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    Clinical Trial Results:
    A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children

    Summary
    EudraCT number
    		 2013-002780-26
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Jun 2021
    First version publication date
    13 Jun 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-292-0106
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01854775
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
    Scientific contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001460-PIP01-13
    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?
    Yes
    Results analysis stage
    Analysis stage
    Interim
    Date of interim/final analysis
    06 Oct 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 May 2020
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of Cohort 1 were to evaluate the steady state pharmacokinetics (PK) for elvitegravir (EVG) and TAF and confirm the dose of E/C/F/TAF STR (Part A) and to evaluate the safety and tolerability of E/C/F/TAF single-tablet regimen (STR) through Week 24 (Part B) in HIV-1 infected, antiretroviral (ARV) treatment-naive adolescents. The primary objectives of Cohort 2 were to evaluate the PK of EVG and TAF in virologically suppressed HIV-1 infected children 6 to < 12 years of age weighing ≥ 25 kg administered E/C/F/TAF STR (Part A) and to evaluate the safety and tolerability of E/C/F/TAF STR through Week 24 in virologically suppressed HIV-1 infected children 6 to < 12 years of age weighing ≥ 25 kg (Part B). The primary objectives of Cohort 3 were to evaluate the PK of EVG and TAF and confirm the dose of STR, and to evaluate the safety and tolerability of E/C/F/TAF low dose STR in virologically suppressed HIV-1 infected children ≥ 2 years of age and weighing ≥ 14 < 25 kg.
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 May 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Thailand: 20
    Country: Number of subjects enrolled
    South Africa: 16
    Country: Number of subjects enrolled
    Uganda: 65
    Country: Number of subjects enrolled
    United States: 26
    Country: Number of subjects enrolled
    Zimbabwe: 2
    Worldwide total number of subjects
    129
    EEA total number of subjects
    0
    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)
    79
    Adolescents (12-17 years)
    50
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants were enrolled at study sites in South Africa, Thailand, Uganda, United States of America, and Zimbabwe. The first participant was screened on 06 May 2013. The data are reported up to the data-cut date of 06 Oct 2020 for Week 48.

    Period 1
    Period 1 title
    Treatment Phase (48 Weeks)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg
    Arm description
    		 Human immunodeficiency virus (HIV)-infected, ARV treatment-naive adolescents (12 to < 18 years of age) received E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant was enrolled; or c) Gilead elected to terminate development of E/C/F/TAF in that country.
    Arm type
    		 Experimental

    Investigational medicinal product name
    E/C/F/TAF
    Investigational medicinal product code
    Other name
    Genvoya®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablets administered once daily.

    Arm title
    		 Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg
    Arm description
    		 Virologically suppressed HIV-infected children (6 to < 12 years of age weighing ≥ 25 kg) received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant was enrolled; or c) Gilead elected to terminate development of E/C/F/TAF in that country.
    Arm type
    		 Experimental

    Investigational medicinal product name
    E/C/F/TAF
    Investigational medicinal product code
    Other name
    Genvoya®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablets administered once daily.

    Arm title
    		 Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg
    Arm description
    		 Virologically suppressed HIV-infected children (≥ 2 years of age weighing ≥ 14 to < 25 kg) received E/C/F/TAF (90/90/120/6 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who attained a weight of ≥ 25 kg during the course of the study were switched to adult E/C/F/TAF (150/150/200/10 mg) tablets administered orally, once daily with food. Participants who completed 48 weeks of study treatment had the option to continue E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant was enrolled; or c) Gilead elected to terminate development of E/C/F/TAF in that country.
    Arm type
    		 Experimental

    Investigational medicinal product name
    E/C/F/TAF (Low Dose)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablets administered once daily.

    Number of subjects in period 1
    		Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg
    Started
    50
    52
    27
    Completed
    48
    51
    18
    Not completed
    2
    1
    9
         Consent withdrawn by subject
    1
    1
    -
         Lost to follow-up
    1
    -
    -
         Still on Study up to the Data-Cut-Date
    -
    -
    9
    Period 2
    Period 2 title
    Extension Phase
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg
    Arm description
    		 Human immunodeficiency virus (HIV)-infected, ARV treatment-naive adolescents (12 to < 18 years of age) received E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant was enrolled; or c) Gilead elected to terminate development of E/C/F/TAF in that country.
    Arm type
    		 Experimental

    Investigational medicinal product name
    E/C/F/TAF
    Investigational medicinal product code
    Other name
    Genvoya®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablets administered once daily.

    Arm title
    		 Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg
    Arm description
    		 Virologically suppressed HIV-infected children (6 to < 12 years of age weighing ≥ 25 kg) received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant was enrolled; or c) Gilead elected to terminate development of E/C/F/TAF in that country.
    Arm type
    		 Experimental

    Investigational medicinal product name
    E/C/F/TAF
    Investigational medicinal product code
    Other name
    Genvoya®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablets administered once daily.

    Arm title
    		 Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg
    Arm description
    		 Virologically suppressed HIV-infected children (≥ 2 years of age weighing ≥ 14 to < 25 kg) received E/C/F/TAF (90/90/120/6 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who attained a weight of ≥ 25 kg during the course of the study were switched to adult E/C/F/TAF (150/150/200/10 mg) tablets administered orally, once daily with food. Participants who completed 48 weeks of study treatment had the option to continue E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant was enrolled; or c) Gilead elected to terminate development of E/C/F/TAF in that country.
    Arm type
    		 Experimental

    Investigational medicinal product name
    E/C/F/TAF (Low Dose)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablets administered once daily.

    Number of subjects in period 2 [1]
    		Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg
    Started
    48
    50
    18
    Completed
    9
    3
    0
    Not completed
    39
    47
    18
         Non- Compliance with Study Drug
    1
    -
    -
         Investigator's Discretion
    1
    -
    -
         Pregnancy
    3
    -
    -
         Still on Study
    32
    47
    18
         Lost to follow-up
    2
    -
    -
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: 1 participant in arm 'Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg' completed the Treatment Phase, but did not enter in the Extension Phase.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg
    Reporting group description
    		 Human immunodeficiency virus (HIV)-infected, ARV treatment-naive adolescents (12 to < 18 years of age) received E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant was enrolled; or c) Gilead elected to terminate development of E/C/F/TAF in that country.

