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    Clinical Trial Results:
    A Phase 2/3, Open-Label, Multi-Cohort Switch Study to Evaluate Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected Children and Adolescents Virologically Suppressed on a 2-NRTI-Containing Regimen

    Summary
    EudraCT number
    		 2015-001339-19
    Trial protocol
    		 Outside EU/EEA   GB  
    Global end of trial date
    11 Dec 2024

    Results information
    Results version number
    		 v2(current)
    This version publication date
    25 Jun 2025
    First version publication date
    14 Aug 2021
    Other versions
    		 v1
    Version creation reason
    • New data added to full data set
    The record is revised to add final analysis data.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GS-US-311-1269
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02285114
    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-001577-PIP02-14
    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
    Final
    Date of interim/final analysis
    11 Dec 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Dec 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to confirm the tenofovir alafenamide (TAF) dose and to evaluate the pharmacokinetics (PK) of TAF, safety, and tolerability of emtricitabine/tenofovir alafenamide (F/TAF) in human immunodeficiency virus-1 (HIV-1) infected children and adolescents virologically suppressed (defined as having < 50 copies/mL of HIV-1 ribonucleic acid [RNA] for a period of at least 6 months) while on a stable 2 nucleoside reverse transcriptase inhibitor (NRTI) containing regimen.
    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
    		 A 3rd antiretroviral (ARV) agent may include one of the following: boosted atazanavir (ATV), boosted lopinavir (LPV), boosted darunavir (DRV), unboosted efavirenz (EFV), unboosted nevirapine (NVP), unboosted raltegravir (RAL), or unboosted dolutegravir (DTG).
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Jan 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Panama: 19
    Country: Number of subjects enrolled
    South Africa: 12
    Country: Number of subjects enrolled
    United States: 10
    Worldwide total number of subjects
    41
    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)
    12
    Adolescents (12-17 years)
    29
    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
    		 49 participants were screened. Participants were enrolled at study sites in Panama, South Africa, and United States. The study had a main treatment phase of 48 weeks and an extension phase.

    Pre-assignment
    Screening details
    		 No participant was enrolled in Cohort 2 (Part B: Groups 1 and 2), and Cohorts 3 and 4 (Parts A and B). Data is reported only for Cohorts 1 and 2 (Part A: Groups 1 and 2). It was prespecified to analyze Cohort 1 together as both treatments were expected to have a similar effect on efficacy and safety for target population.

    Period 1
    Period 1 title
    Main Phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Main Phase: F/TAF+3rd ARV Agent (Cohort 1)
    Arm description
    		 Participants between 12 to < 18 years of age and ≥ 35 kg body weight received emtricitabine/tenofovir alafenamide (F/TAF) 200/10 mg fixed-dose combination (FDC) tablet (with boosted 3rd antiretroviral [ARV] agent) or F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP.
    Arm type
    		 Experimental

    Investigational medicinal product name
    F/TAF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200/25 mg for unboosted 3rd agent and 200/10 mg for boosted 3rd agent, administered orally once daily

    Arm title
    		 Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1)
    Arm description
    		 Participants between 6 to < 12 years of age and ≥ 25 kg body weight received F/TAF 200/25 mg FDC tablet orally once daily while continuing on their boosted protease inhibitor (PI) for 48 weeks. Allowed boosted PIs: ATV, LPV or DRV.
    Arm type
    		 Experimental

    Investigational medicinal product name
    F/TAF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200/25 mg administered orally once daily

    Arm title
    		 Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
    Arm description
    		 Participants between 2 to < 12 years of age and 17 to < 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP.
    Arm type
    		 Experimental

    Investigational medicinal product name
    F/TAF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    120/15 mg administered orally once daily

    Number of subjects in period 1 [1]
    		Main Phase: F/TAF+3rd ARV Agent (Cohort 1) Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1) Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
    Started
    28
    9
    3
    Completed
    28
    7
    2
    Not completed
    0
    2
    1
         Withdrew Consent
    -
    -
    1
         Investigator's Discretion
    -
    2
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 1 participant who was enrolled but not treated was not included in the Safety Analysis Set for Period 1 table reported above.
    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
    		 Extension Phase: F/TAF+3rd ARV Agent (Cohort 1)
    Arm description
    		 After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. The maximum exposure was 438.9 weeks. Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP.
    Arm type
    		 Experimental

    Investigational medicinal product name
    F/TAF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200/25 mg for unboosted 3rd agent and 200/10 mg for boosted 3rd agent, administered orally once daily.

    Arm title
    		 Extension Phase:F/TAF+3rd ARV Agent (Cohort 2, Part A-Group 1)
    Arm description
    		 After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. The maximum exposure was 315.0 weeks. Allowed boosted PIs: ATV, LPV or DRV.
    Arm type
    		 Experimental

    Investigational medicinal product name
    F/TAF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200/25 mg administered orally once daily.

