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TURQUOISE-I: A Multipart, Open-label Study to Evaluate the Safety and Efficacy of ABT-450/r/ABT-267 With and Without ABT-333 Coadministered With and Without Ribavirin in Adult With Genotype 1 or 4 Hepatitis C Virus (HCV) Infection and Human Immunodeficiency Virus, Type 1 Coinfection

Sponsor
AbbVie (Industry)
Overall Status
Completed
CT.gov ID
NCT01939197
Collaborator
(none)
318
Enrollment
12
Arms
37.8
Duration (Months)

Study Details

Study Description

Brief Summary

The primary objectives of this study are to assess the safety of ABT-450/r/ABT-267 with and without ABT-333 coadministered with and without ribavirin (RBV) for 12 and 24 weeks in HCV GT1- or 4-infected participants with HIV-1 coinfection and to evaluate the percentage of subjects achieving HCV ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks following treatment.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
318 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multipart, Open-label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir With and Without Dasabuvir Coadministered With and Without Ribavirin in Adults With Genotype 1 or 4 Chronic Hepatitis C Virus Infection and Human Immunodeficiency Virus, Type 1 Coinfection (TURQUOISE-I)
Study Start Date :
Aug 30, 2013
Actual Primary Completion Date :
Jul 21, 2016
Actual Study Completion Date :
Oct 25, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: ARM A

ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 12 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily

Drug: ABT-450/r/ABT-267
tablet
Other Names:
  • ombitasvir/paritaprevir/ritonavir
  • ombitasvir also known as ABT-267
  • paritaprevir also known as ABT-450

    • Drug: ABT-333
    tablet
    Other Names:
  • Dasabuvir

    • Drug: ribavirin
    tablet
    Experimental: ARM B

    ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily

    Drug: ABT-450/r/ABT-267
    tablet
    Other Names:
  • ombitasvir/paritaprevir/ritonavir
  • ombitasvir also known as ABT-267
  • paritaprevir also known as ABT-450

    • Drug: ABT-333
    tablet
    Other Names:
  • Dasabuvir

    • Drug: ribavirin
    tablet
    Experimental: ARM C

    ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily

    Drug: ABT-450/r/ABT-267
    tablet
    Other Names:
  • ombitasvir/paritaprevir/ritonavir
  • ombitasvir also known as ABT-267
  • paritaprevir also known as ABT-450

    • Drug: ABT-333
    tablet
    Other Names:
  • Dasabuvir

    • Drug: ribavirin
    tablet
    Experimental: ARM D

    ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily

    Drug: ABT-450/r/ABT-267
    tablet
    Other Names:
  • ombitasvir/paritaprevir/ritonavir
  • ombitasvir also known as ABT-267
  • paritaprevir also known as ABT-450

    • Drug: ABT-333
    tablet
    Other Names:
  • Dasabuvir

    • Drug: ribavirin
    tablet
    Experimental: ARM E

    ABT-450/r/ABT-267 and ABT-333 for 12 weeks for noncirrhotic (at screening) GT1b-infected participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily

    Drug: ABT-450/r/ABT-267
    tablet
    Other Names:
  • ombitasvir/paritaprevir/ritonavir
  • ombitasvir also known as ABT-267
  • paritaprevir also known as ABT-450

    • Drug: ABT-333
    tablet
    Other Names:
  • Dasabuvir

    		•
    Experimental: ARM F

    ABT-450/r/ABT-267 and ABT-333 for 12 weeks for cirrhotic (at screening) GT1b-infected sofosbuvir-naive participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily

    Drug: ABT-450/r/ABT-267
    tablet
    Other Names:
  • ombitasvir/paritaprevir/ritonavir
  • ombitasvir also known as ABT-267
  • paritaprevir also known as ABT-450

    • Drug: ABT-333
    tablet
    Other Names:
  • Dasabuvir

    		•
    Experimental: ARM G

    ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for cirrhotic (at screening) GT1b-infected sofosbuvir-naive participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily

    Drug: ABT-450/r/ABT-267
    tablet
    Other Names:
  • ombitasvir/paritaprevir/ritonavir
  • ombitasvir also known as ABT-267
  • paritaprevir also known as ABT-450

    • Drug: ABT-333
    tablet
    Other Names:
  • Dasabuvir

    • Drug: ribavirin
    tablet
    Experimental: ARM H

    ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for cirrhotic (at screening) GT1b-infected sofosbuvir-experienced participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily

    Drug: ABT-450/r/ABT-267
    tablet
    Other Names:
  • ombitasvir/paritaprevir/ritonavir
  • ombitasvir also known as ABT-267
  • paritaprevir also known as ABT-450

    • Drug: ABT-333
    tablet
    Other Names:
  • Dasabuvir

    • Drug: ribavirin
    tablet
    Experimental: ARM I

    ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for noncirrhotic (at screening) GT1a-infected participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily

    Drug: ABT-450/r/ABT-267
    tablet
    Other Names:
  • ombitasvir/paritaprevir/ritonavir
  • ombitasvir also known as ABT-267
  • paritaprevir also known as ABT-450

    • Drug: ABT-333
    tablet
    Other Names:
  • Dasabuvir

    • Drug: ribavirin
    tablet
    Experimental: ARM J

    ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for cirrhotic (at screening) GT1a-infected participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily

    Drug: ABT-450/r/ABT-267
    tablet
    Other Names:
  • ombitasvir/paritaprevir/ritonavir
  • ombitasvir also known as ABT-267
  • paritaprevir also known as ABT-450

    • Drug: ABT-333
    tablet
    Other Names:
  • Dasabuvir

    • Drug: ribavirin
    tablet
    Experimental: ARM K

    ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily

    Drug: ABT-450/r/ABT-267
    tablet
    Other Names:
  • ombitasvir/paritaprevir/ritonavir
  • ombitasvir also known as ABT-267
  • paritaprevir also known as ABT-450

    • Drug: ribavirin
    tablet
    Experimental: ARM L

    ABT-450/r/ABT-267 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily

    Drug: ABT-450/r/ABT-267
    tablet
    Other Names:
  • ombitasvir/paritaprevir/ritonavir
  • ombitasvir also known as ABT-267
  • paritaprevir also known as ABT-450

    • Drug: ribavirin
    tablet

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants in GT1 Analysis Group 1 in Part 2 Achieving Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) [12 weeks after the last actual dose of study drug]

      SVR12 is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ) 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% confidence interval (CI) is calculated using the Wilson score method for binomial distribution. The primary efficacy endpoint was the non-inferiority of the percentage of participants in the GT1 Analysis Group in Part 2 achieving SVR12 compared to the historical SVR12 rate for sofosbuvir plus ribavirin (a non-inferiority threshold of the lower bound of the 95% CI of 74%).

    Secondary Outcome Measures

    1. Percentage of Participants in Part 1a Achieving SVR12 [12 weeks after last dose of study drug]

      SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.

    2. Percentage of Participants in Part 1b Achieving SVR12 [12 weeks after last dose of study drug]

      SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.

