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Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02175758
Recruitment Status : Completed
First Posted : June 26, 2014
Results First Posted : April 30, 2019
Last Update Posted : April 30, 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: SOF
Drug: RBV
Enrollment 106
Recruitment Details Participants were enrolled at study sites in Australia, Europe, Russia, New Zealand, and the United States. The first participant was screened on 07 July 2014. The last study visit occurred on 13 September 2018.
Pre-assignment Details 135 participants were screened.
Arm/Group Title 12 to < 18 Years Old - SOF+RBV 12 Weeks 12 to < 18 Years Old - SOF+RBV 24 Weeks 6 to < 12 Years Old - SOF+RBV 12 Weeks 6 to < 12 Years Old - SOF+RBV 24 Weeks 3 to < 6 Years Old - SOF+RBV 12 Weeks 3 to < 6 Years Old - SOF+RBV 24 Weeks
Hide Arm/Group Description Participants 12 to < 18 years of age with hepatitis C virus (HCV) genotype 2 received sofosbuvir (SOF) 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + ribavirin (RBV) capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. Participants participating in the Pharmacokinetic (PK) Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration. Participants 12 to < 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 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 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) 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 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration. Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) 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 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 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 4 6 2 10 4 8
Completed 4 6 2 10 4 8
Not Completed 0 0 0 0 0 0
Period Title: Treatment Phase
Started 13 [1] 39 [2] 13 [3] 28 [4] 5 [5] 8
Completed 13 38 13 28 4 8
Not Completed 0 1 0 0 1 0
Reason Not Completed
Lost to Follow-up             0             1             0             0             0             0
Adverse Event             0             0             0             0             1             0
[1]
9 participants enrolled directly into the Treatment Phase, without entering the PK Lead-In Phase.
[2]
33 participants enrolled directly into the Treatment Phase, without entering the PK Lead-In Phase.
[3]
11 participants enrolled directly into the Treatment Phase, without entering the PK Lead-In Phase.
[4]
18 participants enrolled directly into the Treatment Phase, without entering the PK Lead-In Phase.
[5]
1 participant enrolled directly into the Treatment Phase, without entering the PK Lead-In Phase.
Arm/Group Title 12 to < 18 Years Old - SOF+RBV 12 Weeks 12 to < 18 Years Old - SOF+RBV 24 Weeks 6 to < 12 Years Old - SOF+RBV 12 Weeks 6 to < 12 Years Old - SOF+RBV 24 Weeks 3 to < 6 Years Old - SOF+RBV 12 Weeks 3 to < 6 Years Old - SOF+RBV 24 Weeks Total
Hide Arm/Group Description Participants 12 to < 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. Participants 12 to < 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. Participants 6 to < 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. Participants 6 to < 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. Participants 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. Total of all reporting groups
Overall Number of Baseline Participants 13 39 13 28 5 8 106
Hide Baseline Analysis Population Description
Safety Analysis Set included all participants who took at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 39 participants 13 participants 28 participants 5 participants 8 participants 106 participants
15  (1.9) 15  (1.9) 8  (2.1) 9  (1.7) 4  (0.8) 5  (0.8) 11  (4.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 39 participants 13 participants 28 participants 5 participants 8 participants 106 participants
Female
5
  38.5%
16
  41.0%
10
  76.9%
20
  71.4%
4
  80.0%
6
  75.0%
61
  57.5%
Male
8
  61.5%
23
  59.0%
3
  23.1%
8
  28.6%
1
  20.0%
2
  25.0%
45
  42.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 39 participants 13 participants 28 participants 5 participants 8 participants 106 participants
Hispanic or Latino
0
   0.0%
2
   5.1%
2
  15.4%
4
  14.3%
1
  20.0%
0
   0.0%
9
   8.5%
Not Hispanic or Latino
13
 100.0%
36
  92.3%
11
  84.6%
23
  82.1%
4
  80.0%
8
 100.0%
95
  89.6%
Unknown or Not Reported
0
   0.0%
1
   2.6%
0
   0.0%
1
   3.6%
0
   0.0%
0
   0.0%
2
   1.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 13 participants 39 participants 13 participants 28 participants 5 participants 8 participants 106 participants
White
11
  84.6%
36
  92.3%
9
  69.2%
20
  71.4%
3
  60.0%
6
  75.0%
85
  80.2%
Asian
0
   0.0%
1
   2.6%
2
  15.4%
6
  21.4%
0
   0.0%
1
  12.5%
10
   9.4%
Other
0
   0.0%
1
   2.6%
2
  15.4%
2
   7.1%
1
  20.0%
1
  12.5%
7
   6.6%
Black or African American
2
  15.4%
0
   0.0%
0
   0.0%
0
   0.0%
1
  20.0%
0
   0.0%
3
   2.8%
Native Hawaiian or Pacific Islander
0
   0.0%
1
   2.6%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 39 participants 13 participants 28 participants 5 participants 8 participants 106 participants
New Zealand
0
   0.0%
1
   2.6%
0
   0.0%
1
   3.6%
0
   0.0%
0
   0.0%
2
   1.9%
Belgium
0
   0.0%
0
   0.0%
1
   7.7%
1
   3.6%
0
   0.0%
0
   0.0%
2
   1.9%
United States
8
  61.5%
11
  28.2%
8
  61.5%
10
  35.7%
4
  80.0%
5
  62.5%
46
  43.4%
Italy
3
  23.1%
4
  10.3%
2
  15.4%
1
   3.6%
0
   0.0%
1
  12.5%
11
  10.4%
United Kingdom
0
   0.0%
2
   5.1%
1
   7.7%
7
  25.0%
1
  20.0%
1
  12.5%
12
  11.3%
Australia
0
   0.0%
2
   5.1%
1
   7.7%
5
  17.9%
0
   0.0%
1
  12.5%
9
   8.5%
Germany
0
   0.0%
4
  10.3%
0
   0.0%
3
  10.7%
0
   0.0%
0
   0.0%
7
   6.6%
Russia
2
  15.4%
15
  38.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
17
  16.0%
HCV RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 39 participants 13 participants 28 participants 5 participants 8 participants 106 participants
< 800,000 IU/mL
5
  38.5%
13
  33.3%
7
  53.8%
15
  53.6%
2
  40.0%
8
 100.0%
50
  47.2%
≥ 800,000 IU/mL
8
  61.5%
26
  66.7%
6
  46.2%
13
  46.4%
3
  60.0%
0
   0.0%
56
  52.8%
1.Primary Outcome
Title For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of 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 6 to < 18 years of age: predose, 0.5, 1, 2, 3, 4, 8, and 12 hours postdose on Day 7; 3 to < 6 years of age: predose, 2, 4, 8, and 12 hours postdose on Day 7
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 - SOF+RBV 12 or 24 Weeks PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks
Hide Arm/Group Description:
Participants 12 to < 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
Participants 6 to < 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
Participants 3 to < 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
Overall Number of Participants Analyzed 10 10 10
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
9106.0  (2601.96) 7651.2  (1723.32) 10293.7  (1860.57)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 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 129.48
Confidence Interval (2-Sided) 90%
109.96 to 152.48
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 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 109.80
Confidence Interval (2-Sided) 90%
93.25 to 129.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 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 149.67
Confidence Interval (2-Sided) 90%
127.12 to 176.21
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 took at least 1 dose of study drug.
