Hepatitis C Virus Infection
Conditions
Brief summary
This study will have two parts as follows: The PK Lead-in Phase of the study will evaluate the steady state pharmacokinetics (PK) and confirm the dose of sofosbuvir (SOF) in hepatitis C virus (HCV)-infected pediatric participants. The PK Lead-in Phase will also evaluate the safety and tolerability of 7 days of dosing of SOF+ribavirin (RBV) in HCV-infected pediatric participants. The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate SOF dosage levels. Participants from the PK Lead-in Phase will immediately rollover into the Treatment Phase with no interruption of study drug administration. The Treatment Phase will evaluate the antiviral efficacy, safety, and tolerability of SOF+RBV for 12 or 24 weeks in pediatric participants with genotype 2 or 3 HCV infection, respectively.
Interventions
DRUGSOF
SOF administered orally once daily
DRUGRBV
RBV oral solution or capsules will be administered orally in a divided daily dose based on weight
Sponsors
Gilead Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Consent of parent or legal guardian required * Chronic HCV infection genotype 2 or 3 * Screening laboratory values within defined thresholds * PK Lead-in only: all individuals must be treatment naive Key
Exclusion criteria
* History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol * Co-infection with HIV, acute hepatitis A virus, or hepatitis B virus * Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage) * Pregnant or nursing females * Known hypersensitivity to study medication * Use of any prohibited concomitant medications as within 28 days of the Day 1 visit Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF) | 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 | AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). |
| Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase | Up to 24 weeks | — |
| For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12) | Posttreatment Week 12 | SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4) | Posttreatment Week 4 | SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment. |
| For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) | Posttreatment Week 24 | SVR24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment. |
| For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough | Up to 24 weeks | Viral breakthrough was defined as having confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment. |
| For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse | Up to Posttreatment Week 24 | Viral relapse was defined as having confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit. |
| For the Treatment Phase, Change From Baseline in HCV RNA | Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only) | — |
| For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | 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 | 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. |
| For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only) | — |
| For the Treatment Phase, Change From Baseline in Weight | 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 | — |
| For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24 | 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. |
| For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24 | 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. |
| For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24 | 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. |
| For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24 | 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. |
| 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 | Day 1 | Participants were asked if they were able to taste the SOF oral granules. |
| For the Treatment Phase, Change From Baseline in Height | 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 | — |
| For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Baseline; Weeks 1, 2, 4, 8, and 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only) | — |
| Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase | Up to Day 7 | — |
Countries
Australia, Belgium, Germany, Italy, New Zealand, Russia, United Kingdom, United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 12 to < 18 Years Old - SOF+RBV 12 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. | 13 |
| 12 to < 18 Years Old - SOF+RBV 24 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. | 39 |
| 6 to < 12 Years Old - SOF+RBV 12 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. | 13 |
| 6 to < 12 Years Old - SOF+RBV 24 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. | 28 |
| 3 to < 6 Years Old - SOF+RBV 12 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. | 5 |
| 3 to < 6 Years Old - SOF+RBV 24 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. | 8 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Treatment Phase | Adverse Event | 0 | 0 | 0 | 0 | 1 | 0 |
| Treatment Phase | Lost to Follow-up | 0 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | 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 |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 15 years STANDARD_DEVIATION 1.9 | 15 years STANDARD_DEVIATION 1.9 | 8 years STANDARD_DEVIATION 2.1 | 9 years STANDARD_DEVIATION 1.7 | 4 years STANDARD_DEVIATION 0.8 | 5 years STANDARD_DEVIATION 0.8 | 11 years STANDARD_DEVIATION 4.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants | 4 Participants | 1 Participants | 0 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 36 Participants | 11 Participants | 23 Participants | 4 Participants | 8 Participants | 95 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| HCV RNA Category < 800,000 IU/mL | 5 Participants | 13 Participants | 7 Participants | 15 Participants | 2 Participants | 8 Participants | 50 Participants |
| HCV RNA Category ≥ 800,000 IU/mL | 8 Participants | 26 Participants | 6 Participants | 13 Participants | 3 Participants | 0 Participants | 56 Participants |
| Race/Ethnicity, Customized Race Asian | 0 Participants | 1 Participants | 2 Participants | 6 Participants | 0 Participants | 1 Participants | 10 Participants |
| Race/Ethnicity, Customized Race Black or African American | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Other | 0 Participants | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 7 Participants |
| Race/Ethnicity, Customized Race White | 11 Participants | 36 Participants | 9 Participants | 20 Participants | 3 Participants | 6 Participants | 85 Participants |
