PEARL-I: A Study to Evaluate the Safety and Effect of Co-administration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection

Sponsor
AbbVie (prior sponsor, Abbott) (Industry)
Overall Status
Completed
CT.gov ID
NCT01685203
Collaborator
(none)
316
8
30

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of co-administration of ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as ombitasvir) in adults with chronic hepatitis C virus infection.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

This was a Phase 2, randomized, open-label, combination treatment study of the 2-DAA regimen (ABT-450 150 mg QD + ritonavir 100 mg QD + ABT-267 25 mg QD) in adult HCV GT1b-infected treatment-naïve and Pegylated-interferon/ribavirin (pegIFN/RBV) treatment-experienced participants without cirrhosis and with compensated cirrhosis, and in adult GT4-infected treatment-naïve and pegIFN/RBV treatment-experienced participants without cirrhosis. Treatment Group 5 was not open to enrollment, based on a protocol-specified interim review of results from the treatment-naïve GT4 Groups 1 and 4 that indicated higher sustained virologic response (SVR) rates among participants receiving the 2-DAA regimen with RBV. All other groups completed the study.

Study Design

Study Type:
Interventional
Actual Enrollment :
316 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Coadministration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection (PEARL-I)
Study Start Date :
Aug 1, 2012
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Feb 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1

ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants

Drug: ABT-450/r
Tablet; ABT-450; Capsule; ritonavir
Other Names:
  • ABT-450 also known as paritaprevir
  • Drug: ABT-267
    Tablet
    Other Names:
  • ABT-267 also known as ombitasvir
  • Experimental: Group 2

    ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants

    Drug: ABT-450/r
    Tablet; ABT-450; Capsule; ritonavir
    Other Names:
  • ABT-450 also known as paritaprevir
  • Drug: ABT-267
    Tablet
    Other Names:
  • ABT-267 also known as ombitasvir
  • Experimental: Group 3

    ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants

    Drug: ABT-450/r
    Tablet; ABT-450; Capsule; ritonavir
    Other Names:
  • ABT-450 also known as paritaprevir
  • Drug: ABT-267
    Tablet
    Other Names:
  • ABT-267 also known as ombitasvir
  • Experimental: Group 4

    ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants

    Drug: ABT-450/r
    Tablet; ABT-450; Capsule; ritonavir
    Other Names:
  • ABT-450 also known as paritaprevir
  • Drug: ABT-267
    Tablet
    Other Names:
  • ABT-267 also known as ombitasvir
  • Drug: Ribavirin (RBV)
    Tablet

    Experimental: Group 5

    ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-experienced, HCV GT4-infected participants

    Drug: ABT-450/r
    Tablet; ABT-450; Capsule; ritonavir
    Other Names:
  • ABT-450 also known as paritaprevir
  • Drug: ABT-267
    Tablet
    Other Names:
  • ABT-267 also known as ombitasvir
  • Experimental: Group 6

    ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants

    Drug: ABT-450/r
    Tablet; ABT-450; Capsule; ritonavir
    Other Names:
  • ABT-450 also known as paritaprevir
  • Drug: ABT-267
    Tablet
    Other Names:
  • ABT-267 also known as ombitasvir
  • Drug: Ribavirin (RBV)
    Tablet

    Experimental: Group 7

    ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis

    Drug: ABT-450/r
    Tablet; ABT-450; Capsule; ritonavir
    Other Names:
  • ABT-450 also known as paritaprevir
  • Drug: ABT-267
    Tablet
    Other Names:
  • ABT-267 also known as ombitasvir
  • Experimental: Group 8

    ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis

    Drug: ABT-450/r
    Tablet; ABT-450; Capsule; ritonavir
    Other Names:
  • ABT-450 also known as paritaprevir
  • Drug: ABT-267
    Tablet
    Other Names:
  • ABT-267 also known as ombitasvir
  • Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants in Each Treatment Group With Sustained Virologic Response 12 Weeks Post-treatment [12 weeks after the last actual dose of study drug]

      The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [<LLOQ]) 12 weeks after the last dose of study drug.

