Hepatitis C Virus Infection
Conditions
Brief summary
This study will have 2 parts: Pharmacokinetics (PK) Lead-in Phase and the Treatment Phase. The primary objective of the PK Lead-in Phase is to evaluate the steady state PK and confirm the dose of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in pediatric participants with chronic hepatitis C virus (HCV) infection. The primary objective of the Treatment Phase is to evaluate the safety and tolerability of SOF/VEL for 12 weeks in pediatric participants with chronic HCV.
Interventions
DRUGSOF/VEL
SOF/VEL fixed-dose combination (FDC) 400/100 mg tablets or SOF/VEL FDC 200/50 mg tablets (based on swallowability assessment)
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: * Chronic HCV-infected, treatment-naive and treatment-experienced adolescent and pediatric individuals aged 3 to \< 18 as determined at Day 1. Note: Other protocol defined Inclusion/
Exclusion criteria
may apply.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of Velpatasvir (VEL) | Day 7: 0 (predose), 0.5, 1, 2, 3, 4, 6 (Cohorts 1 and 2 only), 8, and 12 hours postdose | AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval). |
| PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of Sofosbuvir (SOF) | Day 7: 0 (predose), 0.5, 1, 2, 3, 4, 6 (Cohorts 1 and 2 only), 8, and 12 hours postdose | AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval). |
| PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of GS-331007 (Metabolite of SOF) | Day 7: 0 (predose), 0.5, 1, 2, 3, 4, 6 (Cohorts 1 and 2 only), 8, and 12 hours postdose | AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). |
| Treatment Phase: Percentage of Participants Who Discontinued Study Drug Due to Any Treatment-Emergent Adverse Event (TEAE) | From first dose through last dose of the study drug (Up to 12 weeks) plus 30 days | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as 1 or both of the following: Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or Any AEs leading to premature discontinuation of study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Phase: Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) | Posttreatment Week 24 | SVR 24 was defined as HCV RNA \< LLOQ (ie, 15 IU/mL) at 24 weeks after stopping study treatment. |
| Treatment Phase: Percentage of Participants With Virologic Failure | Up to Posttreatment Week 24 | Virologic failure was defined as: On-treatment virologic failure - Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment); Virologic relapse: Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit. |
| Treatment Phase: Percentage of Participants With HCV RNA < LLOQ On Treatment | Weeks 1, 4, 8, and 12 | Percentage of participants with HCV RNA \< LLOQ while on treatment by analysis visit. |
| Treatment Phase: Percentage of Participants Who Develop Viral Resistance to SOF and/or VEL During Treatment and After Discontinuation of Treatment | First dose date up to Posttreatment Week 24 | Drug-resistant substitutions were analyzed as part of the Virology Study. Plasma samples were collected and stored for potential HCV sequencing. Impact on the treatment outcomes of SVR12 and SVR24 were observed during the study. Baseline deep sequencing of the HCV nonstructural protein (NS)5A and NS5B genes was performed for all participants at the first time point after virologic failure if the plasma or serum sample was available. Pretreatment full-length NS5A deep sequencing data were obtained at a 15% assay cutoff for the Resistance Analysis Population which covered all NS5A and NS5B nucleoside inhibitor (NI) resistance-associated variants (RAVs). |
| Treatment Phase: Change From Baseline in HCV RNA at Weeks 1, 4, 8, and 12 | Baseline; Weeks 1, 4, 8, and 12 | — |
| Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey | Baseline; Week 12, End of Treatment (EOT), Posttreatment/Follow-up (FU) Week-12 (FU-12), and FU Week-24 (FU-24) | To evaluate the effect of treatment with SOF/VEL on general and disease-specific health-related QoL, the PedsQL™ Pediatric QoL Inventory V4.0 Short Form (SF15) was completed at Day 1, end of treatment, early termination (if applicable), and posttreatment Weeks 12 and 24. The SF15 questionnaire represented 4 domains: physical, emotional, social, and school functioning, with the emotional, social, and school functioning domains representing the psychosocial health summary. Neuropsychiatric assessment was conducted using the PedsQL™ Pediatric QoL Inventory V4.0 SF15 psychosocial domain-related scores. Items were calculated and transformed into an overall score with a range of 0 to 100 points, with more points indicating better QoL. |