    Reporting group title
    Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg
    Reporting group description
    		 Virologically suppressed HIV-infected children (6 to < 12 years of age weighing ≥ 25 kg) received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant was enrolled; or c) Gilead elected to terminate development of E/C/F/TAF in that country.

    Reporting group title
    Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg
    Reporting group description
    		 Virologically suppressed HIV-infected children (≥ 2 years of age weighing ≥ 14 to < 25 kg) received E/C/F/TAF (90/90/120/6 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who attained a weight of ≥ 25 kg during the course of the study were switched to adult E/C/F/TAF (150/150/200/10 mg) tablets administered orally, once daily with food. Participants who completed 48 weeks of study treatment had the option to continue E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant was enrolled; or c) Gilead elected to terminate development of E/C/F/TAF in that country.

    Reporting group values
    		 Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg Total
    Number of subjects
    		 50 52 27 129
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 15 ± 1.9 10 ± 1.2 6 ± 1.9 -
    Gender categorical
    Units: Subjects
        Female
    		 28 30 17 75
        Male
    		 22 22 10 54
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    		 50 52 27 129
    Race
    Units: Subjects
        Asian
    		 6 13 3 22
        Black or African American
    		 44 37 24 105
        White
    		 0 2 0 2

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg
    Reporting group description
    		 Human immunodeficiency virus (HIV)-infected, ARV treatment-naive adolescents (12 to < 18 years of age) received E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant was enrolled; or c) Gilead elected to terminate development of E/C/F/TAF in that country.

    Reporting group title
    Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg
    Reporting group description
    		 Virologically suppressed HIV-infected children (6 to < 12 years of age weighing ≥ 25 kg) received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant was enrolled; or c) Gilead elected to terminate development of E/C/F/TAF in that country.

    Reporting group title
    Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg
    Reporting group description
    		 Virologically suppressed HIV-infected children (≥ 2 years of age weighing ≥ 14 to < 25 kg) received E/C/F/TAF (90/90/120/6 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who attained a weight of ≥ 25 kg during the course of the study were switched to adult E/C/F/TAF (150/150/200/10 mg) tablets administered orally, once daily with food. Participants who completed 48 weeks of study treatment had the option to continue E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant was enrolled; or c) Gilead elected to terminate development of E/C/F/TAF in that country.
    Reporting group title
    Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg
    Reporting group description
    		 Human immunodeficiency virus (HIV)-infected, ARV treatment-naive adolescents (12 to < 18 years of age) received E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant was enrolled; or c) Gilead elected to terminate development of E/C/F/TAF in that country.

    Reporting group title
    Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg
    Reporting group description
    		 Virologically suppressed HIV-infected children (6 to < 12 years of age weighing ≥ 25 kg) received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant was enrolled; or c) Gilead elected to terminate development of E/C/F/TAF in that country.

    Reporting group title
    Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg
    Reporting group description
    		 Virologically suppressed HIV-infected children (≥ 2 years of age weighing ≥ 14 to < 25 kg) received E/C/F/TAF (90/90/120/6 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who attained a weight of ≥ 25 kg during the course of the study were switched to adult E/C/F/TAF (150/150/200/10 mg) tablets administered orally, once daily with food. Participants who completed 48 weeks of study treatment had the option to continue E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant was enrolled; or c) Gilead elected to terminate development of E/C/F/TAF in that country.

    Primary: Pharmacokinetic (PK) Parameter: AUCtau of Elvitegravir (EVG) (Cohort 1)

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    End point title
    		 Pharmacokinetic (PK) Parameter: AUCtau of Elvitegravir (EVG) (Cohort 1) [1] [2]
    End point description
    AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). The PK Substudy Analysis Set included all enrolled and treated participants from Part A who had any nonmissing key PK parameters (AUCtau, AUClast, Cmax) from Week 4 intensive PK data for the respective analyte.
    End point type
    Primary
    End point timeframe
    0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
    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: No statistical comparison was planned or performed.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 1 only.
    End point values
    		 Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg
    Number of subjects analysed
    24
    Units: hr*ng/mL
        arithmetic mean (standard deviation)
    23840.1 ± 6076.15
    No statistical analyses for this end point

    Primary: PK Parameter: AUCtau of EVG (Cohort 2)

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    End point title
    		 PK Parameter: AUCtau of EVG (Cohort 2) [3] [4]
    End point description
    AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). Participants in the PK Substudy Analysis Set with available data were analyzed.
    End point type
    Primary
    End point timeframe
    0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4
    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: No statistical comparison was planned or performed.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 2 only.
    End point values
    		 Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg
    Number of subjects analysed
    22
    Units: hr*ng/mL
        arithmetic mean (standard deviation)
    33813.9 ± 19536.30
    No statistical analyses for this end point

    Primary: PK Parameter: AUCtau of EVG (Cohort 3)

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    End point title
    		 PK Parameter: AUCtau of EVG (Cohort 3) [5] [6]
    End point description
    AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). The Intensive PK Analysis Set included all enrolled and treated participants who had any nonmissing key PK parameters (AUCtau, AUClast, Cmax) from Week 2 intensive PK data for the respective analyte.
    End point type
    Primary
    End point timeframe
    0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2
    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: No statistical comparison was planned or performed.
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 3 only.
    End point values
    		 Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg
    Number of subjects analysed
    27
    Units: hr*ng/mL
        arithmetic mean (standard deviation)
    29666.6 ± 17321.81
    No statistical analyses for this end point

    Primary: PK Parameter: AUClast of Tenofovir Alafenamide (TAF) (Cohort 1)

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    End point title
    		 PK Parameter: AUClast of Tenofovir Alafenamide (TAF) (Cohort 1) [7] [8]
    End point description
    AUClast is defined as the concentration of drug from time zero to the last observable concentration. Participants in the PK Substudy Analysis Set were analyzed.
    End point type
    Primary
    End point timeframe
    0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
    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: No statistical comparison was planned or performed.
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 1 only.
    End point values
    		 Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg
    Number of subjects analysed
    24
    Units: hr*ng/mL
        arithmetic mean (standard deviation)
    188.9 ± 105.45
    No statistical analyses for this end point

    Primary: PK Parameter: AUClast of TAF (Cohort 2)

