A Study to Evaluate the Efficacy and Safety of Experimental Drugs ABT- 493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1-6 Infection and Human Immunodeficiency Virus -1 Coinfection (EXPEDITION-2)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-17

Study Completion Date

2017-06-07

Brief Summary

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The purpose of this study is to assess the efficacy and safety of ABT-493/ABT-530 in adults with chronic hepatitis C virus genotype 1-6 infection and human immunodeficiency virus-1 co-infection.

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Detailed Description

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Conditions

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Hepatitis C Virus Infection Human Immunodeficiency Virus Infection Chronic Hepatitis C Compensated Cirrhosis and Non-cirrhotics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ABT-493/ABT-530 for 8 weeks

HCV Genotype (GT)1-6/HIV-1 co-infected non-cirrhotic subjects treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 8 weeks

Group Type EXPERIMENTAL

ABT-493 coformulated with ABT-530

Intervention Type DRUG

Tablet

ABT-493/ABT-530 for 12 weeks

HCV GT1-6/HIV-1 co-infected subjects with compensated cirrhosis treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 12 weeks

Group Type EXPERIMENTAL

ABT-493 coformulated with ABT-530

Intervention Type DRUG

Tablet

Interventions

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ABT-493 coformulated with ABT-530

Tablet

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

1. Male or female, at least 18 years of age at time of Screening.
2. Screening laboratory result indicating Hepatitis C virus (HCV) genotype (GT)1-, 2-, 3-, 4-, 5-, or 6-infection.
3. Subject has positive anti-HCV antibody (Ab) and plasma HCV ribonucleic acid (RNA) viral load greater than or equal to 1000 IU/mL at Screening visit.
4. Subjects must be HCV treatment-naïve (i.e., subject has never received a single dose of any approved or investigational anti-HCV medication) or HCV treatment-experienced (subject who has failed prior IFN or pegylated-interferon \[pegIFN\] with or without ribavirin \[RBV\], or sofosbuvir \[SOF\] plus RBV with or without pegIFN). GT3 subjects must be HCV treatment-naïve. Previous HCV treatment must have been completed greater than or equal to 2 months prior to Screening.
5. Subjects naïve to antiretroviral treatment (ART) must have CD4+ count greater than or equal to 500 cells/mm\^3 (or CD4+ % greater than or equal to 29%) at Screening; or Subjects on a stable ART regimen must have

* CD4+ count greater than or equal to 200 cells/mm\^3 (or CD4+ % greater than or equal to 14%) at Screening; and
* Plasma HIV-1 RNA below lower limit of quantification (LLOQ) at Screening and at least once during the 12 months prior to Screening.

Exclusion Criteria

1. 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.
2. Positive test result at Screening for hepatitis B surface antigen (HBsAg).
3. Positive Human Immunodeficiency virus, type 2 (HIV-2) Ab at Screening.
4. Receipt of any other investigational or commercially available direct acting anti-HCV agents other than sofosbuvir (e.g., telaprevir, boceprevir, simeprevir, paritaprevir, grazoprevir, daclatasvir, ledipasvir, ombitasvir, elbasvir or dasabuvir).
5. Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-493/ABT-530.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No