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)

Sponsor
AbbVie (Industry)
Overall Status
Completed
CT.gov ID
NCT02738138
Collaborator
(none)
153
Enrollment
2
Arms
12.7
Actual Duration (Months)

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: ABT-493 coformulated with ABT-530
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
153 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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)
Actual Study Start Date :
May 17, 2016
Actual Primary Completion Date :
Mar 15, 2017
Actual Study Completion Date :
Jun 7, 2017

Arms and Interventions

ArmIntervention/Treatment
Experimental: 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

Drug: ABT-493 coformulated with ABT-530
Tablet
Other Names:
  • ABT-493 also known as glecaprevir
  • ABT-530 also known as pibrentasvir
  • MAVYRET
  • Experimental: 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

    Drug: ABT-493 coformulated with ABT-530
    Tablet
    Other Names:
  • ABT-493 also known as glecaprevir
  • ABT-530 also known as pibrentasvir
  • MAVYRET
  • Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [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 Outcome Measures

    1. Percentage of Participants With On-treatment Virologic Failure [Up to 12 weeks]

      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.

    2. Percentage of Participants With Post-treatment Relapse [From the end of treatment through 12 weeks after the last dose of study drug]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: AbbVie Inc, AbbVie

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT02738138
    Other Study ID Numbers:
    • M14-730
    • 2015-005577-20
    First Posted:
    Apr 14, 2016
    Last Update Posted:
    Jul 13, 2021
    Last Verified:
    Jul 1, 2021

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment DetailThe study included a 35-day screening period.
    Arm/Group TitleABT-493/ABT-530 for 8 WeeksABT-493/ABT-530 for 12 Weeks
    Arm/Group DescriptionHCV GT1-6/HIV-1 co-infected non-cirrhotic subjects treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 8 weeksHCV 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
    Period Title: Overall Study
    STARTED13716
    COMPLETED13415
    NOT COMPLETED31

    Baseline Characteristics

    Arm/Group TitleABT-493/ABT-530 for 8 WeeksABT-493/ABT-530 for 12 WeeksTotal
    Arm/Group DescriptionHCV GT1-6/HIV-1 co-infected non-cirrhotic subjects treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 8 weeksHCV 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 weeksTotal of all reporting groups
    Overall Participants13716153
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    45.00
    (10.22)
    50.00
    (8.36)
    45.00
    (10.16)
    Sex: Female, Male (Count of Participants)
    Female
    24
    17.5%
    1
    6.3%
    25
    16.3%
    Male
    113
    82.5%
    15
    93.8%
    128
    83.7%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    6
    4.4%
    0
    0%
    6
    3.9%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    24
    17.5%
    1
    6.3%
    25
    16.3%
    White
    106
    77.4%
    15
    93.8%
    121
    79.1%
    More than one race
    1
    0.7%
    0
    0%
    1
    0.7%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%

    Outcome Measures

    1. Primary Outcome
    TitlePercentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
    DescriptionSVR12 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.
    Time Frame12 weeks after last dose of study drug

    Outcome Measure Data

    Analysis Population Description
    Per protocol, all efficacy analyses were performed using the intention-to-treat (ITT) population (all enrolled participants who received at least 1 dose of study drug); in addition, efficacy analyses were performed overall, combining Treatment Arms A and B.
    Arm/Group TitleABT-493/ABT-530
    Arm/Group DescriptionHCV GT1-6/HIV-1 co-infected participants treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD)
    Measure Participants153
    Number (95% Confidence Interval) [percentage of participants]
    98.0
    71.5%
    2. Secondary Outcome
    TitlePercentage of Participants With On-treatment Virologic Failure
    DescriptionOn-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.
    Time FrameUp to 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Per protocol, all efficacy analyses were performed using the ITT population; in addition, efficacy analyses were performed overall, combining Treatment Arms A and B.
    Arm/Group TitleABT-493/ABT-530
    Arm/Group DescriptionHCV GT1-6/HIV-1 co-infected participants treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD)
    Measure Participants153
    Number (95% Confidence Interval) [percentage of participants]
    0.7
    0.5%
    3. Secondary Outcome
    TitlePercentage of Participants With Post-treatment Relapse
    DescriptionPost-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.
    Time FrameFrom the end of treatment through 12 weeks after the last dose of study drug