| Treatment Phase: Change From Baseline in Growth and Development as Measured by Height Percentiles | Baseline; Weeks 1, 4, 8, 12, Follow-up (FU) Week 4 (FU-4), FU-12, and FU-24 | An age- and sex-specific percentile was derived for each weight, height, and body mass index (BMI) measurement according to the statistical analysis system (SAS) program available on the Centers for Disease Control and Prevention (CDC) website using the year 2000 growth charts. |
| PK Lead-in Phase: Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 7 | Baseline; Day 7 | — |
| Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Baseline; EOT, FU-12 and FU-24 | Tanner Pubertal Staging was assessed for pubic hair growth and genitalia development (males) and for pubic hair growth and breast development (females) in stages 1 to 5. Tanner stages were used to evaluate the onset and progression of pubertal changes from stage 1 (pre-pubertal) to stage 5 (adult). If a participant had reached Tanner stage 5, no further Tanner pubertal stage assessments were to be completed. Pubic hair growth: Tanner stages (1: No hair, 2: Downy hair, 3: More coarse and curly hair, 4: Adult-like hair quality; 5: Hair extends to the medial surface of the thighs); Breast development: Tanner stages (1: No glandular tissue, 2: Breast bud forms,3: More elevated, outside areola, 4: Increased breast size,5: Final adult-size breasts); Genitalia development: Tanner stages (1: Testes, scrotum, and penis about same size, 2: Enlargement of scrotum, testes and penis, 3: Enlargement of penis, 4: Penis size enlargement, 5: Genitalia adult in size and shape). |
| Treatment Phase: Growth and Development as Measured by Parental Height | Day 1 | Mid-parental height was calculated as the average of the biological father's and mother's heights. For boys, the sex-adjusted mid-parental height was calculated by adding 2.5 inches or 6.5 cm to the mean of the parents' heights. For girls, 2.5 inches or 6.5 cm was subtracted from the mean of the parents' heights. |
| Treatment Phase: Change From Baseline in Growth and Development as Measured by Bone Age | Baseline; FU-24 | Bone age was determined based on x-ray of the left wrist, hand, and fingers. Baseline value is the last available value on or prior to first dose date of study drug. |
| Treatment Phase: Swallowability of SOF/VEL as Assessed by the Participant's Ability to Swallow SOF/VEL Placebo Tablets at Baseline | Baseline | A SOF/VEL FDC swallowability assessment was performed using placebo tablets at baseline. |
| Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Day 1 | Acceptability was assessed by numeric response marked on line between numbers 0 - 100. Higher scores indicate better acceptability and/or palatability. |
| Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Week 12 | Acceptability was assessed by numeric response marked on line between numbers 0 - 100. Higher scores indicate better acceptability and/or palatability. |
| Treatment Phase: Change From Baseline in Growth and Development as Measured by Weight Percentiles | Baseline; Weeks 1, 4, 8, 12, FU-4, FU-12, and FU-24 | An age- and sex-specific percentile was derived for each weight, height, and BMI measurement according to the SAS program available on the CDC website using the year 2000 growth charts. |
| PK Lead-in Phase: Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event (AE) | First dose date up to Day 7 | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. |
| Treatment Phase: Percentage of Participants With Sustained Virologic Response (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. |
| Treatment Phase: Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) | Posttreatment Week 4 | SVR4 was defined as HCV RNA \< LLOQ (ie, 15 IU/mL) at 4 weeks after stopping study treatment. |
Countries
Belgium, Italy, United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled at 28 study sites in Belgium, Italy, the United Kingdom, and the United States. The first participant was screened on 26 January 2017. The last study visit occurred on 26 February 2020.
