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Trial record 19 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/- Ribavirin in Adolescents and Children With Chronic HCV-Infection

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ClinicalTrials.gov Identifier: NCT02249182
Recruitment Status : Completed
First Posted : September 25, 2014
Results First Posted : April 24, 2019
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C Virus Infection
Interventions Drug: LDV/SOF
Drug: RBV
Enrollment 226
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 Details 240 participants were screened.
Arm/Group Title 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
Hide Arm/Group Description Participants 12 to < 18 years of age with hepatitis C virus (HCV) genotype 1 treatment-naive (TN) with or without cirrhosis or treatment-experienced (TE) without cirrhosis received ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration. 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. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration. 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. 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 (RBV) capsules or oral solution (dose depending on weight) for 24 weeks. 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. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.
Period Title: PK Lead-In Phase
Started 10 12 0 0 17
Completed 10 12 0 0 17
Not Completed 0 0 0 0 0
Period Title: Treatment Phase
Started 100 [1] 89 [2] 1 [3] 2 [4] 34 [5]
Completed 96 89 1 2 34
Not Completed 4 0 0 0 0
Reason Not Completed
Lost to Follow-up             4             0             0             0             0
[1]
90 participants enrolled directly into the Treatment Phase, without entering the PK Lead-In Phase.
[2]
77 participants enrolled directly into the Treatment Phase, without entering the PK Lead-In Phase.
[3]
1 participant enrolled directly into the Treatment Phase, without entering the PK Lead-In Phase.
[4]
2 participants enrolled directly into the Treatment Phase, without entering the PK Lead-In Phase.
[5]
17 participants enrolled directly into the Treatment Phase, without entering the PK Lead-In Phase.
Arm/Group Title 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
Hide Arm/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. 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. 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. 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 100 89 1 2 34 226
Hide Baseline Analysis Population Description
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants 89 participants 1 participants 2 participants 34 participants 226 participants
15  (1.7) 9  (1.6) 11 [1]   (NA) 9  (2.8) 4  (0.7) 11  (4.1)
[1]
Standard deviation of a single sample is undefined.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 89 participants 1 participants 2 participants 34 participants 226 participants
Female
63
  63.0%
36
  40.4%
1
 100.0%
1
  50.0%
24
  70.6%
125
  55.3%
Male
37
  37.0%
53
  59.6%
0
   0.0%
1
  50.0%
10
  29.4%
101
  44.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 89 participants 1 participants 2 participants 34 participants 226 participants
White
91
  91.0%
70
  78.7%
1
 100.0%
2
 100.0%
27
  79.4%
191
  84.5%
Black or African American
7
   7.0%
7
   7.9%
0
   0.0%
0
   0.0%
1
   2.9%
15
   6.6%
Other
0
   0.0%
5
   5.6%
0
   0.0%
0
   0.0%
4
  11.8%
9
   4.0%
Asian
2
   2.0%
5
   5.6%
0
   0.0%
0
   0.0%
2
   5.9%
9
   4.0%
Native Hawaiian or Pacific Islander
0
   0.0%
2
   2.2%
0
   0.0%
0
   0.0%
0
   0.0%
2
   0.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 89 participants 1 participants 2 participants 34 participants 226 participants
Hispanic or Latino
13
  13.0%
9
  10.1%
0
   0.0%
0
   0.0%
6
  17.6%
28
  12.4%
Not Hispanic or Latino
85
  85.0%
75
  84.3%
1
 100.0%
2
 100.0%
28
  82.4%
191
  84.5%
Not Disclosed
2
   2.0%
5
   5.6%
0
   0.0%
0
   0.0%
0
   0.0%
7
   3.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 89 participants 1 participants 2 participants 34 participants 226 participants
New Zealand
0
   0.0%
4
   4.5%
0
   0.0%
0
   0.0%
0
   0.0%
4
   1.8%
United States
91
  91.0%
70
  78.7%
0
   0.0%
0
   0.0%
29
  85.3%
190
  84.1%
United Kingdom
1
   1.0%
9
  10.1%
0
   0.0%
2
 100.0%
3
   8.8%
15
   6.6%
Australia
8
   8.0%
6
   6.7%
1
 100.0%
0
   0.0%
2
   5.9%
17
   7.5%
HCV Genotype  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 89 participants 1 participants 2 participants 34 participants 226 participants
Genotype 1
100
 100.0%
87
  97.8%
1
 100.0%
0
   0.0%
33
  97.1%
221
  97.8%
Genotype 3
0
   0.0%
0
   0.0%
0
   0.0%
2
 100.0%
0
   0.0%
2
   0.9%
Genotype 4
0
   0.0%
2
   2.2%
0
   0.0%
0
   0.0%
1
   2.9%
3
   1.3%
Cirrhosis Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 89 participants 1 participants 2 participants 34 participants 226 participants
Yes
1
   1.0%
1
   1.1%
1
 100.0%
0
   0.0%
0
   0.0%
3
   1.3%
No
43
  43.0%
33
  37.1%
0
   0.0%
2
 100.0%
14
  41.2%
92
  40.7%
Unknown
56
  56.0%
55
  61.8%
0
   0.0%
0
   0.0%
20
  58.8%
131
  58.0%
IL28b Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 89 participants 1 participants 2 participants 34 participants 226 participants
CC
24
  24.0%
23
  25.8%
0
   0.0%
0
   0.0%
10
  29.4%
57
  25.2%
CT
53
  53.0%
53
  59.6%
0
   0.0%
2
 100.0%
16
  47.1%
124
  54.9%
TT
23
  23.0%
12
  13.5%
1
 100.0%
0
   0.0%
6
  17.6%
42
  18.6%
Missing
0
   0.0%
1
   1.1%
0
   0.0%
0
   0.0%
2
   5.9%
3
   1.3%
[1]
Measure Description: The CC, CT, and TT alleles are different forms of the IL28b gene.