Arm/Group Title 12 to < 18 Years Old - SOF+RBV 12 Weeks 12 to < 18 Years Old - SOF+RBV 24 Weeks 6 to < 12 Years Old - SOF+RBV 12 Weeks 6 to < 12 Years Old - SOF+RBV 24 Weeks 3 to < 6 Years Old - SOF+RBV 12 Weeks 3 to < 6 Years Old - SOF+RBV 24 Weeks
Hide Arm/Group Description:
Participants 12 to < 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 12 to < 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Participants 6 to < 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 6 to < 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Overall Number of Participants Analyzed 13 39 13 28 5 8
Measure Type: Number
Unit of Measure: percentage of participants
0 0 0 0 20.0 0
3.Primary 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 < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Time Frame Posttreatment Week 12
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 (Total) - SOF+RBV 12 or 24 Weeks 3 to < 12 Years Old (Total) - SOF+RBV 12 or 24 Weeks 12 to < 18 Years Old - SOF+RBV 12 Weeks 12 to < 18 Years Old - SOF+RBV 24 Weeks 6 to < 12 Years Old - SOF+RBV 12 Weeks 6 to < 12 Years Old - SOF+RBV 24 Weeks 3 to < 6 Years Old - SOF+RBV 12 Weeks 3 to < 6 Years Old - SOF+RBV 24 Weeks
Hide Arm/Group Description:
Participants 12 to < 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.

Participants 6 to < 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.

Participants 3 to < 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.

Participants 12 to < 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 12 to < 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Participants 6 to < 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 6 to < 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Overall Number of Participants Analyzed 52 54 13 39 13 28 5 8
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
98.1
(89.7 to 100.0)
98.1
(90.1 to 100.0)
100.0
(75.3 to 100.0)
97.4
(86.5 to 99.9)
100.0
(75.3 to 100.0)
100.0
(87.7 to 100.0)
80.0
(28.4 to 99.5)
100.0
(63.1 to 100.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 12 to < 18 Years Old (Total) - SOF+RBV 12 or 24 Weeks
Comments The SVR12 rate for the 12 to < 18 Years Old group was compared with the historical SVR12 rate of 80% using a 2-sided exact 1-sample binomial test at the 0.05 significance level. If superiority was demonstrated in the 12 to < 18 Years Old group, then the SVR12 rate for participants aged 3 to < 12 years would be compared with 80% at the 0.05 significance level.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method 2-sided exact 1-sample binomial test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 3 to < 12 Years Old (Total) - SOF+RBV 12 or 24 Weeks
Comments The SVR12 rate for the 3 to < 12 Years Old group was compared with the historical SVR12 rate of 80% using a 2-sided exact 1-sample binomial test at the 0.05 significance level.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method 2-sided exact 1-sample binomial test
Comments [Not Specified]
4.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, 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 who were enrolled in the PK lead-in phase 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 PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 Weeks PK Lead-in: 12 to < 18 Years Old - SOF+RBV 24 Weeks PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 Weeks PK Lead-in: 6 to < 12 Years Old - SOF+RBV 24 Weeks PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 Weeks PK Lead-in: 3 to < 6 Years Old - SOF+RBV 24 Weeks
Hide Arm/Group Description:
Participants 12 to < 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 12 to < 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Participants 6 to < 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 6 to < 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Overall Number of Participants Analyzed 4 6 2 10 4 8
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Change at Week 1 Number Analyzed 4 participants 6 participants 2 participants 10 participants 4 participants 8 participants
-3.98  (1.056) -4.23  (0.765) -3.82  (0.447) -3.78  (1.234) -4.12  (0.632) -3.53  (0.347)
Change at Week 2 Number Analyzed 4 participants 6 participants 2 participants 9 participants 4 participants 8 participants
-4.84  (0.743) -4.34  (0.758) -4.92  (0.674) -4.56  (1.553) -4.31  (0.846) -3.94  (0.422)
Change at Week 4 Number Analyzed 4 participants 6 participants 2 participants 10 participants 4 participants 8 participants
-4.84  (0.743) -4.34  (0.758) -4.92  (0.674) -4.60  (1.686) -4.42  (1.006) -3.97  (0.453)
Change at Week 8 Number Analyzed 4 participants 6 participants 2 participants 10 participants 4 participants 8 participants
-4.84  (0.743) -4.34  (0.758) -4.92  (0.674) -4.61  (1.700) -4.52  (1.177) -3.97  (0.453)
Change at Week 12 Number Analyzed 4 participants 6 participants 2 participants 10 participants 4 participants 8 participants
-4.84  (0.743) -4.34  (0.758) -4.92  (0.674) -4.61  (1.700) -4.52  (1.177) -3.97  (0.453)
Change at Week 16 Number Analyzed 0 participants 6 participants 0 participants 10 participants 0 participants 8 participants
-4.34  (0.758) -4.61  (1.700) -3.97  (0.453)
Change at Week 20 Number Analyzed 0 participants 6 participants 0 participants 10 participants 0 participants 8 participants
-4.34  (0.758) -4.61  (1.700) -3.97  (0.453)
Change at Week 24 Number Analyzed 0 participants 6 participants 0 participants 10 participants 0 participants 8 participants
-4.34  (0.758) -4.61  (1.700) -3.97  (0.453)
5.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 7
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 - SOF+RBV 12 or 24 Weeks PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks
Hide Arm/Group Description:
Participants 12 to < 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
Participants 6 to < 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
Participants 3 to < 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
Overall Number of Participants Analyzed 10 12 12
Measure Type: Number
Unit of Measure: percentage of participants
0 0 0
6.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 < LLOQ at 4 weeks after stopping study treatment.
