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    Clinical Trial Results:
    ING200336: A Prospective, Interventional Pharmacokinetic and Safety Study of DTG/ABC/3TC in Pregnant Women

    Summary
    EudraCT number
    		 2013-003527-11
    Trial protocol
    		 ES  
    Global end of trial date
    15 Sep 2021

    Results information
    Results version number
    		 v2(current)
    This version publication date
    25 Sep 2022
    First version publication date
    10 Feb 2022
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    200336
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02075593
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ViiV Healthcare
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom, TW8 9GS
    Public contact
    GSK Response Center, ViiV Healthcare, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, ViiV Healthcare, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    25 Oct 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Sep 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the total plasma dolutegravir (DTG) Pharmacokinetic (PK) parameters with the DTG/ abacavir (ABC)/ lamivudine (3TC) fixed dose combination (FDC) during Weeks 18-26, Weeks 30-36 of the third trimester of the pregnancy and 8-12 weeks postpartum; and to further characterize the safety and tolerability of DTG/ABC/3TC FDC when used during pregnancy.
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Dec 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Russian Federation: 3
    Country: Number of subjects enrolled
    Spain: 1
    Worldwide total number of subjects
    4
    EEA total number of subjects
    1
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    4
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This is a single arm open-label study in women who became pregnant while participating in study ING117172 (NCT01910402).

    Pre-assignment
    Screening details
    		 In this study, 4 pregnant women were enrolled. Participant flow data was collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 DTG/ABC/3TC - Mother
    Arm description
    		 Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dolutegravir/Abacavir/Lamivudine fixed dose combination
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Fixed dose combination of dolutegravir 50 milligrams (mg), abacavir 600 mg and lamivudine 300 mg tablet was administered once daily, with or without food.

    Number of subjects in period 1
    		DTG/ABC/3TC - Mother
    Started
    4
    Infants born to pregnant women
    4
    Completed
    3
    Not completed
    1
         Consent withdrawn by subject
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DTG/ABC/3TC - Mother
    Reporting group description
    		 Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.

    Reporting group values
    		 DTG/ABC/3TC - Mother Total
    Number of subjects
    		 4 4
    Age categorical
    Baseline Characteristics data was collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
    Units: Participants
        Adults (18-64 years)
    		 4 4
    Age Continuous
    Baseline Characteristics data was collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
    Units: years
        arithmetic mean (standard deviation)
    		 29.3 ± 5.56 -
    Sex: Female, Male
    Baseline Characteristics data was collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
    Units: Participants
        Female
    		 4 4
        Male
    		 0 0
    Race/Ethnicity, Customized
    Baseline Characteristics data was collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
    Units: Subjects
        White/Caucasian/European heritage
    		 4 4
    Subject analysis sets

    Subject analysis set title
    DTG/ABC/3TC - Infant
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    This group consisted of Infants born to pregnant women who received a fixed dose combination tablet of dolutegravir, abacavir and lamivudine during pregnancy.

    Subject analysis sets values
    		 DTG/ABC/3TC - Infant
    Number of subjects
    4
    Age categorical
    Baseline Characteristics data was collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
    Units: Participants
        Adults (18-64 years)
    0
    Age Continuous
    Baseline Characteristics data was collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
    Units: years
        arithmetic mean (standard deviation)
    ±
    Sex: Female, Male
    Baseline Characteristics data was collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
    Units: Participants
        Female
        Male
    Race/Ethnicity, Customized
    Baseline Characteristics data was collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
    Units: Subjects
        White/Caucasian/European heritage

    End points

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    End points reporting groups
    Reporting group title
    DTG/ABC/3TC - Mother
    Reporting group description
    		 Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.

    Subject analysis set title
    DTG/ABC/3TC - Infant
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    This group consisted of Infants born to pregnant women who received a fixed dose combination tablet of dolutegravir, abacavir and lamivudine during pregnancy.

    Primary: Area under the plasma concentration time curve at steady state during a dosing interval (AUC [0-tau]) for dolutegravir

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    End point title
    		 Area under the plasma concentration time curve at steady state during a dosing interval (AUC [0-tau]) for dolutegravir [1]
    End point description
    Blood samples were collected at indicated timepoints for Pharmacokinetic (PK) analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum. Pharmacokinetic Population consists of all participants in the Safety Population (comprised of all participants (pregnant women) who received at least one dose of study treatment) who had at least 1 non-missing PK assessment
    End point type
    Primary
    End point timeframe
    Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report
    End point values
    		 DTG/ABC/3TC - Mother
    Number of subjects analysed
    4 [2]
    Units: Micrograms*hours per milliliter
    geometric mean (confidence interval 95%)
        Trimester 2 (Weeks 18-26 of pregnancy)
    55.045 (37.918 to 79.907)
        Trimester 3 (Weeks 30-36 of pregnancy)
    42.473 (27.613 to 65.330)
        8-12 Weeks Postpartum
    78.917 (53.195 to 117.075)
    Notes
    [2] - Pharmacokinetic Population
    No statistical analyses for this end point

