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)

AbbVie0 sites153 target enrollmentMay 17, 2016

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

InterventionsABT-493 coformulated with ABT-530

DrugsABT-493 coformulated with ABT-530

Overview

Phase: Phase 3
Intervention: ABT-493 coformulated with ABT-530
Conditions: Hepatitis C Virus Infection
Sponsor: AbbVie
Enrollment: 153
Primary Endpoint: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 17, 2016

End Date

June 7, 2017

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AbbVie

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

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

Intervention: ABT-493 coformulated with ABT-530

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

Intervention: ABT-493 coformulated with ABT-530

Outcomes

Primary Outcomes

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

Time Frame: 12 weeks after last 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 active study drug.

Secondary Outcomes

Percentage of Participants With On-treatment Virologic Failure(Up to 12 weeks)
Percentage of Participants With Post-treatment Relapse(From the end of treatment through 12 weeks after the last dose of study drug)