Time Frame Posttreatment Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title 12 to < 18 Years Old - SOF+RBV 12 Weeks 12 to < 18 Years Old - SOF+RBV 24 Weeks 6 to < 12 Years Old - SOF+RBV 12 Weeks 6 to < 12 Years Old - SOF+RBV 24 Weeks 3 to < 6 Years Old - SOF+RBV 12 Weeks 3 to < 6 Years Old - SOF+RBV 24 Weeks
Hide Arm/Group Description:
Participants 12 to < 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 12 to < 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Participants 6 to < 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 6 to < 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Overall Number of Participants Analyzed 13 39 13 28 5 8
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100.0
(75.3 to 100.0)
100.0
(91.0 to 100.0)
100.0
(75.3 to 100.0)
100.0
(87.7 to 100.0)
80.0
(28.4 to 99.5)
100.0
(63.1 to 100.0)
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 - SOF+RBV 12 Weeks 12 to < 18 Years Old - SOF+RBV 24 Weeks 6 to < 12 Years Old - SOF+RBV 12 Weeks 6 to < 12 Years Old - SOF+RBV 24 Weeks 3 to < 6 Years Old - SOF+RBV 12 Weeks 3 to < 6 Years Old - SOF+RBV 24 Weeks
Hide Arm/Group Description:
Participants 12 to < 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 12 to < 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Participants 6 to < 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 6 to < 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Overall Number of Participants Analyzed 13 39 13 28 5 8
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100.0
(75.3 to 100.0)
97.4
(86.5 to 99.9)
100.0
(75.3 to 100.0)
100.0
(87.7 to 100.0)
80.0
(28.4 to 99.5)
100.0
(63.1 to 100.0)
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 - SOF+RBV 12 Weeks 12 to < 18 Years Old - SOF+RBV 24 Weeks 6 to < 12 Years Old - SOF+RBV 12 Weeks 6 to < 12 Years Old - SOF+RBV 24 Weeks 3 to < 6 Years Old - SOF+RBV 12 Weeks 3 to < 6 Years Old - SOF+RBV 24 Weeks
Hide Arm/Group Description:
Participants 12 to < 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 12 to < 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Participants 6 to < 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 6 to < 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Overall Number of Participants Analyzed 13 39 13 28 5 8
Measure Type: Number
Unit of Measure: percentage of participants
0 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 - SOF+RBV 12 Weeks 12 to < 18 Years Old - SOF+RBV 24 Weeks 6 to < 12 Years Old - SOF+RBV 12 Weeks 6 to < 12 Years Old - SOF+RBV 24 Weeks 3 to < 6 Years Old - SOF+RBV 12 Weeks 3 to < 6 Years Old - SOF+RBV 24 Weeks
Hide Arm/Group Description:
Participants 12 to < 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 12 to < 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Participants 6 to < 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 6 to < 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Overall Number of Participants Analyzed 13 39 13 28 5 8
Measure Type: Number
Unit of Measure: percentage of participants
0 0 0 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 - SOF+RBV 12 Weeks 12 to < 18 Years Old - SOF+RBV 24 Weeks 6 to < 12 Years Old - SOF+RBV 12 Weeks 6 to < 12 Years Old - SOF+RBV 24 Weeks 3 to < 6 Years Old - SOF+RBV 12 Weeks 3 to < 6 Years Old - SOF+RBV 24 Weeks
Hide Arm/Group Description:
Participants 12 to < 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 12 to < 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Participants 6 to < 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 6 to < 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Overall Number of Participants Analyzed 13 39 13 28 5 8
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Change at Week 1 Number Analyzed 13 participants 38 participants 13 participants 28 participants 4 participants 8 participants
-4.25  (0.986) -4.12  (0.733) -4.12  (0.692) -3.88  (0.928) -4.12  (0.632) -3.53  (0.347)
Change at Week 2 Number Analyzed 13 participants 39 participants 13 participants 27 participants 4 participants 8 participants
-4.74  (0.980) -4.86  (0.702) -4.55  (0.812) -4.51  (1.102) -4.31  (0.846) -3.94  (0.422)
Change at Week 4 Number Analyzed 13 participants 39 participants 13 participants 28 participants 4 participants 8 participants
-4.74  (0.980) -5.01  (0.760) -4.68  (0.843) -4.56  (1.171) -4.42  (1.006) -3.97  (0.453)
Change at Week 8 Number Analyzed 13 participants 39 participants 13 participants 28 participants 4 participants 8 participants
-4.74  (0.980) -5.02  (0.771) -4.68  (0.843) -4.54  (1.191) -4.52  (1.177) -3.97  (0.453)
Change at Week 12 Number Analyzed 13 participants 39 participants 13 participants 28 participants 4 participants 8 participants
-4.74  (0.980) -5.02  (0.771) -4.68  (0.843) -4.57  (1.178) -4.52  (1.177) -3.97  (0.453)
Change at Week 16 Number Analyzed 0 participants 39 participants 0 participants 28 participants 0 participants 8 participants
-5.02  (0.771) -4.57  (1.178) -3.97  (0.453)
Change at Week 20 Number Analyzed 0 participants 39 participants 0 participants 28 participants 0 participants 8 participants
-5.02  (0.771) -4.57  (1.178) -3.97  (0.453)
Change at Week 24 Number Analyzed 0 participants 39 participants 0 participants 28 participants 0 participants 8 participants
-5.02  (0.771) -4.57  (1.178) -3.97  (0.453)
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 - SOF+RBV 12 Weeks 12 to < 18 Years Old - SOF+RBV 24 Weeks 6 to < 12 Years Old - SOF+RBV 12 Weeks 6 to < 12 Years Old - SOF+RBV 24 Weeks 3 to < 6 Years Old - SOF+RBV 12 Weeks 3 to < 6 Years Old - SOF+RBV 24 Weeks
Hide Arm/Group Description:
Participants 12 to < 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 12 to < 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Participants 6 to < 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 6 to < 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Overall Number of Participants Analyzed 13 39 13 28 5 8
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 1 Number Analyzed 13 participants 39 participants 13 participants 28 participants 4 participants 8 participants
30.8
(9.1 to 61.4)
30.8
(17.0 to 47.6)
46.2
(19.2 to 74.9)
39.3
(21.5 to 59.4)
50.0
(6.8 to 93.2)
37.5
(8.5 to 75.5)
Week 2 Number Analyzed 13 participants 39 participants 13 participants 28 participants 4 participants 8 participants
100.0
(75.3 to 100.0)
74.4
(57.9 to 87.0)
76.9
(46.2 to 95.0)
78.6
(59.0 to 91.7)
75.0
(19.4 to 99.4)
87.5
(47.3 to 99.7)
Week 4 Number Analyzed 13 participants 39 participants 13 participants 28 participants 4 participants 8 participants
100.0
(75.3 to 100.0)
92.3
(79.1 to 98.4)
100.0
(75.3 to 100.0)
96.4
(81.7 to 99.9)
75.0
(19.4 to 99.4)
100.0
(63.1 to 100.0)
Week 8 Number Analyzed 13 participants 39 participants 13 participants 28 participants 4 participants 8 participants
100.0
(75.3 to 100.0)
100.0
(91.0 to 100.0)
100.0
(75.3 to 100.0)
96.4
(81.7 to 99.9)
100.0
(39.8 to 100.0)
100.0
(63.1 to 100.0)
Week 12 Number Analyzed 13 participants 39 participants 13 participants 28 participants 4 participants 8 participants
100.0
(75.3 to 100.0)
100.0
(91.0 to 100.0)
100.0
(75.3 to 100.0)
100.0
(87.7 to 100.0)
100.0
(39.8 to 100.0)
100.0
(63.1 to 100.0)
Week 16 Number Analyzed 0 participants 39 participants 0 participants 28 participants 0 participants 8 participants
100.0
(91.0 to 100.0)
100.0
(87.7 to 100.0)
100.0
(63.1 to 100.0)
Week 20 Number Analyzed 0 participants 39 participants 0 participants 28 participants 0 participants 8 participants
100.0
(91.0 to 100.0)
100.0
(87.7 to 100.0)
100.0
(63.1 to 100.0)
Week 24 Number Analyzed 0 participants 39 participants 0 participants 28 participants 0 participants 8 participants
100.0
(91.0 to 100.0)
100.0
(87.7 to 100.0)
100.0
(63.1 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. One participant in the 3 to < 6 Years Old 12 Weeks group had ALT > ULN at Baseline, but had no other available data.