    Primary: Maximum observed plasma concentration (Cmax) for dolutegravir

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    End point title
    		 Maximum observed plasma concentration (Cmax) for dolutegravir [3]
    End point description
    Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.
    End point type
    Primary
    End point timeframe
    Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report
    End point values
    		 DTG/ABC/3TC - Mother
    Number of subjects analysed
    4 [4]
    Units: Micrograms per milliliter
    geometric mean (confidence interval 95%)
        Trimester 2 (Weeks 18-26 of pregnancy)
    4.420 (2.906 to 6.724)
        Trimester 3 (Weeks 30-36 of pregnancy)
    3.424 (2.038 to 5.753)
        8-12 Weeks Postpartum
    5.578 (3.866 to 8.049)
    Notes
    [4] - Pharmacokinetic Population
    No statistical analyses for this end point

    Primary: Drug concentration at the end of dosing interval (Ctau) for dolutegravir

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    End point title
    		 Drug concentration at the end of dosing interval (Ctau) for dolutegravir [5]
    End point description
    Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.
    End point type
    Primary
    End point timeframe
    24 hours post dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report
    End point values
    		 DTG/ABC/3TC - Mother
    Number of subjects analysed
    4 [6]
    Units: Nanograms per milliliter
    geometric mean (confidence interval 95%)
        Trimester 2 (Weeks 18-26 of pregnancy)
    930.1 (562.0 to 1539.3)
        Trimester 3 (Weeks 30-36 of pregnancy)
    657.5 (266.1 to 1624.4)
        8-12 Weeks Postpartum
    2154.7 (901.4 to 5150.5)
    Notes
    [6] - Pharmacokinetic Population
    No statistical analyses for this end point

    Primary: Apparent oral clearance (CL/F) for dolutegravir

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    End point title
    		 Apparent oral clearance (CL/F) for dolutegravir [7]
    End point description
    Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.
    End point type
    Primary
    End point timeframe
    Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report
    End point values
    		 DTG/ABC/3TC - Mother
    Number of subjects analysed
    4 [8]
    Units: Liters per hour
    geometric mean (confidence interval 95%)
        Trimester 2 (Weeks 18-26 of pregnancy)
    0.739 (0.484 to 1.130)
        Trimester 3 (Weeks 30-36 of pregnancy)
    0.952 (0.559 to 1.620)
        8-12 Weeks Postpartum
    0.464 (0.062 to 3.476)
    Notes
    [8] - Pharmacokinetic Population
    No statistical analyses for this end point

    Primary: Steady state volume of distribution (Vss/F) after extravascular administration for dolutegravir

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    End point title
    		 Steady state volume of distribution (Vss/F) after extravascular administration for dolutegravir [9]
    End point description
    Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.
    End point type
    Primary
    End point timeframe
    Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report
    End point values
    		 DTG/ABC/3TC - Mother
    Number of subjects analysed
    4 [10]
    Units: Liters
    geometric mean (confidence interval 95%)
        Trimester 2 (Weeks 18-26 of pregnancy)
    9.665 (6.651 to 14.044)
        Trimester 3 (Weeks 30-36 of pregnancy)
    12.326 (7.878 to 19.285)
        8-12 Weeks Postpartum
    6.326 (0.048 to 833.336)
    Notes
    [10] - Pharmacokinetic Population
    No statistical analyses for this end point

    Primary: Half-life (T1/2) for dolutegravir

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    End point title
    		 Half-life (T1/2) for dolutegravir [11]
    End point description
    Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.
    End point type
    Primary
    End point timeframe
    Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report
    End point values
    		 DTG/ABC/3TC - Mother
    Number of subjects analysed
    4 [12]
    Units: Hours
    arithmetic mean (standard deviation)
        Trimester 2 (Weeks 18-26 of pregnancy)
    9.215 ± 1.8968
        Trimester 3 (Weeks 30-36 of pregnancy)
    9.401 ± 3.0322
        8-12 Weeks Postpartum
    9.699 ± 3.0427
    Notes
    [12] - Pharmacokinetic Population
    No statistical analyses for this end point

    Primary: Number of participants (pregnant women) with maximum severity of post-Baseline emergent hematology toxicities: Hemoglobin

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    End point title
    		 Number of participants (pregnant women) with maximum severity of post-Baseline emergent hematology toxicities: Hemoglobin [13]
    End point description
    Blood samples were collected for analysis of hemoglobin. Any abnormality was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). Number of participants (pregnant women) with maximum severity of post-Baseline emergent toxicities with respect to hemoglobin has been presented. Safety Population comprised of all participants (pregnant women) who received at least one dose of study treatment.
    End point type
    Primary
    End point timeframe
    Up to Week 32 of study
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report
    End point values
    		 DTG/ABC/3TC - Mother
    Number of subjects analysed
    4 [14]
    Units: Participants
        Grade 1
    1
        Grade 2
    0
        Grade 3
    0
        Grade 4
    0
    Notes
    [14] - Safety Population
    No statistical analyses for this end point

    Primary: Absolute values of the chemistry parameters: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)