| Region of Enrollment Australia | 0 Participants | 2 Participants | 1 Participants | 5 Participants | 0 Participants | 1 Participants | 9 Participants |
| Region of Enrollment Belgium | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Region of Enrollment Germany | 0 Participants | 4 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 7 Participants |
| Region of Enrollment Italy | 3 Participants | 4 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 11 Participants |
| Region of Enrollment New Zealand | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Region of Enrollment Russia | 2 Participants | 15 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 17 Participants |
| Region of Enrollment United Kingdom | 0 Participants | 2 Participants | 1 Participants | 7 Participants | 1 Participants | 1 Participants | 12 Participants |
| Region of Enrollment United States | 8 Participants | 11 Participants | 8 Participants | 10 Participants | 4 Participants | 5 Participants | 46 Participants |
| Sex: Female, Male Female | 5 Participants | 16 Participants | 10 Participants | 20 Participants | 4 Participants | 6 Participants | 61 Participants |
| Sex: Female, Male Male | 8 Participants | 23 Participants | 3 Participants | 8 Participants | 1 Participants | 2 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 39 | 0 / 13 | 0 / 28 | 0 / 5 | 0 / 8 |
| other Total, other adverse events | 12 / 13 | 27 / 39 | 9 / 13 | 24 / 28 | 5 / 5 | 8 / 8 |
| serious Total, serious adverse events | 0 / 13 | 0 / 39 | 0 / 13 | 0 / 28 | 0 / 5 | 1 / 8 |
Outcome results
Primary
For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF)
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF) | 9106.0 h*ng/mL | Standard Deviation 2601.96 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF) | 7651.2 h*ng/mL | Standard Deviation 1723.32 |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF) | 10293.7 h*ng/mL | Standard Deviation 1860.57 |
Comparison: 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.90% CI: [109.96, 152.48]
Comparison: 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.90% CI: [93.25, 129.29]
Comparison: 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.90% CI: [127.12, 176.21]
Primary
For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12)
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
Population: Full Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12) | 98.1 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12) | 98.1 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12) | 100.0 percentage of participants |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12) | 97.4 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12) | 100.0 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12) | 100.0 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12) | 80.0 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12) | 100.0 percentage of participants |
Comparison: 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.p-value: <0.0012-sided exact 1-sample binomial test
Comparison: 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.p-value: <0.0012-sided exact 1-sample binomial test
Primary
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase
Time frame: Up to 24 weeks
Population: Safety Analysis Set included all participants who took at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase | 0 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase | 0 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase | 0 percentage of participants |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase | 0 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase | 20.0 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase | 0 percentage of participants |
Secondary
For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA
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)
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 1 | -3.98 log10 IU/mL | Standard Deviation 1.056 |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 8 | -4.84 log10 IU/mL | Standard Deviation 0.743 |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 12 | -4.84 log10 IU/mL | Standard Deviation 0.743 |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 2 | -4.84 log10 IU/mL | Standard Deviation 0.743 |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 4 | -4.84 log10 IU/mL | Standard Deviation 0.743 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 12 | -4.34 log10 IU/mL | Standard Deviation 0.758 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 8 | -4.34 log10 IU/mL | Standard Deviation 0.758 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 24 | -4.34 log10 IU/mL | Standard Deviation 0.758 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 20 | -4.34 log10 IU/mL | Standard Deviation 0.758 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 2 | -4.34 log10 IU/mL | Standard Deviation 0.758 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 16 | -4.34 log10 IU/mL | Standard Deviation 0.758 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 4 | -4.34 log10 IU/mL | Standard Deviation 0.758 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 1 | -4.23 log10 IU/mL | Standard Deviation 0.765 |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 1 | -3.82 log10 IU/mL | Standard Deviation 0.447 |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 8 | -4.92 log10 IU/mL | Standard Deviation 0.674 |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 2 | -4.92 log10 IU/mL | Standard Deviation 0.674 |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 4 | -4.92 log10 IU/mL | Standard Deviation 0.674 |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 12 | -4.92 log10 IU/mL | Standard Deviation 0.674 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 20 | -4.61 log10 IU/mL | Standard Deviation 1.7 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 1 | -3.78 log10 IU/mL | Standard Deviation 1.234 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 2 | -4.56 log10 IU/mL | Standard Deviation 1.553 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 4 | -4.60 log10 IU/mL | Standard Deviation 1.686 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 8 | -4.61 log10 IU/mL | Standard Deviation 1.7 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 12 | -4.61 log10 IU/mL | Standard Deviation 1.7 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 16 | -4.61 log10 IU/mL | Standard Deviation 1.7 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 24 | -4.61 log10 IU/mL | Standard Deviation 1.7 |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 2 | -4.31 log10 IU/mL | Standard Deviation 0.846 |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 12 | -4.52 log10 IU/mL | Standard Deviation 1.177 |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 8 | -4.52 log10 IU/mL | Standard Deviation 1.177 |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 1 | -4.12 log10 IU/mL | Standard Deviation 0.632 |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 4 | -4.42 log10 IU/mL | Standard Deviation 1.006 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 1 | -3.53 log10 IU/mL | Standard Deviation 0.347 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 20 | -3.97 log10 IU/mL | Standard Deviation 0.453 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 8 | -3.97 log10 IU/mL | Standard Deviation 0.453 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 4 | -3.97 log10 IU/mL | Standard Deviation 0.453 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 2 | -3.94 log10 IU/mL | Standard Deviation 0.422 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 12 | -3.97 log10 IU/mL | Standard Deviation 0.453 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 24 | -3.97 log10 IU/mL | Standard Deviation 0.453 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 16 | -3.97 log10 IU/mL | Standard Deviation 0.453 |
Secondary
For the Treatment Phase, Change From Baseline in HCV RNA
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)
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 1 | -4.25 log10 IU/mL | Standard Deviation 0.986 |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 2 | -4.74 log10 IU/mL | Standard Deviation 0.98 |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 8 | -4.74 log10 IU/mL | Standard Deviation 0.98 |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 4 | -4.74 log10 IU/mL | Standard Deviation 0.98 |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 12 | -4.74 log10 IU/mL | Standard Deviation 0.98 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 16 | -5.02 log10 IU/mL | Standard Deviation 0.771 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 1 | -4.12 log10 IU/mL | Standard Deviation 0.733 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 24 | -5.02 log10 IU/mL | Standard Deviation 0.771 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 2 | -4.86 log10 IU/mL | Standard Deviation 0.702 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 8 | -5.02 log10 IU/mL | Standard Deviation 0.771 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 4 | -5.01 log10 IU/mL | Standard Deviation 0.76 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 12 | -5.02 log10 IU/mL | Standard Deviation 0.771 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 20 | -5.02 log10 IU/mL | Standard Deviation 0.771 |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 12 | -4.68 log10 IU/mL | Standard Deviation 0.843 |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 4 | -4.68 log10 IU/mL | Standard Deviation 0.843 |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 1 | -4.12 log10 IU/mL | Standard Deviation 0.692 |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 8 | -4.68 log10 IU/mL | Standard Deviation 0.843 |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 2 | -4.55 log10 IU/mL | Standard Deviation 0.812 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 8 | -4.54 log10 IU/mL | Standard Deviation 1.191 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 2 | -4.51 log10 IU/mL | Standard Deviation 1.102 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 20 | -4.57 log10 IU/mL | Standard Deviation 1.178 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 12 | -4.57 log10 IU/mL | Standard Deviation 1.178 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 4 | -4.56 log10 IU/mL | Standard Deviation 1.171 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 16 | -4.57 log10 IU/mL | Standard Deviation 1.178 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 1 | -3.88 log10 IU/mL | Standard Deviation 0.928 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 24 | -4.57 log10 IU/mL | Standard Deviation 1.178 |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 12 | -4.52 log10 IU/mL | Standard Deviation 1.177 |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 1 | -4.12 log10 IU/mL | Standard Deviation 0.632 |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 8 | -4.52 log10 IU/mL | Standard Deviation 1.177 |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 4 | -4.42 log10 IU/mL | Standard Deviation 1.006 |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 2 | -4.31 log10 IU/mL | Standard Deviation 0.846 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 24 | -3.97 log10 IU/mL | Standard Deviation 0.453 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 1 | -3.53 log10 IU/mL | Standard Deviation 0.347 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 2 | -3.94 log10 IU/mL | Standard Deviation 0.422 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 8 | -3.97 log10 IU/mL | Standard Deviation 0.453 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 12 | -3.97 log10 IU/mL | Standard Deviation 0.453 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 16 | -3.97 log10 IU/mL | Standard Deviation 0.453 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 20 | -3.97 log10 IU/mL | Standard Deviation 0.453 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 4 | -3.97 log10 IU/mL | Standard Deviation 0.453 |
Secondary
For the Treatment Phase, Change From Baseline in Height
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Posttreatment Week 24 | 1.6 centimeters | Standard Deviation 1.89 |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 8 | 0.3 centimeters | Standard Deviation 1.27 |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 4 | 0.2 centimeters | Standard Deviation 1.2 |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 1 | 0.1 centimeters | Standard Deviation 1.1 |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 12 | 0.5 centimeters | Standard Deviation 1.68 |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 2 | 0.1 centimeters | Standard Deviation 1.07 |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Posttreatment Week 12 | 1.4 centimeters | Standard Deviation 1.65 |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Posttreatment Week 4 | 0.5 centimeters | Standard Deviation 1.79 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Posttreatment Week 12 | 1.3 centimeters | Standard Deviation 1.9 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Posttreatment Week 4 | 0.9 centimeters | Standard Deviation 1.7 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 