HCV RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 89 participants 1 participants 2 participants 34 participants 226 participants
< 800,000 IU/mL
45
  45.0%
37
  41.6%
0
   0.0%
1
  50.0%
15
  44.1%
98
  43.4%
≥ 800,000 IU/mL
55
  55.0%
52
  58.4%
1
 100.0%
1
  50.0%
19
  55.9%
128
  56.6%
Prior Treatment Experience  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 89 participants 1 participants 2 participants 34 participants 226 participants
Treatment-Naive
80
  80.0%
72
  80.9%
0
   0.0%
0
   0.0%
34
 100.0%
186
  82.3%
Treatment-Experienced
20
  20.0%
17
  19.1%
1
 100.0%
2
 100.0%
0
   0.0%
40
  17.7%
1.Primary Outcome
Title For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF), LDV, and SOF
Hide Description AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title PK Lead-in: 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
Hide Arm/Group Description:
Participants 12 to < 18 years of age weighing ≥ 45 kg 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.
Participants 6 to < 12 years of age weighing ≥ 17 kg and < 45 kg 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.
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.
Overall Number of Participants Analyzed 10 10 13
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
GS-331007 (metabolite of SOF) Number Analyzed 10 participants 10 participants 13 participants
12682.5  (1732.66) 8210.3  (2542.42) 11688.9  (3400.79)
LDV Number Analyzed 10 participants 10 participants 13 participants
10202.4  (5196.49) 7288.3  (4547.33) 9316.3  (3280.51)
SOF Number Analyzed 10 participants 9 participants 3 participants
2175.7  (578.92) 1754.4  (419.18) 2495.2  (412.64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks
Comments AUCtau of GS-331007 for the 12 to < 18 Years old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.
Type of Statistical Test Equivalence
Comments Equivalence was determined if the 90% confidence intervals (CI) were within the predefined equivalence boundaries of 50% to 200% for all age groups.
Method of Estimation Estimation Parameter Percentage Geometric Mean Ratio
Estimated Value 105.20
Confidence Interval (2-Sided) 90%
90.61 to 122.13
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks
Comments AUCtau of GS-331007 for the 6 to < 12 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.
Type of Statistical Test Equivalence
Comments Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.
Method of Estimation Estimation Parameter Percentage Geometric Mean Ratio
Estimated Value 65.76
Confidence Interval (2-Sided) 90%
56.62 to 76.37
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks
Comments AUCtau of GS-331007 for the 3 to < 6 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.
Type of Statistical Test Equivalence
Comments Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.
Method of Estimation Estimation Parameter Percentage Geometric Mean Ratio
Estimated Value 94.08
Confidence Interval (2-Sided) 90%
82.51 to 107.27
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks
Comments AUCtau of LDV for the 12 to < 18 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.
Type of Statistical Test Equivalence
Comments Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.
Method of Estimation Estimation Parameter Percentage Geometric Mean Ratio
Estimated Value 127.18
Confidence Interval (2-Sided) 90%
94.89 to 170.45
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks
Comments AUCtau of LDV for the 6 to < 12 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.
Type of Statistical Test Equivalence
Comments Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.
Method of Estimation Estimation Parameter Percentage Geometric Mean Ratio
Estimated Value 82.25
Confidence Interval (2-Sided) 90%
61.34 to 110.30
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks
Comments AUCtau of LDV for the 3 to < 6 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.
Type of Statistical Test Equivalence
Comments Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.
Method of Estimation Estimation Parameter Percentage Geometric Mean Ratio
Estimated Value 120.46
Confidence Interval (2-Sided) 90%
93.18 to 155.73
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks
Comments AUCtau of SOF for the 12 to < 18 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.
Type of Statistical Test Equivalence
Comments Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.
Method of Estimation Estimation Parameter Percentage Geometric Mean Ratio
Estimated Value 159.88
Confidence Interval (2-Sided) 90%
137.89 to 185.37
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks
Comments AUCtau of SOF for the 6 to < 12 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.