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. One participant in the 3 to < 6 Years Old 12 Weeks group had ALT > ULN at Baseline, but had no other available data.
Arm/Group Title 12 to < 18 Years Old - SOF+RBV 12 Weeks 12 to < 18 Years Old - SOF+RBV 24 Weeks 6 to < 12 Years Old - SOF+RBV 12 Weeks 6 to < 12 Years Old - SOF+RBV 24 Weeks 3 to < 6 Years Old - SOF+RBV 12 Weeks 3 to < 6 Years Old - SOF+RBV 24 Weeks
Hide Arm/Group Description:
Participants 12 to < 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 12 to < 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Participants 6 to < 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 6 to < 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Overall Number of Participants Analyzed 4 22 4 16 0 2
Measure Type: Number
Unit of Measure: percentage of participants
Week 1 Number Analyzed 4 participants 22 participants 4 participants 16 participants 0 participants 2 participants
50.0 63.6 25.0 75.0 100.0
Week 2 Number Analyzed 4 participants 22 participants 3 participants 15 participants 0 participants 2 participants
100.0 90.9 100.0 93.3 100.0
Week 4 Number Analyzed 3 participants 22 participants 4 participants 15 participants 0 participants 2 participants
100.0 95.5 100.0 100.0 100.0
Week 8 Number Analyzed 4 participants 22 participants 3 participants 15 participants 0 participants 2 participants
100.0 95.5 100.0 100.0 100.0
Week 12 Number Analyzed 4 participants 22 participants 4 participants 16 participants 0 participants 2 participants
100.0 100.0 100.0 100.0 100.0
Week 16 Number Analyzed 0 participants 21 participants 0 participants 15 participants 0 participants 2 participants
100.0 100.0 100.0
Week 20 Number Analyzed 0 participants 22 participants 0 participants 16 participants 0 participants 2 participants
100.0 100.0 100.0
Week 24 Number Analyzed 0 participants 21 participants 0 participants 15 participants 0 participants 2 participants
100.0 100.0 100.0
Posttreatment Week 4 Number Analyzed 4 participants 16 participants 3 participants 12 participants 0 participants 2 participants
100.0 100.0 100.0 100.0 100.0
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 - SOF+RBV 12 Weeks 12 to < 18 Years Old - SOF+RBV 24 Weeks 6 to < 12 Years Old - SOF+RBV 12 Weeks 6 to < 12 Years Old - SOF+RBV 24 Weeks 3 to < 6 Years Old - SOF+RBV 12 Weeks 3 to < 6 Years Old - SOF+RBV 24 Weeks
Hide Arm/Group Description:
Participants 12 to < 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 12 to < 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Participants 6 to < 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 6 to < 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Overall Number of Participants Analyzed 13 39 13 28 5 8
Mean (Standard Deviation)
Unit of Measure: centimeters
Change at Week 1 Number Analyzed 13 participants 39 participants 13 participants 28 participants 4 participants 8 participants
0.1  (1.10) 0.0  (0.57) 0.0  (0.57) 0.0  (0.73) 0.3  (1.12) 0.3  (0.75)
Change at Week 2 Number Analyzed 13 participants 39 participants 13 participants 28 participants 4 participants 8 participants
0.1  (1.07) -0.1  (0.59) 0.1  (0.66) 0.0  (0.54) 0.7  (1.09) 0.3  (0.50)
Change at Week 4 Number Analyzed 13 participants 39 participants 13 participants 28 participants 4 participants 8 participants
0.2  (1.20) 0.2  (0.78) 0.3  (0.67) 0.4  (0.74) 0.9  (0.87) 0.5  (0.67)
Change at Week 8 Number Analyzed 13 participants 39 participants 13 participants 28 participants 4 participants 8 participants
0.3  (1.27) 0.2  (0.85) 1.0  (1.00) 0.4  (0.62) 0.9  (0.72) 0.8  (0.51)
Change at Week 12 Number Analyzed 12 participants 39 participants 13 participants 28 participants 4 participants 8 participants
0.5  (1.68) 0.3  (0.95) 0.8  (0.81) 0.7  (0.68) 1.5  (0.45) 1.7  (1.84)
Change at Week 16 Number Analyzed 0 participants 38 participants 0 participants 28 participants 0 participants 8 participants
0.4  (0.91) 1.1  (0.93) 1.8  (0.79)
Change at Week 20 Number Analyzed 0 participants 39 participants 0 participants 28 participants 0 participants 8 participants
0.5  (1.10) 1.6  (1.15) 2.5  (1.01)
Change at Week 24 Number Analyzed 0 participants 36 participants 0 participants 27 participants 0 participants 8 participants
0.8  (1.54) 2.1  (0.88) 2.7  (1.05)
Change at Posttreatment Week 4 Number Analyzed 13 participants 38 participants 13 participants 28 participants 4 participants 8 participants
0.5  (1.79) 0.9  (1.70) 1.4  (0.80) 2.6  (1.17) 1.6  (0.91) 3.5  (0.85)
Change at Posttreatment Week 12 Number Analyzed 12 participants 38 participants 13 participants 28 participants 4 participants 8 participants
1.4  (1.65) 1.3  (1.90) 2.4  (1.02) 3.8  (1.30) 2.8  (1.81) 4.0  (0.95)
Change at Posttreatment Week 24 Number Analyzed 13 participants 37 participants 13 participants 27 participants 3 participants 8 participants
1.6  (1.89) 1.8  (2.83) 4.2  (1.11) 5.1  (1.59) 5.0  (1.61) 5.7  (1.27)
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 - SOF+RBV 12 Weeks 12 to < 18 Years Old - SOF+RBV 24 Weeks 6 to < 12 Years Old - SOF+RBV 12 Weeks 6 to < 12 Years Old - SOF+RBV 24 Weeks 3 to < 6 Years Old - SOF+RBV 12 Weeks 3 to < 6 Years Old - SOF+RBV 24 Weeks
Hide Arm/Group Description:
Participants 12 to < 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 12 to < 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Participants 6 to < 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 6 to < 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
Participants 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
Overall Number of Participants Analyzed 13 39 13 28 5 8
Mean (Standard Deviation)
Unit of Measure: kilograms
Change at Week 1 Number Analyzed 13 participants 39 participants 13 participants 28 participants 4 participants 8 participants
-0.7  (1.28) -0.4  (1.36) 0.2  (0.82) 0.0  (0.55) 0.2  (0.10) -0.2  (0.51)
Change at Week 2 Number Analyzed 13 participants 39 participants 13 participants 28 participants 4 participants 8 participants
-0.2  (0.87) -0.3  (0.99) 0.3  (1.08) 0.0  (0.64) 0.5  (0.21) -0.1  (0.50)
Change at Week 4 Number Analyzed 13 participants 39 participants 13 participants 28 participants 4 participants 8 participants
-0.2  (1.67) -0.1  (1.15) 0.4  (0.90) 0.1  (0.90) 0.0  (0.22) -0.1  (0.49)