2 | -0.1 centimeters | Standard Deviation 0.59 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 4 | 0.2 centimeters | Standard Deviation 0.78 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Posttreatment Week 24 | 1.8 centimeters | Standard Deviation 2.83 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 8 | 0.2 centimeters | Standard Deviation 0.85 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 1 | 0.0 centimeters | Standard Deviation 0.57 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 12 | 0.3 centimeters | Standard Deviation 0.95 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 16 | 0.4 centimeters | Standard Deviation 0.91 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 20 | 0.5 centimeters | Standard Deviation 1.1 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 24 | 0.8 centimeters | Standard Deviation 1.54 |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Posttreatment Week 24 | 4.2 centimeters | Standard Deviation 1.11 |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 1 | 0.0 centimeters | Standard Deviation 0.57 |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Posttreatment Week 12 | 2.4 centimeters | Standard Deviation 1.02 |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 4 | 0.3 centimeters | Standard Deviation 0.67 |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 12 | 0.8 centimeters | Standard Deviation 0.81 |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 8 | 1.0 centimeters | Standard Deviation 1 |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 2 | 0.1 centimeters | Standard Deviation 0.66 |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Posttreatment Week 4 | 1.4 centimeters | Standard Deviation 0.8 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 1 | 0.0 centimeters | Standard Deviation 0.73 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 16 | 1.1 centimeters | Standard Deviation 0.93 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Posttreatment Week 12 | 3.8 centimeters | Standard Deviation 1.3 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 2 | 0.0 centimeters | Standard Deviation 0.54 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 8 | 0.4 centimeters | Standard Deviation 0.62 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 24 | 2.1 centimeters | Standard Deviation 0.88 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Posttreatment Week 4 | 2.6 centimeters | Standard Deviation 1.17 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 20 | 1.6 centimeters | Standard Deviation 1.15 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 12 | 0.7 centimeters | Standard Deviation 0.68 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Posttreatment Week 24 | 5.1 centimeters | Standard Deviation 1.59 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 4 | 0.4 centimeters | Standard Deviation 0.74 |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Posttreatment Week 12 | 2.8 centimeters | Standard Deviation 1.81 |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 1 | 0.3 centimeters | Standard Deviation 1.12 |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 2 | 0.7 centimeters | Standard Deviation 1.09 |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 4 | 0.9 centimeters | Standard Deviation 0.87 |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 8 | 0.9 centimeters | Standard Deviation 0.72 |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 12 | 1.5 centimeters | Standard Deviation 0.45 |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Posttreatment Week 4 | 1.6 centimeters | Standard Deviation 0.91 |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Posttreatment Week 24 | 5.0 centimeters | Standard Deviation 1.61 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 24 | 2.7 centimeters | Standard Deviation 1.05 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 20 | 2.5 centimeters | Standard Deviation 1.01 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 16 | 1.8 centimeters | Standard Deviation 0.79 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 12 | 1.7 centimeters | Standard Deviation 1.84 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Posttreatment Week 12 | 4.0 centimeters | Standard Deviation 0.95 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 8 | 0.8 centimeters | Standard Deviation 0.51 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 4 | 0.5 centimeters | Standard Deviation 0.67 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 2 | 0.3 centimeters | Standard Deviation 0.5 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 1 | 0.3 centimeters | Standard Deviation 0.75 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Posttreatment Week 24 | 5.7 centimeters | Standard Deviation 1.27 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Posttreatment Week 4 | 3.5 centimeters | Standard Deviation 0.85 |
Secondary
For the Treatment Phase, Change From Baseline in Weight
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 8 | -0.5 kilograms | Standard Deviation 2.39 |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Posttreatment Week 4 | -0.3 kilograms | Standard Deviation 3.19 |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Posttreatment Week 24 | 2.5 kilograms | Standard Deviation 4.98 |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 4 | -0.2 kilograms | Standard Deviation 1.67 |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Posttreatment Week 12 | 0.9 kilograms | Standard Deviation 2.69 |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 2 | -0.2 kilograms | Standard Deviation 0.87 |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 12 | -0.4 kilograms | Standard Deviation 2.62 |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 1 | -0.7 kilograms | Standard Deviation 1.28 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 1 | -0.4 kilograms | Standard Deviation 1.36 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 20 | 0.1 kilograms | Standard Deviation 2.65 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 12 | -0.1 kilograms | Standard Deviation 2.01 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 16 | 0.2 kilograms | Standard Deviation 2.35 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 8 | 0.0 kilograms | Standard Deviation 1.53 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Posttreatment Week 24 | 3.0 kilograms | Standard Deviation 4.62 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Posttreatment Week 12 | 2.1 kilograms | Standard Deviation 3.73 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 