    3. Percentage of Participants in Arm F and Arm G of Part 2 Achieving SVR12 [12 weeks after last dose of study drug]

      SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.

    4. Percentage of Participants With GT4 HCV in Part 2 Achieving SVR12, by Arm and Overall [12 weeks after last dose of study drug]

      SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.

    5. Percentage of Participants in Part 1a With On-Treatment HCV Virologic Failure During the Treatment Period [up to 12 or 24 weeks, based on treatment duration]

      Percentage of participants with on-treatment HCV virologic failure during the treatment period for each arm in Part 1a. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment.

    6. Percentage of Participants in Part 1b With On-Treatment HCV Virologic Failure During the Treatment Period [up to 12 weeks]

      Percentage of participants with on-treatment HCV virologic failure during the treatment period for each arm and overall in Part 1b. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment.

    7. Percentage of Participants in Part 2 With On-Treatment HCV Virologic Failure During the Treatment Period [up to 12 or 24 weeks, based on treatment duration]

      Percentage of participants with on-treatment HCV virologic failure during the treatment period for arms in Part 2. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment.

    8. Percentage of Participants in Part 1a With Relapse12 [up to 12 or 24 weeks, based on treatment duration, after the last actual dose of study drug]

      Percentage of participants who experienced Relapse12 among participants who completed treatment with HCV RNA < LLOQ at final treatment visit and had at least one post-treatment HCV RNA value. Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 assessment time point) for a participant with HCV RNA < LLOQ at final treatment visit who completed treatment and had post-treatment data. Completion of treatment is defined as study drug duration ≥ 77 days for Arm A and ≥ 154 days for Arm B. The 95% CI is calculated using Wilson score method for the binomial distribution.

    9. Percentage of Participants in Part 1b With Relapse12 for Each Arm and Overall [up to 12 weeks after the last actual dose of study drug]

      Percentage of participants who experienced Relapse12 among participants who completed treatment with HCV RNA < LLOQ at final treatment visit and had at least one post-treatment HCV RNA value. Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 assessment time point) for a participant with HCV RNA < LLOQ at final treatment visit who completed treatment and had post-treatment data. Completion of treatment is defined as study drug duration ≥ 77 days for Arm C and Arm D. The 95% CI is calculated using Wilson score method for the binomial distribution.

    10. Percentage of Participants in Part 2 With Relapse12 [up to 12 or 24 weeks, based on treatment duration, after the last actual dose of study drug]

      Percentage of participants who experienced Relapse12 among those who completed treatment with HCV RNA < LLOQ at final treatment visit and had ≥1 post-treatment HCV RNA value. Relapse12=confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 window) for a participant with HCV RNA < LLOQ at final treatment visit who completed treatment and had post-treatment data, excluding reinfection. Completion of treatment=study drug duration ≥ 77 days for participants who received 12 weeks of treatment and ≥154 days for participants who received 24 weeks of treatment. HCV reinfection=confirmed HCV RNA ≥ LLOQ after the end of treatment in a subject who had HCV RNA < LLOQ at final treatment visit, along with the post-treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis. The 95% CI is calculated using Wilson score method for the binomial distribution.

    11. Percentage of Participants in Part 1a With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment [End of treatment: HIV Week 12 window for 12-weeks of treatment (Treatment Day 71 - 98) or HIV Week 24 window (Treatment Day 155 - 182) for 24-weeks of treatment. Post-Treatment Week 12 (PTW12): HIV PTW12 window (Post-Treatment Day 57 - 126)]

      HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value < 40 copies/mL).

    12. Percentage of Participants in Part 1b With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment [End of treatment: HIV Week 12 window (Treatment Day 78 - 98). PTW12: HIV PTW12 window (Post-Treatment Day 57 - 126)]

      HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value < 40 copies/mL).

    13. Percentage of Participants in Part 2 With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment [End of treatment: HIV Week 12 window for 12-weeks of treatment (Treatment Day 71 - 98) or HIV Week 24 window (Treatment Day 155 - 182) for 24-weeks of treatment. PTW12: HIV PTW12 window (Post-Treatment Day 57 - 126)]

      HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value < 40 copies/mL).

    Eligibility Criteria

    Criteria

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

    • Chronic HCV infection at screening defined as: positive anti-HCV antibodies (Ab) at screening and HCV RNA > 1,000 IU/mL at screening.

    • Plasma HIV-1 RNA < 40 copies/mL during screening using Abbott RealTime HIV-1 assay.

    • On a stable qualifying HIV-1 antiretroviral therapy regimen.

    Exclusion Criteria:

    • Positive test result at screening for hepatitis B surface antigen.

    • Evidence of HCV genotype other than genotype 1 or genotype 4 during screening.

    • Receipt of any other investigational or commercially available anti-HCV agents (for example, telaprevir, boceprevir, simeprevir, daclatasvir and ledipasvir) with the exception of interferon (including pegylated-interferon alfa-2a or alfa-2b), sofosbuvir and ribavirin.

    • Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-450, ABT-267, ABT-333, ritonavir or ribavirin.

    • Chronic human immunodeficiency virus, type 2 (HIV-2) infection.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: Rolando Viani, MD, AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT01939197
    Other Study ID Numbers:
    • M14-004
    • 2012-005143-24
    First Posted:
    Sep 11, 2013
    Last Update Posted:
    Jul 12, 2021
    Last Verified:
    Jul 1, 2021
    Keywords provided by AbbVie
    HCV Genotype 4
    Interferon-Free
    Hepatitis C Genotype 1
    Compensated Cirrhosis
    Hepatitis C Genotype 4
    HCV / HIV coinfection
    Cirrhotic
    Hepatitis C
    HIV-1
    HCV Genotype 1
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Hepatitis A
    Virus Diseases
    Hepatitis C
    Hepatitis C, Chronic
    Acquired Immunodeficiency Syndrome
    HIV Infections
    Coinfection
    Hepatitis
    Hepatitis, Chronic
    Immunologic Deficiency Syndromes
    Fibrosis
    Ritonavir
    Ribavirin

    Study Results

    Participant Flow

    Recruitment Details Part 2 was not designed to test different treatments on the same subject population. Rather, the arms in Part 2 represent subpopulations with different baseline characteristics (hepatitis C virus [HCV] genotype [GT], cirrhotic status, prior HCV therapy experience). Arms F and G were randomized to regimens without and with ribavirin, respectively.
    Pre-assignment Detail In Part 2, participants in Arms E, F, H, I, J all had GT1 infection and received 1 consistent treatment regimen based on label recommendations; they were therefore combined and named the "GT1 Analysis Group."
    Arm/Group Title Part 1a: Arm A Part 1a: Arm B Part 1b: Arm C Part 1b: Arm D Part 2: GT1 Analysis Group Part 2: Arm G GT4 Analysis Group
    Arm/Group Description ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 12 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily Participants with HCV genotype (GT)1a or GT1b at screening in Arms E, F, H, I, J (no participants enrolled in Arm H) Arm E: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm F: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm I: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm J: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Participants with HCV GT4 at screening in Arms K and L (no participants enrolled in Arm L). Arm K: ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily
    Period Title: Overall Study
    STARTED 31 32 10 12 200 5 28
    COMPLETED 30 31 10 11 196 4 26
    NOT COMPLETED 1 1 0 1 4 1 2