Type of Statistical Test Equivalence
Comments Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.
Method of Estimation Estimation Parameter Percentage Geometric Mean Ratio
Estimated Value 129.48
Confidence Interval (2-Sided) 90%
110.79 to 151.32
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks
Comments AUCtau of SOF for the 3 to < 6 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.
Type of Statistical Test Equivalence
Comments Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.
Method of Estimation Estimation Parameter Percentage Geometric Mean Ratio
Estimated Value 187.76
Confidence Interval (2-Sided) 90%
143.41 to 245.82
Estimation Comments [Not Specified]
2.Primary Outcome
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
Hide Description [Not Specified]
Time Frame Up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
Arm/Group Title 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
Hide Arm/Group Description:
Participants 12 to < 18 years of age with HCV genotype 1 TN with or without cirrhosis or 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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 100 89 1 2 34
Measure Type: Number
Unit of Measure: percentage of participants
0 0 0 0 2.9
3.Secondary Outcome
Title For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA
Hide Description [Not Specified]
Time Frame Baseline; Weeks 1, 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were enrolled in the PK lead-in phase with available data were analyzed.
Arm/Group Title PK Lead-in: 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
Hide Arm/Group Description:
Participants 12 to < 18 years of age weighing ≥ 45 kg 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.
Participants 6 to < 12 years of age weighing ≥ 17 kg and < 45 kg 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.
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.
Overall Number of Participants Analyzed 10 12 17
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Change at Week 1 Number Analyzed 10 participants 12 participants 17 participants
-4.34  (0.621) -4.29  (0.518) -4.32  (0.616)
Change at Week 2 Number Analyzed 10 participants 12 participants 15 participants
-4.71  (0.651) -4.55  (0.636) -4.87  (0.724)
Change at Week 4 Number Analyzed 10 participants 12 participants 16 participants
-4.73  (0.667) -4.75  (0.702) -4.92  (0.715)
Change at Week 8 Number Analyzed 10 participants 12 participants 16 participants
-4.73  (0.667) -4.76  (0.710) -4.92  (0.715)
Change at Week 12 Number Analyzed 10 participants 12 participants 16 participants
-4.73  (0.667) -4.76  (0.710) -4.92  (0.715)
4.Secondary Outcome
Title Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase
Hide Description [Not Specified]
Time Frame Up to Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were enrolled in the PK lead-in phase were analyzed.
Arm/Group Title PK Lead-in: 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
Hide Arm/Group Description:
Participants 12 to < 18 years of age weighing ≥ 45 kg 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.
Participants 6 to < 12 years of age weighing ≥ 17 kg and < 45 kg 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.
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.
Overall Number of Participants Analyzed 10 12 17
Measure Type: Number
Unit of Measure: percentage of participants
0 0 5.9
5.Secondary Outcome
Title For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4)
Hide Description SVR4 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 4 weeks after stopping study treatment.
Time Frame Posttreatment Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
Arm/Group Title 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
Hide Arm/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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 100 89 1 2 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
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)
6.Secondary Outcome
Title For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12)
Hide Description SVR12 was defined as HCV RNA < LLOQ at 12 weeks after stopping study treatment.
Time Frame Posttreatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title 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
Hide Arm/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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 100 89 1 2 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
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)
7.Secondary Outcome
Title For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
Hide Description SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.
Time Frame Posttreatment Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title 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
Hide Arm/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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 100 89 1 2 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
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)
8.Secondary Outcome
Title For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough
Hide Description Viral breakthrough was defined as having confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment.
Time Frame Up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title 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
Hide Arm/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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 100 89 1 2 34
Measure Type: Number
Unit of Measure: percentage of participants
0 0 0 0 0
9.Secondary Outcome
Title For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse
Hide 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.
Time Frame Up to Posttreatment Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title 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
Hide Arm/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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 100 89 1 2 34
Measure Type: Number
Unit of Measure: percentage of participants
0 1.1 0 0 0
10.Secondary Outcome
Title For the Treatment Phase, Change From Baseline in HCV RNA
Hide Description [Not Specified]
Time Frame Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed. 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.
