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A Study to Evaluate the Safety and Antiviral Effect of Multiple Doses of ABT-493 and ABT-530 in Adults With Genotype 1 Hepatitis C Virus (HCV)

NCT ID: NCT01995071

Last Updated: 2021-07-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-06-30

Brief Summary

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The purpose of this study is to evaluate the safety and antiviral effect of multiple doses of ABT-493 and ABT-530 in adults with genotype 1 HCV.

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Detailed Description

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Conditions

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Chronic Hepatitis C Hepatitis C Virus Compensated Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1 Non-cirrhotic

ABT-493 Dose A (100 mg once daily \[QD\]) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

Group Type EXPERIMENTAL

ABT-493

Intervention Type DRUG

Tablet

ABT-450/r/ABT-267, ABT-333

Intervention Type DRUG

Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet

Ribavirin (RBV)

Intervention Type DRUG

Tablet

Arm 2 Non-cirrhotic

ABT-493 Dose B (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

Group Type EXPERIMENTAL

ABT-493

Intervention Type DRUG

Tablet

ABT-450/r/ABT-267, ABT-333

Intervention Type DRUG

Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet

Ribavirin (RBV)

Intervention Type DRUG

Tablet

Arm 3 Non-cirrhotic

ABT-493 Dose C (700 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

Group Type EXPERIMENTAL

ABT-493

Intervention Type DRUG

Tablet

ABT-450/r/ABT-267, ABT-333

Intervention Type DRUG

Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet

Ribavirin (RBV)

Intervention Type DRUG

Tablet

Arm 4 Non-cirrhotic

ABT-493 Dose D (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

Group Type EXPERIMENTAL

ABT-493

Intervention Type DRUG

Tablet

ABT-450/r/ABT-267, ABT-333

Intervention Type DRUG

Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet

Ribavirin (RBV)

Intervention Type DRUG

Tablet

Arm 5 Compensated cirrhotic

ABT-493 Dose E (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

Group Type EXPERIMENTAL

ABT-493

Intervention Type DRUG

Tablet

ABT-450/r/ABT-267, ABT-333

Intervention Type DRUG

Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet

Ribavirin (RBV)

Intervention Type DRUG

Tablet

Arm 6 Non-cirrhotic

ABT-530 Dose A (15 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

Group Type EXPERIMENTAL

ABT-530

Intervention Type DRUG

Tablet

ABT-450/r/ABT-267, ABT-333

Intervention Type DRUG

Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet

Ribavirin (RBV)

Intervention Type DRUG

Tablet

Arm 7 Non-cirrhotic

ABT-530 Dose B (120 mg QD) for 3 days,followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

Group Type EXPERIMENTAL

ABT-530

Intervention Type DRUG

Tablet

ABT-450/r/ABT-267, ABT-333

Intervention Type DRUG

Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet

Ribavirin (RBV)

Intervention Type DRUG

Tablet

Arm 8 Non-cirrhotic

ABT-530 Dose C (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

Group Type EXPERIMENTAL

ABT-530

Intervention Type DRUG

Tablet

ABT-450/r/ABT-267, ABT-333

Intervention Type DRUG

Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet

Ribavirin (RBV)

Intervention Type DRUG

Tablet

Arm 9 Non-cirrhotic

ABT-530 Dose D (40 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

Group Type EXPERIMENTAL

ABT-530

Intervention Type DRUG

Tablet

ABT-450/r/ABT-267, ABT-333

Intervention Type DRUG

Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet

Ribavirin (RBV)

Intervention Type DRUG

Tablet

Arm 10 Compensated cirrhotic

ABT-530 Dose E (120 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

Group Type EXPERIMENTAL

ABT-530

Intervention Type DRUG

Tablet

ABT-450/r/ABT-267, ABT-333

Intervention Type DRUG

Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet

Ribavirin (RBV)

Intervention Type DRUG

Tablet

Arm 11 Non-cirrhotic

ABT-493 Dose F (300 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

Group Type EXPERIMENTAL

ABT-493

Intervention Type DRUG

Tablet

ABT-450/r/ABT-267, ABT-333

Intervention Type DRUG

Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet

Ribavirin (RBV)

Intervention Type DRUG

Tablet

Arm 12 Non-cirrhotic

ABT-530 Dose F (≤ 400 mg) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

Group Type EXPERIMENTAL

ABT-530

Intervention Type DRUG

Tablet

ABT-450/r/ABT-267, ABT-333

Intervention Type DRUG

Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet

Ribavirin (RBV)

Intervention Type DRUG

Tablet

Interventions

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ABT-493

Tablet

Intervention Type DRUG

ABT-530

Tablet

Intervention Type DRUG

ABT-450/r/ABT-267, ABT-333

Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet

Intervention Type DRUG

Ribavirin (RBV)

Tablet

Intervention Type DRUG

Other Intervention Names

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glecaprevir pibrentasvir ABT-267 also known as ombitasvir ABT-450 also known as paritaprevir ABT-333 also known as dasabuvir Viekira PAK

Eligibility Criteria

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Inclusion Criteria

* Chronic HCV infection prior to study enrollment.
* Screening laboratory result indicating HCV genotype 1-infection.
* Subject has plasma HCV RNA level greater than 10,000 IU/mL at Screening.
* Per local standard, subject is considered to be non-cirrhotic or to have compensated cirrhosis.

Exclusion Criteria

* History of severe, life-threatening or other significant sensitivity to any drug.
* Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency Virus antibody (HIV Ab).
* Prior therapy for the treatment of HCV.
* Any current or past clinical evidence of Child Pugh B or C classification of clinical history of liver decompensation including ascites (noted on physical exam), variceal bleeding or hepatic encephalopathy.
* Any cause of liver disease other than chronic HCV infection.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AbbVie Inc

Role: STUDY_DIRECTOR

AbbVie

References

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Lawitz E, Freilich B, Link J, German P, Mo H, Han L, Brainard DM, McNally J, Marbury T, Rodriguez-Torres M. A phase 1, randomized, dose-ranging study of GS-5816, a once-daily NS5A inhibitor, in patients with genotype 1-4 hepatitis C virus. J Viral Hepat. 2015 Dec;22(12):1011-9. doi: 10.1111/jvh.12435. Epub 2015 Jul 16.

Reference Type BACKGROUND
PMID: 26183611 (View on PubMed)

Lawitz EJ, O'Riordan WD, Asatryan A, Freilich BL, Box TD, Overcash JS, Lovell S, Ng TI, Liu W, Campbell A, Lin CW, Yao B, Kort J. Potent Antiviral Activities of the Direct-Acting Antivirals ABT-493 and ABT-530 with Three-Day Monotherapy for Hepatitis C Virus Genotype 1 Infection. Antimicrob Agents Chemother. 2015 Dec 28;60(3):1546-55. doi: 10.1128/AAC.02264-15.

Reference Type DERIVED
PMID: 26711747 (View on PubMed)

Related Links

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http://rxabbvie.com

Related Info

Other Identifiers

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M13-595

Identifier Type: -

Identifier Source: org_study_id

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