    Baseline Characteristics

    Arm/Group Title Part 1a: Arm A Part 1a: Arm B Part 1b: Arm C Part 1b: Arm D Part 2: GT1 Analysis Group Part 2: Arm G Part 2: GT4 Analysis Group Total
    Arm/Group Description ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily Participants with HCV GT1a or GT1b at screening in Arms E, F, H, I, J (no participants enrolled in Arm H) Arm E: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm F: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm I: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm J: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm K: ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily Arm L: no participants enrolled Total of all reporting groups
    Overall Participants 31 32 10 12 200 5 28 318
    Age, Customized (Count of Participants)
    < 55 years
    23
    74.2%
    20
    62.5%
    5
    50%
    8
    66.7%
    145
    72.5%
    2
    40%
    24
    85.7%
    227
    71.4%
    ≥ 55 years
    8
    25.8%
    12
    37.5%
    5
    50%
    4
    33.3%
    55
    27.5%
    3
    60%
    4
    14.3%
    91
    28.6%
    Sex: Female, Male (Count of Participants)
    Female
    2
    6.5%
    3
    9.4%
    2
    20%
    3
    25%
    44
    22%
    1
    20%
    2
    7.1%
    57
    17.9%
    Male
    29
    93.5%
    29
    90.6%
    8
    80%
    9
    75%
    156
    78%
    4
    80%
    26
    92.9%
    261
    82.1%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants in GT1 Analysis Group 1 in Part 2 Achieving Sustained Virologic Response 12 Weeks Post-Treatment (SVR12)
    Description SVR12 is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ) 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% confidence interval (CI) is calculated using the Wilson score method for binomial distribution. The primary efficacy endpoint was the non-inferiority of the percentage of participants in the GT1 Analysis Group in Part 2 achieving SVR12 compared to the historical SVR12 rate for sofosbuvir plus ribavirin (a non-inferiority threshold of the lower bound of the 95% CI of 74%).
    Time Frame 12 weeks after the last actual dose of study drug

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population: Part 2 randomized or enrolled participants who received at least 1 dose of study drug. Imputation applied; participants with missing HCV RNA data after imputation were counted as failures. The primary efficacy endpoint analysis was based on subjects in the GT 1 Analysis Group in Part 2 containing Arms E, F, H, I, and J.
    Arm/Group Title Part 2: GT1 Analysis Group
    Arm/Group Description Participants with HCV GT1a or GT1b at screening in Arms E, F, H, I, J (no participants enrolled in Arm H) Arm E: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm F: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm I: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm J: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
    Measure Participants 200
    Number (95% Confidence Interval) [percentage of participants]
    97.0
    312.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Part 2: GT1 Analysis Group
    Comments
    Type of Statistical Test Non-Inferiority
    Comments The primary efficacy endpoint was the non-inferiority of the percentage of participants in the GT1 Analysis Group in Part 2 achieving SVR12 compared to the historical SVR12 rate for sofosbuvir plus ribavirin (a non-inferiority threshold of the lower bound of the 95% CI of 74%).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Other Statistical Analysis The historical SVR rate, as reported in the PHOTON-1 study, for sofosbuvir and RBV in HCV/HIV-1 coinfected adults is 76% (87/114) with a 95% confidence interval of (67%, 84%). Reference: Sulkowski MS, Naggie S, Lalezari J, et al. Sofosbuvir and ribavirin for hepatitis C in patients with HIV coinfection. JAMA. 2014;312(4):353-61.
    2. Secondary Outcome
    Title Percentage of Participants in Part 1a Achieving SVR12
    Description SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.
    Time Frame 12 weeks after last dose of study drug

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population: Part 1a randomized participants who received at least 1 dose of study drug. Imputation applied; participants with missing HCV RNA data after imputation were counted as failures.
    Arm/Group Title Part 1a: Arm A Part 1a: Arm B
    Arm/Group Description ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
    Measure Participants 31 32
    Number (95% Confidence Interval) [percentage of participants]
    93.5
    301.6%
    90.6
    283.1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Part 2: GT1 Analysis Group, Part 1a: Arm B
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.000
    Comments
    Method Fisher Exact
    Comments
    3. Secondary Outcome
    Title Percentage of Participants in Part 1b Achieving SVR12
    Description SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.
    Time Frame 12 weeks after last dose of study drug

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population: Part 1b randomized participants who received at least 1 dose of study drug. Imputation applied; participants with missing HCV RNA data after imputation were counted as failures.
    Arm/Group Title Part 1b: Arm C Part 1b: Arm D Part 1b: Total
    Arm/Group Description ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily Arm C: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily Arm D: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily
    Measure Participants 10 12 22
    Number (95% Confidence Interval) [percentage of participants]
    100
    322.6%
    100
    312.5%
    100
    1000%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Part 2: GT1 Analysis Group, Part 1a: Arm B
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Other Statistical Analysis The Fisher exact test was performed as prespecified on the SAP but the p-value couldn't be calculated because SVR12 rates in both arms were 100%, hence p-value appeared as "not available."
    4. Secondary Outcome
    Title Percentage of Participants in Arm F and Arm G of Part 2 Achieving SVR12
    Description SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.
    Time Frame 12 weeks after last dose of study drug

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population: Part 2 randomized or enrolled participants who received at least 1 dose of study drug. Imputation applied; participants with missing HCV RNA data after imputation were counted as failures.
    Arm/Group Title Part 2: Arm F Part 2: Arm G
    Arm/Group Description ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
    Measure Participants 4 5
    Number (95% Confidence Interval) [percentage of participants]
    75.0
    241.9%
    80.0
    250%
    5. Secondary Outcome
    Title Percentage of Participants With GT4 HCV in Part 2 Achieving SVR12, by Arm and Overall
    Description SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.
    Time Frame 12 weeks after last dose of study drug

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population: Part 2 randomized or enrolled participants who received at least 1 dose of study drug. Imputation applied; participants with missing HCV RNA data after imputation were counted as failures.
    Arm/Group Title Part 2: GT4 Analysis Group Part 2: Arm K
    Arm/Group Description Arm K: ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily Arm L: no participants enrolled ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily
    Measure Participants 28 28
    Number (95% Confidence Interval) [percentage of participants]
    96.4
    311%
    96.4
    301.3%
    6. Secondary Outcome
    Title Percentage of Participants in Part 1a With On-Treatment HCV Virologic Failure During the Treatment Period
    Description Percentage of participants with on-treatment HCV virologic failure during the treatment period for each arm in Part 1a. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment.
    Time Frame up to 12 or 24 weeks, based on treatment duration