Arm/Group Title 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
Hide Arm/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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 100 89 1 2 34
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Change at Week 1 Number Analyzed 98 participants 85 participants 1 participants 2 participants 34 participants
-4.34  (0.634) -4.27  (0.592) -4.30 [1]   (NA) -4.54  (0.308) -4.25  (0.505)
Change at Week 2 Number Analyzed 99 participants 88 participants 1 participants 2 participants 32 participants
-4.74  (0.585) -4.73  (0.544) -5.09 [1]   (NA) -4.54  (0.308) -4.80  (0.628)
Change at Week 4 Number Analyzed 100 participants 89 participants 1 participants 2 participants 33 participants
-4.84  (0.557) -4.87  (0.592) -5.09 [1]   (NA) -4.54  (0.308) -4.85  (0.628)
Change at Week 8 Number Analyzed 99 participants 89 participants 1 participants 2 participants 33 participants
-4.85  (0.556) -4.89  (0.597) -5.09 [1]   (NA) -4.54  (0.308) -4.86  (0.633)
Change at Week 12 Number Analyzed 99 participants 89 participants 1 participants 2 participants 33 participants
-4.85  (0.556) -4.89  (0.597) -5.09 [1]   (NA) -4.54  (0.308) -4.86  (0.633)
Change at Week 16 Number Analyzed 0 participants 0 participants 1 participants 2 participants 0 participants
-5.09 [1]   (NA) -4.54  (0.308)
Change at Week 20 Number Analyzed 0 participants 0 participants 1 participants 2 participants 0 participants
-5.09 [1]   (NA) -4.54  (0.308)
Change at Week 24 Number Analyzed 0 participants 0 participants 1 participants 2 participants 0 participants
-5.09 [1]   (NA) -4.54  (0.308)
[1]
Standard deviation of a single sample is undefined.
11.Secondary Outcome
Title For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment
Hide Description [Not Specified]
Time Frame Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set 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.
Arm/Group Title 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
Hide Arm/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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 100 89 1 2 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 1 Number Analyzed 100 participants 89 participants 1 participants 2 participants 34 participants
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 Number Analyzed 100 participants 89 participants 1 participants 2 participants 33 participants
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 Number Analyzed 100 participants 89 participants 1 participants 2 participants 33 participants
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 Number Analyzed 99 participants 89 participants 1 participants 2 participants 33 participants
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 Number Analyzed 99 participants 89 participants 1 participants 2 participants 33 participants
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 Number Analyzed 0 participants 0 participants 1 participants 2 participants 0 participants
100.0
(2.5 to 100.0)
100.0
(15.8 to 100.0)
Week 20 Number Analyzed 0 participants 0 participants 1 participants 2 participants 0 participants
100.0
(2.5 to 100.0)
100.0
(15.8 to 100.0)
Week 24 Number Analyzed 0 participants 0 participants 1 participants 2 participants 0 participants
100.0
(2.5 to 100.0)
100.0
(15.8 to 100.0)
12.Secondary Outcome
Title For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
Hide Description ALT normalization was defined as ALT > the upper limit of normal (ULN) at baseline and ALT ≤ ULN at each visit.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 49 72 1 2 27
Measure Type: Number
Unit of Measure: percentage of participants
Week 1 Number Analyzed 47 participants 70 participants 1 participants 2 participants 27 participants
72.3 75.7 0 50.0 63.0
Week 2 Number Analyzed 49 participants 66 participants 1 participants 2 participants 25 participants
89.8 84.8 0 50.0 84.0
Week 4 Number Analyzed 48 participants 72 participants 1 participants 2 participants 25 participants
93.8 93.1 0 100.0 96.0
Week 8 Number Analyzed 46 participants 71 participants 1 participants 2 participants 25 participants
91.3 90.1 0 100.0 92.0
Week 12 Number Analyzed 45 participants 67 participants 1 participants 2 participants 24 participants
93.3 95.5 100.0 100.0 91.7
Week 16 Number Analyzed 0 participants 0 participants 1 participants 2 participants 0 participants
100.0 100.0
Week 20 Number Analyzed 0 participants 0 participants 1 participants 2 participants 0 participants
100.0 100.0
Week 24 Number Analyzed 0 participants 0 participants 1 participants 2 participants 0 participants
100.0 100.0
Posttreatment Week 4 Number Analyzed 41 participants 62 participants 0 participants 2 participants 23 participants
90.2 98.4 100.0 91.3
13.Secondary Outcome
Title For the Treatment Phase, Change From Baseline in Height
Hide Description [Not Specified]
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed. 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.