2 | -0.3 kilograms | Standard Deviation 0.99 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Posttreatment Week 4 | 0.9 kilograms | Standard Deviation 3.24 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 24 | 0.5 kilograms | Standard Deviation 3.13 |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 4 | -0.1 kilograms | Standard Deviation 1.15 |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Posttreatment Week 12 | 2.1 kilograms | Standard Deviation 3.28 |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 1 | 0.2 kilograms | Standard Deviation 0.82 |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 2 | 0.3 kilograms | Standard Deviation 1.08 |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 4 | 0.4 kilograms | Standard Deviation 0.9 |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 8 | 0.6 kilograms | Standard Deviation 1.57 |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 12 | 0.9 kilograms | Standard Deviation 2.15 |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Posttreatment Week 4 | 1.2 kilograms | Standard Deviation 2.2 |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Posttreatment Week 24 | 3.8 kilograms | Standard Deviation 3.67 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 8 | 0.1 kilograms | Standard Deviation 1.21 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Posttreatment Week 24 | 3.5 kilograms | Standard Deviation 2.42 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 12 | 0.5 kilograms | Standard Deviation 1.35 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 16 | 0.6 kilograms | Standard Deviation 1.34 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 4 | 0.1 kilograms | Standard Deviation 0.9 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 20 | 0.9 kilograms | Standard Deviation 1.59 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 24 | 1.2 kilograms | Standard Deviation 1.91 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 2 | 0.0 kilograms | Standard Deviation 0.64 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Posttreatment Week 4 | 1.3 kilograms | Standard Deviation 2.19 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Posttreatment Week 12 | 2.2 kilograms | Standard Deviation 2.21 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 1 | 0.0 kilograms | Standard Deviation 0.55 |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 12 | 0.3 kilograms | Standard Deviation 0.22 |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 8 | 0.3 kilograms | Standard Deviation 0.14 |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 4 | 0.0 kilograms | Standard Deviation 0.22 |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Posttreatment Week 4 | 0.5 kilograms | Standard Deviation 0.27 |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 2 | 0.5 kilograms | Standard Deviation 0.21 |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Posttreatment Week 24 | 1.3 kilograms | Standard Deviation 1.1 |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Posttreatment Week 12 | 1.0 kilograms | Standard Deviation 0.88 |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 1 | 0.2 kilograms | Standard Deviation 0.1 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 16 | 0.1 kilograms | Standard Deviation 0.76 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 8 | 0.0 kilograms | Standard Deviation 0.55 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 2 | -0.1 kilograms | Standard Deviation 0.5 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 20 | 0.4 kilograms | Standard Deviation 0.86 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 4 | -0.1 kilograms | Standard Deviation 0.49 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 24 | 0.4 kilograms | Standard Deviation 1.03 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Posttreatment Week 24 | 1.7 kilograms | Standard Deviation 1.28 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Posttreatment Week 4 | 0.7 kilograms | Standard Deviation 1.05 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 1 | -0.2 kilograms | Standard Deviation 0.51 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 12 | 0.1 kilograms | Standard Deviation 0.85 |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Posttreatment Week 12 | 0.9 kilograms | Standard Deviation 1.12 |
Secondary
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development
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
Population: Female participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 24 | No Change | 16 Participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 12 | No Change | 17 Participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | End of Treatment | Increase | 1 Participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 12 | Decrease | 0 Participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 12 | Increase | 3 Participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | End of Treatment | No Change | 20 Participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 24 | Increase | 4 Participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | End of Treatment | Decrease | 0 Participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 24 | Decrease | 0 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 24 | No Change | 19 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | End of Treatment | No Change | 24 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | End of Treatment | Increase | 5 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | End of Treatment | Decrease | 1 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 12 | No Change | 24 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 12 | Increase | 5 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 12 | Decrease | 0 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 24 | Increase | 11 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 24 | Decrease | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 12 | Decrease | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | End of Treatment | Decrease | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 24 | No Change | 8 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | End of Treatment | Increase | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 24 | Decrease | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 24 | Increase | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 12 | Increase | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 12 | No Change | 8 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | End of Treatment | No Change | 8 Participants |