Change at Week 8 Number Analyzed 13 participants 39 participants 13 participants 28 participants 4 participants 8 participants
-0.5  (2.39) 0.0  (1.53) 0.6  (1.57) 0.1  (1.21) 0.3  (0.14) 0.0  (0.55)
Change at Week 12 Number Analyzed 13 participants 39 participants 13 participants 28 participants 4 participants 8 participants
-0.4  (2.62) -0.1  (2.01) 0.9  (2.15) 0.5  (1.35) 0.3  (0.22) 0.1  (0.85)
Change at Week 16 Number Analyzed 0 participants 38 participants 0 participants 28 participants 0 participants 8 participants
0.2  (2.35) 0.6  (1.34) 0.1  (0.76)
Change at Week 20 Number Analyzed 0 participants 39 participants 0 participants 28 participants 0 participants 8 participants
0.1  (2.65) 0.9  (1.59) 0.4  (0.86)
Change at Week 24 Number Analyzed 0 participants 36 participants 0 participants 27 participants 0 participants 8 participants
0.5  (3.13) 1.2  (1.91) 0.4  (1.03)
Change at Posttreatment Week 4 Number Analyzed 13 participants 38 participants 13 participants 28 participants 4 participants 8 participants
-0.3  (3.19) 0.9  (3.24) 1.2  (2.20) 1.3  (2.19) 0.5  (0.27) 0.7  (1.05)
Change at Posttreatment Week 12 Number Analyzed 13 participants 38 participants 13 participants 28 participants 4 participants 8 participants
0.9  (2.69) 2.1  (3.73) 2.1  (3.28) 2.2  (2.21) 1.0  (0.88) 0.9  (1.12)
Change at Posttreatment Week 24 Number Analyzed 13 participants 37 participants 13 participants 27 participants 3 participants 8 participants
2.5  (4.98) 3.0  (4.62) 3.8  (3.67) 3.5  (2.42) 1.3  (1.10) 1.7  (1.28)
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 - SOF+RBV 12 or 24 Weeks 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks
Hide Arm/Group Description:
Male participants 12 to < 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
Male participants 6 to < 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
Male participants 3 to < 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
Overall Number of Participants Analyzed 31 11 3
Measure Type: Count of Participants
Unit of Measure: Participants
End of Treatment Number Analyzed 31 participants 11 participants 3 participants
No Change
23
  74.2%
10
  90.9%
3
 100.0%
Increase
8
  25.8%
1
   9.1%
0
   0.0%
Decrease
0
   0.0%
0
   0.0%
0
   0.0%
Posttreatment Week 12 Number Analyzed 30 participants 11 participants 3 participants
No Change
20
  66.7%
9
  81.8%
3
 100.0%
Increase
10
  33.3%
2
  18.2%
0
   0.0%
Decrease
0
   0.0%
0
   0.0%
0
   0.0%
Posttreatment Week 24 Number Analyzed 31 participants 11 participants 3 participants
No Change
20
  64.5%
9
  81.8%
3
 100.0%
Increase
11
  35.5%
2
  18.2%
0
   0.0%
Decrease
0
   0.0%
0
   0.0%
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 - SOF+RBV 12 or 24 Weeks 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks
Hide Arm/Group Description:
Male participants 12 to < 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
Male participants 6 to < 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
Male participants 3 to < 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
Overall Number of Participants Analyzed 31 11 3
Measure Type: Count of Participants
Unit of Measure: Participants
End of Treatment Number Analyzed 31 participants 11 participants 3 participants
No Change
24
  77.4%
11
 100.0%
3
 100.0%
Increase
7
  22.6%
0
   0.0%
0
   0.0%
Decrease
0
   0.0%
0
   0.0%
0
   0.0%
Posttreatment Week 12 Number Analyzed 30 participants 11 participants 3 participants
No Change
21
  70.0%
10
  90.9%
3
 100.0%
Increase
9
  30.0%
1
   9.1%
0
   0.0%
Decrease
0
   0.0%
0
   0.0%
0
   0.0%
Posttreatment Week 24 Number Analyzed 31 participants 11 participants 3 participants
No Change
20
  64.5%
9
  81.8%
3
 100.0%
Increase
11
  35.5%
2
  18.2%
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 - SOF+RBV 12 or 24 Weeks 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks
Hide Arm/Group Description:
Female participants 12 to < 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
Female participants 6 to < 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
Female participants 3 to < 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
Overall Number of Participants Analyzed 21 30 8
Measure Type: Count of Participants
Unit of Measure: Participants
End of Treatment Number Analyzed 21 participants 30 participants 8 participants
No Change
20
  95.2%
24
  80.0%
8
 100.0%
Increase
1
   4.8%
6
  20.0%
0
   0.0%
Decrease
0
   0.0%
0
   0.0%
0
   0.0%
Posttreatment Week 12 Number Analyzed 20 participants 29 participants 8 participants
No Change
18
  90.0%
23
  79.3%
8
 100.0%
Increase
2
  10.0%
6
  20.7%
0
   0.0%
Decrease
0
   0.0%
0
   0.0%
0
   0.0%
Posttreatment Week 24 Number Analyzed 20 participants 30 participants 8 participants
No Change
18
  90.0%
22
  73.3%
8
 100.0%
Increase
2
  10.0%
8
  26.7%
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 - SOF+RBV 12 or 24 Weeks 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks
Hide Arm/Group Description:
Female participants 12 to < 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
Female participants 6 to < 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
Female participants 3 to < 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
Overall Number of Participants Analyzed 21 30 8
Measure Type: Count of Participants
Unit of Measure: Participants
End of Treatment Number Analyzed 21 participants 30 participants 8 participants
No Change
20
  95.2%
24
  80.0%
8
 100.0%
Increase
1
   4.8%
5
  16.7%
0
   0.0%
Decrease
0
   0.0%
1
   3.3%
0
   0.0%
Posttreatment Week 12 Number Analyzed 20 participants 29 participants 8 participants
No Change
17
  85.0%
24
  82.8%
8
 100.0%
Increase
3
  15.0%
5
  17.2%
0
   0.0%
Decrease
0
   0.0%
0
   0.0%
0
   0.0%
Posttreatment Week 24 Number Analyzed 20 participants 30 participants 8 participants
No Change
16
  80.0%
19
  63.3%
8
 100.0%
Increase
4
  20.0%
11
  36.7%
0
   0.0%
Decrease
0
   0.0%
0
   0.0%
0
   0.0%
19.Secondary Outcome
Title For the Treatment Phase, Palatability of SOF Granules at Day 1 as Assessed by the Percentage of Participants Able/Unable to Taste the SOF Oral Granules
Hide Description Participants were asked if they were able to taste the SOF oral granules.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set who performed the palatability assessment were analyzed.