Arm/Group Title 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
Hide Arm/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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 100 89 1 2 34
Mean (Standard Deviation)
Unit of Measure: centimeters
Change at Week 1 Number Analyzed 97 participants 85 participants 1 participants 2 participants 34 participants
0.1  (0.68) 0.1  (0.83) 0.3 [1]   (NA) 0.7  (1.13) 0.2  (1.24)
Change at Week 2 Number Analyzed 97 participants 86 participants 1 participants 2 participants 32 participants
0.0  (0.70) 0.3  (0.73) 0.5 [1]   (NA) 0.5  (0.85) 0.3  (0.72)
Change at Week 4 Number Analyzed 98 participants 87 participants 1 participants 2 participants 33 participants
0.1  (0.84) 0.5  (0.79) 1.2 [1]   (NA) 0.6  (0.92) 0.7  (0.79)
Change at Week 8 Number Analyzed 98 participants 88 participants 1 participants 2 participants 33 participants
0.4  (1.04) 0.8  (0.79) 1.3 [1]   (NA) 0.8  (0.92) 1.0  (0.82)
Change at Week 12 Number Analyzed 92 participants 84 participants 1 participants 2 participants 31 participants
0.5  (1.10) 1.3  (0.83) 2.1 [1]   (NA) 1.1  (1.41) 1.6  (0.98)
Change at Week 16 Number Analyzed 0 participants 0 participants 1 participants 2 participants 0 participants
3.2 [1]   (NA) 1.4  (1.06)
Change at Week 20 Number Analyzed 0 participants 0 participants 1 participants 2 participants 0 participants
4.3 [1]   (NA) 1.6  (0.85)
Change at Week 24 Number Analyzed 0 participants 0 participants 1 participants 2 participants 0 participants
4.3 [1]   (NA) 2.5  (1.48)
Change at Posttreatment Week 4 Number Analyzed 97 participants 89 participants 1 participants 2 participants 34 participants
0.8  (1.46) 1.8  (1.04) 4.3 [1]   (NA) 2.4  (1.27) 2.1  (1.13)
Change at Posttreatment Week 12 Number Analyzed 96 participants 87 participants 1 participants 2 participants 34 participants
1.2  (1.82) 2.7  (0.97) 5.0 [1]   (NA) 3.4  (1.56) 3.3  (1.18)
Change at Posttreatment Week 24 Number Analyzed 95 participants 88 participants 1 participants 2 participants 34 participants
1.8  (2.31) 4.1  (1.39) 7.6 [1]   (NA) 5.6  (0.85) 4.7  (1.31)
[1]
Standard deviation of a single sample is undefined.
14.Secondary Outcome
Title For the Treatment Phase, Change From Baseline in Weight
Hide Description [Not Specified]
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed. 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.
Arm/Group Title 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
Hide Arm/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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 100 89 1 2 34
Mean (Standard Deviation)
Unit of Measure: kilograms
Change at Week 1 Number Analyzed 98 participants 86 participants 1 participants 2 participants 34 participants
0.1  (1.00) 0.3  (0.51) -0.5 [1]   (NA) 0.3  (1.34) 0.1  (0.39)
Change at Week 2 Number Analyzed 97 participants 87 participants 1 participants 2 participants 33 participants
0.3  (1.11) 0.4  (0.54) 0.0 [1]   (NA) 0.3  (1.77) 0.2  (0.44)
Change at Week 4 Number Analyzed 98 participants 89 participants 1 participants 2 participants 33 participants
0.4  (1.44) 0.5  (0.64) 0.5 [1]   (NA) 0.7  (1.91) 0.3  (0.64)
Change at Week 8 Number Analyzed 98 participants 89 participants 1 participants 2 participants 33 participants
0.5  (1.90) 0.8  (0.84) 1.3 [1]   (NA) 0.6  (2.33) 0.5  (0.66)
Change at Week 12 Number Analyzed 92 participants 84 participants 1 participants 2 participants 31 participants
0.6  (2.32) 1.1  (1.27) 2.1 [1]   (NA) 0.9  (2.90) 0.6  (0.70)
Change at Week 16 Number Analyzed 0 participants 0 participants 1 participants 2 participants 0 participants
1.6 [1]   (NA) 1.2  (3.68)
Change at Week 20 Number Analyzed 0 participants 0 participants 1 participants 2 participants 0 participants
2.2 [1]   (NA) 1.8  (3.96)
Change at Week 24 Number Analyzed 0 participants 0 participants 1 participants 2 participants 0 participants
3.1 [1]   (NA) 2.4  (3.68)
Change at Posttreatment Week 4 Number Analyzed 97 participants 89 participants 1 participants 2 participants 34 participants
0.9  (2.70) 1.4  (1.48) 1.8 [1]   (NA) 2.2  (3.68) 1.1  (1.09)
Change at Posttreatment Week 12 Number Analyzed 96 participants 89 participants 1 participants 2 participants 34 participants
1.6  (3.48) 2.1  (1.87) 3.1 [1]   (NA) 3.7  (2.90) 1.2  (0.93)
Change at Posttreatment Week 24 Number Analyzed 95 participants 89 participants 1 participants 2 participants 34 participants
3.2  (4.38) 3.5  (2.75) 4.5 [1]   (NA) 5.7  (1.41) 2.0  (1.57)
[1]
Standard deviation of a single sample is undefined.
15.Secondary Outcome
Title For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair
Hide 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.
Time Frame Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Male participants in the Safety Analysis Set with available data were analyzed.
Arm/Group Title 12 to < 18 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks 3 to < 6 Years Old - LDV/SOF 12 Weeks
Hide Arm/Group 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.
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.
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.