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    End point title
    		 Absolute values of the chemistry parameters: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) [15]
    End point description
    Blood samples were collected for the analysis of chemistry parameters including ALT and AST. 99999 indicates that standard deviation could not be calculated as a single participant was analyzed. Safety Population comprised of all participants (pregnant women) who received at least one dose of study treatment. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles).
    End point type
    Primary
    End point timeframe
    At Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study
    Notes
    [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report
    End point values
    		 DTG/ABC/3TC - Mother
    Number of subjects analysed
    4 [16]
    Units: International units per Liter
    arithmetic mean (standard deviation)
        ALT, Baseline (Day 1), n=4
    10.8 ± 5.56
        ALT, Week 4, n=4
    15.3 ± 4.43
        ALT, Week 8, n=4
    19.3 ± 17.21
        ALT, Week 12, n=4
    11.0 ± 3.16
        ALT, Week 16, n=4
    10.8 ± 2.36
        ALT, Week 20, n=4
    10.3 ± 7.27
        ALT, Week 24, n=1
    19.0 ± 99999
        ALT, Week 32, n=2
    28.0 ± 15.56
        AST, Baseline (Day 1), n=4
    14.8 ± 4.19
        AST, Week 4, n=4
    17.3 ± 2.22
        AST, Week 8, n=4
    17.3 ± 6.18
        AST, Week 12, n=4
    15.0 ± 1.83
        AST, Week 16, n=4
    14.8 ± 2.63
        AST, Week 20, n=4
    16.3 ± 3.30
        AST, Week 24, n=1
    20.0 ± 99999
        AST, Week 32, n=2
    24.0 ± 8.49
    Notes
    [16] - Safety Population
    No statistical analyses for this end point

    Primary: Change from Baseline in chemistry parameters: ALT and AST

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    End point title
    		 Change from Baseline in chemistry parameters: ALT and AST [17]
    End point description
    Blood samples were collected for the analysis of chemistry parameters including ALT and AST. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. 99999 indicates that standard deviation could not be calculated as a single participant was analyzed. Safety Population comprised of all participants (pregnant women) who received at least one dose of study treatment. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles).
    End point type
    Primary
    End point timeframe
    Baseline and at Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study
    Notes
    [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report
    End point values
    		 DTG/ABC/3TC - Mother
    Number of subjects analysed
    4 [18]
    Units: International units per Liter
    arithmetic mean (standard deviation)
        ALT, Week 4, n=4
    4.5 ± 6.03
        ALT, Week 8, n=4
    8.5 ± 11.79
        ALT, Week 12, n=4
    0.3 ± 3.30
        ALT, Week 16, n=4
    0.0 ± 3.56
        ALT, Week 20, n=4
    -0.5 ± 1.73
        ALT, Week 24, n=1
    0.0 ± 99999
        ALT, Week 32, n=2
    19.5 ± 14.85
        AST, Week 4, n=4
    2.5 ± 4.43
        AST, Week 8, n=4
    2.5 ± 2.38
        AST, Week 12, n=4
    0.3 ± 3.10
        AST, Week 16, n=4
    0.0 ± 3.37
        AST, Week 20, n=4
    1.5 ± 1.29
        AST, Week 24, n=1
    -1.0 ± 99999
        AST, Week 32, n=2
    11.0 ± 8.49
    Notes
    [18] - Safety Population
    No statistical analyses for this end point

    Primary: Absolute values of the chemistry parameters: Bilirubin and Creatinine

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    End point title
    		 Absolute values of the chemistry parameters: Bilirubin and Creatinine [19]
    End point description
    Blood samples were collected for the analysis of chemistry parameters including Bilirubin and Creatinine. 99999 indicates that standard deviation could not be calculated as a single participant was analyzed. Safety Population comprised of all participants (pregnant women) who received at least one dose of study treatment. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles).
    End point type
    Primary
    End point timeframe
    At Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study
    Notes
    [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report
    End point values
    		 DTG/ABC/3TC - Mother
    Number of subjects analysed
    4 [20]
    Units: Micromoles per Liter
    arithmetic mean (standard deviation)
        Bilirubin, Baseline (Day 1), n=4
    7.3 ± 3.77
        Bilirubin, Week 4, n=4
    5.0 ± 1.83
        Bilirubin, Week 8, n=4
    5.5 ± 2.65
        Bilirubin, Week 12, n=4
    4.5 ± 1.29
        Bilirubin, Week 16, n=4
    4.5 ± 1.29
        Bilirubin, Week 20, n=4
    4.5 ± 1.29
        Bilirubin, Week 24, n=1
    7.0 ± 99999
        Bilirubin, Week 32, n=2
    6.5 ± 0.71
        Creatinine, Baseline (Day 1), n=4
    57.73 ± 16.661
        Creatinine, Week 4, n=4
    50.50 ± 2.990
        Creatinine, Week 8, n=4
    51.58 ± 3.067
        Creatinine, Week 12, n=4
    50.68 ± 3.293
        Creatinine, Week 16, n=4
    47.45 ± 2.001
        Creatinine, Week 20, n=4
    50.60 ± 6.424
        Creatinine, Week 24, n=1
    63.60 ± 99999
        Creatinine, Week 32, n=2
    68.90 ± 3.677
    Notes
    [20] - Safety Population
    No statistical analyses for this end point