    Arm title
    		 Extension Phase:F/TAF+3rd ARV Agent (Cohort 2, Part A-Group 2)
    Arm description
    		 After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV Agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. The maximum exposure was 103.1 weeks. Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP.
    Arm type
    		 Experimental

    Investigational medicinal product name
    F/TAF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    120/15 mg administered orally once daily.

    Number of subjects in period 2
    		Extension Phase: F/TAF+3rd ARV Agent (Cohort 1) Extension Phase:F/TAF+3rd ARV Agent (Cohort 2, Part A-Group 1) Extension Phase:F/TAF+3rd ARV Agent (Cohort 2, Part A-Group 2)
    Started
    28
    7
    2
    Completed
    10
    5
    2
    Not completed
    18
    2
    0
         Non-compliance with Study Drug
    2
    -
    -
         Investigator's Discretion
    14
    1
    -
         Pregnancy
    1
    -
    -
         Lost to follow-up
    1
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Main Phase: F/TAF+3rd ARV Agent (Cohort 1)
    Reporting group description
    		 Participants between 12 to < 18 years of age and ≥ 35 kg body weight received emtricitabine/tenofovir alafenamide (F/TAF) 200/10 mg fixed-dose combination (FDC) tablet (with boosted 3rd antiretroviral [ARV] agent) or F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP.

    Reporting group title
    Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1)
    Reporting group description
    		 Participants between 6 to < 12 years of age and ≥ 25 kg body weight received F/TAF 200/25 mg FDC tablet orally once daily while continuing on their boosted protease inhibitor (PI) for 48 weeks. Allowed boosted PIs: ATV, LPV or DRV.

    Reporting group title
    Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
    Reporting group description
    		 Participants between 2 to < 12 years of age and 17 to < 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP.

    Reporting group values
    		 Main Phase: F/TAF+3rd ARV Agent (Cohort 1) Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1) Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2) Total
    Number of subjects
    		 28 9 3 40
    Age categorical
    Units: Subjects
        6 to < 12 years
    		 0 9 3 12
        12 to < 15 years
    		 19 0 0 19
        15 to < 18 years
    		 9 0 0 9
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 14 ( 1.6 ) 10 ( 1.0 ) 7 ( 1.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 12 5 2 19
        Male
    		 16 4 1 21
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 14 5 1 20
        Not Hispanic or Latino
    		 14 4 2 20
    Race
    Units: Subjects
        Asian
    		 1 0 0 1
        Black
    		 12 4 2 18
        White
    		 3 0 0 3
        Other
    		 12 5 1 18
    Human Immunodeficiency Virus, Type 1 Ribonucleic Acid (HIV-1 RNA)
    Units: Subjects
        < 50 copies/mL
    		 27 9 3 39
        ≥ 50 copies/mL
    		 1 0 0 1
    Cluster of Differentiation 4 (CD4) Cell Count
    Units: cells/µL
        arithmetic mean (standard deviation)
    		 909 ( 242.7 ) 871 ( 364.8 ) 1209 ( 306.3 ) -
    CD4 Percentage (%)
    Units: Percentage of lymphocytes
        arithmetic mean (standard deviation)
    		 36.1 ( 6.40 ) 36.7 ( 4.35 ) 36.1 ( 3.35 ) -

    End points

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    End points reporting groups
    Reporting group title
    Main Phase: F/TAF+3rd ARV Agent (Cohort 1)
    Reporting group description
    		 Participants between 12 to < 18 years of age and ≥ 35 kg body weight received emtricitabine/tenofovir alafenamide (F/TAF) 200/10 mg fixed-dose combination (FDC) tablet (with boosted 3rd antiretroviral [ARV] agent) or F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP.

    Reporting group title
    Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1)
    Reporting group description
    		 Participants between 6 to < 12 years of age and ≥ 25 kg body weight received F/TAF 200/25 mg FDC tablet orally once daily while continuing on their boosted protease inhibitor (PI) for 48 weeks. Allowed boosted PIs: ATV, LPV or DRV.

    Reporting group title
    Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
    Reporting group description
    		 Participants between 2 to < 12 years of age and 17 to < 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP.
    Reporting group title
    Extension Phase: F/TAF+3rd ARV Agent (Cohort 1)
    Reporting group description
    		 After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. The maximum exposure was 438.9 weeks. Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP.

    Reporting group title
    Extension Phase:F/TAF+3rd ARV Agent (Cohort 2, Part A-Group 1)
    Reporting group description
    		 After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant is enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. The maximum exposure was 315.0 weeks. Allowed boosted PIs: ATV, LPV or DRV.

    Reporting group title
    Extension Phase:F/TAF+3rd ARV Agent (Cohort 2, Part A-Group 2)
    Reporting group description
    		 After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV Agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. The maximum exposure was 103.1 weeks. Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP.

    Subject analysis set title
    Main Phase: F/TAF 200/10 mg+3rd ARV Agent (Cohort 1)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants between 12 to < 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV). The participants received the study drug up to a maximum of 438.9 weeks.

