug: OBV/PTV/r; Co-formulated tablet; Other Names: Ombitasvir/paritaprevir/ritonavir ombitasvir (ABT-267) paritaprevir (ABT-450) norvir (ritonavir)
Experimental: Arm C ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120mg) QD for 12 weeks in HCV GT1- or GT2-infected participants with compensated cirrhosis, HCV GT3-, 4-, 5- and 6-infected participants (with compensated cirrhosis or without cirrhosis), HCV GT1- and GT2-infected participants who had failed prior DAA treatments (with compensated cirrhosis or without cirrhosis), and HCV GT1- or GT2-infected participants with severe renal impairment and compensated cirrhosis.	Drug: ABT-493/ABT-530; Co-formulated tablet; Other Names: Glecaprevir/Pibrentasvir glecaprevir (ABT-493) pibrentasvir (ABT-530)
Experimental: Arm D ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in GT1- or GT2-infected participants with severe renal impairment and without cirrhosis.	Drug: ABT-493/ABT-530; Co-formulated tablet; Other Names: Glecaprevir/Pibrentasvir glecaprevir (ABT-493) pibrentasvir (ABT-530)

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants in Arms A and B 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.

Secondary Outcome Measures

1. Percentage of Participants in Arm A 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. 95% CI was calculated using the normal approximation to the binomial distribution.

2. Percentage of Participants for Each Sub-Population in Arms C and D 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. Subpopulations defined as Genotype 1 and 2 infected cirrhotic participants, prior direct acting antiviral agent (DAA) treatment experienced (T-exp) participants, Genotype 3, 4, 5 or 6-infected participants, and participants with severe renal impairment (RI). 95% CI was calculated using the Wilson score method.

3. 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. 95% CI was calculated using the Wilson score method.

4. 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 with HCV RNA levels < LLOQ at the end of treatment, excluding participants who were been shown to be re-infected. The confidence interval was calculated using the Wilson score method.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Females were postmenopausal for at least 2 years; surgically sterile or had a vasectomized partner; or, if of childbearing potential and sexually active with a male partner, were currently using at least 1 effective method of birth control at the time of Screening and agreed to practice 1 effective method of birth control from Screening through 30 days after stopping study drug. Sexually active males were surgically sterile or, if sexually active with a female partner of childbearing potential, agreed to practice 1 effective form of birth control from Screening through 30 days after stopping study drug.

• Screening central laboratory result indicated HCV single genotype infection for the appropriate treatment arm, without co-infection of any other genotype.

• Chronic HCV infection is defined as one of the following:

• Positive for anti-HCV antibody (Ab) and/or HCV RNA at least 6 months before Screening.

• A liver biopsy consistent with chronic HCV infection.

• Agreed to voluntarily sign and date an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) prior to the initiation of any screening or study specific procedures.

• Participants who were able to understand and adhere to the study visit schedule and all other protocol requirements.

• Absence of hepatocellular carcinoma (HCC) as indicated by an ultrasound, computed tomography (CT) scan or magnetic resonance imaging (MRI).

Exclusion Criteria:

• Females who were pregnant or planned to become pregnant, or breastfeeding or males whose partner was pregnant or planning to become pregnant during the study.

• Participants co-infected with hepatitis B virus or human immunodeficiency virus.

• Use of contraindicated medications or supplements within 2 weeks or 10 half-lives (if known), whichever was longer, prior to the first dose of any study drug.

• 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.

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

• Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of decompensated liver disease.

• Consideration by the investigator, for any reason, that the participant is an unsuitable candidate to receive ABT-493/ABT-530.