    Primary: Change from Baseline in chemistry parameters: Bilirubin and Creatinine

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    End point title
    		 Change from Baseline in chemistry parameters: Bilirubin and Creatinine [21]
    End point description
    Blood samples were collected for the analysis of chemistry parameters including Bilirubin and Creatinine. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. 99999 indicates that standard deviation could not be calculated as a single participant was analyzed. Safety Population comprised of all participants (pregnant women) who received at least one dose of study treatment. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles).
    End point type
    Primary
    End point timeframe
    Baseline and at Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study
    Notes
    [21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report
    End point values
    		 DTG/ABC/3TC - Mother
    Number of subjects analysed
    4 [22]
    Units: Micromoles per Liter
    arithmetic mean (standard deviation)
        Bilirubin, Week 4, n=4
    -2.3 ± 2.06
        Bilirubin, Week 8, n=4
    -1.8 ± 1.26
        Bilirubin, Week 12, n=4
    -2.8 ± 2.99
        Bilirubin, Week 16, n=4
    -2.8 ± 2.99
        Bilirubin, Week 20, n=4
    -2.8 ± 2.99
        Bilirubin, Week 24, n=1
    -5.0 ± 99999
        Bilirubin, Week 32, n=2
    2.0 ± 2.83
        Creatinine, Week 4, n=4
    -7.23 ± 14.014
        Creatinine, Week 8, n=4
    -6.15 ± 16.700
        Creatinine, Week 12, n=4
    -7.05 ± 14.328
        Creatinine, Week 16, n=4
    -10.28 ± 17.453
        Creatinine, Week 20, n=4
    -7.13 ± 11.154
        Creatinine, Week 24, n=1
    -19.10 ± 99999
        Creatinine, Week 32, n=2
    19.10 ± 3.253
    Notes
    [22] - Safety Population
    No statistical analyses for this end point

    Primary: Absolute values of the hematology parameters: hemoglobin

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    End point title
    		 Absolute values of the hematology parameters: hemoglobin [23]
    End point description
    Blood samples were collected for the analysis of hematology parameters including hemoglobin. 99999 indicates that standard deviation could not be calculated as a single participant was analyzed. Safety Population comprised of all participants (pregnant women) who received at least one dose of study treatment. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles).
    End point type
    Primary
    End point timeframe
    At Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study
    Notes
    [23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report
    End point values
    		 DTG/ABC/3TC - Mother
    Number of subjects analysed
    4 [24]
    Units: Grams per Liter
    arithmetic mean (standard deviation)
        Baseline (Day 1), n=4
    127.8 ± 11.24
        Week 4, n=4
    120.8 ± 7.23
        Week 8, n=4
    113.5 ± 7.05
        Week 12, n=4
    116.5 ± 7.14
        Week 16, n=4
    115.0 ± 4.69
        Week 20, n=4
    115.8 ± 8.30
        Week 24, n=1
    127.0 ± 99999
        Week 32, n=2
    140.5 ± 0.71
    Notes
    [24] - Safety Population
    No statistical analyses for this end point

    Primary: Change from Baseline in hematology parameters: Hemoglobin

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    End point title
    		 Change from Baseline in hematology parameters: Hemoglobin [25]
    End point description
    Blood samples were collected for the analysis of hematology parameters including hemoglobin. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. 99999 indicates that standard deviation could not be calculated as a single participant was analyzed. Safety Population comprised of all participants (pregnant women) who received at least one dose of study treatment. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles).
    End point type
    Primary
    End point timeframe
    Baseline and at Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study
    Notes
    [25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report
    End point values
    		 DTG/ABC/3TC - Mother
    Number of subjects analysed
    4 [26]
    Units: Grams per Liter
    arithmetic mean (standard deviation)
        Week 4, n=4
    -7.0 ± 10.17
        Week 8, n=4
    -14.3 ± 7.37
        Week 12, n=4
    -11.3 ± 4.92
        Week 16, n=4
    -12.8 ± 6.65
        Week 20, n=4
    -12.0 ± 4.97
        Week 24, n=1
    -14.0 ± 99999
        Week 32, n=2
    14.0 ± 8.49
    Notes
    [26] - Safety Population
    No statistical analyses for this end point

    Primary: Absolute values of the hematology parameters: leukocytes and platelets

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    End point title
    		 Absolute values of the hematology parameters: leukocytes and platelets [27]
    End point description
    Blood samples were collected for the analysis of hematology parameters including leukocytes and platelets. 99999 indicates that standard deviation could not be calculated as a single participant was analyzed. Safety Population comprised of all participants (pregnant women) who received at least one dose of study treatment. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles).
    End point type
    Primary
    End point timeframe
    At Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study
    Notes
    [27] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report
    End point values
    		 DTG/ABC/3TC - Mother
    Number of subjects analysed
    4 [28]
    Units: Giga cells per Liter
    arithmetic mean (standard deviation)
        Leukocytes, Baseline (Day 1), n=4
    6.48 ± 1.415
        Leukocytes, Week 4, n=4
    7.88 ± 2.095
        Leukocytes, Week 8, n=4
    8.43 ± 1.959
        Leukocytes, Week 12, n=4
    9.15 ± 2.053
        Leukocytes, Week 16, n=4
    9.23 ± 1.821
        Leukocytes, Week 20, n=4
    10.03 ± 2.848
        Leukocytes, Week 24, n=1
    12.60 ± 99999
        Leukocytes, Week 32, n=2
    5.85 ± 0.636
        Platelets, Baseline (Day 1), n=4
    204.8 ± 37.03
        Platelets, Week 4, n=4
    200.5 ± 2.38
        Platelets, Week 8, n=4
    220.8 ± 16.07
        Platelets, Week 12, n=4
    195.5 ± 25.38
        Platelets, Week 16, n=4
    198.0 ± 10.80
        Platelets, Week 20, n=4
    216.5 ± 10.91
        Platelets, Week 24, n=1
    250.0 ± 99999
        Platelets, Week 32, n=2
    206.0 ± 24.04
    Notes
    [28] - Safety Population
    No statistical analyses for this end point

