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
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ClinicalTrials.gov Identifier: NCT02243293 |
Recruitment Status :
Completed
First Posted : September 17, 2014
Results First Posted : October 2, 2017
Last Update Posted : July 30, 2021
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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 |
Study Type : | Interventional (Clinical Trial) |
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 : | September 19, 2014 |
Actual Primary Completion Date : | October 25, 2016 |
Actual Study Completion Date : | February 23, 2017 |

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 Name: glecaprevir Drug: ABT-530 Tablet
Other Name: 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 Name: glecaprevir Drug: ABT-530 Tablet
Other Name: 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 Name: glecaprevir Drug: ABT-530 Tablet
Other Name: 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 Name: glecaprevir Drug: ABT-530 Tablet
Other Name: 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 Name: glecaprevir Drug: ABT-530 Tablet
Other Name: 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 Name: glecaprevir Drug: ABT-530 Tablet
Other Name: 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 Name: glecaprevir Drug: ABT-530 Tablet
Other Name: 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 Name: glecaprevir Drug: ABT-530 Tablet
Other Name: 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 Name: glecaprevir Drug: ABT-530 Tablet
Other Name: 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 Name: glecaprevir Drug: ABT-530 Tablet
Other Name: 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 Name: glecaprevir Drug: ABT-530 Tablet
Other Name: 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 Name: glecaprevir Drug: ABT-530 Tablet
Other Name: 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 Name: glecaprevir Drug: ABT-530 Tablet
Other Name: 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 Name: glecaprevir Drug: ABT-530 Tablet
Other Name: 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 Name: glecaprevir Drug: ABT-530 Tablet
Other Name: 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 Name: glecaprevir Drug: ABT-530 Tablet
Other Name: 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:
|
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:
|
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:
|
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:
|
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:
|
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:
|
- Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [ Time Frame: 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.
- 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 [ Time Frame: 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.
- Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4) [ Time Frame: 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.
- Percentage of Participants With On-treatment Virologic Failure [ Time Frame: 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.
- Percentage of Participants With Post-treatment Relapse [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02243293
Study Director: | AbbVie Inc. | AbbVie |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | AbbVie |
ClinicalTrials.gov Identifier: | NCT02243293 |
Other Study ID Numbers: |
M14-868 2014-002927-90 ( EudraCT Number ) |
First Posted: | September 17, 2014 Key Record Dates |
Results First Posted: | October 2, 2017 |
Last Update Posted: | July 30, 2021 |
Last Verified: | July 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |
Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis Hepatitis, Chronic Infections Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections |
Picornaviridae Infections RNA Virus Infections Blood-Borne Infections Communicable Diseases Flaviviridae Infections Ribavirin Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents |