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    Clinical Trial Results:
    A Phase 2, Open-Label, Multicenter, Multi-cohort Study to Investigate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/- Ribavirin in Adolescents and Children with Chronic HCV-Infection

    Summary
    EudraCT number
    		 2014-003578-17
    Trial protocol
    		 Outside EU/EEA   GB  
    Global end of trial date
    24 Aug 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Mar 2019
    First version publication date
    03 Mar 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-337-1116
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02249182
    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-001411-PIP01-12
    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
    24 Aug 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Jun 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the PK Lead-in Phase of the study is to evaluate the steady state pharmacokinetics (PK) and confirm the dose of ledipasvir/sofobuvir (LDV/SOF) fixed dose combination (FDC) in hepatitis C virus (HCV)-infected pediatric participants. The PK Lead-in Phase will also evaluate the safety, tolerability, and antiviral activity of 10 days of dosing of LDV/SOF FDC in HCV-infected pediatric participants. The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate LDV/SOF FDC dosage levels. Participants from the PK Lead-in Phase will immediately rollover into the Treatment Phase with no interruption of study drug administration. The primary objective of the Treatment Phase is to evaluate the antiviral efficacy, safety, and tolerability of LDV/SOF FDC +/- ribavirin (RBV) for 12 or 24 weeks in pediatric participants with HCV.
    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
    05 Nov 2014
    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
    United Kingdom: 15
    Country: Number of subjects enrolled
    New Zealand: 4
    Country: Number of subjects enrolled
    Australia: 17
    Country: Number of subjects enrolled
    United States: 190
    Worldwide total number of subjects
    226
    EEA total number of subjects
    15
    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)
    126
    Adolescents (12-17 years)
    100
    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
    		 Participants were enrolled at study sites in the United States, United Kingdom, Australia, and New Zealand. The first participant was screened on 05 November 2014. The last study visit occurred on 24 August 2018.

    Pre-assignment
    Screening details
    		 240 participants were screened.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 12 to < 18 Years Old - LDV/SOF 12 Weeks
    Arm description
    		 Participants 12 to < 18 years of age with HCV genotype 1 treatment-naive (TN) with or without cirrhosis or treatment-experienced (TE) without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ledipasvir/sofosbuvir
    Investigational medicinal product code
    Other name
    LDV/SOF, Harvoni®, GS-5885/GS-7977
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily

    Arm title
    		 6 to < 12 Years Old - LDV/SOF 12 Weeks
    Arm description
    		 Participants 6 to < 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ledipasvir/sofosbuvir
    Investigational medicinal product code
    Other name
    LDV/SOF, Harvoni®, GS-5885/GS-7977
    Pharmaceutical forms
    Tablet, Granules
    Routes of administration
    Oral use
    Dosage and administration details
    45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily

    Arm title
    		 6 to < 12 Years Old - LDV/SOF 24 Weeks
    Arm description
    		 Participants 6 to < 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ledipasvir/sofosbuvir
    Investigational medicinal product code
    Other name
    LDV/SOF, Harvoni®, GS-5885/GS-7977
    Pharmaceutical forms
    Granules, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily

    Arm title
    		 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks
    Arm description
    		 Participants 6 to < 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks. Note: Participants with cirrhosis could have enrolled in this age group, but none were actually enrolled. Only participants in the United Kingdom were enrolled in this group.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ledipasvir/sofosbuvir
    Investigational medicinal product code
    Other name
    LDV/SOF, Harvoni®, GS-5885/GS-7977
    Pharmaceutical forms
    Granules, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    RBV, REBETOL®
    Pharmaceutical forms
    Oral solution, Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Administered orally in a divided daily dose based on weight

    Arm title
    		 3 to < 6 Years Old - LDV/SOF 12 Weeks
    Arm description
    		 Participants 3 to < 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight < 17 kg: 33.75/150 mg granules) once daily for 12 weeks. Note: Participants with cirrhosis could have enrolled in this age group, but none were actually enrolled.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ledipasvir/sofosbuvir
    Investigational medicinal product code
    Other name
    LDV/SOF, Harvoni®, GS-5885/GS-7977
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    LDV/SOF (weight ≥ 17 kg: 45/200 mg granules; weight < 17 kg: 33.75/150 mg granules) once daily

    Number of subjects in period 1
    		12 to < 18 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF 24 Weeks 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks 3 to < 6 Years Old - LDV/SOF 12 Weeks
    Started
    100
    89
    1
    2
    34
    Completed
    96
    89
    1
    2
    34
    Not completed
    4
    0
    0
    0
    0
         Lost to follow-up
    4
    -
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    12 to < 18 Years Old - LDV/SOF 12 Weeks
    Reporting group description
    		 Participants 12 to < 18 years of age with HCV genotype 1 treatment-naive (TN) with or without cirrhosis or treatment-experienced (TE) without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.

    Reporting group title
    6 to < 12 Years Old - LDV/SOF 12 Weeks
    Reporting group description
    		 Participants 6 to < 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.

    Reporting group title
    6 to < 12 Years Old - LDV/SOF 24 Weeks
    Reporting group description
    		 Participants 6 to < 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks.

    Reporting group title
    6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks
    Reporting group description
    		 Participants 6 to < 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks. Note: Participants with cirrhosis could have enrolled in this age group, but none were actually enrolled. Only participants in the United Kingdom were enrolled in this group.

    Reporting group title
    3 to < 6 Years Old - LDV/SOF 12 Weeks
    Reporting group description
    		 Participants 3 to < 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight < 17 kg: 33.75/150 mg granules) once daily for 12 weeks. Note: Participants with cirrhosis could have enrolled in this age group, but none were actually enrolled.

    Reporting group values
    		 12 to < 18 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF 24 Weeks 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks 3 to < 6 Years Old - LDV/SOF 12 Weeks Total
    Number of subjects
    		 100 89 1 2 34 226
    Age categorical
    Units: Subjects
    Age continuous
    999 = NA; Standard deviation of a single sample is undefined.
    Units: years
        arithmetic mean (standard deviation)
    		 15 ± 1.7 9 ± 1.6 11 ± 999 9 ± 2.8 4 ± 0.7 -
    Gender categorical
    Units: Subjects
        Female
    		 63 36 1 1 24 125
        Male
    		 37 53 0 1 10 101
    Race
    Units: Subjects
        White
    		 91 70 1 2 27 191
        Black or African American
    		 7 7 0 0 1 15
        Other
    		 0 5 0 0 4 9
        Asian
    		 2 5 0 0 2 9
        Native Hawaiian or Pacific Islander
    		 0 2 0 0 0 2
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 13 9 0 0 6 28
        Not Hispanic or Latino
    		 85 75 1 2 28 191
        Not Disclosed
    		 2 5 0 0 0 7
    HCV Genotype
    Units: Subjects
        Genotype 1
    		 100 87 1 0 33 221
        Genotype 3
    		 0 0 0 2 0 2
        Genotype 4
    		 0 2 0 0 1 3
    Cirrhosis Status
    Units: Subjects
        Yes
    		 1 1 1 0 0 3
        No
    		 43 33 0 2 14 92
        Unknown
    		 56 55 0 0 20 131
    IL28b Status
    The CC, CT, and TT alleles are different forms of the IL28b gene.
    Units: Subjects
        CC
    		 24 23 0 0 10 57
        CT
    		 53 53 0 2 16 124
        TT
    		 23 12 1 0 6 42
        Missing
    		 0 1 0 0 2 3
    HCV RNA Category
    Units: Subjects
        < 800,000 IU/mL
    		 45 37 0 1 15 98
        ≥ 800,000 IU/mL
    		 55 52 1 1 19 128
    Prior Treatment Experience
    Units: Subjects
        Treatment-Naive
    		 80 72 0 0 34 186
        Treatment-Experienced
    		 20 17 1 2 0 40

    End points

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    End points reporting groups
    Reporting group title
    12 to < 18 Years Old - LDV/SOF 12 Weeks
    Reporting group description
    		 Participants 12 to < 18 years of age with HCV genotype 1 treatment-naive (TN) with or without cirrhosis or treatment-experienced (TE) without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.

    Reporting group title
    6 to < 12 Years Old - LDV/SOF 12 Weeks
    Reporting group description
    		 Participants 6 to < 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.

    Reporting group title
    6 to < 12 Years Old - LDV/SOF 24 Weeks
    Reporting group description
    		 Participants 6 to < 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks.

    Reporting group title
    6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks
    Reporting group description
    		 Participants 6 to < 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks. Note: Participants with cirrhosis could have enrolled in this age group, but none were actually enrolled. Only participants in the United Kingdom were enrolled in this group.

    Reporting group title
    3 to < 6 Years Old - LDV/SOF 12 Weeks
    Reporting group description
    		 Participants 3 to < 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight < 17 kg: 33.75/150 mg granules) once daily for 12 weeks. Note: Participants with cirrhosis could have enrolled in this age group, but none were actually enrolled.

    Subject analysis set title
    12 to < 18 Years Old - LDV/SOF 12 Weeks (PK Lead-in)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants 12 to < 18 years of age received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks. Intensive PK Analysis Set included all participants in the PK lead-in phase who received at least 1 dose of study drug and for whom at least 1 nonmissing PK concentration value, during the intensive sampling period, was reported by the PK laboratory.

    Subject analysis set title
    6 to < 12 Years Old - LDV/SOF 12 Weeks (PK Lead-in)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants 6 to < 12 years of age received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks. Intensive PK Analysis Set included all participants in the PK lead-in phase who received at least 1 dose of study drug and for whom at least 1 nonmissing PK concentration value, during the intensive sampling period, was reported by the PK laboratory.

    Subject analysis set title
    3 to < 6 Years Old - LDV/SOF 12 Weeks (PK Lead-in)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants 3 to < 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight < 17 kg: 33.75/150 mg granules) once daily for 12 weeks. Intensive PK Analysis Set included all participants in the PK lead-in phase who received at least 1 dose of study drug and for whom at least 1 nonmissing PK concentration value, during the intensive sampling period, was reported by the PK laboratory.

    Subject analysis set title
    Males 12 to < 18 Years Old - LDV/SOF 12 Weeks
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Male participants 12 to < 18 years of age received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.

    Subject analysis set title
    Males 6 to < 12 Years Old - LDV/SOF± RBV 12 or 24 Weeks
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Male participants 6 to < 12 years of age received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily ± RBV capsules or oral solution (dose depending on weight) for 12 or 24 weeks.

    Subject analysis set title
    Males 3 to < 6 Years Old - LDV/SOF 12 Weeks
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Male participants 3 to < 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight < 17 kg: 33.75/150 mg granules) once daily for 12 weeks.

    Subject analysis set title
    Females 12 to < 18 Years Old - LDV/SOF 12 Weeks
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Female participants 12 to < 18 years of age received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.

    Subject analysis set title
    Females 6 to < 12 Years Old - LDV/SOF± RBV 12 or 24 Weeks
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Female participants 6 to < 12 years of age received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily ± RBV capsules or oral solution (dose depending on weight) for 12 or 24 weeks.

    Subject analysis set title
    Females 3 to < 6 Years Old - LDV/SOF 12 Weeks
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Female participants 3 to < 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight < 17 kg: 33.75/150 mg granules) once daily for 12 weeks.

    Subject analysis set title
    12 to < 18 Years Old - LDV/SOF 12 Weeks
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants 12 to < 18 years of age received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.

    Subject analysis set title
    6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants 6 to < 12 years of age received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily ± RBV capsules or oral solution (dose depending on weight) for 12 or 24 weeks.

    Subject analysis set title
    3 to < 6 Years Old - LDV/SOF 12 Weeks
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants 3 to < 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight < 17 kg: 33.75/150 mg granules) once daily for 12 weeks.

    Primary: For Participants in the PK Lead-in Phase, PK Parameter: AUCtau of GS-331007, LDV, and SOF

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    End point title
    		 For Participants in the PK Lead-in Phase, PK Parameter: AUCtau of GS-331007, LDV, and SOF [1]
    End point description
    AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). Intensive PK Analysis Set included all participants in the PK lead-in phase who received at least 1 dose of study drug and for whom at least 1 nonmissing PK concentration value, during the intensive sampling period, was reported by the PK laboratory.
    End point type
    Primary
    End point timeframe
    Cohorts 1 and 2 (6 to < 18 years of age): predose, 0.5, 1, 2, 3, 4, 5, 8, and 12 hours postdose on Day 10; Cohort 3 (3 to < 6 years of age): predose, 0.5, 2, 4, 8, and 12 hours postdose on Day 10
    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: The statistical analysis of this primary endpoint is provided in the attachment. AUCtau of GS-331007, LDV, and SOF for each age group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies. Equivalence was determined if the 90% confidence intervals (CI) were within the predefined equivalence boundaries of 50% to 200% for all age groups.
    End point values
    		 12 to < 18 Years Old - LDV/SOF 12 Weeks (PK Lead-in) 6 to < 12 Years Old - LDV/SOF 12 Weeks (PK Lead-in) 3 to < 6 Years Old - LDV/SOF 12 Weeks (PK Lead-in)
    Number of subjects analysed
    10
    10
    13
    Units: h*ng/mL
    arithmetic mean (standard deviation)
        GS-331007 (N = 10, 10, 13)
    12682.5 ± 1732.66
    8210.3 ± 2542.42
    11688.9 ± 3400.79
        LDV (N = 10, 10, 13)
    10202.4 ± 5196.49
    7288.3 ± 4547.33
    9316.3 ± 3280.51
        SOF (N = 10, 9, 3)
    2175.7 ± 578.92
    1754.4 ± 419.18
    2495.2 ± 412.64
    Attachments
    		 Statistical Analysis
    No statistical analyses for this end point

    Primary: Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event during the PK Lead-in Phase or the Treatment Phase

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    End point title
    		 Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event during the PK Lead-in Phase or the Treatment Phase [2]
    End point description
    Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Up to 24 weeks
    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: No statistical comparison was planned or performed.
    End point values
    		 12 to < 18 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF 24 Weeks 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks 3 to < 6 Years Old - LDV/SOF 12 Weeks
    Number of subjects analysed
    100
    89
    1
    2
    34
    Units: percentage of participants
        number (not applicable)
    0
    0
    0
    0
    2.9
    No statistical analyses for this end point

    Secondary: For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA

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    End point title
    		 For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA
    End point description
    Participants who were enrolled in the PK lead-in phase with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 1, 2, 4, 8, and 12
    End point values
    		 12 to < 18 Years Old - LDV/SOF 12 Weeks (PK Lead-in) 6 to < 12 Years Old - LDV/SOF 12 Weeks (PK Lead-in) 3 to < 6 Years Old - LDV/SOF 12 Weeks (PK Lead-in)
    Number of subjects analysed
    10
    12
    17
    Units: log10 IU/mL
    arithmetic mean (standard deviation)
        Change at Week 1 (N = 10, 12, 17)
    -4.34 ± 0.621
    -4.29 ± 0.518
    -4.32 ± 0.616
        Change at Week 2 (N = 10, 12, 15)
    -4.71 ± 0.651
    -4.55 ± 0.636
    -4.87 ± 0.724
        Change at Week 4 (N = 10, 12, 16)
    -4.73 ± 0.667
    -4.75 ± 0.702
    -4.92 ± 0.715
        Change at Week 8 (N = 10, 12, 16)
    -4.73 ± 0.667
    -4.76 ± 0.710
    -4.92 ± 0.715
        Change at Week 12 (N = 10, 12, 16)
    -4.73 ± 0.667
    -4.76 ± 0.710
    -4.92 ± 0.715
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event during the PK Lead-in Phase

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    End point title
    		 Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event during the PK Lead-in Phase
    End point description
    Participants who were enrolled in the PK lead-in phase were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to Day 10
    End point values
    		 12 to < 18 Years Old - LDV/SOF 12 Weeks (PK Lead-in) 6 to < 12 Years Old - LDV/SOF 12 Weeks (PK Lead-in) 3 to < 6 Years Old - LDV/SOF 12 Weeks (PK Lead-in)
    Number of subjects analysed
    10
    12
    17
    Units: percentage of participants
        number (not applicable)
    0
    0
    5.9
    No statistical analyses for this end point

    Secondary: For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4)

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    End point title
    		 For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4)
    End point description
    SVR4 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 4 weeks after stopping study treatment. Full Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Posttreatment Week 4
    End point values
    		 12 to < 18 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF 24 Weeks 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks 3 to < 6 Years Old - LDV/SOF 12 Weeks
    Number of subjects analysed
    100
    89
    1
    2
    34
    Units: percentage of participants
        number (confidence interval 95%)
    98.0 (93.0 to 99.8)
    98.9 (93.9 to 100.0)
    100.0 (2.5 to 100.0)
    100.0 (15.8 to 100.0)
    97.1 (84.7 to 99.9)
    No statistical analyses for this end point

    Secondary: For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12)

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    End point title
    		 For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12)
    End point description
    SVR12 was defined as HCV RNA < LLOQ at 12 weeks after stopping study treatment. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Posttreatment Week 12
    End point values
    		 12 to < 18 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF 24 Weeks 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks 3 to < 6 Years Old - LDV/SOF 12 Weeks
    Number of subjects analysed
    100
    89
    1
    2
    34
    Units: percentage of participants
        number (confidence interval 95%)
    98.0 (93.0 to 99.8)
    98.9 (93.9 to 100.0)
    100.0 (2.5 to 100.0)
    100.0 (15.8 to 100.0)
    97.1 (84.7 to 99.9)
    No statistical analyses for this end point

    Secondary: For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)

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    End point title
    		 For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
    End point description
    SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Posttreatment Week 24
    End point values
    		 12 to < 18 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF 24 Weeks 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks 3 to < 6 Years Old - LDV/SOF 12 Weeks
    Number of subjects analysed
    100
    89
    1
    2
    34
    Units: percentage of participants
        number (confidence interval 95%)
    98.0 (93.0 to 99.8)
    98.9 (93.9 to 100.0)
    100.0 (2.5 to 100.0)
    100.0 (15.8 to 100.0)
    97.1 (84.7 to 99.9)
    No statistical analyses for this end point

    Secondary: For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough

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    End point title
    		 For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough
    End point description
    Viral breakthrough was defined as having confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 24 weeks
    End point values
    		 12 to < 18 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF 24 Weeks 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks 3 to < 6 Years Old - LDV/SOF 12 Weeks
    Number of subjects analysed
    100
    89
    1
    2
    34
    Units: percentage of participants
        number (not applicable)
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse