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    End point title
    		 PK Parameter: AUClast of TAF (Cohort 2) [9] [10]
    End point description
    AUClast is defined as the concentration of drug from time zero to the last observable concentration. Participants in the PK Substudy Analysis set were analyzed.
    End point type
    Primary
    End point timeframe
    0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4
    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: No statistical comparison was planned or performed.
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 2 only.
    End point values
    		 Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg
    Number of subjects analysed
    23
    Units: hr*ng/mL
        arithmetic mean (standard deviation)
    332.9 ± 149.12
    No statistical analyses for this end point

    Primary: PK Parameter: AUCtau of TAF (Cohort 3)

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    End point title
    		 PK Parameter: AUCtau of TAF (Cohort 3) [11] [12]
    End point description
    AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). Participants in the Intensive PK Analysis Set (all enrolled and treated participants who had any nonmissing key PK parameters [AUCtau, AUClast, Cmax] from Week 2 intensive PK data for the respective analyte) with available data were analyzed.
    End point type
    Primary
    End point timeframe
    0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2
    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: No statistical comparison was planned or performed.
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 3 only.
    End point values
    		 Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg
    Number of subjects analysed
    17
    Units: hr*ng/mL
        arithmetic mean (standard deviation)
    366.4 ± 144.91
    No statistical analyses for this end point

    Primary: Cohort 1: Percentage of Participants With All Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs)

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    End point title
    		 Cohort 1: Percentage of Participants With All Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs) [13] [14]
    End point description
    Treatment-emergent adverse events (TEAEs) were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the Gilead Sciences Grading Scale for Severity of Adverse Events. An AE that met one or more of the following outcomes was classified as serious: • Fatal • Life-threatening • Disabling/incapacitating • Results in hospitalization or prolongs a hospital stay • A congenital abnormality • Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above. Participants in the Safety Analysis Set (all participants who received at least 1 dose of study drug) with available data were analyzed.
    End point type
    Primary
    End point timeframe
    From first dose date up to Week 24
    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: No statistical comparison was planned or performed.
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 1 only.
    End point values
    		 Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg
    Number of subjects analysed
    48
    Units: percentage of participants
    number (not applicable)
        Any TEAEs
    81.3
        SAEs
    8.3
    No statistical analyses for this end point

    Primary: Cohort 2: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs

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    End point title
    		 Cohort 2: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs [15] [16]
    End point description
    TEAEs were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the Gilead Sciences Grading Scale for Severity of Adverse Events. An AE that met one or more of the following outcomes was classified as serious: • Fatal • Life-threatening • Disabling/incapacitating • Results in hospitalization or prolongs a hospital stay • A congenital abnormality • Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above. Participants in the Safety Analysis Set with available data were analyzed.
    End point type
    Primary
    End point timeframe
    From first dose date up to Week 24
    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: No statistical comparison was planned or performed.
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 2 only.
    End point values
    		 Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg
    Number of subjects analysed
    23
    Units: percentage of participants
    number (not applicable)
        Any TEAEs
    73.9
        SAEs
    0
    No statistical analyses for this end point

    Primary: Cohort 3: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs

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    End point title
    		 Cohort 3: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs [17] [18]
    End point description
    TEAEs were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the Gilead Sciences Grading Scale for Severity of Adverse Events. An AE that met one or more of the following outcomes was classified as serious: • Fatal • Life-threatening • Disabling/incapacitating • Results in hospitalization or prolongs a hospital stay • A congenital abnormality • Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above. Participants in the Safety Analysis Set were analyzed.
    End point type
    Primary
    End point timeframe
    From first dose date up to Week 24
    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: No statistical comparison was planned or performed.
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 3 only.
    End point values
    		 Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg
    Number of subjects analysed
    27
    Units: percentage of participants
    number (not applicable)
        Any TEAEs
    70.4
        SAEs
    3.7
    No statistical analyses for this end point

    Secondary: PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 1)

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    End point title
    		 PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 1) [19]
    End point description
    Ctau is defined as the observed drug concentration at the end of the dosing interval. Participants in the PK Substudy Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
    Notes
    [19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 1 only.
    End point values
    		 Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg
    Number of subjects analysed
    24
    Units: ng/mL
    arithmetic mean (standard deviation)
        EVG (n = 24)
    300.8 ± 243.69
        FTC (n = 23)
    102.4 ± 39.85
        TFV (n = 24)
    10.0 ± 2.13
        COBI (n = 15)
    25.0 ± 44.97
    No statistical analyses for this end point

    Secondary: PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 2)

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    End point title
    		 PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 2) [20]
    End point description
    Ctau is defined as the observed drug concentration at the end of the dosing interval. Participants in the PK Substudy Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4
    Notes
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 2 only.
    End point values
    		 Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg
    Number of subjects analysed
    23
    Units: ng/mL
    arithmetic mean (standard deviation)
        EVG
    370.0 ± 438.52
        FTC
    114.9 ± 27.70
        TFV
    15.1 ± 3.77
        COBI
    96.0 ± 162.01
    No statistical analyses for this end point

    Secondary: PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 3)

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    End point title
    		 PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 3) [21]
    End point description
    Ctau is defined as the observed drug concentration at the end of the dosing interval. Participants in the Intensive PK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2
    Notes
    [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 3 only.
    End point values
    		 Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg
    Number of subjects analysed
    27
    Units: ng/mL
    arithmetic mean (standard deviation)
        EVG (n = 22)
    277.5 ± 223.43
        FTC (n = 27)
    82.5 ± 26.47
        TFV (n = 27)
    11.4 ± 2.65
        COBI (n = 18)
    23.0 ± 23.02
    No statistical analyses for this end point

    Secondary: PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 1)

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    End point title
    		 PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 1) [22]
    End point description
    Cmax is defined as the maximum concentration of drug. Participants in the PK Substudy Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
    Notes
    [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 1 only.
    End point values
    		 Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg
    Number of subjects analysed
    24
    Units: ng/mL
    arithmetic mean (standard deviation)
        EVG
    2229.6 ± 427.93
        TAF
    166.8 ± 107.44
        FTC
    2265.0 ± 510.55
        TFV
    17.6 ± 4.18
        COBI
    1202.4 ± 421.21
    No statistical analyses for this end point

    Secondary: PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 2)

