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

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

AbbVie

Study Description

Brief Summary:

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

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

Detailed Description:

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

Study Design

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C Viral Infections

Genetic and Rare Diseases Information Center resources: Chronic Graft Versus Host Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm A ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.	Drug: ABT-493 Tablet Other 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: ABT-493 also known as glecaprevir ABT-530 also known as pibrentasvir MAVYRET
Experimental: Arm Q2 ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.	Drug: ABT-493/ABT-530 Tablet; ABT-493 co-formulated ABT-530 Other Names: ABT-493 also known as glecaprevir ABT-530 also known as pibrentasvir MAVYRET
Experimental: Arm R1 ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.	Drug: ABT-493/ABT-530 Tablet; ABT-493 co-formulated ABT-530 Other Names: ABT-493 also known as glecaprevir ABT-530 also known as pibrentasvir MAVYRET
Experimental: Arm R2 ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.	Drug: ABT-493/ABT-530 Tablet; ABT-493 co-formulated ABT-530 Other Names: ABT-493 also known as glecaprevir ABT-530 also known as pibrentasvir MAVYRET
Experimental: Arm S1 ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.	Drug: ABT-493/ABT-530 Tablet; ABT-493 co-formulated ABT-530 Other Names: ABT-493 also known as glecaprevir ABT-530 also known as pibrentasvir MAVYRET
Experimental: Arm S2 ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.	Drug: ABT-493/ABT-530 Tablet; ABT-493 co-formulated ABT-530 Other Names: ABT-493 also known as glecaprevir ABT-530 also known as pibrentasvir MAVYRET

Outcome Measures

Primary Outcome Measures :

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.

Secondary Outcome Measures :

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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Screening laboratory result indicating HCV Genotype 2, 3, 4, 5, or 6 infection.
Chronic HCV infection.
Participant had to be either HCV treatment-naïve or treatment-experienced.
Participant had to be documented as non-cirrhotic or as having compensated cirrhosis (GT3 only).

Exclusion Criteria:

History of severe, life-threatening or other significant sensitivity to any drug.
Female who was pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner was pregnant or planning to become pregnant during the study.
Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
HCV genotype performed during screening indicating co-infection with more than one HCV genotype.

Contacts and Locations

Information from the National Library of Medicine

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

Sponsors and Collaborators

AbbVie

Investigators

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Study Director:	AbbVie Inc.	AbbVie

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Brown A, Welzel TM, Conway B, Negro F, Brau N, Grebely J, Puoti M, Aghemo A, Kleine H, Pugatch D, Mensa FJ, Chen YJ, Lei Y, Lawitz E, Asselah T. Adherence to pan-genotypic glecaprevir/pibrentasvir and efficacy in HCV-infected patients: A pooled analysis of clinical trials. Liver Int. 2020 Apr;40(4):778-786. doi: 10.1111/liv.14266. Epub 2019 Oct 18.

Back D, Belperio P, Bondin M, Negro F, Talal AH, Park C, Zhang Z, Pinsky B, Crown E, Mensa FJ, Marra F. Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic HCV infection and psychiatric disorders: An integrated analysis. J Viral Hepat. 2019 Aug;26(8):951-960. doi: 10.1111/jvh.13110. Epub 2019 May 20.

Gane E, Poordad F, Zadeikis N, Valdes J, Lin CW, Liu W, Asatryan A, Wang S, Stedman C, Greenbloom S, Nguyen T, Elkhashab M, Worns MA, Tran A, Mulkay JP, Setze C, Yu Y, Pilot-Matias T, Porcalla A, Mensa FJ. Safety and Pharmacokinetics of Glecaprevir/Pibrentasvir in Adults With Chronic Genotype 1-6 Hepatitis C Virus Infections and Compensated Liver Disease. Clin Infect Dis. 2019 Oct 30;69(10):1657-1664. doi: 10.1093/cid/ciz022.

Flamm S, Reddy KR, Zadeikis N, Hassanein T, Bacon BR, Maieron A, Zeuzem S, Bourliere M, Calleja JL, Kosloski MP, Oberoi RK, Lin CW, Yu Y, Lovell S, Semizarov D, Mensa FJ. Efficacy and Pharmacokinetics of Glecaprevir and Pibrentasvir With Concurrent Use of Acid-Reducing Agents in Patients With Chronic HCV Infection. Clin Gastroenterol Hepatol. 2019 Feb;17(3):527-535.e6. doi: 10.1016/j.cgh.2018.07.003. Epub 2018 Sep 10.

Asselah T, Kowdley KV, Zadeikis N, Wang S, Hassanein T, Horsmans Y, Colombo M, Calinas F, Aguilar H, de Ledinghen V, Mantry PS, Hezode C, Marinho RT, Agarwal K, Nevens F, Elkhashab M, Kort J, Liu R, Ng TI, Krishnan P, Lin CW, Mensa FJ. Efficacy of Glecaprevir/Pibrentasvir for 8 or 12 Weeks in Patients With Hepatitis C Virus Genotype 2, 4, 5, or 6 Infection Without Cirrhosis. Clin Gastroenterol Hepatol. 2018 Mar;16(3):417-426. doi: 10.1016/j.cgh.2017.09.027. Epub 2017 Sep 22.

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.

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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

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by AbbVie:


Hepatitis C Virus (HCV) Hepatitis C Chronic Hepatitis C interferon free Hepatitis C Genotype 2	Hepatitis C Genotype 3 Hepatitis C Genotype 4 Hepatitis C Genotype 5 Hepatitis C Genotype 6

Additional relevant MeSH terms:

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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

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