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

• Chayama K, Suzuki F, Karino Y, Kawakami Y, Sato K, Atarashi T, Naganuma A, Watanabe T, Eguchi Y, Yoshiji H, Seike M, Takei Y, Kato K, Alves K, Burroughs M, Redman R, Pugatch DL, Pilot-Matias TJ, Krishnan P, Oberoi RK, Xie W, Kumada H. Efficacy and safety of glecaprevir/pibrentasvir in Japanese patients with chronic genotype 1 hepatitis C virus infection with and without cirrhosis. J Gastroenterol. 2018 Apr;53(4):557-565. doi: 10.1007/s00535-017-1391-5. Epub 2017 Sep 25.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT02707952
• Other Study ID Numbers: M15-594
• First Posted: Mar 14, 2016
• Last Update Posted: Jul 16, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by AbbVie: Compensated cirrhosis; Non-cirrhotic; Renal impairment; Hepatitis C virus (HCV); Hepatitis C; Chronic Hepatitis C; Hepatitis C Genotype 1; Hepatitis C Genotype 2; Hepatitis C Genotype 3; Hepatitis C Genotype 4; Hepatitis C Genotype 5; Hepatitis C Genotype 6; DAA-experienced
• Additional relevant MeSH terms: Hepatitis A; Virus Diseases; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Ritonavir

Study Results

Participant Flow

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/Group Description	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) for 8 weeks in HCV genotype 1 (GT1) -infected, DAA treatment-naïve participants without cirrhosis.	Ombitasvir (25 mg)/paritaprevir (150 mg)/ritonavir (100mg) (OBV/PTV/r) QD for 12 weeks in HCV GT1 infected, DAA treatment-naïve participants without cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT1- or GT2-infected participants with compensated cirrhosis, HCV GT3-, 4-, 5- and 6-infected participants (with compensated cirrhosis or without cirrhosis), HCV GT1- and GT2-infected participants who had failed prior DAA treatments (with compensated cirrhosis or without cirrhosis), and HCV GT1- or GT2-infected participants with severe renal impairment and compensated cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in GT1- or GT2-infected participants with severe renal impairment and without cirrhosis.
Period Title: Overall Study
STARTED	129	53	103	10
Participants Who Received Study Drug	129	52	103	10
COMPLETED	127	52	101	10
NOT COMPLETED	2	1	2	0

Baseline Characteristics

Arm/Group Title	Arm A	Arm B	Arm C	Arm D	Total
Arm/Group Description	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) for 8 weeks in HCV genotype 1 (GT1) -infected, DAA treatment-naïve participants without cirrhosis.	Ombitasvir (25 mg)/paritaprevir (150 mg)/ritonavir (100mg) (OBV/PTV/r) QD for 12 weeks in HCV GT1 infected, DAA treatment-naïve participants without cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT1- or GT2-infected participants with compensated cirrhosis, HCV GT3-, 4-, 5- and 6-infected participants (with compensated cirrhosis or without cirrhosis), HCV GT1- and GT2-infected participants who had failed prior DAA treatments (with compensated cirrhosis or without cirrhosis), and HCV GT1- or GT2-infected participants with severe renal impairment and compensated cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in GT1- or GT2-infected participants with severe renal impairment and without cirrhosis.	Total of all reporting groups
Overall Participants	129	52	103	10	294
Age, Customized (participants) [Number]
< 65 years	66 51.2%	22 42.3%	33 32%	4 40%	125 42.5%
>= 65 years to < 75 years	37 28.7%	23 44.2%	43 41.7%	4 40%	107 36.4%
>= 75 years	26 20.2%	7 13.5%	27 26.2%	2 20%	62 21.1%
Sex: Female, Male (Count of Participants)
Female	82 63.6%	38 73.1%	58 56.3%	6 60%	184 62.6%
Male	47 36.4%	14 26.9%	45 43.7%	4 40%	110 37.4%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants in Arms A and B 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, excluding participants with the Y93H polymorphism in NS5A at baseline (ITT-PS population); participants with missing data after backwards imputation were imputed as nonresponders.

Arm/Group Title	Arm A	Arm B
Arm/Group Description	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) for 8 weeks in HCV genotype 1 (GT1) -infected, DAA treatment-naïve participants without cirrhosis.	Ombitasvir (25 mg)/paritaprevir (150 mg)/ritonavir (100mg) (OBV/PTV/r) QD for 12 weeks in HCV GT1 infected, DAA treatment-naïve participants without cirrhosis.
Measure Participants	106	52
Number [percentage of participants]	99.1 76.8%	100 192.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm A, Arm B
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	The percentage of participants achieving SVR12 was calculated for each arm and a 2-sided 95% CI for the difference in SVR12 rates (Arm A minus Arm B) was calculated using the normal approximation to the binomial distribution to assess non-inferiority in SVR12 rates of arm A to arm B. If the lower bound of the confidence interval (CI) for the difference was above the non-inferiority margin of -10%, then arm A was considered non-inferior to arm B.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Rate Difference
	Estimated Value	-0.9
	Confidence Interval	(2-Sided) 95%; -2.8 to 0.9
	Parameter Dispersion	Type: Value:
	Estimation Comments	95% CI was calculated using the normal approximation to the binomial distribution.

2. Secondary Outcome

Title	Percentage of Participants in Arm A 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. 95% CI was calculated using the normal approximation to the binomial distribution.
Time Frame	12 weeks after the last actual dose of study drug

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all participants who received at least 1 dose of study drug; participants with missing data after backwards imputation were imputed as nonresponders.

Arm/Group Title	Arm A
Arm/Group Description	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) for 8 weeks in HCV genotype 1 (GT1) -infected, DAA treatment-naïve participants without cirrhosis.
Measure Participants	129
Number (95% Confidence Interval) [percentage of participants]	99.2 76.9%

3. Secondary Outcome

Title	Percentage of Participants for Each Sub-Population in Arms C and D 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. Subpopulations defined as Genotype 1 and 2 infected cirrhotic participants, prior direct acting antiviral agent (DAA) treatment experienced (T-exp) participants, Genotype 3, 4, 5 or 6-infected participants, and participants with severe renal impairment (RI). 95% CI was calculated using the Wilson score method.
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); participants with missing data after backwards imputation were imputed as nonresponders.

Arm/Group Title	Arm C	Arm D
Arm/Group Description	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT1- or GT2-infected participants with compensated cirrhosis, HCV GT3-, 4-, 5- and 6-infected participants (with compensated cirrhosis or without cirrhosis), HCV GT1- and GT2-infected participants who had failed prior DAA treatments (with compensated cirrhosis or without cirrhosis), and HCV GT1- or GT2-infected participants with severe renal impairment and compensated cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in GT1- or GT2-infected participants with severe renal impairment and without cirrhosis.
Measure Participants	103	10
HCV GT1 Participants with Compensated Cirrhosis	100 77.5%
HCV GT2 Participants with Compensated Cirrhosis	100 77.5%
DAA Experienced Participants	93.9 72.8%
HCV GT3,4,5 and 6 Participants	83.3 64.6%
Participants With Severe RI and with Cirrhosis	100.0 77.5%
Participants With Severe RI and without Cirrhosis	100 77.5%

4. 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. 95% CI was calculated using the Wilson score method.
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	Arm A	Arm B	Arm C	Arm D
Arm/Group Description	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) for 8 weeks in HCV genotype 1 (GT1) -infected, DAA treatment-naïve participants without cirrhosis.	Ombitasvir (25 mg)/paritaprevir (150 mg)/ritonavir (100mg) (OBV/PTV/r) QD for 12 weeks in HCV GT1 infected, DAA treatment-naïve participants without cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT1- or GT2-infected participants with compensated cirrhosis, HCV GT3-, 4-, 5- and 6-infected participants (with compensated cirrhosis or without cirrhosis), HCV GT1- and GT2-infected participants who had failed prior DAA treatments (with compensated cirrhosis or without cirrhosis), and HCV GT1- or GT2-infected participants with severe renal impairment and compensated cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in GT1- or GT2-infected participants with severe renal impairment and without cirrhosis.
Measure Participants	129	52	103	10
Number (95% Confidence Interval) [percentage of participants]	0 0%	0 0%	1.0 1%	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 with HCV RNA levels < LLOQ at the end of treatment, excluding participants who were been shown to be re-infected. The confidence interval was calculated using the Wilson score method.
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 at least one post-treatment HCV RNA value, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.