Pre-assignment details
221 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| 12 to < 18 Years Old PK Lead-in Phase: Sofosbuvir/Velpatasvir (SOF/VEL) fixed-dose combination (FDC) 400/100 mg tablets once daily for 7 days. Participants who completed the PK lead-in phase, continued into the treatment phase with no interruption of study drug administration and additional participants were enrolled into the treatment phase once the appropriateness of the dose was confirmed by PK results from the PK lead-in phase.
Treatment Phase: SOF/VEL 400/100 mg (adult and smaller size tablets based on swallowability assessment) once daily for 12 weeks. | 102 |
| 6 to < 12 Years Old PK Lead-in Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 7 days. Participants who completed the PK lead-in phase, continued into the treatment phase with no interruption of study drug administration and additional participants were enrolled into the treatment phase once the appropriateness of the dose was confirmed by PK results from the PK lead-in phase.
Treatment Phase: SOF/VEL FDC 200/50 mg tablets or oral granules once daily for 12 weeks. | 73 |
| 3 to < 6 Years Old PK Lead-in Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 7 days for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 7 days for participants who weighed \< 17 kg. Participants who completed the PK lead-in phase, continued into the treatment phase with no interruption of study drug administration and additional participants were enrolled into the treatment phase once the appropriateness of the dose was confirmed by PK results from the PK lead-in phase.
Treatment Phase: SOF/VEL FDC 200/50 mg oral granules once daily for 12 weeks for participants who weighed ≥ 17 kg. SOF/VEL FDC 150/37.5 mg oral granules once daily for 12 weeks for participants who weighed \< 17 kg. | 41 |
| Total | 216 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 |
| Overall Study | Investigator's Discretion | 0 | 1 | 2 |
| Overall Study | Lost to Follow-up | 6 | 2 | 1 |
| Overall Study | Non-Compliance With Study Drug | 0 | 0 | 2 |
| Overall Study | Withdrew Assent By Parent/Guardian | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | 6 to < 12 Years Old | 3 to < 6 Years Old | 12 to < 18 Years Old | Total |
|---|---|---|---|---|
| Age, Continuous | 8 years STANDARD_DEVIATION 1.6 | 4 years STANDARD_DEVIATION 0.8 | 15 years STANDARD_DEVIATION 1.9 | 10 years STANDARD_DEVIATION 4.5 |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 7 Participants | 4 Participants | 14 Participants | 25 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 64 Participants | 36 Participants | 83 Participants | 183 Participants |
| Race/Ethnicity, Customized Ethnicity Not Permitted | 2 Participants | 1 Participants | 5 Participants | 8 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Asian | 1 Participants | 0 Participants | 11 Participants | 12 Participants |
| Race/Ethnicity, Customized Race Black or African American | 4 Participants | 3 Participants | 9 Participants | 16 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Not Permitted | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Other | 2 Participants | 5 Participants | 5 Participants | 12 Participants |
| Race/Ethnicity, Customized Race White | 66 Participants | 32 Participants | 74 Participants | 172 Participants |
| Region of Enrollment Belgium | 2 Participants | 0 Participants | 3 Participants | 5 Participants |
| Region of Enrollment Italy | 5 Participants | 2 Participants | 17 Participants | 24 Participants |
| Region of Enrollment United Kingdom | 9 Participants | 1 Participants | 5 Participants | 15 Participants |
| Region of Enrollment United States | 57 Participants | 38 Participants | 77 Participants | 172 Participants |
| Sex: Female, Male Female | 38 Participants | 24 Participants | 52 Participants | 114 Participants |
| Sex: Female, Male Male | 35 Participants | 17 Participants | 50 Participants | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 102 | 0 / 73 | 0 / 41 |
| other Total, other adverse events | 65 / 102 | 53 / 73 | 26 / 41 |
| serious Total, serious adverse events | 2 / 102 | 2 / 73 | 0 / 41 |
Outcome results
Primary
PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval 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: Day 7: 0 (predose), 0.5, 1, 2, 3, 4, 6 (Cohorts 1 and 2 only), 8, and 12 hours postdose
Population: Participants in the Lead-in Phase PK Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 12 to < 18 Years Old | PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of GS-331007 (Metabolite of SOF) | 13852.9 h*ng/mL | Standard Deviation 3565.85 |
| 6 to < 12 Years Old | PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of GS-331007 (Metabolite of SOF) | 9913.8 h*ng/mL | Standard Deviation 3071.79 |
| 3 to < 6 Years Old | PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of GS-331007 (Metabolite of SOF) | 11604.0 h*ng/mL | Standard Deviation 2732.57 |
Primary
PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of Sofosbuvir (SOF)
AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval).