Overall Number of Participants Analyzed 37 54 10
Measure Type: Count of Participants
Unit of Measure: Participants
End of Treatment Number Analyzed 36 participants 54 participants 10 participants
No Change
35
  97.2%
52
  96.3%
10
 100.0%
Increase
1
   2.8%
1
   1.9%
0
   0.0%
Decrease
0
   0.0%
1
   1.9%
0
   0.0%
Posttreatment Week 12 Number Analyzed 35 participants 54 participants 9 participants
No Change
32
  91.4%
51
  94.4%
9
 100.0%
Increase
3
   8.6%
2
   3.7%
0
   0.0%
Decrease
0
   0.0%
1
   1.9%
0
   0.0%
Posttreatment Week 24 Number Analyzed 35 participants 53 participants 10 participants
No Change
28
  80.0%
48
  90.6%
9
  90.0%
Increase
7
  20.0%
4
   7.5%
1
  10.0%
Decrease
0
   0.0%
1
   1.9%
0
   0.0%
16.Secondary Outcome
Title For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development
Hide 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.
Time Frame Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Male participants in the Safety Analysis Set with available data were analyzed.
Arm/Group Title 12 to < 18 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks 3 to < 6 Years Old - LDV/SOF 12 Weeks
Hide Arm/Group 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.
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.
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.
Overall Number of Participants Analyzed 37 54 10
Measure Type: Count of Participants
Unit of Measure: Participants
End of Treatment Number Analyzed 35 participants 54 participants 10 participants
No Change
34
  97.1%
52
  96.3%
10
 100.0%
Increase
1
   2.9%
1
   1.9%
0
   0.0%
Decrease
0
   0.0%
1
   1.9%
0
   0.0%
Posttreatment Week 12 Number Analyzed 35 participants 54 participants 9 participants
No Change
33
  94.3%
50
  92.6%
9
 100.0%
Increase
2
   5.7%
4
   7.4%
0
   0.0%
Decrease
0
   0.0%
0
   0.0%
0
   0.0%
Posttreatment Week 24 Number Analyzed 35 participants 53 participants 10 participants
No Change
29
  82.9%
47
  88.7%
10
 100.0%
Increase
6
  17.1%
6
  11.3%
0
   0.0%
Decrease
0
   0.0%
0
   0.0%
0
   0.0%
17.Secondary Outcome
Title For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair
Hide 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.
Time Frame Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Female participants in the Safety Analysis Set with available data were analyzed.
Arm/Group Title 12 to < 18 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks 3 to < 6 Years Old - LDV/SOF 12 Weeks
Hide Arm/Group 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.
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.
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.
Overall Number of Participants Analyzed 63 38 24
Measure Type: Count of Participants
Unit of Measure: Participants
End of Treatment Number Analyzed 62 participants 36 participants 21 participants
No Change
52
  83.9%
34
  94.4%
21
 100.0%
Increase
9
  14.5%
2
   5.6%
0
   0.0%
Decrease
1
   1.6%
0
   0.0%
0
   0.0%
Posttreatment Week 12 Number Analyzed 60 participants 34 participants 22 participants
No Change
45
  75.0%
31
  91.2%
22
 100.0%
Increase
15
  25.0%
3
   8.8%
0
   0.0%
Decrease
0
   0.0%
0
   0.0%
0
   0.0%
Posttreatment Week 24 Number Analyzed 61 participants 35 participants 22 participants
No Change
40
  65.6%
27
  77.1%
22
 100.0%
Increase
21
  34.4%
8
  22.9%
0
   0.0%
Decrease
0
   0.0%
0
   0.0%
0
   0.0%
18.Secondary Outcome
Title For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development
Hide 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.
Time Frame Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Female participants in the Safety Analysis Set with available data were analyzed.
Arm/Group Title 12 to < 18 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks 3 to < 6 Years Old - LDV/SOF 12 Weeks
Hide Arm/Group 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.
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.
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.
Overall Number of Participants Analyzed 63 38 24
Measure Type: Count of Participants
Unit of Measure: Participants
End of Treatment Number Analyzed 62 participants 36 participants 21 participants
No Change
53
  85.5%
31
  86.1%
21
 100.0%
Increase
8
  12.9%
5
  13.9%
0
   0.0%
Decrease
1
   1.6%
0
   0.0%
0
   0.0%
Posttreatment Week 12 Number Analyzed 60 participants 34 participants 22 participants
No Change
49
  81.7%
25
  73.5%
21
  95.5%
Increase
11
  18.3%
8
  23.5%
1
   4.5%
Decrease
0
   0.0%
1
   2.9%
0
   0.0%
Posttreatment Week 24 Number Analyzed 61 participants 35 participants 22 participants
No Change
43
  70.5%
21
  60.0%
21
  95.5%
Increase
18
  29.5%
14
  40.0%
1
   4.5%
Decrease
0
   0.0%
0
   0.0%
0
   0.0%
19.Secondary Outcome
Title Acceptability of LDV/SOF Tablets as Measured by the Percentage of Participants Able/Unable to Swallow Placebo Tablet at Day 1
Hide 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.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants between 6 to <18 years old in the Safety Analysis Set who performed the swallowability assessment were analyzed.
Arm/Group Title 12 to < 18 Years Old - LDV/SOF 12 Weeks 6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks
Hide Arm/Group Description:
Participants 12 to < 18 years of age received placebo to match LDV/SOF FDC to assess ability to swallow tablets on Day 1. They then 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.