Arm/Group Title	Arm A	Arm B	Arm C	Arm D
Arm/Group Description	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) for 8 weeks in HCV genotype 1 (GT1) -infected, DAA treatment-naïve participants without cirrhosis.	Ombitasvir (25 mg)/paritaprevir (150 mg)/ritonavir (100mg) (OBV/PTV/r) QD for 12 weeks in HCV GT1 infected, DAA treatment-naïve participants without cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT1- or GT2-infected participants with compensated cirrhosis, HCV GT3-, 4-, 5- and 6-infected participants (with compensated cirrhosis or without cirrhosis), HCV GT1- and GT2-infected participants who had failed prior DAA treatments (with compensated cirrhosis or without cirrhosis), and HCV GT1- or GT2-infected participants with severe renal impairment and compensated cirrhosis.	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in GT1- or GT2-infected participants with severe renal impairment and without cirrhosis.
Measure Participants	129	51	100	10
Number (95% Confidence Interval) [percentage of participants]	0 0%	0 0%	3.0 2.9%	0 0%

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 (SAEs) were collected starting from the time that the informed consent was signed until the end of the study (up to 21 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/Group Description	ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) for 8 weeks in HCV genotype(GT)1 -infected, DAA treatment-naïve participants without cirrhosis.		Ombitasvir (25 mg)/paritaprevir (150 mg)/ritonavir (100mg) (OBV/PTV/r) QD for 12 weeks in HCV GT1 infected, DAA treatment-naïve participants without cirrhosis.		ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120mg) QD for 12 weeks in HCV GT1- or GT2-infected participants with compensated cirrhosis, HCV GT3-, 4-, 5- and 6-infected participants (with compensated cirrhosis or without cirrhosis), HCV GT1- and GT2-infected participants who had failed prior DAA treatments (with compensated cirrhosis or without cirrhosis), and HCV GT1- or GT2-infected participants with severe renal impairment and compensated cirrhosis.		ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in GT1- or GT2-infected participants with severe renal impairment and without cirrhosis.
All Cause Mortality
	ARM A		ARM B		ARM C		ARM D
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	ARM A		ARM B		ARM C		ARM D
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/129 (0%)		3/52 (5.8%)		0/103 (0%)		1/10 (10%)
Gastrointestinal disorders
CONSTIPATION	0/129 (0%)		1/52 (1.9%)		0/103 (0%)		0/10 (0%)
Hepatobiliary disorders
CHOLANGITIS ACUTE	0/129 (0%)		1/52 (1.9%)		0/103 (0%)		0/10 (0%)
Injury, poisoning and procedural complications
LIGAMENT SPRAIN	0/129 (0%)		1/52 (1.9%)		0/103 (0%)		0/10 (0%)