Secondary
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair
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
Population: Female participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | No Change | 18 Participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | Decrease | 0 Participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | Decrease | 0 Participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | Increase | 2 Participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | No Change | 20 Participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | Increase | 2 Participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | Decrease | 0 Participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | Increase | 1 Participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | No Change | 18 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | Increase | 6 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | No Change | 24 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | Increase | 6 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | Decrease | 0 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | No Change | 23 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | Decrease | 0 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | No Change | 22 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | Increase | 8 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | Decrease | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | Decrease | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | No Change | 8 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | No Change | 8 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | Increase | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | Decrease | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | Increase | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | No Change | 8 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | Increase | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | Decrease | 0 Participants |
Secondary
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development
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
Population: Male participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 24 | No Change | 20 Participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | End of Treatment | Increase | 7 Participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 24 | Increase | 11 Participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 24 | Decrease | 0 Participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | End of Treatment | Decrease | 0 Participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 12 | Increase | 9 Participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 12 | No Change | 21 Participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | End of Treatment | No Change | 24 Participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 12 | Decrease | 0 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | End of Treatment | No Change | 11 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 24 | No Change | 9 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 12 | Increase | 1 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | End of Treatment | Decrease | 0 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 24 | Increase | 2 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | End of Treatment | Increase | 0 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 12 | No Change | 10 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 24 | Decrease | 0 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 12 | Decrease | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 24 | Decrease | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | End of Treatment | No Change | 3 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | End of Treatment | Increase | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | End of Treatment | Decrease | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 12 | No Change | 3 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 12 | Increase | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 12 | Decrease | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 24 | No Change | 3 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 24 | Increase | 0 Participants |
Secondary
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair
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
Population: Male participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | Decrease | 0 Participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | Decrease | 0 Participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | No Change | 20 Participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | Increase | 11 Participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | Increase | 10 Participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | Increase | 8 Participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | No Change | 23 Participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | No Change | 20 Participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | Decrease | 0 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | Decrease | 0 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | No Change | 10 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | Increase | 1 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | Decrease | 0 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | No Change | 9 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | Increase | 2 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | Decrease | 0 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | No Change | 9 Participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | Increase | 2 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | Decrease | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | Decrease | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | Increase | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | Increase | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | No Change | 3 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | No Change | 3 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | No Change | 3 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | Increase | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | Decrease | 0 Participants |
Secondary
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
Participants were asked if they were able to taste the SOF oral granules.