    Subject analysis set title
    Main Phase: F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants between 12 to < 18 years of age and ≥ 35 kg body weight received F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 438.9 weeks.

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

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    End point title
    		 Pharmacokinetic (PK) Parameter (Cohort 1): AUCtau of Tenofovir Alafenamide (TAF) [1]
    End point description
    AUCtau is defined as the area under the drug concentration versus time curve over the dosing interval. Participants in the Intensive PK (IPK) Analysis Set (participants who were enrolled in Cohort 1 for IPK evaluation, had received at least one dose of study medication, and had at least 1 non-missing PK concentration data for any analyte of interest [e.g., emtricitabine {FTC}, TAF, and tenofovir {TFV}]) with available data were analyzed.
    End point type
    Primary
    End point timeframe
    Any time at Week 2 visit
    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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Main Phase: F/TAF 200/10 mg+3rd ARV Agent (Cohort 1) Main Phase: F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
    Number of subjects analysed
    9
    9
    Units: h*ng/mL
        arithmetic mean (standard deviation)
    139.9 ( 113.23 )
    200.6 ( 83.80 )
    No statistical analyses for this end point

    Primary: PK Parameter (Cohort 2: Part A - Groups 1 and 2): AUCtau of TAF

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    End point title
    		 PK Parameter (Cohort 2: Part A - Groups 1 and 2): AUCtau of TAF [2] [3]
    End point description
    AUCtau is defined as the area under the drug concentration versus time curve over the dosing interval. The IPK Analysis Set included all participants who were enrolled into the study, had received at least one dose of study medication, and had at least 1 non-missing PK concentration data for any analyte of interest (e.g., FTC, TAF, and TFV).
    End point type
    Primary
    End point timeframe
    Any time at Week 2 or Week 4 visit, or within 7 days after the completion of Week 2 or Week 4 visits
    Notes
    [2] - 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: Only descriptive analyses were planned for this endpoint.
    [3] - 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 data for this endpoint is reported separately for Cohorts 1 and 2.
    End point values
    		 Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1) Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
    Number of subjects analysed
    9
    3
    Units: h*ng/mL
        arithmetic mean (standard deviation)
    210.8 ( 97.35 )
    220.2 ( 187.96 )
    No statistical analyses for this end point

    Primary: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Through Week 24

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    End point title
    		 Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Through Week 24 [4]
    End point description
    An AE is any untoward medical occurrence in a clinical study participant which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The TEAEs were defined as any AEs with an onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug. The Safety Analysis Set included all participants who were enrolled in the study and had received at least one dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population.
    End point type
    Primary
    End point timeframe
    Baseline through Week 24
    Notes
    [4] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Main Phase: F/TAF+3rd ARV Agent (Cohort 1) Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1) Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
    Number of subjects analysed
    28
    9
    3
    Units: percentage of participants
    number (not applicable)
        Any AEs
    82.1
    66.7
    66.7
        SAEs
    7.1
    0
    0
    No statistical analyses for this end point

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

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    End point title
    		 PK Parameter (Cohort 1): Cmax of TAF, FTC, and TFV
    End point description
    Cmax is defined as the maximum concentration of drug. Participants in the IPK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Any time at Week 2 visit
    End point values
    		 Main Phase: F/TAF 200/10 mg+3rd ARV Agent (Cohort 1) Main Phase: F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
    Number of subjects analysed
    13
    11
    Units: ng/mL
    arithmetic mean (standard deviation)
        Cmax of TAF
    89.1 ( 77.63 )
    139.3 ( 76.17 )
        Cmax of FTC
    2259.2 ( 470.75 )
    2320.0 ( 482.18 )
        Cmax of TFV
    21.2 ( 4.89 )
    11.6 ( 2.74 )
    No statistical analyses for this end point

    Secondary: PK Parameter (Cohort 2: Part A - Groups 1 and 2): Cmax of TAF, FTC, and TFV

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    End point title
    		 PK Parameter (Cohort 2: Part A - Groups 1 and 2): Cmax of TAF, FTC, and TFV [5]
    End point description
    Cmax is defined as the maximum concentration of drug. Participants in the IPK Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Any time at Week 2 or Week 4 visit, or within 7 days after the completion of Week 2 or Week 4 visits
    Notes
    [5] - 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 data for this endpoint is reported separately for Cohorts 1 and 2.
    End point values
    		 Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1) Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
    Number of subjects analysed
    9
    3
    Units: ng/mL
    arithmetic mean (standard deviation)
        Cmax of TAF
    230.4 ( 264.70 )
    232.0 ( 253.59 )
        Cmax of FTC
    2074.4 ( 565.91 )
    2020.0 ( 1151.91 )
        Cmax of TFV
    55.8 ( 19.20 )
    48.1 ( 8.07 )
    No statistical analyses for this end point