    Secondary Outcome Measures

    1. Percentage of Participants in Each Treatment Group With Sustained Virologic Response 24 Weeks Post-treatment [24 weeks after the last actual dose of study drug]

      The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [<LLOQ]) 24 weeks after the last dose of study drug.

    2. Percentage of Participants in Each Treatment Group With On-treatment Virologic Failure. [Baseline (Day 1), Day 3, and Treatment Weeks 1, 2 ,3 ,4, 6, 8, 10, and 12 for all participants and Treatment Weeks 16, 20 and 24 for Groups 7 and 8]

      Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment), or fail to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).

    3. Percentage of Participants in Each Treatment Group With Post-treatment Virologic Relapse. [Within 12 weeks after the last dose of study drug]

      Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.

    4. Percentage of Participants in Each Treatment Group With Treatment-emergent Adverse Events [From the start of study drug administration until 30 days after the last dose,16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8.]

      Treatment-emergent adverse events were defined as any event that began or worsened in severity after initiation of study drug through 30 days after the last dose of study drug.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Females must be practicing specific forms of birth control on study treatment, or be postmenopausal for more than 2 years or surgically sterile

    • Subjects must meet one of the following:

    • Treatment-naive: Subject has never received antiviral treatment for hepatitis C infection OR

    • Treatment Experienced (Prior null responders, Partial responders or Relapsers to pegIFN/RBV);

    • Body mass index (BMI) is ≥ 18 to < 38 kg/m^2.

    • Chronic HCV genotype 1b infection/with or without cirrhosis or HCV genotype 4 infection/without cirrhosis for at least 6 months prior to study screening.

    • Subject has plasma HCV RNA level > 10,000 IU/mL at Screening

    Exclusion Criteria:
    • History of severe, life-threatening or other significant sensitivity to any drug.

    • Females who were pregnant or planned to become pregnant, or breastfeeding, or GT4-infected males whose partners were pregnant or planning to become pregnant within 7 months (or per local RBV label) after their last dose of study drug/RBV.

    • Recent history of drug or alcohol abuse that could preclude adherence to the protocol.

    • Positive test result for hepatitis B surface antigen or anti-Human Immunodeficiency Virus (HIV) antibodies.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • AbbVie (prior sponsor, Abbott)

    Investigators

    • Study Director: Nilou Mobashery, MD, AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    AbbVie (prior sponsor, Abbott)
    ClinicalTrials.gov Identifier:
    NCT01685203
    Other Study ID Numbers:
    • M13-393
    • 2011-005762-38
    First Posted:
    Sep 14, 2012
    Last Update Posted:
    Jul 30, 2021
    Last Verified:
    Jul 1, 2021

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail The study originally planned to enroll Group 5 (GT4 treatment-experienced, 2-DAA regimen for 12 weeks), but based on a protocol-specified interim review of results from the treatment-naïve GT4 Groups 1 and 4 that indicated higher SVR rates among participants receiving the 2-DAA regimen with RBV, Group 5 was not opened to enrollment.
    Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 6 Group 7 Group 8
    Arm/Group Description ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
    Period Title: Overall Study
    STARTED 44 42 40 42 49 47 52
    Completed Study Drug 42 40 39 42 49 43 52
    COMPLETED 40 39 40 41 49 44 52
    NOT COMPLETED 4 3 0 1 0 3 0

    Baseline Characteristics

    Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 6 Group 7 Group 8 Total
    Arm/Group Description ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis Total of all reporting groups
    Overall Participants 44 42 40 42 49 47 52 316
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    48.9
    (10.0)
    55.8
    (6.9)
    54.2
    (9.6)
    44.2
    (12.7)
    50.9
    (10.1)
    57.8
    (7.1)
    57.1
    (6.0)
    52.8
    (10.1)
    Sex: Female, Male (Count of Participants)
    Female
    20
    45.5%
    17
    40.5%
    25
    62.5%
    14
    33.3%
    13
    26.5%
    24
    51.1%
    19
    36.5%
    132
    41.8%
    Male
    24
    54.5%
    25
    59.5%
    15
    37.5%
    28
    66.7%
    36
    73.5%
    23
    48.9%
    33
    63.5%
    184
    58.2%