    Outcome Measure Data

    Analysis Population Description
    Per protocol, all efficacy analyses were performed using the ITT population including only those participants who had post-treatment data available, excluding reinfection (N = 151). In addition, efficacy analyses were performed overall, combining Treatment Arms A and B.
    Arm/Group TitleABT-493/ABT-530
    Arm/Group DescriptionHCV GT1-6/HIV-1 co-infected participants treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD)
    Measure Participants151
    Number (95% Confidence Interval) [percentage of participants]
    0
    0%

    Adverse Events

    Time FrameTreatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
    Adverse Event Reporting Description TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks).
    Arm/Group TitleABT-493/ABT-530 for 8 WeeksABT-493/ABT-530 for 12 Weeks
    Arm/Group DescriptionHCV GT1-6/HIV-1 co-infected non-cirrhotic subjects will be treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 8 weeksHCV GT1-6/HIV-1 co-infected subjects with compensated cirrhosis will be treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 12 weeks
    All Cause Mortality
    ABT-493/ABT-530 for 8 WeeksABT-493/ABT-530 for 12 Weeks
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/137 (0%) 0/16 (0%)
    Serious Adverse Events
    ABT-493/ABT-530 for 8 WeeksABT-493/ABT-530 for 12 Weeks
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total3/137 (2.2%) 1/16 (6.3%)
    Gastrointestinal disorders
    UPPER GASTROINTESTINAL HAEMORRHAGE1/137 (0.7%) 10/16 (0%) 0
    Nervous system disorders
    CEREBRAL HAEMORRHAGE0/137 (0%) 01/16 (6.3%) 1
    CEREBROVASCULAR ACCIDENT0/137 (0%) 01/16 (6.3%) 1
    Renal and urinary disorders
    CALCULUS URINARY1/137 (0.7%) 10/16 (0%) 0
    Vascular disorders
    PERIPHERAL ARTERIAL OCCLUSIVE DISEASE1/137 (0.7%) 10/16 (0%) 0
    Other (Not Including Serious) Adverse Events
    ABT-493/ABT-530 for 8 WeeksABT-493/ABT-530 for 12 Weeks
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total50/137 (36.5%) 7/16 (43.8%)
    Gastrointestinal disorders
    ABDOMINAL PAIN2/137 (1.5%) 21/16 (6.3%) 1
    CONSTIPATION1/137 (0.7%) 11/16 (6.3%) 1
    DENTAL CARIES1/137 (0.7%) 11/16 (6.3%) 1
    GASTROINTESTINAL SOUNDS ABNORMAL0/137 (0%) 01/16 (6.3%) 1
    NAUSEA12/137 (8.8%) 121/16 (6.3%) 1
    General disorders
    FATIGUE18/137 (13.1%) 180/16 (0%) 0
    Immune system disorders
    SEASONAL ALLERGY0/137 (0%) 01/16 (6.3%) 1
    Infections and infestations
    CANDIDA INFECTION0/137 (0%) 01/16 (6.3%) 1
    SINUSITIS BACTERIAL0/137 (0%) 01/16 (6.3%) 1
    VIRAL UPPER RESPIRATORY TRACT INFECTION12/137 (8.8%) 120/16 (0%) 0
    Nervous system disorders
    DIZZINESS3/137 (2.2%) 31/16 (6.3%) 1
    HEADACHE12/137 (8.8%) 120/16 (0%) 0
    Psychiatric disorders
    ANXIETY2/137 (1.5%) 21/16 (6.3%) 1
    Respiratory, thoracic and mediastinal disorders
    COUGH2/137 (1.5%) 21/16 (6.3%) 1
    SINUS CONGESTION1/137 (0.7%) 11/16 (6.3%) 1
    UPPER-AIRWAY COUGH SYNDROME0/137 (0%) 01/16 (6.3%) 1
    Skin and subcutaneous tissue disorders
    PRURITUS3/137 (2.2%) 31/16 (6.3%) 1
    RASH5/137 (3.6%) 51/16 (6.3%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.

    Results Point of Contact

    Name/TitleGlobal Medical Services
    OrganizationAbbVie
    Phone800-633-9110
    Emailabbvieclinicaltrials@abbvie.com
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT02738138
    Other Study ID Numbers:
    • M14-730
    • 2015-005577-20
    First Posted:
    Apr 14, 2016
    Last Update Posted:
    Jul 13, 2021
    Last Verified:
    Jul 1, 2021