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    End point title
    		 PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 2) [23]
    End point description
    Cmax is defined as the maximum concentration of drug. Participants in the PK Substudy Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4
    Notes
    [23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 2 only.
    End point values
    		 Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg
    Number of subjects analysed
    23
    Units: ng/mL
    arithmetic mean (standard deviation)
        EVG
    3055.2 ± 1180.90
        TAF
    313.3 ± 191.68
        FTC
    3397.4 ± 916.06
        TFV
    26.1 ± 5.43
        COBI
    2079.4 ± 970.81
    No statistical analyses for this end point

    Secondary: PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 3)

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    End point title
    		 PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 3) [24]
    End point description
    Cmax is defined as the maximum concentration of drug. Participants in the Intensive PK Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2
    Notes
    [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 3 only.
    End point values
    		 Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg
    Number of subjects analysed
    27
    Units: ng/mL
    arithmetic mean (standard deviation)
        EVG
    3297.2 ± 1720.38
        TAF
    286.6 ± 206.97
        FTC
    3007.4 ± 1138.10
        TFV
    19.6 ± 4.72
        COBI
    1525.5 ± 788.12
    No statistical analyses for this end point

    Secondary: PK Parameter: CL of EVG and TAF (Cohort 1)

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    End point title
    		 PK Parameter: CL of EVG and TAF (Cohort 1) [25]
    End point description
    Clearance (CL) is defined as the systemic clearance of the drug following intravenous administration. Participants in the PK Substudy Analysis Set with available data were analyzed
    End point type
    Secondary
    End point timeframe
    0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
    Notes
    [25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 1 only.
    End point values
    		 Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg
    Number of subjects analysed
    24
    Units: L/hr
    arithmetic mean (standard deviation)
        EVF (n = 24)
    6.7 ± 1.74
        TAF (n = 23)
    68.6 ± 52.64
    No statistical analyses for this end point

    Secondary: PK Parameter: CL of EVG and TAF (Cohort 2)

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    End point title
    		 PK Parameter: CL of EVG and TAF (Cohort 2) [26]
    End point description
    Clearance (CL) is defined as the systemic clearance of the drug following intravenous administration. Participants in the PK Substudy Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4
    Notes
    [26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 2 only.
    End point values
    		 Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg
    Number of subjects analysed
    22
    Units: L/hr
    arithmetic mean (standard deviation)
        EVG (n = 22)
    6.3 ± 5.11
        TAF (n = 11)
    31.9 ± 11.21
    No statistical analyses for this end point

    Secondary: PK Parameter: CL of EVG and TAF (Cohort 3)

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    End point title
    		 PK Parameter: CL of EVG and TAF (Cohort 3) [27]
    End point description
    Clearance (CL) is defined as the systemic clearance of the drug following intravenous administration. Participants in the Intensive PK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2
    Notes
    [27] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 3 only.
    End point values
    		 Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg
    Number of subjects analysed
    24
    Units: L/hr
    arithmetic mean (standard deviation)
        EVG (n = 24)
    3.4 ± 1.79
        TAF (n = 17)
    18.5 ± 6.27
    No statistical analyses for this end point

    Secondary: PK Parameter: Vz of EVG and TAF (Cohort 1)

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    End point title
    		 PK Parameter: Vz of EVG and TAF (Cohort 1) [28]
    End point description
    Vz is defined as the volume of distribution of the drug after intravenous administration. Participants in the PK Substudy Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
    Notes
    [28] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 1 only.
    End point values
    		 Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg
    Number of subjects analysed
    24
    Units: liters
    arithmetic mean (standard deviation)
        EVG (n = 24)
    60.5 ± 18.77
        TAF (n = 23)
    49.7 ± 32.54
    No statistical analyses for this end point

    Secondary: PK Parameter: Vz of EVG and TAF (Cohort 2)

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    End point title
    		 PK Parameter: Vz of EVG and TAF (Cohort 2) [29]
    End point description
    Vz is defined as the volume of distribution of the drug after intravenous administration. Participants in the PK Substudy Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4
    Notes
    [29] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 2 only.
    End point values
    		 Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg
    Number of subjects analysed
    14
    Units: liters
    arithmetic mean (standard deviation)
        EVG (n = 14)
    46.8 ± 36.02
        TAF (n = 11)
    28.6 ± 25.74
    No statistical analyses for this end point

    Secondary: PK Parameter: Vz of EVG and TAF (Cohort 3)

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    End point title
    		 PK Parameter: Vz of EVG and TAF (Cohort 3) [30]
    End point description
    Vz is defined as the volume of distribution of the drug after intravenous administration. Participants in the Intensive PK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2
    Notes
    [30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 3 only.
    End point values
    		 Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg
    Number of subjects analysed
    17
    Units: liters
    arithmetic mean (standard deviation)
        EVG (n = 14)
    28.5 ± 28.30
        TAF (n = 17)
    16.3 ± 11.07
    No statistical analyses for this end point

    Secondary: PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 1)

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    End point title
    		 PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 1) [31]
    End point description
    AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). Participants in the PK Substudy Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
    Notes
    [31] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 1 only.
    End point values
    		 Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg
    Number of subjects analysed
    24
    Units: hr*ng/mL
    arithmetic mean (standard deviation)
        FTC (n = 24)
    14424.4 ± 3452.88
        TFV (n = 23)
    287.6 ± 54.09
        COBI (n = 23)
    8240.8 ± 2972.94
    No statistical analyses for this end point

    Secondary: PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 2)

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    End point title
    		 PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 2) [32]
    End point description
    AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). Participants in the PK Substudy Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4
    Notes
    [32] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 2 only.
    End point values
    		 Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg
    Number of subjects analysed
    23
    Units: hr*ng/mL
    arithmetic mean (standard deviation)
        FTC (n = 22)
    20629.2 ± 3906.01
        TFV (n = 23)
    440.2 ± 92.13
        COBI (n = 20)
    15890.7 ± 8208.78
    No statistical analyses for this end point

    Secondary: PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 3)

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    End point title
    		 PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 3) [33]
    End point description
    AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). Participants in the Intensive PK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2
    Notes
    [33] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 3 only.
    End point values
    		 Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg
    Number of subjects analysed
    27
    Units: hr*ng/mL
    arithmetic mean (standard deviation)
        FTC (n = 27)
    19468.1 ± 5635.74
        TFV (n = 27)
    334.9 ± 76.77
        COBI (n = 21)
    14485.2 ± 7166.10
    No statistical analyses for this end point