Time frame: Day 7: 0 (predose), 0.5, 1, 2, 3, 4, 6 (Cohorts 1 and 2 only), 8, and 12 hours postdose
Population: Participants in the Lead-in Phase PK Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 12 to < 18 Years Old | PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of Sofosbuvir (SOF) | 3020.1 h*ng/mL | Standard Deviation 1162.56 |
| 6 to < 12 Years Old | PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of Sofosbuvir (SOF) | 1764.5 h*ng/mL | Standard Deviation 690.12 |
| 3 to < 6 Years Old | PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of Sofosbuvir (SOF) | 3306.2 h*ng/mL | Standard Deviation 3499.49 |
Primary
PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of Velpatasvir (VEL)
AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval).
Time frame: Day 7: 0 (predose), 0.5, 1, 2, 3, 4, 6 (Cohorts 1 and 2 only), 8, and 12 hours postdose
Population: The Lead-in Phase Pharmacokinetic (PK) Analysis Set included all PK lead-in phase participants with available data who received at least 1 dose of study drug and whom at least one non-missing PK concentration data value is available from the PK Lead-in Phase intensive sampling.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 12 to < 18 Years Old | PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of Velpatasvir (VEL) | 4479.3 hours*nanograms per milliliter (h*ng/mL) | Standard Deviation 2105.66 |
| 6 to < 12 Years Old | PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of Velpatasvir (VEL) | 3697.5 hours*nanograms per milliliter (h*ng/mL) | Standard Deviation 1653.25 |
| 3 to < 6 Years Old | PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of Velpatasvir (VEL) | 4450.3 hours*nanograms per milliliter (h*ng/mL) | Standard Deviation 3285.75 |
Primary
Treatment Phase: Percentage of Participants Who Discontinued Study Drug Due to Any Treatment-Emergent Adverse Event (TEAE)
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as 1 or both of the following: Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or Any AEs leading to premature discontinuation of study drug.
Time frame: From first dose through last dose of the study drug (Up to 12 weeks) plus 30 days
Population: The Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug (SOF/VEL FDC).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 12 to < 18 Years Old | Treatment Phase: Percentage of Participants Who Discontinued Study Drug Due to Any Treatment-Emergent Adverse Event (TEAE) | 0.0 percentage of participants |
| 6 to < 12 Years Old | Treatment Phase: Percentage of Participants Who Discontinued Study Drug Due to Any Treatment-Emergent Adverse Event (TEAE) | 2.7 percentage of participants |
| 3 to < 6 Years Old | Treatment Phase: Percentage of Participants Who Discontinued Study Drug Due to Any Treatment-Emergent Adverse Event (TEAE) | 2.4 percentage of participants |
Secondary
PK Lead-in Phase: Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 7
Time frame: Baseline; Day 7
Population: Participants in the Lead-in Phase PK Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 12 to < 18 Years Old | PK Lead-in Phase: Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 7 | Baseline | 6.09 log10 international units per mL (IU/mL) | Standard Deviation 0.569 |
| 12 to < 18 Years Old | PK Lead-in Phase: Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 7 | Change from Baseline at Day 7 | -4.48 log10 international units per mL (IU/mL) | Standard Deviation 0.656 |
| 6 to < 12 Years Old | PK Lead-in Phase: Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 7 | Change from Baseline at Day 7 | -4.20 log10 international units per mL (IU/mL) | Standard Deviation 0.642 |
| 6 to < 12 Years Old | PK Lead-in Phase: Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 7 | Baseline | 5.84 log10 international units per mL (IU/mL) | Standard Deviation 0.656 |
| 3 to < 6 Years Old | PK Lead-in Phase: Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 7 | Baseline | 5.77 log10 international units per mL (IU/mL) | Standard Deviation 1.275 |
| 3 to < 6 Years Old | PK Lead-in Phase: Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 7 | Change from Baseline at Day 7 | -3.94 log10 international units per mL (IU/mL) | Standard Deviation 1.082 |
Secondary
PK Lead-in Phase: Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: First dose date up to Day 7