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    End point title
    		 For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse
    End point description
    Viral relapse was defined as having confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to Posttreatment Week 24
    End point values
    		 12 to < 18 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF 24 Weeks 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks 3 to < 6 Years Old - LDV/SOF 12 Weeks
    Number of subjects analysed
    100
    89
    1
    2
    34
    Units: percentage of participants
        number (not applicable)
    0
    1.1
    0
    0
    0
    No statistical analyses for this end point

    Secondary: For the Treatment Phase, Change From Baseline in HCV RNA

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    End point title
    		 For the Treatment Phase, Change From Baseline in HCV RNA
    End point description
    Participants in the Full Analysis Set with available data were analyzed. 999 = Not Applicable; Participants from the 12 Weeks groups were not analyzed for Change at Weeks 16, 20, and 24 because they were only treated for 12 weeks. 9999 = NA; Standard deviation of a single sample is undefined.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)
    End point values
    		 12 to < 18 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF 24 Weeks 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks 3 to < 6 Years Old - LDV/SOF 12 Weeks
    Number of subjects analysed
    100
    89
    1
    2
    34
    Units: log10 IU/mL
    arithmetic mean (standard deviation)
        Change at Week 1 (N = 98, 85, 1, 2, 34)
    -4.34 ± 0.634
    -4.27 ± 0.592
    -4.30 ± 9999
    -4.54 ± 0.308
    -4.25 ± 0.505
        Change at Week 2 (N = 99, 88, 1, 2, 32)
    -4.74 ± 0.585
    -4.73 ± 0.544
    -5.09 ± 9999
    -4.54 ± 0.308
    -4.80 ± 0.628
        Change at Week 4 (N = 100, 89, 1, 2, 33)
    -4.84 ± 0.557
    -4.87 ± 0.592
    -5.09 ± 9999
    -4.54 ± 0.308
    -4.80 ± 0.628
        Change at Week 8 (N = 99, 89, 1, 2, 33)
    -4.85 ± 0.556
    -4.89 ± 0.597
    -5.09 ± 9999
    -4.54 ± 0.308
    -4.86 ± 0.633
        Change at Week 12 (N = 99, 89, 1, 2, 33)
    -4.85 ± 0.556
    -4.89 ± 0.597
    -5.09 ± 9999
    -4.54 ± 0.308
    -4.86 ± 0.633
        Change at Week 16 (N = NA, NA, 1, 2, NA)
    999 ± 999
    999 ± 999
    -5.09 ± 9999
    -4.54 ± 0.308
    999 ± 999
        Change at Week 20 (N = NA, NA, 1, 2, NA)
    999 ± 999
    999 ± 999
    -5.09 ± 9999
    -4.54 ± 0.308
    999 ± 999
        Change at Week 24 (N = NA, NA, 1, 2, NA)
    999 ± 999
    999 ± 999
    -5.09 ± 9999
    -4.54 ± 0.308
    999 ± 999
    No statistical analyses for this end point

    Secondary: For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment

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    End point title
    		 For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment
    End point description
    Participants in the Full Analysis Set with available data were analyzed. 999, 9999, 99999 = Not Applicable; Participants from the 12 Weeks groups were not analyzed for Weeks 16, 20, and 24 because they were only treated for 12 weeks.
    End point type
    Secondary
    End point timeframe
    Weeks, 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)
    End point values
    		 12 to < 18 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF 24 Weeks 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks 3 to < 6 Years Old - LDV/SOF 12 Weeks
    Number of subjects analysed
    100
    89
    1
    2
    34
    Units: percentage of participants
    number (confidence interval 95%)
        Week 1 (N = 100, 89, 1, 2, 34)
    40.0 (30.3 to 50.3)
    30.3 (21.0 to 41.0)
    0 (0.0 to 97.5)
    100.0 (15.8 to 100.0)
    29.4 (15.1 to 47.5)
        Week 2 (N = 100, 89, 1, 2, 33)
    75.0 (65.3 to 83.1)
    71.9 (61.4 to 80.9)
    100.0 (2.5 to 100.0)
    100.0 (15.8 to 100.0)
    78.8 (61.1 to 91.0)
        Week 4 (N = 100, 89, 1, 2, 33)
    97.0 (91.5 to 99.4)
    96.6 (90.5 to 99.3)
    100.0 (2.5 to 100.0)
    100.0 (15.8 to 100.0)
    97.0 (84.2 to 99.9)
        Week 8 (N = 99, 89, 1, 2, 33)
    100.0 (96.3 to 100.0)
    100.0 (95.9 to 100.0)
    100.0 (2.5 to 100.0)
    100.0 (15.8 to 100.0)
    100.0 (89.4 to 100.0)
        Week 12 (N = 99, 89, 1, 2, 33)
    100.0 (96.3 to 100.0)
    100.0 (95.9 to 100.0)
    100.0 (2.5 to 100.0)
    100.0 (15.8 to 100.0)
    100.0 (89.4 to 100.0)
        Week 16 (N = NA, NA, 1, 2, NA)
    9999 (999 to 99999)
    9999 (999 to 99999)
    100.0 (2.5 to 100.0)
    100.0 (15.8 to 100.0)
    9999 (999 to 99999)
        Week 20 (N = NA, NA, 1, 2, NA)
    9999 (999 to 99999)
    9999 (999 to 99999)
    100.0 (2.5 to 100.0)
    100.0 (15.8 to 100.0)
    9999 (999 to 99999)
        Week 24 (N = NA, NA, 1, 2, NA)
    9999 (999 to 99999)
    9999 (999 to 99999)
    100.0 (2.5 to 100.0)
    100.0 (15.8 to 100.0)
    9999 (999 to 99999)
    No statistical analyses for this end point