    Secondary: PK Parameter (Cohort 1): Clast of TAF

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    End point title
    		 PK Parameter (Cohort 1): Clast of TAF
    End point description
    Clast is defined as the last observable concentration of drug. Participants in the IPK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Any time at Week 2 visit
    End point values
    		 Main Phase: F/TAF 200/10 mg+3rd ARV Agent (Cohort 1) Main Phase: F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
    Number of subjects analysed
    13
    11
    Units: ng/mL
        arithmetic mean (standard deviation)
    2.2 ( 0.98 )
    5.5 ( 3.76 )
    No statistical analyses for this end point

    Secondary: PK Parameter (Cohort 2: Part A - Groups 1 and 2): Clast of TAF

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    End point title
    		 PK Parameter (Cohort 2: Part A - Groups 1 and 2): Clast of TAF [6]
    End point description
    Clast is defined as the last observable concentration of drug. Participants in the IPK Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Any time at Week 2 or Week 4 visit, or within 7 days after the completion of Week 2 or Week 4 visits
    Notes
    [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 data for this endpoint is reported separately for Cohorts 1 and 2.
    End point values
    		 Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1) Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
    Number of subjects analysed
    9
    3
    Units: ng/mL
        arithmetic mean (standard deviation)
    2.9 ( 2.32 )
    2.1 ( 0.86 )
    No statistical analyses for this end point

    Secondary: PK Parameter (Cohort 1): CL/F of TAF

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    End point title
    		 PK Parameter (Cohort 1): CL/F of TAF
    End point description
    CL/F is defined as the apparent clearance following oral administration of the drug. Participants in the IPK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Any time at Week 2 visit
    End point values
    		 Main Phase: F/TAF 200/10 mg+3rd ARV Agent (Cohort 1) Main Phase: F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
    Number of subjects analysed
    9
    9
    Units: L/hr
        arithmetic mean (standard deviation)
    129.8 ( 101.67 )
    143.4 ( 53.55 )
    No statistical analyses for this end point

    Secondary: PK Parameter (Cohort 2: Part A - Groups 1 and 2): CL/F of TAF

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    End point title
    		 PK Parameter (Cohort 2: Part A - Groups 1 and 2): CL/F of TAF [7]
    End point description
    CL/F is defined as the apparent clearance following oral administration of the drug. Participants in the IPK Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Any time at Week 2 or Week 4 visit, or within 7 days after the completion of Week 2 or Week 4 visits
    Notes
    [7] - 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 data for this endpoint is reported separately for Cohorts 1 and 2.
    End point values
    		 Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1) Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
    Number of subjects analysed
    9
    3
    Units: L/hr
        arithmetic mean (standard deviation)
    174.3 ( 156.75 )
    102.1 ( 60.75 )
    No statistical analyses for this end point

    Secondary: PK Parameter (Cohort 1): Vz/F of TAF

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    End point title
    		 PK Parameter (Cohort 1): Vz/F of TAF
    End point description
    Vz/F is defined as the apparent volume of distribution following oral administration of the drug. Participants in the IPK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Any time at Week 2 visit
    End point values
    		 Main Phase: F/TAF 200/10 mg+3rd ARV Agent (Cohort 1) Main Phase: F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
    Number of subjects analysed
    9
    9
    Units: liters
        arithmetic mean (standard deviation)
    87.3 ( 60.68 )
    95.3 ( 43.47 )
    No statistical analyses for this end point

    Secondary: PK Parameter (Cohort 2: Part A - Groups 1 and 2): Vz/F of TAF

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    End point title
    		 PK Parameter (Cohort 2: Part A - Groups 1 and 2): Vz/F of TAF [8]
    End point description
    Vz/F is defined as the apparent volume of distribution following oral administration of the drug. Participants in the IPK Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Any time at Week 2 or Week 4 visit, or within 7 days after the completion of Week 2 or Week 4 visits
    Notes
    [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 data for this endpoint is reported separately for Cohorts 1 and 2.
    End point values
    		 Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1) Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
    Number of subjects analysed
    9
    3
    Units: liters
        arithmetic mean (standard deviation)
    160.8 ( 145.57 )
    63.1 ( 63.39 )
    No statistical analyses for this end point

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

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    End point title
    		 PK Parameter (Cohort 1): AUCtau of FTC and TFV
    End point description
    AUCtau is defined as the area under the drug concentration versus time curve over the dosing interval. Participants in the IPK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Any time at Week 2 visit
    End point values
    		 Main Phase: F/TAF 200/10 mg+3rd ARV Agent (Cohort 1) Main Phase: F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
    Number of subjects analysed
    13
    11
    Units: h*ng/mL
    arithmetic mean (standard deviation)
        AUCtau of FTC
    14769.9 ( 4481.23 )
    14339.8 ( 6099.55 )
        AUCtau of TFV
    415.5 ( 105.92 )
    193.2 ( 46.73 )
    No statistical analyses for this end point