Population: Participants in the Lead-in Phase PK Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 12 to < 18 Years Old | PK Lead-in Phase: Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event (AE) | 0.0 percentage of participants |
| 6 to < 12 Years Old | PK Lead-in Phase: Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event (AE) | 0.0 percentage of participants |
| 3 to < 6 Years Old | PK Lead-in Phase: Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event (AE) | 0.0 percentage of participants |
Secondary
Treatment Phase: Change From Baseline in Growth and Development as Measured by Bone Age
Bone age was determined based on x-ray of the left wrist, hand, and fingers. Baseline value is the last available value on or prior to first dose date of study drug.
Time frame: Baseline; FU-24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| 12 to < 18 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Bone Age | Baseline | 15.5 years |
| 12 to < 18 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Bone Age | Change From Baseline at FU-24 | 0.6 years |
| 6 to < 12 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Bone Age | Baseline | 7.8 years |
| 6 to < 12 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Bone Age | Change From Baseline at FU-24 | 1.0 years |
| 3 to < 6 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Bone Age | Baseline | 4.8 years |
| 3 to < 6 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Bone Age | Change From Baseline at FU-24 | 0.5 years |
Secondary
Treatment Phase: Change From Baseline in Growth and Development as Measured by Height Percentiles
An age- and sex-specific percentile was derived for each weight, height, and body mass index (BMI) measurement according to the statistical analysis system (SAS) program available on the Centers for Disease Control and Prevention (CDC) website using the year 2000 growth charts.
Time frame: Baseline; Weeks 1, 4, 8, 12, Follow-up (FU) Week 4 (FU-4), FU-12, and FU-24
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| 12 to < 18 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Height Percentiles | Change From Baseline at Week 1 | 0.0 percentile |
| 12 to < 18 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Height Percentiles | Change From Baseline at FU-4 | 0.0 percentile |
| 12 to < 18 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Height Percentiles | Change From Baseline at FU-24 | -0.6 percentile |
| 12 to < 18 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Height Percentiles | Baseline | 44.5 percentile |
| 12 to < 18 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Height Percentiles | Change From Baseline at Week 4 | 0.0 percentile |
| 12 to < 18 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Height Percentiles | Change From Baseline at Week 8 | 0.0 percentile |
| 12 to < 18 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Height Percentiles | Change From Baseline at FU-12 | -0.2 percentile |
| 12 to < 18 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Height Percentiles | Change From Baseline at Week 12 | -0.1 percentile |
| 6 to < 12 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Height Percentiles | Change From Baseline at Week 8 | -0.1 percentile |
| 6 to < 12 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Height Percentiles | Change From Baseline at Week 4 | 0.2 percentile |
| 6 to < 12 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Height Percentiles | Change From Baseline at FU-4 | 0.2 percentile |
| 6 to < 12 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Height Percentiles | Change From Baseline at FU-12 | 0.1 percentile |
| 6 to < 12 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Height Percentiles | Change From Baseline at Week 1 | 0.1 percentile |
| 6 to < 12 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Height Percentiles | Baseline | 41.9 percentile |
| 6 to < 12 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Height Percentiles | Change From Baseline at FU-24 | -0.2 percentile |
| 6 to < 12 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Height Percentiles | Change From Baseline at Week 12 | 0.2 percentile |
| 3 to < 6 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Height Percentiles | Change From Baseline at FU-24 | 0.3 percentile |
| 3 to < 6 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Height Percentiles | Baseline | 39.3 percentile |