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population: Part 1a randomized participants who received at least 1 dose of study drug.
    Arm/Group Title Part 1a: Arm A Part 1a: Arm B
    Arm/Group Description ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
    Measure Participants 31 32
    Number (95% Confidence Interval) [percentage of participants]
    0
    0%
    3.1
    9.7%
    7. Secondary Outcome
    Title Percentage of Participants in Part 1b With On-Treatment HCV Virologic Failure During the Treatment Period
    Description Percentage of participants with on-treatment HCV virologic failure during the treatment period for each arm and overall in Part 1b. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment.
    Time Frame up to 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population: Part 1b randomized participants who received at least 1 dose of study drug.
    Arm/Group Title Part 1b: Arm C Part 1b: Arm D Part 1b: Total
    Arm/Group Description ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily Arm C: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily Arm D: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily
    Measure Participants 10 12 22
    Number (95% Confidence Interval) [percentage of participants]
    0
    0%
    0
    0%
    0
    0%
    8. Secondary Outcome
    Title Percentage of Participants in Part 2 With On-Treatment HCV Virologic Failure During the Treatment Period
    Description Percentage of participants with on-treatment HCV virologic failure during the treatment period for arms in Part 2. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment.
    Time Frame up to 12 or 24 weeks, based on treatment duration

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population: Part 2 randomized or enrolled participants in the GT1 analysis group (and its composing arms) and GT4 analysis group who received at least 1 dose of study drug. Due to a label change after study start that no longer recommended the Arm G treatment regimen to GT1b cirrhotic subjects, Arm G data was not analyzed.
    Arm/Group Title Part 2: GT1 Analysis Group Part 2: Arm E Part 2: Arm F Part 2: Arm I Part 2: Arm J Part 2: GT4 Analysis Group Group 2: Arm K
    Arm/Group Description Participants with HCV GT1a or GT1b at screening in Arms E, F, H, I, J (no participants enrolled in Arm H) Arm E: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm F: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm I: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm J: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily Arm L: no participants enrolled ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily
    Measure Participants 200 42 4 135 19 28 28
    Number (95% Confidence Interval) [percentage of participants]
    0.5
    1.6%
    0
    0%
    25.0
    250%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    9. Secondary Outcome
    Title Percentage of Participants in Part 1a With Relapse12
    Description Percentage of participants who experienced Relapse12 among participants who completed treatment with HCV RNA < LLOQ at final treatment visit and had at least one post-treatment HCV RNA value. Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 assessment time point) for a participant with HCV RNA < LLOQ at final treatment visit who completed treatment and had post-treatment data. Completion of treatment is defined as study drug duration ≥ 77 days for Arm A and ≥ 154 days for Arm B. The 95% CI is calculated using Wilson score method for the binomial distribution.
    Time Frame up to 12 or 24 weeks, based on treatment duration, after the last actual dose of study drug

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population: Part 1a randomized participants who received at least 1 dose of study drug and who completed treatment with HCV RNA < LLOQ at final treatment visit and had at least one post-treatment HCV RNA value.
    Arm/Group Title Part 1a: Arm A Part 1a: Arm B
    Arm/Group Description ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
    Measure Participants 30 31
    Number (95% Confidence Interval) [percentage of participants]
    3.3
    10.6%
    0
    0%
    10. Secondary Outcome
    Title Percentage of Participants in Part 1b With Relapse12 for Each Arm and Overall
    Description Percentage of participants who experienced Relapse12 among participants who completed treatment with HCV RNA < LLOQ at final treatment visit and had at least one post-treatment HCV RNA value. Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 assessment time point) for a participant with HCV RNA < LLOQ at final treatment visit who completed treatment and had post-treatment data. Completion of treatment is defined as study drug duration ≥ 77 days for Arm C and Arm D. The 95% CI is calculated using Wilson score method for the binomial distribution.
    Time Frame up to 12 weeks after the last actual dose of study drug

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population: all Part 1b randomized participants who received at least 1 dose of study drug and who completed treatment with HCV RNA < LLOQ at final treatment visit and had at least one post-treatment HCV RNA value.
    Arm/Group Title Part 1b: Arm C Part 1b: Arm D Part 1b: Total
    Arm/Group Description ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily Arm C: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily Arm D: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily
    Measure Participants 10 12 22
    Number (95% Confidence Interval) [percentage of participants]
    0
    0%
    0
    0%
    0
    0%
    11. Secondary Outcome
    Title Percentage of Participants in Part 2 With Relapse12
    Description Percentage of participants who experienced Relapse12 among those who completed treatment with HCV RNA < LLOQ at final treatment visit and had ≥1 post-treatment HCV RNA value. Relapse12=confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 window) for a participant with HCV RNA < LLOQ at final treatment visit who completed treatment and had post-treatment data, excluding reinfection. Completion of treatment=study drug duration ≥ 77 days for participants who received 12 weeks of treatment and ≥154 days for participants who received 24 weeks of treatment. HCV reinfection=confirmed HCV RNA ≥ LLOQ after the end of treatment in a subject who had HCV RNA < LLOQ at final treatment visit, along with the post-treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis. The 95% CI is calculated using Wilson score method for the binomial distribution.
    Time Frame up to 12 or 24 weeks, based on treatment duration, after the last actual dose of study drug

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population: Part 2 randomized or enrolled participants in the GT1 analysis group (and its composing arms) and GT4 analysis group who received ≥1 dose of study drug, who completed treatment with HCV RNA < LLOQ at final treatment visit, and had ≥1 post-treatment HCV RNA value. Arm G data was not analyzed (see Outcome Measure 8).
    Arm/Group Title Part 2: GT1 Analysis Group Part 2: Arm E Part 2: Arm F Part 2: Arm I Part 2: Arm J Part 2: GT4 Analysis Group Group 2: Arm K
    Arm/Group Description Participants with HCV GT1a or GT1b at screening in Arms E, F, H, I, J (no participants enrolled in Arm H) Arm E: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm F: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm I: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm J: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm K: ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily Arm L: no participants enrolled ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily
    Measure Participants 192 42 3 131 16 27 27
    Number (95% Confidence Interval) [percentage of participants]
    0.5
    1.6%
    0
    0%
    0
    0%
    0.8
    6.7%
    0
    0%
    0
    0%
    0
    0%
    12. Secondary Outcome
    Title Percentage of Participants in Part 1a With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment
    Description HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value < 40 copies/mL).
    Time Frame End of treatment: HIV Week 12 window for 12-weeks of treatment (Treatment Day 71 - 98) or HIV Week 24 window (Treatment Day 155 - 182) for 24-weeks of treatment. Post-Treatment Week 12 (PTW12): HIV PTW12 window (Post-Treatment Day 57 - 126)

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population: Part 1a randomized participants who received at least 1 dose of study drug.
    Arm/Group Title Part 1a: Arm A Part 1a: Arm B
    Arm/Group Description ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
    Measure Participants 31 32
    End of Treatment
    93.5
    301.6%
    90.6
    283.1%
    Post-Treatment Week 12
    96.8
    312.3%
    93.8
    293.1%
    13. Secondary Outcome
    Title Percentage of Participants in Part 1b With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment
    Description HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value < 40 copies/mL).
    Time Frame End of treatment: HIV Week 12 window (Treatment Day 78 - 98). PTW12: HIV PTW12 window (Post-Treatment Day 57 - 126)

