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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

703 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-01-31

Brief Summary

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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

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Detailed Description

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Conditions

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Chronic Hepatitis C Hepatitis C Virus HCV

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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ABT-493/ABT-530 for 12 weeks

ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.

Group Type EXPERIMENTAL

ABT-493/ABT-530

Intervention Type DRUG

Tablet; ABT-493 coformulated with ABT-530

ABT-493/ABT-530 for 8 weeks

ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.

Group Type EXPERIMENTAL

ABT-493/ABT-530

Intervention Type DRUG

Tablet; ABT-493 coformulated with ABT-530

Interventions

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ABT-493/ABT-530

Tablet; ABT-493 coformulated with ABT-530

Intervention Type DRUG

Other Intervention Names

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ABT-493 also known as glecaprevir ABT-530 also known as pibrentasvir MAVYRET

Eligibility Criteria

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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.

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No