    Primary: Change from Baseline in hematology parameters: leukocytes and platelets

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    End point title
    		 Change from Baseline in hematology parameters: leukocytes and platelets [29]
    End point description
    Blood samples were collected for the analysis of hematology parameters including leukocytes and platelets. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. 99999 indicates that standard deviation could not be calculated as a single participant was analyzed. Safety Population comprised of all participants (pregnant women) who received at least one dose of study treatment. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles).
    End point type
    Primary
    End point timeframe
    Baseline and at Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 32 of study
    Notes
    [29] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report
    End point values
    		 DTG/ABC/3TC - Mother
    Number of subjects analysed
    4 [30]
    Units: Giga cells per Liter
    arithmetic mean (standard deviation)
        Leukocytes, Week 4, n=4
    1.40 ± 1.817
        Leukocytes, Week 8, n=4
    1.95 ± 2.047
        Leukocytes, Week 12, n=4
    2.68 ± 1.173
        Leukocytes, Week 16, n=4
    2.75 ± 1.654
        Leukocytes, Week 20, n=4
    3.55 ± 2.340
        Leukocytes, Week 24, n=1
    4.90 ± 99999
        Leukocytes, Week 32, n=2
    -0.65 ± 1.061
        Platelets, Week 4, n=4
    -4.3 ± 39.09
        Platelets, Week 8, n=4
    16.0 ± 33.44
        Platelets, Week 12, n=4
    -9.3 ± 39.08
        Platelets, Week 16, n=4
    -6.8 ± 47.16
        Platelets, Week 20, n=4
    11.8 ± 45.49
        Platelets, Week 24, n=1
    10.0 ± 99999
        Platelets, Week 32, n=2
    -4.0 ± 50.91
    Notes
    [30] - Safety Population
    No statistical analyses for this end point

    Primary: Number of participants (pregnant women) who discontinued the treatment due to adverse events (AE)

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    End point title
    		 Number of participants (pregnant women) who discontinued the treatment due to adverse events (AE) [31]
    End point description
    An AE is any untoward medical occurrence in a participants or clinical investigation participant, temporally associated with the use of a study treatment. Number of participants (pregnant women) who discontinued the treatment due to adverse events have been presented. Safety Population comprised of all participants (pregnant women) who received at least one dose of study treatment.
    End point type
    Primary
    End point timeframe
    Up to Week 292
    Notes
    [31] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report
    End point values
    		 DTG/ABC/3TC - Mother
    Number of subjects analysed
    4 [32]
    Units: Participants
    0
    Notes
    [32] - Safety Population
    No statistical analyses for this end point

    Primary: Number of participants (pregnant women) demonstrated congenital malformations

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    End point title
    		 Number of participants (pregnant women) demonstrated congenital malformations [33]
    End point description
    Data for participants (pregnant women) demonstrated congenital malformations was reported. Safety Population comprised of all participants (pregnant women) who received at least one dose of study treatment.
    End point type
    Primary
    End point timeframe
    At delivery (up to Week 40 of pregnancy)
    Notes
    [33] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report
    End point values
    		 DTG/ABC/3TC - Mother
    Number of subjects analysed
    4 [34]
    Units: Participants
    0
    Notes
    [34] - Safety Population
    No statistical analyses for this end point

    Primary: Number of participants (pregnant women) with adverse events (AE) as per severity grades

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    End point title
    		 Number of participants (pregnant women) with adverse events (AE) as per severity grades [35]
    End point description
    Number of participants (pregnant women) with adverse events (AE) as per severity grades were presented. Grade 1 is mild, grade 2 is moderate, grade 3 is severe or medically significant but not immediately life-threatening and grade 4 is life-threatening consequences; urgent intervention required. Safety Population comprised of all participants (pregnant women) who received at least one dose of study treatment.
    End point type
    Primary
    End point timeframe
    Up to 292 Weeks
    Notes
    [35] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report
    End point values
    		 DTG/ABC/3TC - Mother
    Number of subjects analysed
    4 [36]
    Units: Participants
    number (not applicable)
        Grade 1
    2
        Grade 2
    2
        Grade 3
    0
        Grade 4
    0
    Notes
    [36] - Safety Population
    No statistical analyses for this end point

    Secondary: Time to Cmax (tmax) for dolutegravir

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    End point title
    		 Time to Cmax (tmax) for dolutegravir
    End point description
    Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.
    End point type
    Secondary
    End point timeframe
    Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum
    End point values
    		 DTG/ABC/3TC - Mother
    Number of subjects analysed
    4 [37]
    Units: Hours
    arithmetic mean (standard deviation)
        Trimester 2 (Weeks 18-26 of pregnancy)
    3.508 ± 1.7082
        Trimester 3 (Weeks 30-36 of pregnancy)
    2.729 ± 0.4877
        8-12 Weeks Postpartum
    4.242 ± 2.0522
    Notes
    [37] - Pharmacokinetic Population
    No statistical analyses for this end point

    Secondary: Pre-dose concentration (C0) for dolutegravir

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    End point title
    		 Pre-dose concentration (C0) for dolutegravir
    End point description
    Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.
    End point type
    Secondary
    End point timeframe
    Pre-dose at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum
    End point values
    		 DTG/ABC/3TC - Mother
    Number of subjects analysed
    4 [38]
    Units: Nanograms per milliliter
    geometric mean (confidence interval 95%)
        Trimester 2 (Weeks 18-26 of pregnancy)
    666.9 (149.5 to 2974.6)
        Trimester 3 (Weeks 30-36 of pregnancy)
    1084.6 (676.7 to 1738.3)
        8-12 Weeks Postpartum
    1225.0 (522.8 to 2870.1)
    Notes
    [38] - Pharmacokinetic Population
    No statistical analyses for this end point