Arm/Group Title 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks
Hide Arm/Group Description:
Participants 12 to < 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
Participants 6 to < 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
Participants 3 to < 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
Overall Number of Participants Analyzed 1 7 12
Measure Type: Number
Unit of Measure: percentage of participants
Able to Taste SOF Granules: Yes 0 42.9 75.0
Able to Taste SOF Granules: No 100.0 57.1 25.0
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 took at least 1 dose of study drug.
 
Arm/Group Title 12 to < 18 Years Old - SOF+RBV 12 Weeks 12 to < 18 Years Old - SOF+RBV 24 Weeks 6 to < 12 Years Old - SOF+RBV 12 Weeks 6 to < 12 Years Old - SOF+RBV 24 Weeks 3 to < 6 Years Old - SOF+RBV 12 Weeks 3 to < 6 Years Old - SOF+RBV 24 Weeks
Hide Arm/Group Description Participants 12 to < 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. Participants 12 to < 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. Participants 6 to < 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. Participants 6 to < 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. Participants 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
All-Cause Mortality
12 to < 18 Years Old - SOF+RBV 12 Weeks 12 to < 18 Years Old - SOF+RBV 24 Weeks 6 to < 12 Years Old - SOF+RBV 12 Weeks 6 to < 12 Years Old - SOF+RBV 24 Weeks 3 to < 6 Years Old - SOF+RBV 12 Weeks 3 to < 6 Years Old - SOF+RBV 24 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/39 (0.00%)   0/13 (0.00%)   0/28 (0.00%)   0/5 (0.00%)   0/8 (0.00%) 
Hide Serious Adverse Events
12 to < 18 Years Old - SOF+RBV 12 Weeks 12 to < 18 Years Old - SOF+RBV 24 Weeks 6 to < 12 Years Old - SOF+RBV 12 Weeks 6 to < 12 Years Old - SOF+RBV 24 Weeks 3 to < 6 Years Old - SOF+RBV 12 Weeks 3 to < 6 Years Old - SOF+RBV 24 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/39 (0.00%)   0/13 (0.00%)   0/28 (0.00%)   0/5 (0.00%)   1/8 (12.50%) 
Injury, poisoning and procedural complications             
Accidental overdose  1  0/13 (0.00%)  0/39 (0.00%)  0/13 (0.00%)  0/28 (0.00%)  0/5 (0.00%)  1/8 (12.50%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
12 to < 18 Years Old - SOF+RBV 12 Weeks 12 to < 18 Years Old - SOF+RBV 24 Weeks 6 to < 12 Years Old - SOF+RBV 12 Weeks 6 to < 12 Years Old - SOF+RBV 24 Weeks 3 to < 6 Years Old - SOF+RBV 12 Weeks 3 to < 6 Years Old - SOF+RBV 24 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/13 (92.31%)   27/39 (69.23%)   9/13 (69.23%)   24/28 (85.71%)   5/5 (100.00%)   8/8 (100.00%) 
Blood and lymphatic system disorders             
Lymphadenopathy  1  0/13 (0.00%)  1/39 (2.56%)  0/13 (0.00%)  2/28 (7.14%)  0/5 (0.00%)  0/8 (0.00%) 
Ear and labyrinth disorders             
Ear pain  1  0/13 (0.00%)  0/39 (0.00%)  1/13 (7.69%)  1/28 (3.57%)  0/5 (0.00%)  0/8 (0.00%) 
Motion sickness  1  0/13 (0.00%)  0/39 (0.00%)  0/13 (0.00%)  1/28 (3.57%)  0/5 (0.00%)  1/8 (12.50%) 
Gastrointestinal disorders             
Abdominal pain  1  0/13 (0.00%)  0/39 (0.00%)  0/13 (0.00%)  3/28 (10.71%)  0/5 (0.00%)  0/8 (0.00%) 
Abdominal pain lower  1  0/13 (0.00%)  3/39 (7.69%)  0/13 (0.00%)  0/28 (0.00%)  0/5 (0.00%)  0/8 (0.00%) 
Abdominal pain upper  1  2/13 (15.38%)  2/39 (5.13%)  1/13 (7.69%)  0/28 (0.00%)  1/5 (20.00%)  0/8 (0.00%) 
Anal pruritus  1  0/13 (0.00%)  0/39 (0.00%)  0/13 (0.00%)  0/28 (0.00%)  0/5 (0.00%)  1/8 (12.50%) 
Diarrhoea  1  2/13 (15.38%)  1/39 (2.56%)  1/13 (7.69%)  3/28 (10.71%)  2/5 (40.00%)  3/8 (37.50%) 
Epigastric discomfort  1  0/13 (0.00%)  0/39 (0.00%)  0/13 (0.00%)  0/28 (0.00%)  0/5 (0.00%)  1/8 (12.50%) 
Gastrooesophageal reflux disease  1  1/13 (7.69%)  0/39 (0.00%)  0/13 (0.00%)  0/28 (0.00%)  0/5 (0.00%)  0/8 (0.00%) 
Mouth ulceration  1  0/13 (0.00%)  0/39 (0.00%)  1/13 (7.69%)  0/28 (0.00%)  0/5 (0.00%)  1/8 (12.50%) 
Nausea  1  3/13 (23.08%)  11/39 (28.21%)  0/13 (0.00%)  4/28 (14.29%)  0/5 (0.00%)  1/8 (12.50%) 
Oral contusion  1  0/13 (0.00%)  0/39 (0.00%)  0/13 (0.00%)  0/28 (0.00%)  0/5 (0.00%)  1/8 (12.50%) 
Tooth loss  1  0/13 (0.00%)  0/39 (0.00%)  0/13 (0.00%)  0/28 (0.00%)  0/5 (0.00%)  1/8 (12.50%) 