    Secondary: For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization

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    End point title
    		 For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
    End point description
    ALT normalization was defined as ALT > the upper limit of normal (ULN) at baseline and ALT ≤ ULN at each visit. 999 = Not Applicable; Participants in the Full Analysis Set with ALT > ULN at Baseline with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Weeks 16, 20, and 24 because they were only treated for 12 weeks.
    End point type
    Secondary
    End point timeframe
    Weeks, 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Week 4
    End point values
    		 12 to < 18 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF 24 Weeks 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks 3 to < 6 Years Old - LDV/SOF 12 Weeks
    Number of subjects analysed
    49
    72
    1
    2
    27
    Units: percentage of participants
    number (not applicable)
        Week 1 (N = 47, 70, 1, 2, 27)
    72.3
    75.7
    0
    50.0
    63.0
        Week 2 (N = 49, 66, 1, 2, 25)
    89.8
    84.8
    0
    50.0
    84.0
        Week 4 (N = 48, 72, 1, 2, 25)
    93.8
    93.1
    0
    100.0
    96.0
        Week 8 (N = 46, 71, 1, 2, 25)
    91.3
    90.1
    0
    100.0
    92.0
        Week 12 (N = 45, 67, 1, 2, 24)
    93.3
    95.5
    100.0
    100.0
    91.7
        Week 16 (N = NA, NA, 1, 2, NA)
    999
    999
    100.0
    100.0
    999
        Week 20 (N = NA, NA, 1, 2, NA)
    999
    999
    100.0
    100.0
    999
        Week 24 (N = NA, NA, 1, 2, NA)
    999
    999
    100.0
    100.0
    999
        Posttreatment Week 4 (N = 41, 62, 0, 2, 23)
    90.2
    98.4
    999
    100.0
    91.3
    No statistical analyses for this end point

    Secondary: For the Treatment Phase, Change From Baseline in Height

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    End point title
    		 For the Treatment Phase, Change From Baseline in Height
    End point description
    Participants in the Safety Analysis Set with available data were analyzed. 999 = Not Applicable; Participants from the 12 Weeks groups were not analyzed for Change at Weeks 16, 20, and 24 because they were only treated for 12 weeks. 9999 = NA; Standard deviation of a single sample is undefined.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks, 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24
    End point values
    		 12 to < 18 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF 24 Weeks 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks 3 to < 6 Years Old - LDV/SOF 12 Weeks
    Number of subjects analysed
    100
    89
    1
    2
    34
    Units: centimeters
    arithmetic mean (standard deviation)
        Change at Week 1 (N = 97, 85, 1, 2, 34)
    0.1 ± 0.68
    0.1 ± 0.83
    0.3 ± 9999
    0.7 ± 1.13
    0.2 ± 1.24
        Change at Week 2 (N = 97, 86, 1, 2, 32)
    0.0 ± 0.70
    0.3 ± 0.73
    0.5 ± 9999
    0.5 ± 0.85
    0.3 ± 0.72
        Change at Week 4 (N = 98, 87, 1, 2, 33)
    0.1 ± 0.84
    0.5 ± 0.79
    1.2 ± 9999
    0.6 ± 0.92
    0.7 ± 0.79
        Change at Week 8 (N = 98, 88, 1, 2, 33)
    0.4 ± 1.04
    0.8 ± 0.79
    1.3 ± 9999
    0.8 ± 0.92
    1.0 ± 0.82
        Change at Week 12 (N = 92, 84, 1, 2, 31)
    0.5 ± 1.10
    1.3 ± 0.83
    2.1 ± 9999
    1.1 ± 1.41
    1.6 ± 0.98
        Change at Week 16 (N = NA, NA, 1, 2, NA)
    999 ± 999
    999 ± 999
    3.2 ± 9999
    1.4 ± 1.06
    999 ± 999
        Change at Week 20 (N = NA, NA, 1, 2, NA)
    999 ± 999
    999 ± 999
    4.3 ± 9999
    1.6 ± 0.85
    999 ± 999
        Change at Week 24 (N = NA, NA, 1, 2, NA)
    999 ± 999
    999 ± 999
    4.3 ± 9999
    2.5 ± 1.48
    999 ± 999
        Change at PT Wk 4 (N = 97, 89, 1, 2, 34)
    0.8 ± 1.46
    1.8 ± 1.04
    4.3 ± 9999
    2.4 ± 1.27
    2.1 ± 1.13
        Change at PT Wk 12 (N = 96, 87, 1, 2, 34)
    1.2 ± 1.82
    2.7 ± 0.97
    5.0 ± 9999
    3.4 ± 1.56
    3.3 ± 1.18
        Change at PT Wk 24 (N = 95, 88, 1, 2, 34)
    1.8 ± 2.31
    4.1 ± 1.39
    7.6 ± 9999
    5.6 ± 0.85
    4.7 ± 1.31
    No statistical analyses for this end point

    Secondary: For the Treatment Phase, Change From Baseline in Weight

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    End point title
    		 For the Treatment Phase, Change From Baseline in Weight
    End point description
    Participants in the Safety Analysis Set with available data were analyzed. 999 = Not Applicable; Participants from the 12 Weeks groups were not analyzed for Change at Weeks 16, 20, and 24 because they were only treated for 12 weeks. 9999 = NA; Standard deviation of a single sample is undefined.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks, 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24
    End point values
    		 12 to < 18 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF 24 Weeks 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks 3 to < 6 Years Old - LDV/SOF 12 Weeks
    Number of subjects analysed
    100
    89
    1
    2
    34
    Units: kilograms
    arithmetic mean (standard deviation)
        Change at Week 1 (N = 98, 86, 1, 2, 34)
    0.1 ± 1.00
    0.3 ± 0.51
    -0.5 ± 9999
    0.3 ± 1.34
    0.1 ± 0.39
        Change at Week 2 (N = 97, 87, 1, 2, 33)
    0.3 ± 1.11
    0.4 ± 0.54
    0.0 ± 9999
    0.3 ± 1.77
    0.2 ± 0.44
        Change at Week 4 (N = 98, 89, 1, 2, 33)
    0.4 ± 1.44
    0.5 ± 0.64
    0.5 ± 9999
    0.7 ± 1.91
    0.3 ± 0.64
        Change at Week 8 (N = 98, 89, 1, 2, 33)
    0.5 ± 1.90
    0.8 ± 0.84
    1.3 ± 9999
    0.6 ± 2.33
    0.5 ± 0.66
        Change at Week 12 (N = 92, 84, 1, 2, 31)
    0.6 ± 2.32
    1.1 ± 1.27
    2.1 ± 9999
    0.9 ± 2.90
    0.6 ± 0.70
        Change at Week 16 (N = NA, NA, 1, 2, NA)
    999 ± 999
    999 ± 999
    1.6 ± 9999
    1.2 ± 3.68
    999 ± 999
        Change at Week 20 (N = NA, NA, 1, 2, NA)
    999 ± 999
    999 ± 999
    2.2 ± 9999
    1.8 ± 3.96
    999 ± 999
        Change at Week 24 (N = NA, NA, 1, 2, NA)
    999 ± 999
    999 ± 999
    3.1 ± 9999
    2.4 ± 3.68
    999 ± 999
        Change at PT Wk 4 (N = 97, 89, 1, 2, 34)
    0.9 ± 2.70
    1.4 ± 1.48
    1.8 ± 9999
    2.2 ± 3.68
    1.1 ± 1.09
        Change at PT Wk 12 (N = 96, 89, 1, 2, 34)
    1.6 ± 3.48
    2.1 ± 1.87
    3.1 ± 9999
    3.7 ± 2.90
    1.2 ± 0.93
        Change at PT Wk 24 (N = 95, 89, 1, 2, 34)
    3.2 ± 4.38
    3.5 ± 2.75
    4.5 ± 9999
    5.7 ± 1.41
    2.0 ± 1.57
    No statistical analyses for this end point