    Secondary: Unbound DTG concentrations in plasma at 3 and 24 hours post dose of dolutegravir

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    End point title
    		 Unbound DTG concentrations in plasma at 3 and 24 hours post dose of dolutegravir
    End point description
    Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.
    End point type
    Secondary
    End point timeframe
    At 3 hours and 24 hours post dose in Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum
    End point values
    		 DTG/ABC/3TC - Mother
    Number of subjects analysed
    4 [39]
    Units: Micrograms per milliliter
    geometric mean (confidence interval 95%)
        At 3 hours post dose in Trimester 2
    7.856 (4.370 to 14.122)
        At 3 hours post dose in Trimester 3
    7.371 (4.594 to 11.827)
        At 3 hours post dose 8-12 Weeks postpartum
    6.898 (4.360 to 10.914)
        At 24 hours post dose in Trimester 2
    1.798 (0.887 to 3.644)
        At 24 hours post dose in Trimester 3
    2.065 (1.229 to 3.471)
        At 24 hours post dose 8-12 Weeks postpartum
    2.881 (1.503 to 5.520)
    Notes
    [39] - Pharmacokinetic Population
    No statistical analyses for this end point

    Secondary: Total DTG concentrations in plasma from cord blood and maternal blood at the time of delivery

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    End point title
    		 Total DTG concentrations in plasma from cord blood and maternal blood at the time of delivery
    End point description
    Blood samples were collected at the time of delivery for PK analysis of dolutegravir.
    End point type
    Secondary
    End point timeframe
    At delivery (up to Week 40 of pregnancy)
    End point values
    		 DTG/ABC/3TC - Mother
    Number of subjects analysed
    4 [40]
    Units: Nanograms per milliliter
    arithmetic mean (standard deviation)
        Cord plasma concentration
    1436.0 ± 1287.43
        Maternal plasma concentration
    1806.3 ± 1125.04
    Notes
    [40] - Pharmacokinetic Population
    No statistical analyses for this end point

    Secondary: Number of participants (pregnant women) with treatment-emergent genotypic and/or phenotypic resistance who met confirmed virologic withdrawal criteria

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    End point title
    		 Number of participants (pregnant women) with treatment-emergent genotypic and/or phenotypic resistance who met confirmed virologic withdrawal criteria
    End point description
    Number of participants (pregnant women) with treatment-emergent genotypic and/or phenotypic resistance who met confirmed virologic withdrawal criteria are presented. Genotypic and phenotypic analyses were carried out by Monogram Biosciences using, but not limited to, their Standard Phenosense and GenoSure testing methods for protease (PRO) and reverse transcriptase (RT), or with their GeneSeq Integrase and PhenoSense Integrase assays. Intent-to-Treat Exposed (ITT-E) Population includes all participants (pregnant women) who received at least one dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Up to Week 32 of study
    End point values
    		 DTG/ABC/3TC - Mother
    Number of subjects analysed
    4 [41]
    Units: Participants
        Participants with genotypic resistance
    0
        Participants with phenotypic resistance
    0
    Notes
    [41] - Safety Population
    No statistical analyses for this end point

    Secondary: Number of participants (pregnant women) with live birth outcome categories

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    End point title
    		 Number of participants (pregnant women) with live birth outcome categories
    End point description
    Participants (pregnant women) with following live birth outcome categories are reported- Vaginal Birth, Planned Caesarean Section, Unscheduled Caesarean Section and Preterm Delivery. Safety Population comprised of all participants (Pregnant Women) who received at least one dose of study treatment.
    End point type
    Secondary
    End point timeframe
    At delivery (up to Week 40 of pregnancy)
    End point values
    		 DTG/ABC/3TC - Mother
    Number of subjects analysed
    4 [42]
    Units: Participants
        Vaginal Birth
    1
        Planned Caesarean Section
    2
        Unscheduled Caesarean Section
    1
        Preterm Delivery
    1
    Notes
    [42] - Safety Population
    No statistical analyses for this end point

    Secondary: Gestational Age of infants

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    End point title
    		 Gestational Age of infants
    End point description
    Gestational age is defined as the number of weeks between the first day of the mother's last normal menstrual period and the day of birth. Data for gestational age of infants has been presented. Analysis was performed on Infant Population which consisted of infants born to pregnant women who received at least one dose of study treatment.
    End point type
    Secondary
    End point timeframe
    At birth
    End point values
    		 DTG/ABC/3TC - Infant
    Number of subjects analysed
    4 [43]
    Units: Weeks
        arithmetic mean (standard deviation)
    38.3 ± 1.71
    Notes
    [43] - Infant Population
    No statistical analyses for this end point

    Secondary: Neonatal length and head circumference at birth

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    End point title
    		 Neonatal length and head circumference at birth
    End point description
    Data for neonatal length and head circumference at birth are reported. Analysis was performed on Infant Population which consisted of infants born to pregnant women who received at least one dose of study treatment.
    End point type
    Secondary
    End point timeframe
    At birth
    End point values
    		 DTG/ABC/3TC - Infant
    Number of subjects analysed
    4 [44]
    Units: Centimeter
    arithmetic mean (standard deviation)
        Neonatal Length
    51.5 ± 3.11
        Neonatal Head Circumference
    34.9 ± 1.65
    Notes
    [44] - Infant Population
    No statistical analyses for this end point