STERNAL FRACTURE	0/129 (0%)		1/52 (1.9%)		0/103 (0%)		0/10 (0%)
Metabolism and nutrition disorders
DECREASED APPETITE	0/129 (0%)		1/52 (1.9%)		0/103 (0%)		0/10 (0%)
FLUID OVERLOAD	0/129 (0%)		0/52 (0%)		0/103 (0%)		1/10 (10%)
Skin and subcutaneous tissue disorders
ANGIOEDEMA	0/129 (0%)		1/52 (1.9%)		0/103 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	ARM A		ARM B		ARM C		ARM D
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	51/129 (39.5%)		28/52 (53.8%)		44/103 (42.7%)		8/10 (80%)
Blood and lymphatic system disorders
EOSINOPHILIA	0/129 (0%)		0/52 (0%)		0/103 (0%)		1/10 (10%)
Eye disorders
EYE PRURITUS	0/129 (0%)		0/52 (0%)		0/103 (0%)		1/10 (10%)
Gastrointestinal disorders
GINGIVAL PAIN	0/129 (0%)		0/52 (0%)		0/103 (0%)		1/10 (10%)
NAUSEA	4/129 (3.1%)		1/52 (1.9%)		0/103 (0%)		1/10 (10%)
General disorders
FATIGUE	0/129 (0%)		0/52 (0%)		3/103 (2.9%)		1/10 (10%)
MALAISE	3/129 (2.3%)		0/52 (0%)		6/103 (5.8%)		0/10 (0%)
PYREXIA	0/129 (0%)		3/52 (5.8%)		2/103 (1.9%)		1/10 (10%)
Infections and infestations
CYSTITIS	1/129 (0.8%)		3/52 (5.8%)		0/103 (0%)		0/10 (0%)
NASOPHARYNGITIS	20/129 (15.5%)		7/52 (13.5%)		9/103 (8.7%)		1/10 (10%)
Injury, poisoning and procedural complications
ARTHROPOD BITE	3/129 (2.3%)		1/52 (1.9%)		0/103 (0%)		1/10 (10%)
CONTUSION	1/129 (0.8%)		0/52 (0%)		1/103 (1%)		1/10 (10%)
Investigations
BLOOD BILIRUBIN INCREASED	3/129 (2.3%)		3/52 (5.8%)		4/103 (3.9%)		0/10 (0%)
BLOOD CREATININE INCREASED	0/129 (0%)		0/52 (0%)		0/103 (0%)		2/10 (20%)
BLOOD MAGNESIUM INCREASED	0/129 (0%)		0/52 (0%)		0/103 (0%)		1/10 (10%)
BLOOD POTASSIUM DECREASED	0/129 (0%)		0/52 (0%)		0/103 (0%)		1/10 (10%)
HAEMOGLOBIN DECREASED	0/129 (0%)		0/52 (0%)		2/103 (1.9%)		1/10 (10%)
PROTEIN URINE PRESENT	1/129 (0.8%)		1/52 (1.9%)		0/103 (0%)		1/10 (10%)
Metabolism and nutrition disorders
HYPERURICAEMIA	1/129 (0.8%)		0/52 (0%)		0/103 (0%)		1/10 (10%)
Musculoskeletal and connective tissue disorders
ARTHRALGIA	3/129 (2.3%)		0/52 (0%)		0/103 (0%)		2/10 (20%)
BACK PAIN	2/129 (1.6%)		0/52 (0%)		1/103 (1%)		1/10 (10%)
Nervous system disorders
HEADACHE	6/129 (4.7%)		5/52 (9.6%)		7/103 (6.8%)		1/10 (10%)
Psychiatric disorders
INSOMNIA	1/129 (0.8%)		0/52 (0%)		0/103 (0%)		1/10 (10%)
Renal and urinary disorders
RENAL DISORDER	0/129 (0%)		0/52 (0%)		0/103 (0%)		1/10 (10%)
Respiratory, thoracic and mediastinal disorders
ASTHMA	0/129 (0%)		0/52 (0%)		0/103 (0%)		1/10 (10%)
COUGH	1/129 (0.8%)		1/52 (1.9%)		3/103 (2.9%)		1/10 (10%)
Skin and subcutaneous tissue disorders
ERYTHEMA	0/129 (0%)		0/52 (0%)		0/103 (0%)		1/10 (10%)
PRURITUS	8/129 (6.2%)		5/52 (9.6%)		13/103 (12.6%)		0/10 (0%)
RASH	3/129 (2.3%)		3/52 (5.8%)		6/103 (5.8%)		1/10 (10%)
Vascular disorders
HYPERTENSION	4/129 (3.1%)		4/52 (7.7%)		2/103 (1.9%)		1/10 (10%)

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.