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 Overview
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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.

Official Title
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A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus (HCV) Genotype 1 - 6 Infection and Human Immunodeficiency Virus-1 (HIV-1) Co-Infection (EXPEDITION-2)

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

Intervention / Treatment
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* Drug: ABT-493 coformulated with ABT-530


Participation Criteria
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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 (GT)1-, 2-, 3-, 4-, 5-, or 6-infection. 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. 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. 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: 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). Positive Human Immunodeficiency virus, type 2 (HIV-2) Ab at Screening. 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). Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-493/ABT-530.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABT-493/ABT-530 for 8 weeks<br>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 | Drug: ABT-493 coformulated with ABT-530<br>* Tablet<br>* Other names: MAVYRET;|
| Experimental: ABT-493/ABT-530 for 12 weeks<br>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 | Drug: ABT-493 coformulated with ABT-530<br>* Tablet<br>* Other names: MAVYRET;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 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 active study drug. | 12 weeks after last dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With On-treatment Virologic Failure | On-treatment virologic failure was defined as confirmed HCV RNA ≥ 100 IU/mL 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. | Up to 12 weeks | 
| Percentage of Participants With Post-treatment Relapse | 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. | From the end of treatment through 12 weeks after the last dose of study drug | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCV Genotype 3, Non-cirrhotic, HCV Genotype 1, HCV Genotype 6, Human Immunodeficiency Virus (HIV) Infection, HCV Genotype 5, HCV Treatment Naive, HCV Genotype 4, HCV Treatment Experienced, HCV Genotype 2, Hepatitis C Virus (HCV) Infection, Compensated Cirrhosis