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population: Part 1b randomized participants who received at least 1 dose of study drug.
    Arm/Group Title Part 1b: Arm C Part 1b: Arm D Part 1b Total
    Arm/Group Description ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily Arm C: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily Arm D: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily
    Measure Participants 10 12 22
    End of Treatment
    100
    322.6%
    83.3
    260.3%
    90.9
    909%
    Post-Treatment Week 12
    100
    322.6%
    75.0
    234.4%
    86.4
    864%
    14. Secondary Outcome
    Title Percentage of Participants in Part 2 With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment
    Description HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value < 40 copies/mL).
    Time Frame End of treatment: HIV Week 12 window for 12-weeks of treatment (Treatment Day 71 - 98) or HIV Week 24 window (Treatment Day 155 - 182) for 24-weeks of treatment. PTW12: HIV PTW12 window (Post-Treatment Day 57 - 126)

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population: Part 2 randomized or enrolled participants in the GT1 analysis group (and its composing arms) and GT4 analysis group who received at least 1 dose of study drug. Due to a label change after study start that no longer recommended the Arm G treatment regimen to GT1b cirrhotic subjects, Arm G data was not analyzed.
    Arm/Group Title Part 2: GT1 Analysis Group Part 2: Arm E Part 2: Arm F Part 2: Arm I Part 2: Arm J Part 2: GT4 Analysis Group Group 2: Arm K
    Arm/Group Description Participants with HCV GT1a or GT1b at screening in Arms E, F, H, I, J (no participants enrolled in Arm H) Arm E: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm F: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm I: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm J: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm K: ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily Arm L: no participants enrolled ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily
    Measure Participants 200 42 4 135 19 28 28
    End of Treatment
    89
    287.1%
    90.5
    282.8%
    100
    1000%
    89.6
    746.7%
    78.9
    39.5%
    85.7
    1714%
    85.7
    306.1%
    Post-Treatment Week 12
    93
    300%
    97.6
    305%
    100
    1000%
    91.9
    765.8%
    89.5
    44.8%
    92.9
    1858%
    92.9
    331.8%