    Outcome Measures

    1. Secondary Outcome
    Title Percentage of Participants in Each Treatment Group With Sustained Virologic Response 24 Weeks Post-treatment
    Description The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [<LLOQ]) 24 weeks after the last dose of study drug.
    Time Frame 24 weeks after the last actual dose of study drug

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug.
    Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 6 Group 7 Group 8
    Arm/Group Description ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
    Measure Participants 44 42 40 42 49 47 52
    Number (95% Confidence Interval) [Percentage of participants]
    86.4
    196.4%
    92.9
    221.2%
    90.0
    225%
    100.0
    238.1%
    100.0
    204.1%
    97.9
    208.3%
    98.1
    188.7%
    2. Primary Outcome
    Title Percentage of Participants in Each Treatment Group With Sustained Virologic Response 12 Weeks Post-treatment
    Description The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [<LLOQ]) 12 weeks after the last dose of study drug.
    Time Frame 12 weeks after the last actual dose of study drug

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug.
    Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 6 Group 7 Group 8
    Arm/Group Description ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
    Measure Participants 44 42 40 42 49 47 52
    Number (95% Confidence Interval) [Percentage of participants]
    90.9
    206.6%
    95.2
    226.7%
    90.0
    225%
    100
    238.1%
    100
    204.1%
    97.9
    208.3%
    98.1
    188.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group 2, Group 3
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.381
    Comments
    Method Regression, Logistic
    Comments Treatment group, baseline log(subscript)10(subscript) HCV RNA level and Interleukin-28B (IL28B) genotype (CC or non-CC) were used as predictors
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group 1, Group 4
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.086
    Comments Difference in rates after adjusting for Interleukin-28 (IL28) genotype (CC or Non-CC) using stratum-adjusted Mantel-Haenszel proportions and continuity-corrected variances.
    Method Stratum-adjusted Mantel-Haenszel
    Comments
    3. Secondary Outcome
    Title Percentage of Participants in Each Treatment Group With On-treatment Virologic Failure.
    Description Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment), or fail to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).
    Time Frame Baseline (Day 1), Day 3, and Treatment Weeks 1, 2 ,3 ,4, 6, 8, 10, and 12 for all participants and Treatment Weeks 16, 20 and 24 for Groups 7 and 8

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug.
    Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 6 Group 7 Group 8
    Arm/Group Description ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
    Measure Participants 44 42 40 42 49 47 52
    Number (95% Confidence Interval) [Percentage of participants]
    2.3
    5.2%
    0
    0%
    2.5
    6.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    4. Secondary Outcome
    Title Percentage of Participants in Each Treatment Group With Post-treatment Virologic Relapse.
    Description Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.
    Time Frame Within 12 weeks after the last dose of study drug

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug and completed treatment with HCV RNA < LLOQ at the final treatment visit.
    Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 6 Group 7 Group 8
    Arm/Group Description ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
    Measure Participants 42 40 39 42 49 44 52
    Number (95% Confidence Interval) [Percentage of participants]
    4.8
    10.9%
    0
    0%
    7.7
    19.3%
    0
    0%
    0
    0%
    0
    0%
    1.9
    3.7%
    5. Secondary Outcome
    Title Percentage of Participants in Each Treatment Group With Treatment-emergent Adverse Events
    Description Treatment-emergent adverse events were defined as any event that began or worsened in severity after initiation of study drug through 30 days after the last dose of study drug.
    Time Frame From the start of study drug administration until 30 days after the last dose,16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8.

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug.
    Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 6 Group 7 Group 8
    Arm/Group Description ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
    Measure Participants 44 42 40 42 49 47 52
    Number [Percentage of participants]
    77.3
    175.7%
    73.8
    175.7%
    80.0
    200%
    88.1
    209.8%
    85.7
    174.9%
    85.1
    181.1%
    71.2
    136.9%