    Secondary: Neonatal Weight at birth

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    End point title
    		 Neonatal Weight at birth
    End point description
    Data for neonatal weight at birth has been reported. Analysis was performed on Infant Population which consisted of infants born to pregnant women who received at least one dose of study treatment.
    End point type
    Secondary
    End point timeframe
    At birth
    End point values
    		 DTG/ABC/3TC - Infant
    Number of subjects analysed
    4 [45]
    Units: Grams
        arithmetic mean (standard deviation)
    3262.5 ± 731.36
    Notes
    [45] - Infant Population
    No statistical analyses for this end point

    Secondary: Number of infants by their weight categories at birth

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    End point title
    		 Number of infants by their weight categories at birth
    End point description
    Weight of infants at birth were categorized as: Small for Gestational Age (SGA) defined neonates under the 10th percentile in weight, Appropriate for Gestational Age (AGA) characterized neonates between the 10th and 90th percentiles in weight and Large for Gestational Age (LGA) referred to neonates over the 90th percentile in weight. Analysis was performed on Infant Population which consisted of infants born to pregnant women who received at least one dose of study treatment.
    End point type
    Secondary
    End point timeframe
    At birth
    End point values
    		 DTG/ABC/3TC - Infant
    Number of subjects analysed
    4 [46]
    Units: Participants
        LGA
    0
        AGA
    4
        SGA
    0
    Notes
    [46] - Infant Population
    No statistical analyses for this end point

    Secondary: Number of infants by Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) score at 1 and 5 minutes after birth

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    End point title
    		 Number of infants by Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) score at 1 and 5 minutes after birth
    End point description
    APGAR is a quick test to assess the health of new born. The test is performed at 1 and 5 minutes after birth. APGAR scale is determined by evaluating the new born on five categories (appearance, pulse, grimace, activity and respiration) on a scale from zero to two with 2 being the best score, then summing up the values obtained from all five categories. APGAR score ranges from 0 to 10 (Higher score indicates better health) where a score of 7 and above is normal. Number of infants by APGAR score at 1 and 5 minutes after birth are presented. Analysis was performed on Infant Population which consisted of infants born to pregnant women who received at least one dose of study treatment.
    End point type
    Secondary
    End point timeframe
    1 and 5 minutes after birth
    End point values
    		 DTG/ABC/3TC - Infant
    Number of subjects analysed
    4 [47]
    Units: Participants
        1 Minute, Score 0 to 6
    0
        1 Minute, Score 7 to 10
    4
        5 Minute, Score 0 to 6
    0
        5 Minute, Score 7 to 10
    4
    Notes
    [47] - Infant Population
    No statistical analyses for this end point

    Secondary: Percentage of participants (pregnant women) with plasma Human Immunodeficiency Virus type 1 (HIV-1) Ribonucleic Acid (RNA) <50 copies/milliliter (c/mL) by visit

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    End point title
    		 Percentage of participants (pregnant women) with plasma Human Immunodeficiency Virus type 1 (HIV-1) Ribonucleic Acid (RNA) <50 copies/milliliter (c/mL) by visit
    End point description
    Percentage of participants (pregnant women) with plasma HIV-1 RNA <50 c/mL are presented. Plasma samples were collected for quantitative analysis of HIV-1 RNA. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles).
    End point type
    Secondary
    End point timeframe
    At Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32 of study
    End point values
    		 DTG/ABC/3TC - Mother
    Number of subjects analysed
    4 [48]
    Units: Percentage of participants
        Week 4, n=4
    100
        Week 8, n=4
    100
        Week 12, n=4
    100
        Week 16, n=4
    100
        Week 20, n=4
    100
        Week 24, n=2
    100
        Week 28, n=1
    100
        Week 32, n=2
    100
    Notes
    [48] - Intent-to-Treat Exposed Population
    No statistical analyses for this end point

    Secondary: Percentage of participants (pregnant women) with plasma HIV-1 RNA <400 c/mL by visit

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    End point title
    		 Percentage of participants (pregnant women) with plasma HIV-1 RNA <400 c/mL by visit
    End point description
    Percentage of participants (pregnant women) with plasma HIV-1 RNA <400 c/mL are presented. Plasma samples were collected for quantitative analysis of HIV-1 RNA. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles).
    End point type
    Secondary
    End point timeframe
    At Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32 of study
    End point values
    		 DTG/ABC/3TC - Mother
    Number of subjects analysed
    4 [49]
    Units: Percentage of participants
        Week 4, n=4
    100
        Week 8, n=4
    100
        Week 12, n=4
    100
        Week 16, n=4
    100
        Week 20, n=4
    100
        Week 24, n=2
    100
        Week 28, n=1
    100
        Week 32, n=2
    100
    Notes
    [49] - Intent-to-Treat Exposed Population
    No statistical analyses for this end point

    Secondary: Absolute values of cluster of differentiation 4 (CD4+) T cell counts by visit