    Secondary: Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis

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    End point title
    		 Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis [34]
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. The Full analysis set included all participants who were enrolled in the study and had received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Week 24
    Notes
    [34] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 1 only.
    End point values
    		 Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg
    Number of subjects analysed
    50
    Units: percentage of participants
        number (not applicable)
    90.0
    No statistical analyses for this end point

    Secondary: Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis

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    End point title
    		 Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis [35]
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    Notes
    [35] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 1 only.
    End point values
    		 Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg
    Number of subjects analysed
    50
    Units: percentage of participants
        number (not applicable)
    92.0
    No statistical analyses for this end point

    Secondary: Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis

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    End point title
    		 Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis [36]
    End point description
    The percentage of participants with HIV-1 RNA < 400 Copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 24
    Notes
    [36] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 1 only.
    End point values
    		 Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg
    Number of subjects analysed
    50
    Units: percentage of participants
        number (not applicable)
    94.0
    No statistical analyses for this end point

    Secondary: Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis

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    End point title
    		 Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis [37]
    End point description
    The percentage of participants with HIV-1 RNA < 400 Copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    Notes
    [37] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 1 only.
    End point values
    		 Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg
    Number of subjects analysed
    50
    Units: percentage of participants
        number (not applicable)
    94.0
    No statistical analyses for this end point

    Secondary: Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis

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    End point title
    		 Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis [38]
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 24
    Notes
    [38] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 2 only.
    End point values
    		 Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg
    Number of subjects analysed
    52
    Units: percentage of participants
        number (not applicable)
    100
    No statistical analyses for this end point

    Secondary: Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis

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    End point title
    		 Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis [39]
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    Notes
    [39] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 2 only.
    End point values
    		 Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg
    Number of subjects analysed
    52
    Units: percentage of participants
        number (not applicable)
    98.1
    No statistical analyses for this end point

    Secondary: Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis

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    End point title
    		 Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis [40]
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 24
    Notes
    [40] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 3 only.
    End point values
    		 Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg
    Number of subjects analysed
    27
    Units: percentage of participants
        number (not applicable)
    96.3
    No statistical analyses for this end point

    Secondary: Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis

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    End point title
    		 Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis [41]
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    Notes
    [41] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 3 only.
    End point values
    		 Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg
    Number of subjects analysed
    27
    Units: percentage of participants
        number (not applicable)
    96.3
    No statistical analyses for this end point

    Secondary: Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses

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    End point title
    		 Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses [42]
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = failure analyses. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 24
    Notes
    [42] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 1 only.
    End point values
    		 Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg
    Number of subjects analysed
    50
    Units: percentage of participants
        number (not applicable)
    90.0
    No statistical analyses for this end point

    Secondary: Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses

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    End point title
    		 Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses [43]
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = failure analyses. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    Notes
    [43] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 1 only.
    End point values
    		 Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg
    Number of subjects analysed
    50
    Units: percentage of participants
        number (not applicable)
    92.0
    No statistical analyses for this end point

    Secondary: Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses

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    End point title
    		 Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses [44]
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = failure analyses. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 24
    Notes
    [44] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 1 only.
    End point values
    		 Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg
    Number of subjects analysed
    50
    Units: percentage of participants
        number (not applicable)
    94.0
    No statistical analyses for this end point

    Secondary: Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses

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    End point title
    		 Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses [45]
    End point description
    The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed based on missing = failure analyses. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    Notes
    [45] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 1 only.
    End point values
    		 Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg
    Number of subjects analysed
    50
    Units: percentage of participants
        number (not applicable)
    94.0
    No statistical analyses for this end point

    Secondary: Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses

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    End point title
    		 Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses [46]
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = failure analyses. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 24
    Notes
    [46] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 2 only.
    End point values
    		 Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg
    Number of subjects analysed
    52
    Units: percentage of participants
        number (not applicable)
    100
    No statistical analyses for this end point

    Secondary: Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses

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    End point title
    		 Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses [47]
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = failure analyses. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    Notes
    [47] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 2 only.
    End point values
    		 Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg
    Number of subjects analysed
    52
    Units: percentage of participants
        number (not applicable)
    100
    No statistical analyses for this end point

    Secondary: Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses

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    End point title
    		 Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses [48]
    End point description
    The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 24 was analyzed based on missing = failure analyses. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 24
    Notes
    [48] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 2 only.
    End point values
    		 Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg
    Number of subjects analysed
    52
    Units: percentage of participants
        number (not applicable)
    100
    No statistical analyses for this end point

    Secondary: Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses

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    End point title
    		 Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses [49]
    End point description
    The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed based on missing = failure analyses. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    Notes
    [49] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 2 only.
    End point values
    		 Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg
    Number of subjects analysed
    52
    Units: percentage of participants
        number (not applicable)
    100
    No statistical analyses for this end point

    Secondary: Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses

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    End point title
    		 Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses [50]
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = failure analyses. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 24
    Notes
    [50] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 3 only.
    End point values
    		 Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg
    Number of subjects analysed
    27
    Units: percentage of participants
        number (not applicable)
    96.3
    No statistical analyses for this end point

    Secondary: Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses

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    End point title
    		 Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses [51]
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = failure analyses. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    Notes
    [51] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 3 only.
    End point values
    		 Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg
    Number of subjects analysed
    27
    Units: percentage of participants
        number (not applicable)
    96.3
    No statistical analyses for this end point

    Secondary: Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses

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    End point title
    		 Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses [52]
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = excluded analyses. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 24
    Notes
    [52] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 1 only.
    End point values
    		 Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg
    Number of subjects analysed
    48
    Units: percentage of participants
        number (not applicable)
    93.8
    No statistical analyses for this end point

    Secondary: Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses

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    End point title
    		 Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses [53]
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = excluded analyses. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    Notes
    [53] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 1 only.
    End point values
    		 Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg
    Number of subjects analysed
    48
    Units: percentage of participants
        number (not applicable)
    95.8
    No statistical analyses for this end point

    Secondary: Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses

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    End point title
    		 Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses [54]
    End point description
    The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 24 was analyzed based on missing = excluded analyses. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 24
    Notes
    [54] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 1 only.
    End point values
    		 Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg
    Number of subjects analysed
    48
    Units: percentage of participants
        number (not applicable)
    97.9
    No statistical analyses for this end point

    Secondary: Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses

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    End point title
    		 Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses [55]
    End point description
    The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed based on missing = excluded analyses. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    Notes
    [55] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 1 only.
    End point values
    		 Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg
    Number of subjects analysed
    48
    Units: percentage of participants
        number (not applicable)
    97.9
    No statistical analyses for this end point