    Secondary: PK Parameter (Cohort 2: Part A - Groups 1 and 2): AUCtau of FTC and TFV

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    End point title
    		 PK Parameter (Cohort 2: Part A - Groups 1 and 2): AUCtau of FTC and TFV [9]
    End point description
    AUCtau is defined as the area under the drug concentration versus time curve over the dosing interval. Participants in the IPK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Any time at Week 2 or Week 4 visit, or within 7 days after the completion of Week 2 or Week 4 visits
    Notes
    [9] - 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 data for this endpoint is reported separately for Cohorts 1 and 2.
    End point values
    		 Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1) Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
    Number of subjects analysed
    9
    3
    Units: h*ng/mL
    arithmetic mean (standard deviation)
        AUCtau of FTC (N = 8, 3)
    12360.8 ( 2928.36 )
    11171.7 ( 2921.64 )
        AUCtau of TFV (N = 9, 3)
    999.4 ( 409.33 )
    908.2 ( 90.62 )
    No statistical analyses for this end point

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

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    End point title
    		 PK Parameter (Cohort 1): Ctau of FTC and TFV
    End point description
    Ctau is defined as the observed drug concentration at the end of the dosing interval. Participants in the IPK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Any time at Week 2 visit
    End point values
    		 Main Phase: F/TAF 200/10 mg+3rd ARV Agent (Cohort 1) Main Phase: F/TAF 200/25 mg+3rd ARV Agent (Cohort 1)
    Number of subjects analysed
    13
    11
    Units: ng/mL
    arithmetic mean (standard deviation)
        Ctau of FTC
    223.4 ( 482.59 )
    301.7 ( 624.77 )
        Ctau of TFV
    15.7 ( 4.11 )
    6.7 ( 3.00 )
    No statistical analyses for this end point

    Secondary: PK Parameter (Cohort 2: Part A - Groups 1 and 2): Ctau of FTC and TFV

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    End point title
    		 PK Parameter (Cohort 2: Part A - Groups 1 and 2): Ctau of FTC and TFV [10]
    End point description
    Ctau is defined as the observed drug concentration at the end of the dosing interval. Participants in the IPK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Any time at Week 2 or Week 4 visit, or within 7 days after the completion of Week 2 or Week 4 visits
    Notes
    [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 data for this endpoint is reported separately for Cohorts 1 and 2.
    End point values
    		 Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1) Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
    Number of subjects analysed
    9
    3
    Units: ng/mL
    arithmetic mean (standard deviation)
        Ctau of FTC (N = 8, 3)
    75.4 ( 22.71 )
    75.4 ( 27.63 )
        Ctau of TFV (N = 9, 3)
    34.8 ( 16.39 )
    30.9 ( 3.53 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants Experiencing TEAEs and SAEs Through Week 48

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    End point title
    		 Percentage of Participants Experiencing TEAEs and SAEs Through Week 48
    End point description
    An AE is any untoward medical occurrence in a clinical study participant which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The TEAEs were defined as any AEs with an onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug. Participants in the Safety Analysis Set were analyzed. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 48
    End point values
    		 Main Phase: F/TAF+3rd ARV Agent (Cohort 1) Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1) Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
    Number of subjects analysed
    28
    9
    3
    Units: percentage of participants
    number (not applicable)
        Any AEs
    89.3
    77.8
    66.7
        SAEs
    7.1
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined 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 one dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Main Phase: F/TAF+3rd ARV Agent (Cohort 1) Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1) Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
    Number of subjects analysed
    28
    9
    3
    Units: percentage of participants
        number (not applicable)
    92.9
    100.0
    66.7
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the US FDA-Defined Snapshot Algorithm
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defined 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 with available data were analyzed. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 Main Phase: F/TAF+3rd ARV Agent (Cohort 1) Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1) Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
    Number of subjects analysed
    28
    9
    3
    Units: percentage of participants
        number (not applicable)
    89.3
    77.8
    66.7
    No statistical analyses for this end point

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

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    End point title
    		 Change From Baseline in CD4+ Cell Count at Week 24
    End point description
    Participants in the Full Analysis Set with available data were analyzed. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 Main Phase: F/TAF+3rd ARV Agent (Cohort 1) Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1) Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
    Number of subjects analysed
    28
    8
    2
    Units: cells/µL
        arithmetic mean (standard deviation)
    -130 ( 272.6 )
    68 ( 352.5 )
    -299 ( 48.8 )
    No statistical analyses for this end point

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

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    End point title
    		 Change From Baseline in CD4+ Cell Count at Week 48
    End point description
    Participants in the Full Analysis Set with available data were analyzed. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48
    End point values
    		 Main Phase: F/TAF+3rd ARV Agent (Cohort 1) Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1) Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
    Number of subjects analysed
    28
    7
    2
    Units: cells/µL
        arithmetic mean (standard deviation)
    -105 ( 162.9 )
    210 ( 406.5 )
    -124 ( 37.5 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Percentage at Week 24