    Adverse Events

    Time Frame Protocol-related treatment-emergent adverse events were collected from the first dose of study drug through end of treatment Week 12 and Week 24; treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30.
    Adverse Event Reporting Description A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
    Arm/Group Title Part 1a: Arm A Part 1a: Arm B Part 1b: Arm C Part 1b: Arm D Part 2: Arm E Part 2: Arm F Part 2: Arm G Part 2: Arm I Part 2: Arm J Part 2: Arm K
    Arm/Group Description ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily
    All Cause Mortality
    Part 1a: Arm A Part 1a: Arm B Part 1b: Arm C Part 1b: Arm D Part 2: Arm E Part 2: Arm F Part 2: Arm G Part 2: Arm I Part 2: Arm J Part 2: Arm K
    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 Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Part 1a: Arm A Part 1a: Arm B Part 1b: Arm C Part 1b: Arm D Part 2: Arm E Part 2: Arm F Part 2: Arm G Part 2: Arm I Part 2: Arm J Part 2: Arm K
    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 Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/31 (0%) 0/32 (0%) 0/10 (0%) 1/12 (8.3%) 1/42 (2.4%) 0/4 (0%) 0/5 (0%) 6/135 (4.4%) 2/19 (10.5%) 1/28 (3.6%)
    Blood and lymphatic system disorders
    ANAEMIA 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 1/19 (5.3%) 0/28 (0%)
    Cardiac disorders
    ANGINA UNSTABLE 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 1/42 (2.4%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 0/19 (0%) 0/28 (0%)
    PERICARDITIS 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 1/135 (0.7%) 0/19 (0%) 0/28 (0%)
    Gastrointestinal disorders
    ABDOMINAL PAIN 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 1/135 (0.7%) 0/19 (0%) 0/28 (0%)
    COLITIS 0/31 (0%) 0/32 (0%) 0/10 (0%) 1/12 (8.3%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 0/19 (0%) 0/28 (0%)
    RECTAL PERFORATION 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 1/135 (0.7%) 0/19 (0%) 0/28 (0%)
    Infections and infestations
    APPENDICITIS 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 1/135 (0.7%) 0/19 (0%) 0/28 (0%)
    INFLUENZA 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 1/19 (5.3%) 0/28 (0%)
    Injury, poisoning and procedural complications
    OVERDOSE 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 1/135 (0.7%) 0/19 (0%) 0/28 (0%)
    Metabolism and nutrition disorders
    DEHYDRATION 0/31 (0%) 0/32 (0%) 0/10 (0%) 1/12 (8.3%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 0/19 (0%) 0/28 (0%)
    Psychiatric disorders
    DEPRESSION 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 1/19 (5.3%) 0/28 (0%)
    DRUG DEPENDENCE 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 0/19 (0%) 1/28 (3.6%)
    Renal and urinary disorders
    URETEROLITHIASIS 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 1/19 (5.3%) 0/28 (0%)
    Vascular disorders
    HYPERTENSIVE CRISIS 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 1/135 (0.7%) 0/19 (0%) 0/28 (0%)
    Other (Not Including Serious) Adverse Events
    Part 1a: Arm A Part 1a: Arm B Part 1b: Arm C Part 1b: Arm D Part 2: Arm E Part 2: Arm F Part 2: Arm G Part 2: Arm I Part 2: Arm J Part 2: Arm K
    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 Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 28/31 (90.3%) 27/32 (84.4%) 10/10 (100%) 10/12 (83.3%) 23/42 (54.8%) 3/4 (75%) 4/5 (80%) 109/135 (80.7%) 18/19 (94.7%) 23/28 (82.1%)
    Blood and lymphatic system disorders
    ANAEMIA 1/31 (3.2%) 3/32 (9.4%) 1/10 (10%) 2/12 (16.7%) 0/42 (0%) 0/4 (0%) 1/5 (20%) 6/135 (4.4%) 1/19 (5.3%) 0/28 (0%)
    Cardiac disorders
    VENTRICULAR EXTRASYSTOLES 0/31 (0%) 1/32 (3.1%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 1/19 (5.3%) 0/28 (0%)
    Eye disorders
    BLEPHAROSPASM 0/31 (0%) 0/32 (0%) 1/10 (10%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 0/19 (0%) 0/28 (0%)
    DRY EYE 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 1/135 (0.7%) 1/19 (5.3%) 0/28 (0%)
    EYE DISCHARGE 0/31 (0%) 0/32 (0%) 1/10 (10%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 0/19 (0%) 0/28 (0%)
    EYE PRURITUS 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 1/135 (0.7%) 1/19 (5.3%) 0/28 (0%)
    EYELID HAEMATOMA 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 1/135 (0.7%) 1/19 (5.3%) 0/28 (0%)
    EYELID PTOSIS 0/31 (0%) 0/32 (0%) 1/10 (10%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 0/19 (0%) 0/28 (0%)
    OCULAR DISCOMFORT 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 1/19 (5.3%) 0/28 (0%)
    OCULAR HYPERAEMIA 0/31 (0%) 0/32 (0%) 0/10 (0%) 1/12 (8.3%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 1/135 (0.7%) 0/19 (0%) 0/28 (0%)
    OCULAR ICTERUS 5/31 (16.1%) 1/32 (3.1%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 3/135 (2.2%) 0/19 (0%) 0/28 (0%)
    Gastrointestinal disorders
    ABDOMINAL DISCOMFORT 2/31 (6.5%) 1/32 (3.1%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 1/19 (5.3%) 0/28 (0%)
    ABDOMINAL DISTENSION 0/31 (0%) 1/32 (3.1%) 0/10 (0%) 0/12 (0%) 1/42 (2.4%) 0/4 (0%) 0/5 (0%) 3/135 (2.2%) 1/19 (5.3%) 1/28 (3.6%)
    ABDOMINAL PAIN 0/31 (0%) 0/32 (0%) 1/10 (10%) 0/12 (0%) 2/42 (4.8%) 0/4 (0%) 0/5 (0%) 3/135 (2.2%) 1/19 (5.3%) 1/28 (3.6%)
    ABDOMINAL PAIN UPPER 1/31 (3.2%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 2/42 (4.8%) 1/4 (25%) 0/5 (0%) 5/135 (3.7%) 0/19 (0%) 3/28 (10.7%)
    APHTHOUS ULCER 0/31 (0%) 0/32 (0%) 1/10 (10%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 2/135 (1.5%) 0/19 (0%) 0/28 (0%)
    BARRETT'S OESOPHAGUS 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 1/19 (5.3%) 0/28 (0%)
    CONSTIPATION 2/31 (6.5%) 0/32 (0%) 1/10 (10%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 7/135 (5.2%) 2/19 (10.5%) 2/28 (7.1%)
    DIARRHOEA 1/31 (3.2%) 4/32 (12.5%) 1/10 (10%) 2/12 (16.7%) 4/42 (9.5%) 1/4 (25%) 0/5 (0%) 26/135 (19.3%) 1/19 (5.3%) 1/28 (3.6%)
    DIVERTICULUM 0/31 (0%) 0/32 (0%) 1/10 (10%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 0/19 (0%) 0/28 (0%)
    DRY MOUTH 2/31 (6.5%) 1/32 (3.1%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 1/135 (0.7%) 0/19 (0%) 2/28 (7.1%)
    DYSPEPSIA 1/31 (3.2%) 3/32 (9.4%) 0/10 (0%) 1/12 (8.3%) 1/42 (2.4%) 0/4 (0%) 0/5 (0%) 10/135 (7.4%) 0/19 (0%) 3/28 (10.7%)
    FAECES SOFT 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 1/42 (2.4%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 1/19 (5.3%) 0/28 (0%)