    Secondary: Acceptability of LDV/SOF Tablets as Measured by the Percentage of Participants Able/ Unable to Swallow Placebo Tablet at Day 1

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    End point title
    		 Acceptability of LDV/SOF Tablets as Measured by the Percentage of Participants Able/ Unable to Swallow Placebo Tablet at Day 1
    End point description
    Participants who were able/unable to swallow placebo tablets were assessed. Participants 12 to < 18 years old were first asked to perform the swallowability assessment using the 90/400 mg placebo tablet. If they were unable to swallow this, they were then asked to perform the swallowability assessment with 22.5/100 mg placebo tablets. Participants 6 to < 12 years old were to be assessed with the 22.5/100 mg placebo tablets. However, 8 participants were mistakenly assessed using the 90/400 mg placebo tablet. Participants between 6 to <18 years old in the Safety Analysis Set who performed the swallowability assessment were analyzed.
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    		 12 to < 18 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks
    Number of subjects analysed
    100
    92
    Units: percentage of participants
    number (not applicable)
        Able to Swallow 90/400 mg Tablet (N = 100, 8)
    89.0
    100.0
        Unable to Swallow 90/400 mg Tablet (N = 100, 8)
    11.0
    0
        Able to Swallow 22.5/100 mg Tablet (N = 11, 84)
    72.7
    98.8
        Unable to Swallow 22.5/100 mg Tablet (N = 11, 84)
    27.3
    1.2
    No statistical analyses for this end point

    Secondary: Acceptability of LDV/SOF Granules as Measured by Palatability at Day 1

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    End point title
    		 Acceptability of LDV/SOF Granules as Measured by Palatability at Day 1
    End point description
    Participants who were dosed with granules were asked if they tasted the study drug. If they tasted it, then they were asked to provide a number from 0 to 100 to rate the taste of the study drug, with higher scores indicating better taste. Data was then summarized as percentage of participants choosing the following palatability categories: 1) Did not taste the study drug, 2) Tasted drug with score > 60 to 100, 3) Tasted drug with score 40 to 60, and 4) Tasted drug with score of 0 to < 40. Participants between 3 to <6 years old in the Safety Analysis Set who performed the palatability test were analyzed.
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    		 3 to < 6 Years Old - LDV/SOF 12 Weeks
    Number of subjects analysed
    17
    Units: percentage of participants
    number (not applicable)
        Did not taste the study drug
    41.2
        Tasted drug with score > 60 to 100
    17.6
        Tasted drug with score 40 to 60
    11.8
        Tasted drug with score of 0 to < 40
    29.4
    No statistical analyses for this end point

    Secondary: For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair

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    End point title
    		 For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair
    End point description
    Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.
    End point type
    Secondary
    End point timeframe
    Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24
    End point values
    		 Males 12 to < 18 Years Old - LDV/SOF 12 Weeks Males 6 to < 12 Years Old - LDV/SOF± RBV 12 or 24 Weeks Males 3 to < 6 Years Old - LDV/SOF 12 Weeks
    Number of subjects analysed
    37
    54
    10
    Units: participants
        End of Treatment - No Change (N = 36, 54, 10)
    35
    52
    10
        End of Treatment - Increase (N = 36, 54, 10)
    1
    1
    0
        End of Treatment - Decrease (N = 36, 54, 10)
    0
    1
    0
        Posttreatment Week 12 - No Change (N = 35, 54, 9)
    32
    51
    9
        Posttreatment Week 12 - Increase (N = 35, 54, 9)
    3
    2
    0
        Posttreatment Week 12 - Decrease (N = 35, 54, 9)
    0
    1
    0
        Posttreatment Week 24 - No Change (N = 35, 53, 10)
    28
    48
    9
        Posttreatment Week 24 - Increase (N = 35, 53, 10)
    7
    4
    1
        Posttreatment Week 24 - Decrease (N = 35, 53, 10)
    0
    1
    0
    No statistical analyses for this end point

    Secondary: For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development

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    End point title
    		 For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development
    End point description
    Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.
    End point type
    Secondary
    End point timeframe
    Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24
    End point values
    		 Males 12 to < 18 Years Old - LDV/SOF 12 Weeks Males 6 to < 12 Years Old - LDV/SOF± RBV 12 or 24 Weeks Males 3 to < 6 Years Old - LDV/SOF 12 Weeks
    Number of subjects analysed
    37
    54
    10
    Units: participants
        End of Treatment - No Change (N = 35, 54, 10)
    34
    52
    10
        End of Treatment - Increase (N = 35, 54, 10)
    1
    1
    0
        End of Treatment - Decrease (N = 35, 54, 10)
    0
    1
    0
        Posttreatment Week 12 - No Change (N = 35, 54, 9)
    33
    50
    9
        Posttreatment Week 12 - Increase (N = 35, 54, 9)
    2
    4
    0
        Posttreatment Week 12 - Decrease (N = 35, 54, 9)
    0
    0
    0
        Posttreatment Week 24 - No Change (N = 35, 53, 10)
    29
    47
    10
        Posttreatment Week 24 - Increase (N = 35, 53, 10)
    6
    6
    0
        Posttreatment Week 24 - Decrease (N = 35, 53, 10)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair

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    End point title
    		 For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair
    End point description
    Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.
    End point type
    Secondary
    End point timeframe
    Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24
    End point values
    		 Females 12 to < 18 Years Old - LDV/SOF 12 Weeks Females 6 to < 12 Years Old - LDV/SOF± RBV 12 or 24 Weeks Females 3 to < 6 Years Old - LDV/SOF 12 Weeks
    Number of subjects analysed
    63
    38
    24
    Units: participants
        End of Treatment - No Change (N = 62, 36, 21)
    52
    34
    21
        End of Treatment - Increase (N = 62, 36, 21)
    9
    2
    0
        End of Treatment - Decrease (N = 62, 36, 21)
    1
    0
    0
        Posttreatment Week 12 - No Change (N = 60, 34, 22)
    45
    31
    22
        Posttreatment Week 12 - Increase (N = 60, 34, 22)
    15
    3
    0
        Posttreatment Week 12 - Decrease (N = 60, 34, 22)
    0
    0
    0
        Posttreatment Week 24 - No Change (N = 61, 35, 22)
    40
    27
    22
        Posttreatment Week 24 - Increase (N = 61, 35, 22)
    21
    8
    0
        Posttreatment Week 24 - Decrease (N = 61, 35, 22)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development

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    End point title
    		 For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development
    End point description
    Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.
    End point type
    Secondary
    End point timeframe
    Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24
    End point values
    		 Females 12 to < 18 Years Old - LDV/SOF 12 Weeks Females 6 to < 12 Years Old - LDV/SOF± RBV 12 or 24 Weeks Females 3 to < 6 Years Old - LDV/SOF 12 Weeks
    Number of subjects analysed
    63
    38
    24
    Units: participants
        End of Treatment - No Change (N = 62, 36, 21)
    53
    31
    21
        End of Treatment - Increase (N = 62, 36, 21)
    8
    5
    0
        End of Treatment - Decrease (N = 62, 36, 21)
    1
    0
    0
        Posttreatment Week 12 - No Change (N = 60, 34, 22)
    49
    25
    21
        Posttreatment Week 12 - Increase (N = 60, 34, 22)
    11
    8
    1
        Posttreatment Week 12 - Decrease (N = 60, 34, 22)
    0
    1
    0
        Posttreatment Week 24 - No Change (N = 61, 35, 22)
    43
    21
    21
        Posttreatment Week 24 - Increase (N = 61, 35, 22)
    18
    14
    1
        Posttreatment Week 24 - Decrease (N = 61, 35, 22)
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 12 or 24 weeks (depending on group) plus 30 days
    Adverse event reporting additional description
    Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    12 to < 18 Years Old - LDV/SOF 12 Weeks
    Reporting group description
    		 Participants 12 to < 18 years of age with HCV genotype 1 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.

    Reporting group title
    6 to < 12 Years Old - LDV/SOF 12 Weeks
    Reporting group description
    		 Participants 6 to < 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.

    Reporting group title
    6 to < 12 Years Old - LDV/SOF 24 Weeks
    Reporting group description
    		 Participants 6 to < 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks.

    Reporting group title
    6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks
    Reporting group description
    		 Participants 6 to < 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks. Note: Participants with cirrhosis could have enrolled in this age group, but none were actually enrolled. Only participants in the United Kingdom were enrolled in this group.

    Reporting group title
    3 to < 6 Years Old - LDV/SOF 12 Weeks
    Reporting group description
    		 Participants 3 to < 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight < 17 kg: 33.75/150 mg granules) once daily for 12 weeks. Note: Participants with cirrhosis could have enrolled in this age group, but none were actually enrolled.