Participants 6 to < 12 years of age received placebo to match LDV/SOF FDC to assess ability to swallow tablets on Day 1. They then 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.
Overall Number of Participants Analyzed 100 92
Measure Type: Number
Unit of Measure: percentage of participants
Able to Swallow 90/400 mg Placebo Tablet Number Analyzed 100 participants 8 participants
89.0 100.0
Unable to Swallow 90/400 mg Placebo Tablet Number Analyzed 100 participants 8 participants
11.0 0
Able to Swallow 22.5/100 mg Placebo Tablet Number Analyzed 11 participants 84 participants
72.7 98.8
Unable to Swallow 22.5/100 mg Placebo Tablet Number Analyzed 11 participants 84 participants
27.3 1.2
20.Secondary Outcome
Title Acceptability of LDV/SOF Granules as Measured by Palatability at Day 1
Hide 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.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants between 3 to <6 years old in the Safety Analysis Set who performed the palatability test were analyzed.
Arm/Group Title 3 to < 6 Years Old - LDV/SOF 12 Weeks
Hide Arm/Group 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.
Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: percentage of participants
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
Time Frame Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Adverse Event Reporting Description Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
 
Arm/Group Title 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
Hide Arm/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. 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. 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. 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. 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.
All-Cause Mortality
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)   0/89 (0.00%)   0/1 (0.00%)   0/2 (0.00%)   0/34 (0.00%) 
Show Serious Adverse Events Hide 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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)   1/89 (1.12%)   0/1 (0.00%)   0/2 (0.00%)   0/34 (0.00%) 
Gastrointestinal disorders           
Abdominal pain  1  0/100 (0.00%)  1/89 (1.12%)  0/1 (0.00%)  0/2 (0.00%)  0/34 (0.00%) 
Infections and infestations           
Gastroenteritis  1  0/100 (0.00%)  1/89 (1.12%)  0/1 (0.00%)  0/2 (0.00%)  0/34 (0.00%) 
Tooth abscess  1  0/100 (0.00%)  1/89 (1.12%)  0/1 (0.00%)  0/2 (0.00%)  0/34 (0.00%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   62/100 (62.00%)   54/89 (60.67%)   1/1 (100.00%)   2/2 (100.00%)   22/34 (64.71%) 
Ear and labyrinth disorders           
Ear pain  1  0/100 (0.00%)  2/89 (2.25%)  0/1 (0.00%)  1/2 (50.00%)  0/34 (0.00%) 
Gastrointestinal disorders           
Abdominal pain  1  7/100 (7.00%)  14/89 (15.73%)  0/1 (0.00%)  0/2 (0.00%)  2/34 (5.88%) 
Abdominal pain upper  1  7/100 (7.00%)  3/89 (3.37%)  0/1 (0.00%)  0/2 (0.00%)  2/34 (5.88%) 
Diarrhoea  1  13/100 (13.00%)  11/89 (12.36%)  0/1 (0.00%)  0/2 (0.00%)  0/34 (0.00%) 
Mouth ulceration  1  0/100 (0.00%)  2/89 (2.25%)  0/1 (0.00%)  1/2 (50.00%)  1/34 (2.94%) 
Nausea  1  11/100 (11.00%)  9/89 (10.11%)  0/1 (0.00%)  1/2 (50.00%)  1/34 (2.94%) 
Vomiting  1  12/100 (12.00%)  12/89 (13.48%)  0/1 (0.00%)  1/2 (50.00%)  8/34 (23.53%) 
General disorders           
Fatigue  1  13/100 (13.00%)  13/89 (14.61%)  0/1 (0.00%)  1/2 (50.00%)  2/34 (5.88%) 
Pyrexia  1  2/100 (2.00%)  15/89 (16.85%)  0/1 (0.00%)  1/2 (50.00%)  7/34 (20.59%) 
Infections and infestations           
Conjunctivitis  1  0/100 (0.00%)  1/89 (1.12%)  0/1 (0.00%)  0/2 (0.00%)  2/34 (5.88%) 
Ear infection  1  0/100 (0.00%)  0/89 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  2/34 (5.88%) 
Nasopharyngitis  1  7/100 (7.00%)  2/89 (2.25%)  0/1 (0.00%)  1/2 (50.00%)  1/34 (2.94%) 
Pharyngitis streptococcal  1  0/100 (0.00%)  3/89 (3.37%)  0/1 (0.00%)  0/2 (0.00%)  4/34 (11.76%) 
Upper respiratory tract infection  1  5/100 (5.00%)  7/89 (7.87%)  0/1 (0.00%)  0/2 (0.00%)  3/34 (8.82%) 