    GASTROOESOPHAGEAL REFLUX DISEASE 2/31 (6.5%) 1/32 (3.1%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 1/5 (20%) 2/135 (1.5%) 1/19 (5.3%) 0/28 (0%)
    NAUSEA 5/31 (16.1%) 6/32 (18.8%) 2/10 (20%) 2/12 (16.7%) 3/42 (7.1%) 1/4 (25%) 0/5 (0%) 34/135 (25.2%) 4/19 (21.1%) 5/28 (17.9%)
    ORAL PAIN 0/31 (0%) 0/32 (0%) 0/10 (0%) 1/12 (8.3%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 0/19 (0%) 0/28 (0%)
    VOMITING 1/31 (3.2%) 2/32 (6.3%) 0/10 (0%) 1/12 (8.3%) 1/42 (2.4%) 0/4 (0%) 0/5 (0%) 11/135 (8.1%) 1/19 (5.3%) 3/28 (10.7%)
    General disorders
    ASTHENIA 0/31 (0%) 0/32 (0%) 0/10 (0%) 1/12 (8.3%) 1/42 (2.4%) 1/4 (25%) 0/5 (0%) 13/135 (9.6%) 2/19 (10.5%) 3/28 (10.7%)
    CHEST PAIN 0/31 (0%) 2/32 (6.3%) 1/10 (10%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 1/135 (0.7%) 0/19 (0%) 0/28 (0%)
    EARLY SATIETY 0/31 (0%) 0/32 (0%) 0/10 (0%) 1/12 (8.3%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 0/19 (0%) 0/28 (0%)
    FATIGUE 18/31 (58.1%) 12/32 (37.5%) 5/10 (50%) 4/12 (33.3%) 2/42 (4.8%) 0/4 (0%) 0/5 (0%) 40/135 (29.6%) 6/19 (31.6%) 5/28 (17.9%)
    INFLUENZA LIKE ILLNESS 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 3/135 (2.2%) 1/19 (5.3%) 0/28 (0%)
    OEDEMA PERIPHERAL 0/31 (0%) 0/32 (0%) 1/10 (10%) 1/12 (8.3%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 1/135 (0.7%) 0/19 (0%) 0/28 (0%)
    PAIN 1/31 (3.2%) 0/32 (0%) 1/10 (10%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 1/5 (20%) 4/135 (3%) 0/19 (0%) 0/28 (0%)
    PERIPHERAL SWELLING 0/31 (0%) 0/32 (0%) 1/10 (10%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 0/19 (0%) 0/28 (0%)
    PYREXIA 0/31 (0%) 1/32 (3.1%) 0/10 (0%) 1/12 (8.3%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 2/135 (1.5%) 1/19 (5.3%) 2/28 (7.1%)
    TEMPERATURE INTOLERANCE 0/31 (0%) 0/32 (0%) 0/10 (0%) 1/12 (8.3%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 0/19 (0%) 0/28 (0%)
    TENDERNESS 0/31 (0%) 0/32 (0%) 0/10 (0%) 1/12 (8.3%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 0/19 (0%) 0/28 (0%)
    VESSEL PUNCTURE SITE BRUISE 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 1/19 (5.3%) 0/28 (0%)
    Hepatobiliary disorders
    HYPERBILIRUBINAEMIA 4/31 (12.9%) 1/32 (3.1%) 0/10 (0%) 0/12 (0%) 1/42 (2.4%) 0/4 (0%) 0/5 (0%) 4/135 (3%) 1/19 (5.3%) 0/28 (0%)
    JAUNDICE 2/31 (6.5%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 1/4 (25%) 0/5 (0%) 7/135 (5.2%) 0/19 (0%) 1/28 (3.6%)
    Immune system disorders
    SEASONAL ALLERGY 0/31 (0%) 0/32 (0%) 0/10 (0%) 1/12 (8.3%) 1/42 (2.4%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 0/19 (0%) 0/28 (0%)
    Infections and infestations
    ACUTE SINUSITIS 0/31 (0%) 1/32 (3.1%) 1/10 (10%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 0/19 (0%) 0/28 (0%)
    BRONCHITIS 0/31 (0%) 0/32 (0%) 3/10 (30%) 0/12 (0%) 1/42 (2.4%) 1/4 (25%) 0/5 (0%) 6/135 (4.4%) 0/19 (0%) 1/28 (3.6%)
    GASTROENTERITIS 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 2/135 (1.5%) 1/19 (5.3%) 1/28 (3.6%)
    GASTROENTERITIS VIRAL 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 1/5 (20%) 0/135 (0%) 0/19 (0%) 0/28 (0%)
    HERPES ZOSTER 0/31 (0%) 1/32 (3.1%) 0/10 (0%) 1/12 (8.3%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 1/135 (0.7%) 0/19 (0%) 0/28 (0%)
    HERPES ZOSTER OTICUS 0/31 (0%) 0/32 (0%) 1/10 (10%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 0/19 (0%) 0/28 (0%)
    NASOPHARYNGITIS 1/31 (3.2%) 0/32 (0%) 0/10 (0%) 1/12 (8.3%) 1/42 (2.4%) 0/4 (0%) 0/5 (0%) 12/135 (8.9%) 4/19 (21.1%) 4/28 (14.3%)
    ORAL HERPES 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 2/135 (1.5%) 0/19 (0%) 2/28 (7.1%)
    PYELONEPHRITIS 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 1/4 (25%) 0/5 (0%) 1/135 (0.7%) 0/19 (0%) 0/28 (0%)
    PYURIA 0/31 (0%) 0/32 (0%) 1/10 (10%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 0/19 (0%) 0/28 (0%)
    RHINITIS 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 1/5 (20%) 2/135 (1.5%) 0/19 (0%) 2/28 (7.1%)
    SECONDARY SYPHILIS 0/31 (0%) 2/32 (6.3%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 0/19 (0%) 0/28 (0%)
    UPPER RESPIRATORY TRACT INFECTION 4/31 (12.9%) 5/32 (15.6%) 1/10 (10%) 0/12 (0%) 3/42 (7.1%) 0/4 (0%) 0/5 (0%) 12/135 (8.9%) 1/19 (5.3%) 1/28 (3.6%)
    URINARY TRACT INFECTION 2/31 (6.5%) 0/32 (0%) 1/10 (10%) 0/12 (0%) 0/42 (0%) 1/4 (25%) 1/5 (20%) 6/135 (4.4%) 2/19 (10.5%) 0/28 (0%)
    VIRAL UPPER RESPIRATORY TRACT INFECTION 0/31 (0%) 0/32 (0%) 1/10 (10%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 1/135 (0.7%) 0/19 (0%) 0/28 (0%)
    Injury, poisoning and procedural complications
    ARTHROPOD BITE 1/31 (3.2%) 0/32 (0%) 0/10 (0%) 1/12 (8.3%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 0/19 (0%) 0/28 (0%)
    CONTUSION 0/31 (0%) 2/32 (6.3%) 0/10 (0%) 1/12 (8.3%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 1/135 (0.7%) 0/19 (0%) 0/28 (0%)
    EXCORIATION 0/31 (0%) 0/32 (0%) 0/10 (0%) 1/12 (8.3%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 0/19 (0%) 0/28 (0%)
    FALL 0/31 (0%) 0/32 (0%) 0/10 (0%) 1/12 (8.3%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 1/135 (0.7%) 0/19 (0%) 0/28 (0%)
    MUSCLE STRAIN 1/31 (3.2%) 1/32 (3.1%) 1/10 (10%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 0/19 (0%) 0/28 (0%)
    Investigations
    BLOOD BILIRUBIN INCREASED 0/31 (0%) 1/32 (3.1%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 1/4 (25%) 0/5 (0%) 3/135 (2.2%) 0/19 (0%) 0/28 (0%)
    CREATININE RENAL CLEARANCE DECREASED 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 3/135 (2.2%) 1/19 (5.3%) 0/28 (0%)
    HAEMOGLOBIN DECREASED 3/31 (9.7%) 0/32 (0%) 1/10 (10%) 4/12 (33.3%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 13/135 (9.6%) 6/19 (31.6%) 4/28 (14.3%)
    WEIGHT DECREASED 1/31 (3.2%) 1/32 (3.1%) 0/10 (0%) 1/12 (8.3%) 1/42 (2.4%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 1/19 (5.3%) 1/28 (3.6%)
    Metabolism and nutrition disorders
    DECREASED APPETITE 1/31 (3.2%) 2/32 (6.3%) 1/10 (10%) 2/12 (16.7%) 3/42 (7.1%) 0/4 (0%) 1/5 (20%) 3/135 (2.2%) 1/19 (5.3%) 1/28 (3.6%)
    GOUT 0/31 (0%) 0/32 (0%) 0/10 (0%) 1/12 (8.3%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 0/19 (0%) 0/28 (0%)
    HYPOKALAEMIA 1/31 (3.2%) 0/32 (0%) 0/10 (0%) 1/12 (8.3%) 0/42 (0%) 0/4 (0%) 1/5 (20%) 0/135 (0%) 0/19 (0%) 0/28 (0%)
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA 2/31 (6.5%) 1/32 (3.1%) 1/10 (10%) 0/12 (0%) 3/42 (7.1%) 1/4 (25%) 0/5 (0%) 5/135 (3.7%) 0/19 (0%) 1/28 (3.6%)
    BACK PAIN 1/31 (3.2%) 3/32 (9.4%) 0/10 (0%) 1/12 (8.3%) 2/42 (4.8%) 0/4 (0%) 0/5 (0%) 6/135 (4.4%) 3/19 (15.8%) 1/28 (3.6%)