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    End point title
    		 Change From Baseline in CD4 Percentage at Week 24
    End point description
    Participants in the Full Analysis Set with available data were analyzed. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 Main Phase: F/TAF+3rd ARV Agent (Cohort 1) Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1) Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
    Number of subjects analysed
    28
    8
    2
    Units: percentage of lymphocytes
        arithmetic mean (standard deviation)
    -0.21 ( 3.840 )
    1.29 ( 2.395 )
    0.60 ( 5.798 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Percentage at Week 48

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    End point title
    		 Change From Baseline in CD4 Percentage at Week 48
    End point description
    Participants in the Full Analysis Set with available data were analyzed. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48
    End point values
    		 Main Phase: F/TAF+3rd ARV Agent (Cohort 1) Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1) Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
    Number of subjects analysed
    28
    7
    2
    Units: percentage of lymphocytes
        arithmetic mean (standard deviation)
    -0.20 ( 3.407 )
    0.70 ( 3.520 )
    3.65 ( 7.283 )
    No statistical analyses for this end point

    Secondary: Number of Participants With Palatability of F/TAF Formulation

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    End point title
    		 Number of Participants With Palatability of F/TAF Formulation
    End point description
    Palatability was reported based on the pleasant product taste as 'Yes' or 'No'. Data has been reported for Participant Response (PR) and Guardian Response (GR). Participants with missing data were reported as N/A. Participants in the Safety Analysis Set were analyzed. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population. Here, '999' signifies data not available since no participants were analyzed at the specified timepoint.
    End point type
    Secondary
    End point timeframe
    Week 2 (for Cohort 1), Week 2 and Week 4 (for Cohort 2)
    End point values
    		 Main Phase: F/TAF+3rd ARV Agent (Cohort 1) Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1) Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
    Number of subjects analysed
    28 [11]
    9
    3
    Units: Participants
        Week 2: PR: Was the Study Drug Palatable? Yes
    25
    9
    2
        Week 2: PR: Was the Study Drug Palatable? No
    0
    0
    0
        Week 2: PR: Was the Study Drug Palatable? N/A
    3
    0
    1
        Week 4: PR: Was the Study Drug Palatable? Yes
    999
    9
    3
        Week 4: PR: Was the Study Drug Palatable? No
    999
    0
    0
        Week 4: PR: Was the Study Drug Palatable? N/A
    999
    0
    0
        Week 2:GR:Study Drug Palatable to Participant? Yes
    11
    9
    1
        Week 2:GR:Study Drug Palatable to Participant? No
    0
    0
    0
        Week 2:GR:Study Drug Palatable to Participant? N/A
    17
    0
    2
        Week 4:GR:Study Drug Palatable to Participant? Yes
    999
    9
    1
        Week 4:GR:Study Drug Palatable to Participant? No
    999
    0
    0
        Week 4:GR:Study Drug Palatable to Participant? N/A
    999
    0
    2
        Week2:GR:Participant Complain Taste of Tablet? Yes
    0
    0
    0
        Week2:GR:Participant Complain Taste of Tablet? No
    12
    9
    1
        Week2:GR:Participant Complain Taste of Tablet? N/A
    16
    0
    2
        Week4:GR:Participant Complain Taste of Tablet? Yes
    999
    0
    0
        Week4:GR:Participant Complain Taste of Tablet? No
    999
    9
    1
        Week4:GR:Participant Complain Taste of Tablet? N/A
    999
    0
    2
    Notes
    [11] - 28, 0, 28, 0, 28, 0
    No statistical analyses for this end point

    Secondary: Number of Participants With Acceptability of F/TAF Formulation

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    End point title
    		 Number of Participants With Acceptability of F/TAF Formulation
    End point description
    Acceptability has been reported for categories medication size, shape and difficulty swallowing as 'Yes' or 'No' for Participant Response (PR) and Guardian Response (GR). Participants with missing data were reported as N/A. Participants in the Safety Analysis Set with available data were analyzed. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 4
    End point values
    		 Main Phase: F/TAF+3rd ARV Agent (Cohort 1) Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1) Main Phase: F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
    Number of subjects analysed
    25
    9
    3
    Units: Participants
        PR: Was the Study Medication Size Acceptable? Yes
    25
    9
    3
        PR: Was the Study Medication Size Acceptable? No
    0
    0
    0
        PR: Was the Study Medication Size Acceptable? N/A
    0
    0
    0
        PR: Was the Study Medication Shape Acceptable? Yes
    25
    9
    3
        PR: Was the Study Medication Shape Acceptable? No
    0
    0
    0
        PR: Was the Study Medication Shape Acceptable? NA
    0
    0
    0
        GR: Have Difficulty Swallowing Tablet? Yes
    0
    0
    0
        GR: Have Difficulty Swallowing Tablet? No
    21
    9
    2
        GR: Have Difficulty Swallowing Tablet? N/A
    4
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-cause mortality: Up to 439 weeks; Adverse events: Up to 410.4 weeks
    Adverse event reporting additional description
    All-cause mortality: All Enrolled Analysis Set; AEs: Safety Analysis Set. Cohort 1 data was analyzed together as both treatments were expected to have similar effect on efficacy and safety for target population. AEs are reported together for Main and Extension Phase as participants continued same medication from main to extension phase.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.1
    Reporting groups
    Reporting group title
    F/TAF+3rd ARV Agent (Cohort 1)
    Reporting group description
    		 Participants between 12 to <18 years of age and ≥35 kg body weight received emtricitabine/tenofovir alafenamide (F/TAF) 200/10 mg fixed-dose combination (FDC) tablet (with boosted 3rd antiretroviral [ARV] agent:lopinavir [LPV], atazanavir [ATV], darunavir [DRV]) or F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent:efavirenz [EFV], raltegravir [RAL], dolutegravir [DTG], or nevirapine [NVP]) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given an option to participate in extension phase of study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a)participant turned 18 and F/TAF was commercially available for use in adults in the country in which participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in applicable country. Participants received study drug up to a maximum of 438.9 weeks.