Toothache  1  0/13 (0.00%)  1/39 (2.56%)  1/13 (7.69%)  1/28 (3.57%)  0/5 (0.00%)  0/8 (0.00%) 
Vomiting  1  1/13 (7.69%)  3/39 (7.69%)  2/13 (15.38%)  11/28 (39.29%)  3/5 (60.00%)  3/8 (37.50%) 
General disorders             
Asthenia  1  1/13 (7.69%)  5/39 (12.82%)  1/13 (7.69%)  0/28 (0.00%)  0/5 (0.00%)  0/8 (0.00%) 
Fatigue  1  0/13 (0.00%)  4/39 (10.26%)  3/13 (23.08%)  5/28 (17.86%)  1/5 (20.00%)  1/8 (12.50%) 
Influenza like illness  1  0/13 (0.00%)  0/39 (0.00%)  0/13 (0.00%)  0/28 (0.00%)  0/5 (0.00%)  1/8 (12.50%) 
Malaise  1  0/13 (0.00%)  0/39 (0.00%)  1/13 (7.69%)  0/28 (0.00%)  0/5 (0.00%)  0/8 (0.00%) 
Pyrexia  1  0/13 (0.00%)  0/39 (0.00%)  0/13 (0.00%)  4/28 (14.29%)  1/5 (20.00%)  0/8 (0.00%) 
Immune system disorders             
Seasonal allergy  1  0/13 (0.00%)  0/39 (0.00%)  0/13 (0.00%)  0/28 (0.00%)  1/5 (20.00%)  0/8 (0.00%) 
Infections and infestations             
Conjunctivitis viral  1  0/13 (0.00%)  0/39 (0.00%)  0/13 (0.00%)  0/28 (0.00%)  1/5 (20.00%)  0/8 (0.00%) 
Ear infection  1  0/13 (0.00%)  2/39 (5.13%)  0/13 (0.00%)  0/28 (0.00%)  0/5 (0.00%)  1/8 (12.50%) 
Folliculitis  1  0/13 (0.00%)  0/39 (0.00%)  0/13 (0.00%)  0/28 (0.00%)  0/5 (0.00%)  1/8 (12.50%) 
Fungal skin infection  1  1/13 (7.69%)  0/39 (0.00%)  0/13 (0.00%)  0/28 (0.00%)  0/5 (0.00%)  0/8 (0.00%) 
Gastroenteritis  1  0/13 (0.00%)  0/39 (0.00%)  0/13 (0.00%)  3/28 (10.71%)  0/5 (0.00%)  0/8 (0.00%) 
Impetigo  1  0/13 (0.00%)  2/39 (5.13%)  0/13 (0.00%)  0/28 (0.00%)  0/5 (0.00%)  1/8 (12.50%) 
Influenza  1  0/13 (0.00%)  2/39 (5.13%)  0/13 (0.00%)  1/28 (3.57%)  0/5 (0.00%)  0/8 (0.00%) 
Nasopharyngitis  1  0/13 (0.00%)  3/39 (7.69%)  1/13 (7.69%)  4/28 (14.29%)  0/5 (0.00%)  0/8 (0.00%) 
Oral herpes  1  1/13 (7.69%)  2/39 (5.13%)  0/13 (0.00%)  1/28 (3.57%)  0/5 (0.00%)  0/8 (0.00%) 
Pharyngitis  1  1/13 (7.69%)  0/39 (0.00%)  0/13 (0.00%)  0/28 (0.00%)  0/5 (0.00%)  0/8 (0.00%) 
Respiratory tract infection viral  1  0/13 (0.00%)  0/39 (0.00%)  1/13 (7.69%)  1/28 (3.57%)  0/5 (0.00%)  0/8 (0.00%) 
Rhinitis  1  0/13 (0.00%)  1/39 (2.56%)  0/13 (0.00%)  2/28 (7.14%)  0/5 (0.00%)  0/8 (0.00%) 
Tinea infection  1  0/13 (0.00%)  1/39 (2.56%)  0/13 (0.00%)  0/28 (0.00%)  1/5 (20.00%)  0/8 (0.00%) 
Upper respiratory tract infection  1  0/13 (0.00%)  2/39 (5.13%)  0/13 (0.00%)  2/28 (7.14%)  0/5 (0.00%)  1/8 (12.50%) 
Urinary tract infection  1  1/13 (7.69%)  1/39 (2.56%)  0/13 (0.00%)  0/28 (0.00%)  0/5 (0.00%)  0/8 (0.00%) 
Injury, poisoning and procedural complications             
Arthropod bite  1  0/13 (0.00%)  0/39 (0.00%)  0/13 (0.00%)  0/28 (0.00%)  0/5 (0.00%)  2/8 (25.00%) 
Contusion  1  0/13 (0.00%)  1/39 (2.56%)  0/13 (0.00%)  3/28 (10.71%)  0/5 (0.00%)  0/8 (0.00%) 
Fall  1  0/13 (0.00%)  0/39 (0.00%)  0/13 (0.00%)  1/28 (3.57%)  0/5 (0.00%)  1/8 (12.50%) 
Ligament injury  1  1/13 (7.69%)  0/39 (0.00%)  0/13 (0.00%)  0/28 (0.00%)  0/5 (0.00%)  0/8 (0.00%) 
Product use issue  1  0/13 (0.00%)  0/39 (0.00%)  0/13 (0.00%)  0/28 (0.00%)  1/5 (20.00%)  0/8 (0.00%) 
Road traffic accident  1  0/13 (0.00%)  0/39 (0.00%)  0/13 (0.00%)  0/28 (0.00%)  0/5 (0.00%)  1/8 (12.50%) 
Scratch  1  1/13 (7.69%)  0/39 (0.00%)  0/13 (0.00%)  1/28 (3.57%)  0/5 (0.00%)  0/8 (0.00%) 
Investigations             
Blood creatine phosphokinase increased  1  1/13 (7.69%)  0/39 (0.00%)  0/13 (0.00%)  0/28 (0.00%)  0/5 (0.00%)  0/8 (0.00%) 
Cardiac murmur  1  0/13 (0.00%)  0/39 (0.00%)  1/13 (7.69%)  1/28 (3.57%)  0/5 (0.00%)  0/8 (0.00%) 
Weight decreased  1  1/13 (7.69%)  0/39 (0.00%)  1/13 (7.69%)  1/28 (3.57%)  0/5 (0.00%)  0/8 (0.00%) 
Metabolism and nutrition disorders             
Decreased appetite  1  1/13 (7.69%)  2/39 (5.13%)  2/13 (15.38%)  2/28 (7.14%)  0/5 (0.00%)  3/8 (37.50%) 
Musculoskeletal and connective tissue disorders             
Arthralgia  1  0/13 (0.00%)  0/39 (0.00%)  0/13 (0.00%)  2/28 (7.14%)  0/5 (0.00%)  0/8 (0.00%) 
Joint swelling  1  1/13 (7.69%)  0/39 (0.00%)  0/13 (0.00%)  0/28 (0.00%)  0/5 (0.00%)  0/8 (0.00%) 
Muscle spasms  1  1/13 (7.69%)  0/39 (0.00%)  0/13 (0.00%)  1/28 (3.57%)  0/5 (0.00%)  0/8 (0.00%) 
Muscular weakness  1  1/13 (7.69%)  0/39 (0.00%)  0/13 (0.00%)  0/28 (0.00%)  0/5 (0.00%)  0/8 (0.00%) 