Time frame: Day 1
Population: Participants in the Safety Analysis Set who performed the palatability assessment were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | 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 | Able to Taste SOF Granules: Yes | 0 percentage of participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | 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 | Able to Taste SOF Granules: No | 100.0 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | 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 | Able to Taste SOF Granules: Yes | 42.9 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | 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 | Able to Taste SOF Granules: No | 57.1 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | 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 | Able to Taste SOF Granules: Yes | 75.0 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | 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 | Able to Taste SOF Granules: No | 25.0 percentage of participants |
Secondary
For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough
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
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough | 0 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough | 0 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough | 0 percentage of participants |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough | 0 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough | 0 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough | 0 percentage of participants |
Secondary
For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse
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
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse | 0 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse | 0 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse | 0 percentage of participants |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse | 0 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse | 0 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse | 0 percentage of participants |
Secondary
For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 1 | 50.0 percentage of participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Posttreatment Week 4 | 100.0 percentage of participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 12 | 100.0 percentage of participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 4 | 100.0 percentage of participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 2 | 100.0 percentage of participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 8 | 100.0 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 16 | 100.0 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 4 | 95.5 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 12 | 100.0 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 1 | 63.6 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 8 | 95.5 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Posttreatment Week 4 | 100.0 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 24 | 100.0 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 2 | 90.9 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 20 | 100.0 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 12 | 100.0 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 1 | 25.0 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 2 | 100.0 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 4 | 100.0 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 8 | 100.0 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Posttreatment Week 4 | 100.0 percentage of participants |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 16 | 100.0 percentage of participants |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 4 | 100.0 percentage of participants |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 24 | 100.0 percentage of participants |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 2 | 93.3 percentage of participants |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 1 | 75.0 percentage of participants |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 12 | 100.0 percentage of participants |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 20 | 100.0 percentage of participants |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Posttreatment Week 4 | 100.0 percentage of participants |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 8 | 100.0 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 20 | 100.0 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 4 | 100.0 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 12 | 100.0 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 2 | 100.0 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 16 | 100.0 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 8 | 100.0 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 1 | 100.0 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 24 | 100.0 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Posttreatment Week 4 | 100.0 percentage of participants |
Secondary
For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment
Time frame: Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 12 | 100.0 percentage of participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 2 | 100.0 percentage of participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 4 | 100.0 percentage of participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 1 | 30.8 percentage of participants |
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 8 | 100.0 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 12 | 100.0 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 8 | 100.0 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 24 | 100.0 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 20 | 100.0 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 16 | 100.0 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 2 | 74.4 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 1 | 30.8 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 4 | 92.3 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 2 | 76.9 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 8 | 100.0 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 1 | 46.2 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 4 | 100.0 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 12 | 100.0 percentage of participants |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 24 | 100.0 percentage of participants |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 16 | 100.0 percentage of participants |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 20 | 100.0 percentage of participants |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 1 | 39.3 percentage of participants |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 2 | 78.6 percentage of participants |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 4 | 96.4 percentage of participants |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 8 | 96.4 percentage of participants |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 12 | 100.0 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 4 | 75.0 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 2 | 75.0 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 1 | 50.0 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 12 | 100.0 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 8 | 100.0 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 24 | 100.0 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 1 | 37.5 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 4 | 100.0 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 8 | 100.0 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 12 | 100.0 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 16 | 100.0 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 20 | 100.0 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 2 | 87.5 percentage of participants |
Secondary
For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment.
Time frame: Posttreatment Week 4
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4) | 100.0 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4) | 100.0 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4) | 100.0 percentage of participants |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4) | 100.0 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4) | 80.0 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4) | 100.0 percentage of participants |
Secondary
For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
SVR24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment.
Time frame: Posttreatment Week 24
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) | 100.0 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) | 97.4 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) | 100.0 percentage of participants |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) | 100.0 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 12 Weeks | For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) | 80.0 percentage of participants |
| 3 to < 6 Years Old - SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) | 100.0 percentage of participants |
Secondary
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase
Time frame: Up to Day 7
Population: Participants who were enrolled in the PK lead-in phase were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase | 0 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase | 0 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase | 0 percentage of participants |