    Serious adverse events
    		 12 to < 18 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF 24 Weeks 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks 3 to < 6 Years Old - LDV/SOF 12 Weeks
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 89 (1.12%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 34 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 89 (1.12%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 89 (1.12%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tooth abscess
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 89 (1.12%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 12 to < 18 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF 24 Weeks 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks 3 to < 6 Years Old - LDV/SOF 12 Weeks
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    62 / 100 (62.00%)
    54 / 89 (60.67%)
    1 / 1 (100.00%)
    2 / 2 (100.00%)
    22 / 34 (64.71%)
    Injury, poisoning and procedural complications
    Skin abrasion
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 89 (1.12%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    1
    1
    0
    0
    2
    Fall
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 89 (1.12%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    26 / 100 (26.00%)
    16 / 89 (17.98%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    3 / 34 (8.82%)
         occurrences all number
    41
    19
    0
    1
    3
    Dizziness
         subjects affected / exposed
    2 / 100 (2.00%)
    5 / 89 (5.62%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    3
    5
    0
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    13 / 100 (13.00%)
    13 / 89 (14.61%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    2 / 34 (5.88%)
         occurrences all number
    13
    14
    0
    2
    2
    Pyrexia
         subjects affected / exposed
    2 / 100 (2.00%)
    15 / 89 (16.85%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    7 / 34 (20.59%)
         occurrences all number
    2
    17
    0
    2
    11
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 100 (0.00%)
    2 / 89 (2.25%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    12 / 100 (12.00%)
    12 / 89 (13.48%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    8 / 34 (23.53%)
         occurrences all number
    14
    12
    0
    2
    10
    Diarrhoea
         subjects affected / exposed
    13 / 100 (13.00%)
    11 / 89 (12.36%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    15
    13
    0
    0
    0
    Abdominal pain
         subjects affected / exposed
    7 / 100 (7.00%)
    14 / 89 (15.73%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    8
    14
    0
    0
    2
    Nausea
         subjects affected / exposed
    11 / 100 (11.00%)
    9 / 89 (10.11%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    1 / 34 (2.94%)
         occurrences all number
    15
    9
    0
    1
    1
    Abdominal pain upper
         subjects affected / exposed
    7 / 100 (7.00%)
    3 / 89 (3.37%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    7
    3
    0
    0
    2
    Mouth ulceration
         subjects affected / exposed
    0 / 100 (0.00%)
    2 / 89 (2.25%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    2
    0
    1
    2
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    5 / 100 (5.00%)
    0 / 89 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    6
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    10 / 100 (10.00%)
    11 / 89 (12.36%)
    1 / 1 (100.00%)
    1 / 2 (50.00%)
    7 / 34 (20.59%)
         occurrences all number
    11
    12
    3
    1
    8
    Oropharyngeal pain
         subjects affected / exposed
    10 / 100 (10.00%)
    10 / 89 (11.24%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    10
    10
    0
    0
    1
    Nasal congestion
         subjects affected / exposed
    6 / 100 (6.00%)
    5 / 89 (5.62%)
    1 / 1 (100.00%)
    0 / 2 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    7
    5
    1
    0
    3
    Rhinorrhoea
         subjects affected / exposed
    2 / 100 (2.00%)
    3 / 89 (3.37%)
    1 / 1 (100.00%)
    0 / 2 (0.00%)
    6 / 34 (17.65%)
         occurrences all number
    2
    3
    1
    0
    8
    Epistaxis
         subjects affected / exposed
    2 / 100 (2.00%)
    2 / 89 (2.25%)
    1 / 1 (100.00%)
    0 / 2 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    2
    2
    1
    0
    2
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 100 (1.00%)
    8 / 89 (8.99%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    3 / 34 (8.82%)
         occurrences all number
    1
    8
    0
    0
    3
    Dermatitis contact
         subjects affected / exposed
    4 / 100 (4.00%)
    0 / 89 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    6
    0
    0
    0
    2
    Ecchymosis
         subjects affected / exposed
    2 / 100 (2.00%)
    0 / 89 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    2
    0
    0
    0
    3
    Dermatitis allergic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 89 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Rash maculo-papular
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 89 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Skin odour abnormal
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 89 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 89 (1.12%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    1
    1
    0
    0
    2
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    5 / 100 (5.00%)
    3 / 89 (3.37%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    5
    3
    0
    0
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 100 (5.00%)
    7 / 89 (7.87%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    3 / 34 (8.82%)
         occurrences all number
    6
    7
    0
    0
    4
    Nasopharyngitis
         subjects affected / exposed
    7 / 100 (7.00%)
    2 / 89 (2.25%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    1 / 34 (2.94%)
         occurrences all number
    8
    2
    0
    2
    2
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 100 (0.00%)
    3 / 89 (3.37%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    4 / 34 (11.76%)
         occurrences all number
    0
    4
    0
    0
    4
    Conjunctivitis
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 89 (1.12%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    1
    0
    0
    2
    Ear infection
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 89 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    0
    0
    0
    2
    Product issues
    Product taste abnormal
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 89 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    3 / 34 (8.82%)
         occurrences all number
    0
    0
    0
    0
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Oct 2014
    ● Removed Russia from the list of study site countries participating in the trial ● Updated the futility rule to suspend enrollment if 3 or more of the first 10 subjects enrolled have viral breakthrough or are nonresponders at or prior to Week 8 ● Included genotype 3 HCV infection as an exclusion criterion ● Updated the formulation, packaging and labeling, and storage and handling information to include information on the lower dose strength tablet (LDV/SOF 22.5/100 mg and placebo-to-match). ● Clarified that subjects who do not attain SVR24 will also be enrolled in the separate registry study (GS-US-334-1113). ● Changed the growth and development measurements from a PK lead-in secondary endpoint to a treatment phase secondary endpoint. ● Added clarification on pregnancy notification timelines for partners of male subjects participating in the trial. ● Additional administrative updates were made.
    08 Dec 2014
    ● The study design was updated to include a treatment period of 24 weeks with LDV/SOF for treatment-experienced subjects with cirrhosis, to comply with the approved US prescribing information. ● Added clarification on the exclusion criteria (with a history of cirrhosis) for the PK lead-in phase ● Additional statistical analysis was added to include analysis of the LDV/SOF 24-week treatment group (treatment-experienced subjects with cirrhosis) ● Added language in the introduction to reflect the approval of LDV/SOF in the US and EU ● Language added to clarify the reconsent requirement for subjects who become adults while on the study ● Revised statistical endpoints to be consistent with the protocol objectives ● Additional administrative, formatting, section number, and minor grammatical corrections and updates were made throughout the document.
    28 May 2015
    ● The study design was updated to add treatment with LDV/SOF+RBV for 24 weeks for subjects with genotype 3 HCV infection, to comply with the approved UK prescribing information. ● The study design was updated to reflect that subjects with genotypes 3 or 4 HCV infection would only be enrolled in the UK, to comply with the approved UK prescribing information. ● The study design for the long-term follow-up study (GS-US-334-1113) was updated to reduce the number of visits, fulfilling the regulatory requirement minimum. ● The statistical methods were updated to align with the updated treatment regimens. ● New clinical data available for subjects with genotype 3 and 4 HCV infection were added to the introduction to reflect the approved UK prescribing information. ● Added information on RBV to the introduction, investigational medicinal products section, and to the inclusion criteria ● The exclusion criteria contraception language within the synopsis was updated to clarify the contraception requirements. ● Amiodarone was been added to the disallowed agents list in the prior and concomitant medications section ● Pregnancy tests and prevention requirements and RBV toxicity management were added for the subjects receiving RBV. ● References for new clinical data and Tanner Stage Scale were added.
    15 Mar 2016
    ● The study design was updated to include additional genotypes (genotypes 5 and 6) following the availability of supporting data within the adult population. Updates were also made to the background consistent with these changes. ● The study procedures and statistical methods sections were updated to remove the collection and analysis of age of first menses. ● Clarifications were made to the estimated glomerular filtration rate (eGFR) calculation. ● Additional minor updates were made throughout the document.
    04 Nov 2016
    ● Clarified that the swallowability assessment was not required for subjects receiving the oral granule formulation ● Added information regarding oral granule formulation dosing, labeling, packaging, and storage specifications ● Added new clinical data from a Phase 1 bioavailability study to the introduction to supportuse of the oral granule formulation ● Updated the definition of a treatment-emergent adverse event (AE) as any AE with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of the study drug or any AE leading to premature discontinuation of the study drug ● Added additional HBV serological testing (ie, hepatitis B surface antibody [HBsAb], hepatitis B core antibody [HBcAb]) at screening and specified that serial hepatitis B virus (HBV) DNA monitoring should occur for any subjects who were HBcAb positive at screening
    08 Jun 2017
    ● Updated the study design to increase the number of subjects from approximately 200 to approximately 220, including subjects in the PK lead-in phase: approximately 100 adolescent subjects 12 to < 18 years old and approximately 120 pediatric subjects 3 to < 12 years old ● Added a palatability assessment for LDV/SOF oral granules at Day 1 for subjects 3 to < 6 years of age ● Updated the study design to include an optional intensive PK substudy, to be completed at Week 4 or 8, for subjects 3 to < 12 years old who provided written consent

    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/30070726
    http://www.ncbi.nlm.nih.gov/pubmed/28957984
    http://www.ncbi.nlm.nih.gov/pubmed/27997679
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