Myalgia  1  0/13 (0.00%)  0/39 (0.00%)  0/13 (0.00%)  2/28 (7.14%)  0/5 (0.00%)  0/8 (0.00%) 
Pain in extremity  1  0/13 (0.00%)  1/39 (2.56%)  0/13 (0.00%)  2/28 (7.14%)  0/5 (0.00%)  0/8 (0.00%) 
Nervous system disorders             
Dizziness  1  0/13 (0.00%)  4/39 (10.26%)  0/13 (0.00%)  1/28 (3.57%)  0/5 (0.00%)  0/8 (0.00%) 
Headache  1  3/13 (23.08%)  9/39 (23.08%)  4/13 (30.77%)  8/28 (28.57%)  0/5 (0.00%)  0/8 (0.00%) 
Migraine  1  0/13 (0.00%)  0/39 (0.00%)  0/13 (0.00%)  2/28 (7.14%)  0/5 (0.00%)  0/8 (0.00%) 
Presyncope  1  1/13 (7.69%)  0/39 (0.00%)  0/13 (0.00%)  0/28 (0.00%)  0/5 (0.00%)  0/8 (0.00%) 
Product Issues             
Product taste abnormal  1  0/13 (0.00%)  0/39 (0.00%)  0/13 (0.00%)  1/28 (3.57%)  1/5 (20.00%)  0/8 (0.00%) 
Psychiatric disorders             
Insomnia  1  0/13 (0.00%)  1/39 (2.56%)  1/13 (7.69%)  1/28 (3.57%)  0/5 (0.00%)  0/8 (0.00%) 
Irritability  1  1/13 (7.69%)  0/39 (0.00%)  1/13 (7.69%)  0/28 (0.00%)  1/5 (20.00%)  0/8 (0.00%) 
Middle insomnia  1  0/13 (0.00%)  0/39 (0.00%)  0/13 (0.00%)  0/28 (0.00%)  1/5 (20.00%)  0/8 (0.00%) 
Mood swings  1  0/13 (0.00%)  2/39 (5.13%)  0/13 (0.00%)  1/28 (3.57%)  0/5 (0.00%)  0/8 (0.00%) 
Reproductive system and breast disorders             
Dysmenorrhoea  1  0/13 (0.00%)  2/39 (5.13%)  0/13 (0.00%)  0/28 (0.00%)  0/5 (0.00%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Cough  1  0/13 (0.00%)  3/39 (7.69%)  1/13 (7.69%)  7/28 (25.00%)  1/5 (20.00%)  0/8 (0.00%) 
Epistaxis  1  0/13 (0.00%)  1/39 (2.56%)  1/13 (7.69%)  1/28 (3.57%)  0/5 (0.00%)  1/8 (12.50%) 
Oropharyngeal pain  1  0/13 (0.00%)  4/39 (10.26%)  0/13 (0.00%)  4/28 (14.29%)  0/5 (0.00%)  1/8 (12.50%) 
Pharyngeal erythema  1  0/13 (0.00%)  0/39 (0.00%)  0/13 (0.00%)  0/28 (0.00%)  0/5 (0.00%)  1/8 (12.50%) 
Rhinorrhoea  1  1/13 (7.69%)  2/39 (5.13%)  1/13 (7.69%)  3/28 (10.71%)  0/5 (0.00%)  1/8 (12.50%) 
Sinus congestion  1  0/13 (0.00%)  0/39 (0.00%)  0/13 (0.00%)  2/28 (7.14%)  0/5 (0.00%)  0/8 (0.00%) 
Upper respiratory tract congestion  1  0/13 (0.00%)  0/39 (0.00%)  0/13 (0.00%)  0/28 (0.00%)  1/5 (20.00%)  0/8 (0.00%) 
Skin and subcutaneous tissue disorders             
Acne  1  1/13 (7.69%)  1/39 (2.56%)  0/13 (0.00%)  0/28 (0.00%)  0/5 (0.00%)  0/8 (0.00%) 
Alopecia  1  0/13 (0.00%)  2/39 (5.13%)  0/13 (0.00%)  0/28 (0.00%)  1/5 (20.00%)  0/8 (0.00%) 
Erythema  1  0/13 (0.00%)  0/39 (0.00%)  0/13 (0.00%)  0/28 (0.00%)  0/5 (0.00%)  1/8 (12.50%) 
Pruritus  1  1/13 (7.69%)  1/39 (2.56%)  1/13 (7.69%)  1/28 (3.57%)  0/5 (0.00%)  1/8 (12.50%) 
Rash  1  1/13 (7.69%)  3/39 (7.69%)  0/13 (0.00%)  2/28 (7.14%)  0/5 (0.00%)  0/8 (0.00%) 
Rash papular  1  1/13 (7.69%)  0/39 (0.00%)  0/13 (0.00%)  0/28 (0.00%)  0/5 (0.00%)  0/8 (0.00%) 
Skin exfoliation  1  0/13 (0.00%)  2/39 (5.13%)  0/13 (0.00%)  0/28 (0.00%)  0/5 (0.00%)  0/8 (0.00%) 
Surgical and medical procedures             
Tooth extraction  1  1/13 (7.69%)  0/39 (0.00%)  0/13 (0.00%)  0/28 (0.00%)  0/5 (0.00%)  0/8 (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 [Poster 1707]. American Association for the Study of Liver Diseases (AASLD); 2015 November 13-17, San Francisco, USA. 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 [Poster 878]. American Association for the Study of Liver Diseases (AASLD); 2016 11-15 November; Boston, MA. Hepatology 2016;64 (S1): 436A
Schwarz KB, Rosenthal P, Gonzales-Peralta RP, Jonas MM, Balistreri WF, Lin CH, et al. Sofosbuvir + Ribavirin for 12 or 24 Weeks Is Safe and Effective in Adolescents with Genotype 2 or Genotype 3 Chronic Hepatitis C Infection. Hepatology 2016; 63 (Suppl 1): abstract 706.
Rosenthal P, Schwarz KB, Gonzales-Peralta RP, Lin CH, Kelly DA, Nightingale S, et al. Sofosbuvir + Ribavirin for 12 or 24 Weeks Is Safe and Effective in Children 3 to <12 Years Old with Genotype 2 or Genotype 3 Chronic Hepatitis C Infection. Hepatology 2018; 68 (Suppl 1): abstract 1844.
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02175758    
Other Study ID Numbers: GS-US-334-1112
2014-002283-32 ( EudraCT Number )
First Submitted: June 24, 2014
First Posted: June 26, 2014
Results First Submitted: February 28, 2019
Results First Posted: April 30, 2019
Last Update Posted: April 30, 2019