    Reporting group title
    F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2)
    Reporting group description
    		 Participants between 2 to < 12 years of age and 17 to < 25 kg body weight received to F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 103.1 weeks.

    Reporting group title
    F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1)
    Reporting group description
    		 Participants between 6 to < 12 years of age and ≥ 25 kg body weight received F/TAF 200/25 mg FDC tablet orally once daily while continuing on their boosted protease inhibitor (PI) for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted PIs: ATV, LPV or DRV). The participants received the study drug up to a maximum of 315.0 weeks.

    Serious adverse events
    		 F/TAF+3rd ARV Agent (Cohort 1) F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2) F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 28 (14.29%)
    0 / 3 (0.00%)
    1 / 9 (11.11%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Forearm fracture
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 3 (0.00%)
    0 / 9 (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
    Stab wound
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 3 (0.00%)
    0 / 9 (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
    Joint dislocation
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 3 (0.00%)
    0 / 9 (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
    Syncope
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 3 (0.00%)
    0 / 9 (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
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 3 (0.00%)
    0 / 9 (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
    Appendicitis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 3 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Electrolyte imbalance
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 3 (0.00%)
    0 / 9 (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
    		 F/TAF+3rd ARV Agent (Cohort 1) F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2) F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    27 / 28 (96.43%)
    2 / 3 (66.67%)
    8 / 9 (88.89%)
    Surgical and medical procedures
    Circumcision
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    3
    0
    0
    Reproductive system and breast disorders
    Balanoposthitis
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 3 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    1
    0
    1
    Dysmenorrhoea
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    0
    Vaginal discharge
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Respiratory symptom
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    0
    Asthmatic crisis
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    4
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    3 / 28 (10.71%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    3
    0
    0
    Nasal congestion
         subjects affected / exposed
    3 / 28 (10.71%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    3
    0
    0
    Cough
         subjects affected / exposed
    3 / 28 (10.71%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    3
    0
    0
    Rhinitis allergic
         subjects affected / exposed
    4 / 28 (14.29%)
    0 / 3 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    5
    0
    2
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    3 / 28 (10.71%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    3
    0
    0
    Depression
         subjects affected / exposed
    5 / 28 (17.86%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    6
    0
    0
    Adjustment disorder
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    0
    Investigations
    Weight decreased
         subjects affected / exposed
    5 / 28 (17.86%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    6
    0
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 3 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    1
    0
    1
    Vitamin D decreased
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 3 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    3 / 28 (10.71%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    4
    0
    0
    Animal bite
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    0
    Muscle strain
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 3 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    1
    0
    1
    Procedural pain
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    0
    Heat stroke
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 3 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Skin laceration
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 3 (33.33%)
    0 / 9 (0.00%)
         occurrences all number
    1
    2
    0
    Seroma
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 3 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Cardiac disorders
    Sinus bradycardia
         subjects affected / exposed
    4 / 28 (14.29%)
    0 / 3 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    4
    0
    2
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 3 (33.33%)
    0 / 9 (0.00%)
         occurrences all number
    1
    2
    0
    Headache
         subjects affected / exposed
    13 / 28 (46.43%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    16
    0
    0
    Dizziness
         subjects affected / exposed
    6 / 28 (21.43%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    7
    0
    0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 3 (33.33%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 3 (33.33%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    Eye disorders
    Eczema eyelids
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 3 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Vernal keratoconjunctivitis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 3 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Haemorrhoids
         subjects affected / exposed
    3 / 28 (10.71%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    4
    0
    0
    Abdominal pain
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    3
    0
    0
    Dyspepsia
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 3 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    2
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 3 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    Abdominal pain upper
         subjects affected / exposed
    3 / 28 (10.71%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    3
    0
    0
    Nausea
         subjects affected / exposed
    6 / 28 (21.43%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    8
    0
    0
    Diarrhoea