Injury, poisoning and procedural complications           
Fall  1  0/100 (0.00%)  1/89 (1.12%)  0/1 (0.00%)  1/2 (50.00%)  0/34 (0.00%) 
Skin abrasion  1  1/100 (1.00%)  1/89 (1.12%)  0/1 (0.00%)  0/2 (0.00%)  2/34 (5.88%) 
Musculoskeletal and connective tissue disorders           
Back pain  1  5/100 (5.00%)  3/89 (3.37%)  0/1 (0.00%)  0/2 (0.00%)  0/34 (0.00%) 
Nervous system disorders           
Dizziness  1  2/100 (2.00%)  5/89 (5.62%)  0/1 (0.00%)  0/2 (0.00%)  1/34 (2.94%) 
Headache  1  26/100 (26.00%)  16/89 (17.98%)  0/1 (0.00%)  1/2 (50.00%)  3/34 (8.82%) 
Product Issues           
Product taste abnormal  1  0/100 (0.00%)  0/89 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  3/34 (8.82%) 
Psychiatric disorders           
Insomnia  1  1/100 (1.00%)  1/89 (1.12%)  0/1 (0.00%)  0/2 (0.00%)  2/34 (5.88%) 
Reproductive system and breast disorders           
Dysmenorrhoea  1  5/100 (5.00%)  0/89 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/34 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Cough  1  10/100 (10.00%)  11/89 (12.36%)  1/1 (100.00%)  1/2 (50.00%)  7/34 (20.59%) 
Epistaxis  1  2/100 (2.00%)  2/89 (2.25%)  1/1 (100.00%)  0/2 (0.00%)  2/34 (5.88%) 
Nasal congestion  1  6/100 (6.00%)  5/89 (5.62%)  1/1 (100.00%)  0/2 (0.00%)  2/34 (5.88%) 
Oropharyngeal pain  1  10/100 (10.00%)  10/89 (11.24%)  0/1 (0.00%)  0/2 (0.00%)  1/34 (2.94%) 
Rhinorrhoea  1  2/100 (2.00%)  3/89 (3.37%)  1/1 (100.00%)  0/2 (0.00%)  6/34 (17.65%) 
Skin and subcutaneous tissue disorders           
Dermatitis allergic  1  0/100 (0.00%)  0/89 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  0/34 (0.00%) 
Dermatitis contact  1  4/100 (4.00%)  0/89 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  2/34 (5.88%) 
Ecchymosis  1  2/100 (2.00%)  0/89 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  2/34 (5.88%) 
Rash  1  1/100 (1.00%)  8/89 (8.99%)  0/1 (0.00%)  0/2 (0.00%)  3/34 (8.82%) 
Rash maculo-papular  1  0/100 (0.00%)  0/89 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  0/34 (0.00%) 
Skin odour abnormal  1  0/100 (0.00%)  0/89 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  0/34 (0.00%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gilead Clinical Study Information Center
Organization: Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
EMail: GileadClinicalTrials@gilead.com
Publications of Results:
Kirby B, German P, Kanwar B, Ni L, Lakatos I, Ling J, Mathias A. Pharmacokinetics of Once-Daily Sofosbuvir and Ledipasvir/Sofosbuvir in HCV-Infected Adolescents. Hepatology 2015;62 (S1): 1040A-1041A
Garrison KL, Mathias A, Kersey K, Kanwar B, Ni L, Jain A, et al. Pharmacokinetics of Once-Daily Sofosbuvir and Ledipasvir/Sofosbuvir in HCV-Infected Pediatrics Aged 6 to < 12 Years Old. Hepatology 2016;64 (S1): 436A
Schwarz K, Murray KF, Rosenthal P, Bansal S, Lin CH, Ni L, et al. High Rates of SVR12 in Adolescents Treated with the Combination of Ledipasvir/Sofosbuvir. J Hepatol 2016; 64 (2): S184-S185
K.F. Murray, W. Balistreri, S. Bansal, S. Whitworth, H. Evans, R.P. Gonzalez-Peralta, et al. Ledipasvir/sofosbuvir ± ribavirin for 12 or 24 weeks is safe and effective in children 6-11 years old with chronic hepatitis C infection. J Hepatol 2017;66: S33-S62
Begley R, Meng A, Massetto B, Shao J, Ling J, and Mathias A. Pharmacokinetics of Once Daily Sofosbuvir or Ledipasvir/Sofosbuvir in HCV-Infected Pediatrics Aged 3 to <6 Years Old. Hepatology 2018;68 (S1): 582A.
Schwarz KB, Rosenthal P, Murray KF, Honegger JR, Hardikar W, Hague R, et al. Ledipasvir/Sofosbuvir for 12 Weeks Is Safe and Effective in Children 3 to <6 Years Old with Chronic Hepatitis C Virus Infection. Hepatology 2018;68 (S1): 116A-117A.
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02249182     History of Changes
Other Study ID Numbers: GS-US-337-1116
2014-003578-17 ( EudraCT Number )
First Submitted: September 23, 2014
First Posted: September 25, 2014
Results First Submitted: February 15, 2019
Results First Posted: April 24, 2019
Last Update Posted: April 24, 2019