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    End point title
    		 Absolute values of cluster of differentiation 4 (CD4+) T cell counts by visit
    End point description
    Blood samples were collected for the analysis of CD4+ T cell counts using cytometry. 99999 indicates that standard deviation could not be calculated as a single participant was analyzed. Only those participants (pregnant women) with data available at the specified data points were analyzed represented by n=X in the category titles).
    End point type
    Secondary
    End point timeframe
    At Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32 of study
    End point values
    		 DTG/ABC/3TC - Mother
    Number of subjects analysed
    4 [50]
    Units: Cells per cubic millimeter
    arithmetic mean (standard deviation)
        Baseline (Day 1), n=4
    476.3 ± 123.31
        Week 4, n=4
    569.5 ± 238.51
        Week 8, n=4
    569.8 ± 296.43
        Week 12, n=4
    575.0 ± 331.22
        Week 16, n=4
    626.8 ± 270.63
        Week 20, n=4
    791.5 ± 524.96
        Week 24, n=2
    874.5 ± 516.90
        Week 28, n=1
    488.0 ± 99999
        Week 32, n=2
    677.5 ± 40.31
    Notes
    [50] - Intent-to-Treat Exposed Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in CD4+ T cell counts by visit

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    End point title
    		 Change from Baseline in CD4+ T cell counts by visit
    End point description
    Blood samples were collected for the analysis of CD4+ T cell counts using cytometry. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. 99999 indicates that standard deviation could not be calculated as a single participant was analyzed. Only those participants (pregnant women) with data available at the specified data points were analyzed (represented by n=X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline and at Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32 of study
    End point values
    		 DTG/ABC/3TC - Mother
    Number of subjects analysed
    4 [51]
    Units: Cells per cubic millimeter
    arithmetic mean (standard deviation)
        Week 4, n=4
    93.3 ± 124.64
        Week 8, n=4
    93.5 ± 174.54
        Week 12, n=4
    98.8 ± 208.50
        Week 16, n=4
    150.5 ± 148.73
        Week 20, n=4
    315.3 ± 402.00
        Week 24, n=2
    353.0 ± 332.34
        Week 28, n=1
    98.0 ± 99999
        Week 32, n=2
    246.0 ± 97.58
    Notes
    [51] - Intent-to-Treat Exposed Population
    No statistical analyses for this end point

    Secondary: Number of participants (pregnant women) with disease progression

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    End point title
    		 Number of participants (pregnant women) with disease progression
    End point description
    Disease progression included HIV-associated conditions, acquired immunodeficiency syndrome (AIDS) and death. Number of participants (pregnant women) with disease progression to Centers for Disease Control and Prevention (CDC) class C or death have been presented.
    End point type
    Secondary
    End point timeframe
    Up to Week 32 of study
    End point values
    		 DTG/ABC/3TC - Mother
    Number of subjects analysed
    4 [52]
    Units: Participants
    0
    Notes
    [52] - Intent-to-Treat Exposed Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 328
    Adverse event reporting additional description
    Safety population comprised of all pregnant women who received at least one dose of study treatment. All-Cause Mortality, SAEs and non-SAEs were collected only in pregnant women (enrolled population/study participants) and not in infants, as infants were not considered as enrolled per study design.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    DTG/ABC/3TC - Mother
    Reporting group description
    		 Participants (pregnant women) received fixed dose combination (FDC) tablet of dolutegravir (DTG) 50 milligrams (mg), abacavir (ABC) 600 mg and lamivudine (3TC) 300 mg once daily, with or without food.

    Serious adverse events
    		 DTG/ABC/3TC - Mother
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 4 (25.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Pregnancy, puerperium and perinatal conditions
    Premature baby
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 DTG/ABC/3TC - Mother
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 4 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 4 (50.00%)
         occurrences all number
    2
    Migraine
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    2
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 4 (50.00%)
         occurrences all number
    2
    Gastrointestinal disorders
    Dyspepsia
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Dermatitis allergic
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Renal and urinary disorders
    Nephropathy
         subjects affected / exposed
    2 / 4 (50.00%)
         occurrences all number
    4
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Infections and infestations
    Respiratory tract infection
         subjects affected / exposed
    2 / 4 (50.00%)
         occurrences all number
    5
    Gastroenteritis
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Cystitis
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Oral herpes
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Vaginal infection
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Apr 2014
    Amendment 01: Editorial changes, including corrections of minor typographical errors and/or inconsistencies in the Time and Events Table 6 and the protocol, inclusion of infant Human Immunodeficiency Virus (HIV) status if available, and edits to Appendix 3 wording
    23 Apr 2014
    Amendment 02: Specifically, in the Summary of Revisions, page 1, the reader is referred to Time and Events Table 6; it should be Table 4. The Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events was added as a new appendix, changing numbers of other appendices. It’s inclusion also needed to be added to Appendix 6. Lastly, where the Summary of Revisions says Appendix 3, it should be Appendix 4.
    19 Jun 2018
    Amendment 03: Changes were made to the protocol to manage and mitigate risks following identification of a potential safety issue related to neural tube defect in infants born to women with exposure to dolutegravir at the time of conception. The Rationale and Risk Assessment sections (Section 1.2. and Section 1.3.1.) were updated to include language regarding risk and mitigation of neural tube defects. The Withdrawal Criteria (Section 4.5.) were updated to include a reminder that post-delivery, participants who desire to be pregnant, or who state they are not willing/no longer willing to comply with the approved pregnancy avoidance methods, should be withdrawn from the study. The Time and Events table (Section 6.) was updated to include a footnote to clarify the requirement for pregnancy tests post-delivery, and a reminder for investigators to check at every post-delivery visit that participants are avoiding pregnancy. Contraception Requirements for the Post-Partum and Continuation Phases (Section 6.5.4.8.) were updated with the most recent list of ‘highly effective methods for avoiding pregnancy in females of reproductive potential’, which excludes the double barrier method of contraception. Administrative updates were made.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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