         subjects affected / exposed
    6 / 28 (21.43%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    7
    0
    0
    Dental caries
         subjects affected / exposed
    4 / 28 (14.29%)
    0 / 3 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    4
    0
    2
    Vomiting
         subjects affected / exposed
    7 / 28 (25.00%)
    0 / 3 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    10
    0
    1
    Skin and subcutaneous tissue disorders
    Rash papular
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    0
    Dermatitis contact
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    0
    Dermatitis allergic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 3 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    0
    0
    2
    Dermatitis
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 3 (33.33%)
    0 / 9 (0.00%)
         occurrences all number
    1
    1
    0
    Acne
         subjects affected / exposed
    8 / 28 (28.57%)
    0 / 3 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    8
    0
    1
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    0
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 3 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    2
    0
    1
    Arthralgia
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    4
    0
    0
    Back pain
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    0
    Infections and infestations
    Pharyngitis
         subjects affected / exposed
    5 / 28 (17.86%)
    1 / 3 (33.33%)
    1 / 9 (11.11%)
         occurrences all number
    5
    3
    1
    Influenza
         subjects affected / exposed
    8 / 28 (28.57%)
    0 / 3 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    13
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    13 / 28 (46.43%)
    0 / 3 (0.00%)
    5 / 9 (55.56%)
         occurrences all number
    23
    0
    18
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 28 (25.00%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    12
    0
    0
    Gastroenteritis
         subjects affected / exposed
    4 / 28 (14.29%)
    0 / 3 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    5
    0
    2
    Body tinea
         subjects affected / exposed
    4 / 28 (14.29%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    4
    0
    0
    Covid-19
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 3 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    2
    0
    2
    Hordeolum
         subjects affected / exposed
    3 / 28 (10.71%)
    0 / 3 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    3
    0
    1
    Folliculitis
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    0
    Conjunctivitis
         subjects affected / exposed
    3 / 28 (10.71%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    3
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    3 / 28 (10.71%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    8
    0
    0
    Bacterial vaginosis
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    3
    0
    0
    Acarodermatitis
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    0
    Tooth abscess
         subjects affected / exposed
    3 / 28 (10.71%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    5
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 28 (7.14%)
    2 / 3 (66.67%)
    0 / 9 (0.00%)
         occurrences all number
    6
    3
    0
    Gastroenteritis viral
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    0
    Otitis externa
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 3 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    1
    0
    1
    Otitis media acute
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    0
    Pharyngotonsillitis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 3 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    0
    0
    2
    Pneumonia
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    3
    0
    0
    Sinusitis
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    0
    Tonsillitis
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    3
    0
    0
    Urinary tract infection
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    3
    0
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    3
    0
    0
    Helminthic infection
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 3 (33.33%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Vitamin D deficiency
         subjects affected / exposed
    7 / 28 (25.00%)
    0 / 3 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    9
    0
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Nov 2014
    - Study design has been updated from “tenofovir disoproxil fumarate (TDF)-containing regimen” to “2-NRTI-containing regimen” as stable TDF use prior to study entry is no longer a requirement. - There is no longer a requirement to stratify participants by 3rd ARV agents. - Participants are now allowed to use ATV/r and DVR/r as 3rd ARV. - Information regarding recommended F/TAF and FTC/TDF doses for Cohort 2 has been included. - Timing of assessments specific to Cohort 2 is included.
    02 Aug 2017
    - F/TAF was approved in the US and EU for use in adolescents based on Genvoya data, which provides support for opening Cohorts 2 enrollment and adding Cohorts 3 and 4. Dose, statistical methods and study procedures have been amended as appropriate. - FTC/TDF reference therapy has been removed from Cohort 2 since F/TAF has been approved for use in adolescents. Participants will no longer be randomized 2:1 ratio into F/TAF and FTC/TDF. Instead, all participants enrolled into Cohorts 2, 3 and 4 will receive F/TAF. - Treatment Assessment period has been changed from 96 weeks to 48 weeks since FTC/TDF reference therapy has been removed from Cohort 2. Study procedures have been updated to reflect the change. Gilead was interested in long-term (96-week) evaluation of TDF on bone and renal parameters during the initial design of this study due to associations between TDF and early-onset bone demineralization in adults and nephrotoxicity, and because the renal and bone safety of TAF had not yet been established. However, since the initiation of Study GS-US-311-1269, recent studies have demonstrated that renal and bone effects were significantly reduced in participants receiving TAF- versus TDF-containing regimens. As such, randomization to TDF is not deemed pertinent to the clinical development of pediatric DVY and has been removed as the reference therapy from Study GS-US-311-1269. The elimination of the TDF reference therapy arm in the study thus allows for a shortened treatment duration of 48 weeks.

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

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