    Adverse Events

    Time Frame Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8.
    Adverse Event Reporting Description Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
    Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 6 Group 7 Group 8
    Arm/Group Description ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/ RBV (pegIFN/RBV) treatment-experienced participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/ RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
    All Cause Mortality
    Group 1 Group 2 Group 3 Group 4 Group 6 Group 7 Group 8
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Group 1 Group 2 Group 3 Group 4 Group 6 Group 7 Group 8
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/44 (4.5%) 1/42 (2.4%) 1/40 (2.5%) 0/42 (0%) 0/49 (0%) 3/47 (6.4%) 2/52 (3.8%)
    Cardiac disorders
    ATRIAL FIBRILLATION 1/44 (2.3%) 0/42 (0%) 0/40 (0%) 0/42 (0%) 0/49 (0%) 0/47 (0%) 0/52 (0%)
    Gastrointestinal disorders
    OESOPHAGEAL VARICES HAEMORRHAGE 0/44 (0%) 0/42 (0%) 0/40 (0%) 0/42 (0%) 0/49 (0%) 1/47 (2.1%) 0/52 (0%)
    General disorders
    DEVICE EXTRUSION 0/44 (0%) 0/42 (0%) 1/40 (2.5%) 0/42 (0%) 0/49 (0%) 0/47 (0%) 0/52 (0%)
    Injury, poisoning and procedural complications
    CONTUSION 1/44 (2.3%) 0/42 (0%) 0/40 (0%) 0/42 (0%) 0/49 (0%) 0/47 (0%) 0/52 (0%)
    HUMERUS FRACTURE 0/44 (0%) 0/42 (0%) 0/40 (0%) 0/42 (0%) 0/49 (0%) 0/47 (0%) 1/52 (1.9%)
    ROAD TRAFFIC ACCIDENT 1/44 (2.3%) 0/42 (0%) 0/40 (0%) 0/42 (0%) 0/49 (0%) 0/47 (0%) 0/52 (0%)
    Investigations
    ALANINE AMINOTRANSFERASE INCREASED 0/44 (0%) 0/42 (0%) 0/40 (0%) 0/42 (0%) 0/49 (0%) 1/47 (2.1%) 0/52 (0%)
    ASPARTATE AMINOTRANSFERASE INCREASED 0/44 (0%) 0/42 (0%) 0/40 (0%) 0/42 (0%) 0/49 (0%) 1/47 (2.1%) 0/52 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    HEPATIC NEOPLASM 0/44 (0%) 0/42 (0%) 0/40 (0%) 0/42 (0%) 0/49 (0%) 1/47 (2.1%) 0/52 (0%)
    Nervous system disorders
    PARTIAL SEIZURES 0/44 (0%) 0/42 (0%) 0/40 (0%) 0/42 (0%) 0/49 (0%) 0/47 (0%) 1/52 (1.9%)
    Respiratory, thoracic and mediastinal disorders
    CHRONIC OBSTRUCTIVE PULMONARY DISEASE 0/44 (0%) 1/42 (2.4%) 0/40 (0%) 0/42 (0%) 0/49 (0%) 0/47 (0%) 0/52 (0%)
    Vascular disorders
    PERIPHERAL ARTERY ANEURYSM 0/44 (0%) 0/42 (0%) 0/40 (0%) 0/42 (0%) 0/49 (0%) 0/47 (0%) 1/52 (1.9%)
    Other (Not Including Serious) Adverse Events
    Group 1 Group 2 Group 3 Group 4 Group 6 Group 7 Group 8