    Secondary: Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses

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    End point title
    		 Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses [56]
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = excluded analyses. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 24
    Notes
    [56] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 2 only.
    End point values
    		 Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg
    Number of subjects analysed
    52
    Units: percentage of participants
        number (not applicable)
    100
    No statistical analyses for this end point

    Secondary: Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses

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    End point title
    		 Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses [57]
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = excluded analyses. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    Notes
    [57] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 2 only.
    End point values
    		 Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg
    Number of subjects analysed
    52
    Units: percentage of participants
        number (not applicable)
    100
    No statistical analyses for this end point

    Secondary: Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses

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    End point title
    		 Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses [58]
    End point description
    The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 24 was analyzed based on missing = excluded analyses. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 24
    Notes
    [58] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 2 only.
    End point values
    		 Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg
    Number of subjects analysed
    52
    Units: percentage of participants
        number (not applicable)
    100
    No statistical analyses for this end point

    Secondary: Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses

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    End point title
    		 Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses [59]
    End point description
    The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed based on missing = excluded analyses. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    Notes
    [59] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 2 only.
    End point values
    		 Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg
    Number of subjects analysed
    52
    Units: percentage of participants
        number (not applicable)
    100
    No statistical analyses for this end point

    Secondary: Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses

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    End point title
    		 Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses [60]
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = excluded analyses. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 24
    Notes
    [60] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 3 only.
    End point values
    		 Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg
    Number of subjects analysed
    27
    Units: percentage of participants
        number (not applicable)
    96.3
    No statistical analyses for this end point

    Secondary: Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses

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    End point title
    		 Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses [61]
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = excluded analyses. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    Notes
    [61] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 3 only.
    End point values
    		 Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg
    Number of subjects analysed
    27
    Units: percentage of participants
        number (not applicable)
    96.3
    No statistical analyses for this end point

    Secondary: Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 24

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    End point title
    		 Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 24 [62]
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    Notes
    [62] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 1 only.
    End point values
    		 Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg
    Number of subjects analysed
    50
    Units: copies/mL
    arithmetic mean (standard deviation)
        Baseline (n = 50)
    4.62 ± 0.587
        Change at Week 24 (n = 48)
    -3.25 ± 0.645
    No statistical analyses for this end point

    Secondary: Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 48

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    End point title
    		 Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 48 [63]
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48
    Notes
    [63] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 1 only.
    End point values
    		 Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg
    Number of subjects analysed
    50
    Units: copies/mL
    arithmetic mean (standard deviation)
        Baseline (n = 50)
    4.62 ± 0.587
        Change at Week 48 (n = 48)
    -3.26 ± 0.712
    No statistical analyses for this end point

    Secondary: Cohort 1: Change From Baseline in CD4+ Cell Count at Week 24

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    End point title
    		 Cohort 1: Change From Baseline in CD4+ Cell Count at Week 24 [64]
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    Notes
    [64] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 1 only.
    End point values
    		 Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg
    Number of subjects analysed
    50
    Units: cells/μL
    arithmetic mean (standard deviation)
        Baseline (n = 50)
    471 ± 212.2
        Change at Week 24 (n = 48)
    191 ± 175.2
    No statistical analyses for this end point

    Secondary: Cohort 1: Change From Baseline in CD4+ Cell Count at Week 48

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    End point title
    		 Cohort 1: Change From Baseline in CD4+ Cell Count at Week 48 [65]
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48
    Notes
    [65] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 1 only.
    End point values
    		 Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg
    Number of subjects analysed
    50
    Units: cells/μL
    arithmetic mean (standard deviation)
        Baseline (n = 50)
    471 ± 212.2
        Change at Week 48 (n = 48)
    224 ± 170.3
    No statistical analyses for this end point

    Secondary: Cohort 2: Change From Baseline in CD4+ Cell Count at Week 24

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    End point title
    		 Cohort 2: Change From Baseline in CD4+ Cell Count at Week 24 [66]
    End point description
    Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    Notes
    [66] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 2 only.
    End point values
    		 Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg
    Number of subjects analysed
    52
    Units: cells/μL
    arithmetic mean (standard deviation)
        Baseline
    961 ± 275.5
        Change at Week 24
    -118 ± 194.1
    No statistical analyses for this end point

    Secondary: Cohort 2: Change From Baseline in CD4+ Cell Count at Week 48

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    End point title
    		 Cohort 2: Change From Baseline in CD4+ Cell Count at Week 48 [67]
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48
    Notes
    [67] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 2 only.
    End point values
    		 Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg
    Number of subjects analysed
    52
    Units: cells/μL
    arithmetic mean (standard deviation)
        Baseline (n = 52)
    961 ± 275.5
        Change at Week 48 (n = 50)
    -66 ± 203.6
    No statistical analyses for this end point

    Secondary: Cohort 3: Change From Baseline in CD4+ Cell Count at Week 24

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    End point title
    		 Cohort 3: Change From Baseline in CD4+ Cell Count at Week 24 [68]
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    Notes
    [68] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 3 only.
    End point values
    		 Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg
    Number of subjects analysed
    27
    Units: cells/μL
    arithmetic mean (standard deviation)
        Baseline (n = 27)
    1153 ± 459.9
        Change at Week 24 (n = 17)
    -137 ± 278.3
    No statistical analyses for this end point

    Secondary: Cohort 3: Change From Baseline in CD4+ Cell Count at Week 48

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    End point title
    		 Cohort 3: Change From Baseline in CD4+ Cell Count at Week 48 [69]
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48
    Notes
    [69] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 3 only.
    End point values
    		 Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg
    Number of subjects analysed
    27
    Units: cells/μL
    arithmetic mean (standard deviation)
        Baseline (n =27)
    1153 ± 459.9
        Change at Week 48 (n = 24)
    -179 ± 319.2
    No statistical analyses for this end point

    Secondary: Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 24

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    End point title
    		 Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 24 [70]
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    Notes
    [70] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 1 only.
    End point values
    		 Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg
    Number of subjects analysed
    50
    Units: percentage of CD4+ cell
    arithmetic mean (standard deviation)
        Baseline (n = 50)
    23.6 ± 8.80
        Change at Week 24 (n = 48)
    7.7 ± 4.77
    No statistical analyses for this end point