    JOINT STIFFNESS 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 1/19 (5.3%) 0/28 (0%)
    JOINT SWELLING 1/31 (3.2%) 0/32 (0%) 1/10 (10%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 0/19 (0%) 1/28 (3.6%)
    MUSCLE SPASMS 1/31 (3.2%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 2/135 (1.5%) 1/19 (5.3%) 1/28 (3.6%)
    MUSCLE TIGHTNESS 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 1/19 (5.3%) 0/28 (0%)
    MYALGIA 2/31 (6.5%) 0/32 (0%) 1/10 (10%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 4/135 (3%) 0/19 (0%) 2/28 (7.1%)
    NECK PAIN 0/31 (0%) 1/32 (3.1%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 0/19 (0%) 2/28 (7.1%)
    PAIN IN EXTREMITY 0/31 (0%) 0/32 (0%) 1/10 (10%) 0/12 (0%) 1/42 (2.4%) 0/4 (0%) 0/5 (0%) 1/135 (0.7%) 1/19 (5.3%) 2/28 (7.1%)
    PERIARTHRITIS 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 1/5 (20%) 0/135 (0%) 0/19 (0%) 0/28 (0%)
    TENDONITIS 0/31 (0%) 0/32 (0%) 1/10 (10%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 1/135 (0.7%) 0/19 (0%) 0/28 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    SKIN PAPILLOMA 0/31 (0%) 0/32 (0%) 1/10 (10%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 0/19 (0%) 0/28 (0%)
    Nervous system disorders
    DISTURBANCE IN ATTENTION 1/31 (3.2%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 1/135 (0.7%) 1/19 (5.3%) 0/28 (0%)
    DIZZINESS 0/31 (0%) 2/32 (6.3%) 1/10 (10%) 1/12 (8.3%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 10/135 (7.4%) 2/19 (10.5%) 1/28 (3.6%)
    HEADACHE 6/31 (19.4%) 4/32 (12.5%) 2/10 (20%) 1/12 (8.3%) 2/42 (4.8%) 0/4 (0%) 1/5 (20%) 22/135 (16.3%) 4/19 (21.1%) 5/28 (17.9%)
    MEMORY IMPAIRMENT 0/31 (0%) 3/32 (9.4%) 0/10 (0%) 1/12 (8.3%) 1/42 (2.4%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 0/19 (0%) 0/28 (0%)
    NEURALGIA 0/31 (0%) 0/32 (0%) 1/10 (10%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 0/19 (0%) 0/28 (0%)
    PARAESTHESIA 1/31 (3.2%) 1/32 (3.1%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 2/135 (1.5%) 1/19 (5.3%) 0/28 (0%)
    SINUS HEADACHE 0/31 (0%) 0/32 (0%) 0/10 (0%) 1/12 (8.3%) 1/42 (2.4%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 0/19 (0%) 0/28 (0%)
    Psychiatric disorders
    AFFECT LABILITY 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 4/135 (3%) 1/19 (5.3%) 0/28 (0%)
    AGITATION 1/31 (3.2%) 0/32 (0%) 0/10 (0%) 1/12 (8.3%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 0/19 (0%) 0/28 (0%)
    ANXIETY 0/31 (0%) 3/32 (9.4%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 11/135 (8.1%) 1/19 (5.3%) 2/28 (7.1%)
    DEPRESSED MOOD 0/31 (0%) 1/32 (3.1%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 1/5 (20%) 4/135 (3%) 0/19 (0%) 0/28 (0%)
    DEPRESSION 0/31 (0%) 3/32 (9.4%) 1/10 (10%) 1/12 (8.3%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 3/135 (2.2%) 1/19 (5.3%) 1/28 (3.6%)
    INSOMNIA 5/31 (16.1%) 7/32 (21.9%) 1/10 (10%) 0/12 (0%) 3/42 (7.1%) 0/4 (0%) 1/5 (20%) 25/135 (18.5%) 2/19 (10.5%) 2/28 (7.1%)
    IRRITABILITY 3/31 (9.7%) 3/32 (9.4%) 3/10 (30%) 2/12 (16.7%) 0/42 (0%) 1/4 (25%) 0/5 (0%) 7/135 (5.2%) 2/19 (10.5%) 1/28 (3.6%)
    LIBIDO INCREASED 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 1/19 (5.3%) 0/28 (0%)
    STRESS 0/31 (0%) 0/32 (0%) 1/10 (10%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 0/19 (0%) 0/28 (0%)
    WITHDRAWAL SYNDROME 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 1/19 (5.3%) 1/28 (3.6%)
    Renal and urinary disorders
    NEPHROLITHIASIS 0/31 (0%) 0/32 (0%) 1/10 (10%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 0/19 (0%) 0/28 (0%)
    Respiratory, thoracic and mediastinal disorders
    BRONCHOSPASM 0/31 (0%) 0/32 (0%) 1/10 (10%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 0/19 (0%) 0/28 (0%)
    COUGH 2/31 (6.5%) 5/32 (15.6%) 2/10 (20%) 0/12 (0%) 1/42 (2.4%) 0/4 (0%) 0/5 (0%) 7/135 (5.2%) 1/19 (5.3%) 1/28 (3.6%)
    DYSPNOEA 1/31 (3.2%) 2/32 (6.3%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 8/135 (5.9%) 2/19 (10.5%) 2/28 (7.1%)
    DYSPNOEA EXERTIONAL 1/31 (3.2%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 1/5 (20%) 6/135 (4.4%) 1/19 (5.3%) 1/28 (3.6%)
    NASAL CONGESTION 2/31 (6.5%) 1/32 (3.1%) 1/10 (10%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 1/135 (0.7%) 1/19 (5.3%) 0/28 (0%)
    OROPHARYNGEAL PAIN 0/31 (0%) 2/32 (6.3%) 0/10 (0%) 0/12 (0%) 2/42 (4.8%) 0/4 (0%) 0/5 (0%) 3/135 (2.2%) 0/19 (0%) 0/28 (0%)
    RESPIRATORY TRACT CONGESTION 0/31 (0%) 0/32 (0%) 1/10 (10%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 0/19 (0%) 0/28 (0%)
    RHINORRHOEA 3/31 (9.7%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 1/42 (2.4%) 0/4 (0%) 0/5 (0%) 3/135 (2.2%) 0/19 (0%) 0/28 (0%)
    Skin and subcutaneous tissue disorders
    DERMATITIS 0/31 (0%) 1/32 (3.1%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 1/19 (5.3%) 0/28 (0%)
    DRY SKIN 1/31 (3.2%) 1/32 (3.1%) 0/10 (0%) 1/12 (8.3%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 4/135 (3%) 0/19 (0%) 1/28 (3.6%)
    PRURITUS 6/31 (19.4%) 2/32 (6.3%) 0/10 (0%) 1/12 (8.3%) 1/42 (2.4%) 1/4 (25%) 0/5 (0%) 18/135 (13.3%) 2/19 (10.5%) 1/28 (3.6%)
    PRURITUS GENERALISED 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 1/42 (2.4%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 1/19 (5.3%) 0/28 (0%)
    RASH 1/31 (3.2%) 2/32 (6.3%) 0/10 (0%) 1/12 (8.3%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 6/135 (4.4%) 2/19 (10.5%) 1/28 (3.6%)
    RASH MACULAR 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 1/19 (5.3%) 0/28 (0%)
    RASH PRURITIC 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 1/135 (0.7%) 1/19 (5.3%) 0/28 (0%)
    SKIN EXFOLIATION 0/31 (0%) 0/32 (0%) 1/10 (10%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 0/19 (0%) 0/28 (0%)
    SKIN FISSURES 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 1/19 (5.3%) 0/28 (0%)
    Vascular disorders
    HYPERTENSION 0/31 (0%) 1/32 (3.1%) 1/10 (10%) 0/12 (0%) 1/42 (2.4%) 1/4 (25%) 0/5 (0%) 4/135 (3%) 0/19 (0%) 0/28 (0%)
    THROMBOPHLEBITIS SUPERFICIAL 0/31 (0%) 0/32 (0%) 0/10 (0%) 0/12 (0%) 0/42 (0%) 0/4 (0%) 0/5 (0%) 0/135 (0%) 1/19 (5.3%) 0/28 (0%)

    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 Services
    Organization AbbVie
    Phone 800-633-9110
    Email
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT01939197
    Other Study ID Numbers:
    • M14-004
    • 2012-005143-24
    First Posted:
    Sep 11, 2013
    Last Update Posted:
    Jul 12, 2021
    Last Verified:
    Jul 1, 2021