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 30/44 (68.2%) 24/42 (57.1%) 26/40 (65%) 32/42 (76.2%) 38/49 (77.6%) 34/47 (72.3%) 33/52 (63.5%)
    Cardiac disorders
    TACHYCARDIA 0/44 (0%) 0/42 (0%) 0/40 (0%) 1/42 (2.4%) 0/49 (0%) 3/47 (6.4%) 0/52 (0%)
    Ear and labyrinth disorders
    VERTIGO 1/44 (2.3%) 3/42 (7.1%) 1/40 (2.5%) 0/42 (0%) 0/49 (0%) 2/47 (4.3%) 0/52 (0%)
    Gastrointestinal disorders
    ABDOMINAL PAIN 0/44 (0%) 1/42 (2.4%) 0/40 (0%) 2/42 (4.8%) 1/49 (2%) 3/47 (6.4%) 1/52 (1.9%)
    ABDOMINAL PAIN UPPER 1/44 (2.3%) 1/42 (2.4%) 0/40 (0%) 1/42 (2.4%) 1/49 (2%) 1/47 (2.1%) 4/52 (7.7%)
    DIARRHOEA 2/44 (4.5%) 6/42 (14.3%) 0/40 (0%) 6/42 (14.3%) 3/49 (6.1%) 7/47 (14.9%) 7/52 (13.5%)
    DYSPEPSIA 1/44 (2.3%) 0/42 (0%) 0/40 (0%) 2/42 (4.8%) 4/49 (8.2%) 0/47 (0%) 0/52 (0%)
    FLATULENCE 0/44 (0%) 1/42 (2.4%) 0/40 (0%) 0/42 (0%) 0/49 (0%) 1/47 (2.1%) 3/52 (5.8%)
    NAUSEA 4/44 (9.1%) 8/42 (19%) 0/40 (0%) 7/42 (16.7%) 6/49 (12.2%) 5/47 (10.6%) 5/52 (9.6%)
    VOMITING 0/44 (0%) 3/42 (7.1%) 0/40 (0%) 2/42 (4.8%) 0/49 (0%) 2/47 (4.3%) 1/52 (1.9%)
    General disorders
    ASTHENIA 11/44 (25%) 3/42 (7.1%) 2/40 (5%) 10/42 (23.8%) 16/49 (32.7%) 10/47 (21.3%) 7/52 (13.5%)
    FATIGUE 3/44 (6.8%) 6/42 (14.3%) 0/40 (0%) 5/42 (11.9%) 9/49 (18.4%) 4/47 (8.5%) 6/52 (11.5%)
    INFLUENZA LIKE ILLNESS 0/44 (0%) 1/42 (2.4%) 2/40 (5%) 0/42 (0%) 1/49 (2%) 0/47 (0%) 2/52 (3.8%)
    IRRITABILITY 3/44 (6.8%) 0/42 (0%) 0/40 (0%) 6/42 (14.3%) 2/49 (4.1%) 1/47 (2.1%) 0/52 (0%)
    OEDEMA PERIPHERAL 1/44 (2.3%) 3/42 (7.1%) 0/40 (0%) 1/42 (2.4%) 2/49 (4.1%) 2/47 (4.3%) 2/52 (3.8%)
    PYREXIA 0/44 (0%) 1/42 (2.4%) 0/40 (0%) 1/42 (2.4%) 3/49 (6.1%) 1/47 (2.1%) 0/52 (0%)
    Infections and infestations
    BRONCHITIS 1/44 (2.3%) 0/42 (0%) 1/40 (2.5%) 1/42 (2.4%) 2/49 (4.1%) 3/47 (6.4%) 1/52 (1.9%)
    GASTROENTERITIS 0/44 (0%) 0/42 (0%) 2/40 (5%) 0/42 (0%) 0/49 (0%) 0/47 (0%) 0/52 (0%)
    INFLUENZA 1/44 (2.3%) 1/42 (2.4%) 2/40 (5%) 0/42 (0%) 2/49 (4.1%) 1/47 (2.1%) 2/52 (3.8%)
    NASOPHARYNGITIS 2/44 (4.5%) 1/42 (2.4%) 2/40 (5%) 2/42 (4.8%) 6/49 (12.2%) 4/47 (8.5%) 4/52 (7.7%)
    RHINITIS 1/44 (2.3%) 0/42 (0%) 0/40 (0%) 0/42 (0%) 3/49 (6.1%) 0/47 (0%) 0/52 (0%)
    UPPER RESPIRATORY TRACT INFECTION 1/44 (2.3%) 1/42 (2.4%) 0/40 (0%) 2/42 (4.8%) 1/49 (2%) 2/47 (4.3%) 4/52 (7.7%)
    URINARY TRACT INFECTION 3/44 (6.8%) 2/42 (4.8%) 2/40 (5%) 1/42 (2.4%) 2/49 (4.1%) 2/47 (4.3%) 1/52 (1.9%)
    Investigations