    Secondary: Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 48

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    End point title
    		 Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 48 [71]
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48
    Notes
    [71] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 1 only.
    End point values
    		 Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg
    Number of subjects analysed
    50
    Units: percentage of CD4+ cell
    arithmetic mean (standard deviation)
        Baseline (n = 50)
    23.6 ± 8.80
        Change at Week 48 (n = 47)
    9.3 ± 5.19
    No statistical analyses for this end point

    Secondary: Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 24

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    End point title
    		 Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 24 [72]
    End point description
    Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    Notes
    [72] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 2 only.
    End point values
    		 Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg
    Number of subjects analysed
    52
    Units: percentage of CD4+ cell
    arithmetic mean (standard deviation)
        Baseline
    38.2 ± 6.44
        Change at Week 24
    -0.8 ± 3.97
    No statistical analyses for this end point

    Secondary: Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 48

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    End point title
    		 Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 48 [73]
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48
    Notes
    [73] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 2 only.
    End point values
    		 Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg
    Number of subjects analysed
    52
    Units: percentage of CD4+ cell
    arithmetic mean (standard deviation)
        Baseline (n = 52)
    38.2 ± 6.44
        Change at Week 48 (n = 50)
    -0.6 ± 4.37
    No statistical analyses for this end point

    Secondary: Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 24

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    End point title
    		 Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 24 [74]
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    Notes
    [74] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 3 only.
    End point values
    		 Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg
    Number of subjects analysed
    27
    Units: percentage of CD4+ cell
    arithmetic mean (standard deviation)
        Baseline (n = 27)
    35.9 ± 6.73
        Change at Week 24 (n = 17)
    0.0 ± 4.40
    No statistical analyses for this end point

    Secondary: Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 48

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    End point title
    		 Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 48 [75]
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48
    Notes
    [75] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is reporting statistics for Cohort 3 only.
    End point values
    		 Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg
    Number of subjects analysed
    27
    Units: percentage of CD4+ cell
    arithmetic mean (standard deviation)
        Baseline (n = 27)
    35.9 ± 6.73
        Change at Week 48 (n = 24)
    0.2 ± 3.78
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    First dose date up to 89 months
    Adverse event reporting additional description
    The Safety Analysis Set included all participants who received at least 1 dose of study drug. Adverse events were coded according to MedDRA Version 21.1 (for Cohorts 1 and 2) and MedDRA Version 23.0 (for Cohort 3).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg
    Reporting group description
    		 HIV-infected, ARV treatment-naive adolescents (12 to < 18 years of age) received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant was enrolled; or c) Gilead elected to terminate development of E/C/F/TAF in that country.

    Reporting group title
    Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg
    Reporting group description
    		 Virologically suppressed HIV-infected children (6 to < 12 years of age weighing ≥ 25 kg) received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant was enrolled; or c) Gilead elected to terminate development of E/C/F/TAF in that country.

    Reporting group title
    Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg
    Reporting group description
    		 Virologically suppressed HIV-infected children (≥ 2 years of age weighing ≥ 14 to < 25 kg) received E/C/ F/TAF (90/90/120/6 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who attained a weight of ≥ 25 kg during the course of the study were switched to adult E/C/F/TAF (150/150/200/10 mg) tablets administered orally, once daily with food. Participants who completed 48 weeks of study treatment had the option to continue E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant was enrolled; or c) Gilead elected to terminate development of E/C/F/TAF in that country.

    Serious adverse events
    		 Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 50 (16.00%)
    0 / 52 (0.00%)
    1 / 27 (3.70%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Radius fracture
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuralgia
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Autoimmune uveitis
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Visual impairment
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicide attempt
         subjects affected / exposed
    2 / 50 (4.00%)
    0 / 52 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute psychosis
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Agitation
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bipolar I disorder
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Conduct disorder
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug abuse
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Substance abuse
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    47 / 50 (94.00%)
    38 / 52 (73.08%)
    19 / 27 (70.37%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma
         subjects affected / exposed
    4 / 50 (8.00%)
    0 / 52 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    4
    0
    1
    Anogenital warts
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 52 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    4
    0
    0
    Reproductive system and breast disorders
    Menorrhagia
         subjects affected / exposed
    3 / 50 (6.00%)
    1 / 52 (1.92%)
    0 / 27 (0.00%)
         occurrences all number
    4
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    8 / 50 (16.00%)
    6 / 52 (11.54%)
    5 / 27 (18.52%)
         occurrences all number
    9
    6
    8
    Rhinorrhoea
         subjects affected / exposed
    3 / 50 (6.00%)
    5 / 52 (9.62%)
    0 / 27 (0.00%)
         occurrences all number
    4
    5
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 50 (0.00%)
    5 / 52 (9.62%)
    1 / 27 (3.70%)
         occurrences all number
    0
    8
    1
    Oropharyngeal pain
         subjects affected / exposed
    3 / 50 (6.00%)
    1 / 52 (1.92%)
    0 / 27 (0.00%)
         occurrences all number
    3
    2
    0
    Epistaxis
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 52 (1.92%)
    2 / 27 (7.41%)
         occurrences all number
    0
    1
    2
    Product issues
    Product size issue
         subjects affected / exposed
    5 / 50 (10.00%)
    1 / 52 (1.92%)
    0 / 27 (0.00%)
         occurrences all number
    5
    1
    0
    Investigations
    Weight decreased
         subjects affected / exposed
    4 / 50 (8.00%)
    0 / 52 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    4
    0
    1
    Injury, poisoning and procedural complications
    Skin abrasion
         subjects affected / exposed
    0 / 50 (0.00%)
    3 / 52 (5.77%)
    1 / 27 (3.70%)
         occurrences all number
    0
    3
    1
    Contusion
         subjects affected / exposed
    0 / 50 (0.00%)
    3 / 52 (5.77%)
    0 / 27 (0.00%)
         occurrences all number
    0
    3
    0
    Tooth fracture
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 52 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    3
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    13 / 50 (26.00%)
    6 / 52 (11.54%)
    0 / 27 (0.00%)
         occurrences all number
    16
    6
    0
    Dizziness
         subjects affected / exposed
    6 / 50 (12.00%)
    2 / 52 (3.85%)
    0 / 27 (0.00%)
         occurrences all number
    6
    2
    0
    Somnolence
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 52 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    3
    0
    0
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    5 / 50 (10.00%)
    1 / 52 (1.92%)
    0 / 27 (0.00%)
         occurrences all number
    7
    2
    0
    Lymphadenopathy
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 52 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    3
    0
    0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    10 / 50 (20.00%)
    13 / 52 (25.00%)
    4 / 27 (14.81%)
         occurrences all number
    12
    13
    4
    Diarrhoea
         subjects affected / exposed
    14 / 50 (28.00%)
    7 / 52 (13.46%)
    2 / 27 (7.41%)
         occurrences all number
    21
    7
    2
    Abdominal pain
         subjects affected / exposed
    11 / 50 (22.00%)
    9 / 52 (17.31%)
    0 / 27 (0.00%)
         occurrences all number
    12
    9
    0
    Nausea
         subjects affected / exposed
    15 / 50 (30.00%)
    1 / 52 (1.92%)
    0 / 27 (0.00%)
         occurrences all number
    16
    1
    0
    Dental caries
         subjects affected / exposed
    6 / 50 (12.00%)
    3 / 52 (5.77%)
    0 / 27 (0.00%)
         occurrences all number
    6
    3
    0
    Abdominal pain upper
         subjects affected / exposed
    5 / 50 (10.00%)
    1 / 52 (1.92%)
    1 / 27 (3.70%)
         occurrences all number
    8
    1
    1
    Constipation
         subjects affected / exposed
    3 / 50 (6.00%)
    2 / 52 (3.85%)
    2 / 27 (7.41%)
         occurrences all number
    5
    2
    2
    Gastritis
         subjects affected / exposed
    5 / 50 (10.00%)
    1 / 52 (1.92%)
    0 / 27 (0.00%)
         occurrences all number
    5
    1
    0
    Skin and subcutaneous tissue disorders
    Seborrhoeic dermatitis
         subjects affected / exposed
    7 / 50 (14.00%)
    0 / 52 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    8
    0
    0
    Rash
         subjects affected / exposed
    3 / 50 (6.00%)
    1 / 52 (1.92%)
    1 / 27 (3.70%)
         occurrences all number
    3
    1
    1
    Rash papular
         subjects affected / exposed
    5 / 50 (10.00%)
    0 / 52 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    7
    0
    0
    Acne
         subjects affected / exposed
    4 / 50 (8.00%)
    0 / 52 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    4
    0
    0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    3 / 50 (6.00%)
    1 / 52 (1.92%)
    0 / 27 (0.00%)
         occurrences all number
    5
    1
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    19 / 50 (38.00%)
    14 / 52 (26.92%)
    8 / 27 (29.63%)
         occurrences all number
    38
    19
    8
    Respiratory tract infection
         subjects affected / exposed
    19 / 50 (38.00%)
    9 / 52 (17.31%)
    0 / 27 (0.00%)
         occurrences all number
    44
    12
    0
    Malaria
         subjects affected / exposed
    9 / 50 (18.00%)
    1 / 52 (1.92%)
    0 / 27 (0.00%)
         occurrences all number
    10
    1
    0
    Urinary tract infection
         subjects affected / exposed
    7 / 50 (14.00%)
    2 / 52 (3.85%)
    1 / 27 (3.70%)
         occurrences all number
    13
    2
    1
    Body tinea
         subjects affected / exposed
    7 / 50 (14.00%)
    0 / 52 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    7
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    3 / 50 (6.00%)
    2 / 52 (3.85%)
    3 / 27 (11.11%)
         occurrences all number
    3
    2
    4
    Tonsillitis
         subjects affected / exposed
    5 / 50 (10.00%)
    1 / 52 (1.92%)
    2 / 27 (7.41%)
         occurrences all number
    5
    1
    2
    Gastroenteritis
         subjects affected / exposed
    4 / 50 (8.00%)
    3 / 52 (5.77%)
    0 / 27 (0.00%)
         occurrences all number
    4
    3
    0
    Pneumonia
         subjects affected / exposed
    6 / 50 (12.00%)
    1 / 52 (1.92%)
    0 / 27 (0.00%)
         occurrences all number
    8
    1
    0
    Vulvovaginal candidiasis
         subjects affected / exposed
    5 / 50 (10.00%)
    0 / 52 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    9
    0
    0
    Conjunctivitis
         subjects affected / exposed
    4 / 50 (8.00%)
    0 / 52 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    4
    0
    0
    Pharyngitis
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 52 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    3
    0
    1
    Rhinitis
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 52 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    3
    0
    1
    Folliculitis
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 52 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    4
    0
    0
    Hordeolum
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 52 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    4
    0
    0
    Nasal herpes
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 52 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    3
    0
    0
    Proctitis gonococcal
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 52 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    3
    0
    0
    Metabolism and nutrition disorders
    Vitamin D deficiency
         subjects affected / exposed
    8 / 50 (16.00%)
    3 / 52 (5.77%)
    0 / 27 (0.00%)
         occurrences all number
    8
    3
    0
    Decreased appetite
         subjects affected / exposed
    2 / 50 (4.00%)
    0 / 52 (0.00%)
    4 / 27 (14.81%)
         occurrences all number
    2
    0
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Mar 2013
    - Corrected the measurement unit for the CD4 cell count inclusion criterion - Increased the minimum number of participants in each age subgroup of Part A - Added a 24-hour time point to the intensive PK sampling times - Updated the list of disallowed and discouraged medications in the study
    09 Jan 2015
    - Added palatability and acceptability assessment procedures - Added Cohort 2 Part A with virologically suppressed children 6 to < 12 years of age weighing ≥ 25 kg
    11 Aug 2016
    - Added Cohort 2 Part B with virologically suppressed children 6 to < 12 years of age weighing ≥ 25 kg
    11 Jun 2018
    Added Cohort 3, to comprise virologically suppressed, HIV-1 infected children ≥ 2 years of age and weighing ≥ 14 to < 25 kg, in which to allow evaluation of the PK, safety, efficacy, and tolerability of the E/C/F/TAF low dose tablet (E/C/F/TAF 90/90/120/6 mg).
    17 Aug 2018
    Updated CD4 cell inclusion criteria for Cohort 3, and added time points for palatability and acceptability assessments.
    21 Feb 2020
    Clarified that fasting was not required in advance of sample collection for evaluation of urine renal safety parameters and serum bone safety parameters.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30169223
    http://www.ncbi.nlm.nih.gov/pubmed/27765666
    For support, Contact us.
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