    BLOOD PRESSURE INCREASED 0/44 (0%) 0/42 (0%) 2/40 (5%) 0/42 (0%) 0/49 (0%) 0/47 (0%) 0/52 (0%)
    Metabolism and nutrition disorders
    DECREASED APPETITE 1/44 (2.3%) 1/42 (2.4%) 0/40 (0%) 1/42 (2.4%) 3/49 (6.1%) 2/47 (4.3%) 1/52 (1.9%)
    HYPERGLYCAEMIA 0/44 (0%) 0/42 (0%) 2/40 (5%) 0/42 (0%) 0/49 (0%) 0/47 (0%) 0/52 (0%)
    INCREASED APPETITE 0/44 (0%) 1/42 (2.4%) 0/40 (0%) 0/42 (0%) 0/49 (0%) 3/47 (6.4%) 0/52 (0%)
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA 0/44 (0%) 1/42 (2.4%) 0/40 (0%) 2/42 (4.8%) 1/49 (2%) 4/47 (8.5%) 0/52 (0%)
    BACK PAIN 3/44 (6.8%) 0/42 (0%) 0/40 (0%) 2/42 (4.8%) 4/49 (8.2%) 6/47 (12.8%) 5/52 (9.6%)
    MYALGIA 0/44 (0%) 2/42 (4.8%) 2/40 (5%) 0/42 (0%) 5/49 (10.2%) 3/47 (6.4%) 2/52 (3.8%)
    Nervous system disorders
    DIZZINESS 1/44 (2.3%) 1/42 (2.4%) 3/40 (7.5%) 0/42 (0%) 3/49 (6.1%) 0/47 (0%) 1/52 (1.9%)
    HEADACHE 13/44 (29.5%) 14/42 (33.3%) 10/40 (25%) 14/42 (33.3%) 14/49 (28.6%) 9/47 (19.1%) 10/52 (19.2%)
    Psychiatric disorders
    ANXIETY 2/44 (4.5%) 0/42 (0%) 0/40 (0%) 4/42 (9.5%) 2/49 (4.1%) 1/47 (2.1%) 2/52 (3.8%)
    DEPRESSION 1/44 (2.3%) 0/42 (0%) 0/40 (0%) 1/42 (2.4%) 3/49 (6.1%) 1/47 (2.1%) 1/52 (1.9%)
    INSOMNIA 2/44 (4.5%) 1/42 (2.4%) 0/40 (0%) 4/42 (9.5%) 8/49 (16.3%) 3/47 (6.4%) 4/52 (7.7%)
    Respiratory, thoracic and mediastinal disorders
    COUGH 0/44 (0%) 2/42 (4.8%) 2/40 (5%) 2/42 (4.8%) 4/49 (8.2%) 3/47 (6.4%) 5/52 (9.6%)
    DYSPNOEA EXERTIONAL 0/44 (0%) 0/42 (0%) 0/40 (0%) 2/42 (4.8%) 3/49 (6.1%) 0/47 (0%) 0/52 (0%)
    EPISTAXIS 1/44 (2.3%) 0/42 (0%) 2/40 (5%) 0/42 (0%) 1/49 (2%) 0/47 (0%) 1/52 (1.9%)
    RHINORRHOEA 0/44 (0%) 1/42 (2.4%) 0/40 (0%) 0/42 (0%) 0/49 (0%) 2/47 (4.3%) 3/52 (5.8%)
    Skin and subcutaneous tissue disorders
    DRY SKIN 0/44 (0%) 7/42 (16.7%) 0/40 (0%) 0/42 (0%) 3/49 (6.1%) 1/47 (2.1%) 0/52 (0%)
    PRURITUS 2/44 (4.5%) 6/42 (14.3%) 0/40 (0%) 1/42 (2.4%) 5/49 (10.2%) 8/47 (17%) 9/52 (17.3%)
    Vascular disorders
    HYPERTENSION 0/44 (0%) 0/42 (0%) 1/40 (2.5%) 1/42 (2.4%) 1/49 (2%) 7/47 (14.9%) 1/52 (1.9%)

    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/Title Global Medical Information
    Organization AbbVie (prior sponsor, Abbott)
    Phone 800-633-9110
    Email
    Responsible Party:
    AbbVie (prior sponsor, Abbott)
    ClinicalTrials.gov Identifier:
    NCT01685203
    Other Study ID Numbers:
    • M13-393
    • 2011-005762-38
    First Posted:
    Sep 14, 2012
    Last Update Posted:
    Jul 30, 2021
    Last Verified:
    Jul 1, 2021