| 3 to < 6 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Height Percentiles | Change From Baseline at Week 1 | 0.5 percentile |
| 3 to < 6 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Height Percentiles | Change From Baseline at Week 4 | 1.4 percentile |
| 3 to < 6 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Height Percentiles | Change From Baseline at Week 8 | 0.3 percentile |
| 3 to < 6 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Height Percentiles | Change From Baseline at Week 12 | 0.2 percentile |
| 3 to < 6 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Height Percentiles | Change From Baseline at FU-12 | 0.6 percentile |
| 3 to < 6 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Height Percentiles | Change From Baseline at FU-4 | 1.2 percentile |
Secondary
Treatment Phase: Change From Baseline in Growth and Development as Measured by Weight Percentiles
An age- and sex-specific percentile was derived for each weight, height, and BMI measurement according to the SAS program available on the CDC website using the year 2000 growth charts.
Time frame: Baseline; Weeks 1, 4, 8, 12, FU-4, FU-12, and FU-24
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| 12 to < 18 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Weight Percentiles | Baseline | 67.2 percentile |
| 12 to < 18 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Weight Percentiles | Change From Baseline at Week 1 | 0.0 percentile |
| 12 to < 18 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Weight Percentiles | Change From Baseline at Week 4 | 0.0 percentile |
| 12 to < 18 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Weight Percentiles | Change From Baseline at Week 8 | 0.0 percentile |
| 12 to < 18 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Weight Percentiles | Change From Baseline at Week 12 | 0.2 percentile |
| 12 to < 18 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Weight Percentiles | Change From Baseline at FU-4 | 0.1 percentile |
| 12 to < 18 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Weight Percentiles | Change From Baseline at FU-12 | 0.0 percentile |
| 12 to < 18 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Weight Percentiles | Change From Baseline at FU-24 | 0.1 percentile |
| 6 to < 12 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Weight Percentiles | Change From Baseline at Week 4 | 0.2 percentile |
| 6 to < 12 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Weight Percentiles | Change From Baseline at FU-12 | 0.5 percentile |
| 6 to < 12 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Weight Percentiles | Change From Baseline at Week 8 | 0.1 percentile |
| 6 to < 12 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Weight Percentiles | Change From Baseline at Week 12 | 0.5 percentile |
| 6 to < 12 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Weight Percentiles | Change From Baseline at FU-4 | 0.0 percentile |
| 6 to < 12 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Weight Percentiles | Baseline | 45.9 percentile |
| 6 to < 12 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Weight Percentiles | Change From Baseline at Week 1 | 0.1 percentile |
| 6 to < 12 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Weight Percentiles | Change From Baseline at FU-24 | 1.4 percentile |
| 3 to < 6 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Weight Percentiles | Change From Baseline at Week 4 | 0.3 percentile |
| 3 to < 6 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Weight Percentiles | Change From Baseline at Week 1 | -0.5 percentile |
| 3 to < 6 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Weight Percentiles | Baseline | 64.6 percentile |
| 3 to < 6 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Weight Percentiles | Change From Baseline at Week 8 | 0.2 percentile |
| 3 to < 6 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Weight Percentiles | Change From Baseline at FU-12 | -0.8 percentile |
| 3 to < 6 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Weight Percentiles | Change From Baseline at FU-4 | -0.8 percentile |
| 3 to < 6 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Weight Percentiles | Change From Baseline at Week 12 | -1.7 percentile |
| 3 to < 6 Years Old | Treatment Phase: Change From Baseline in Growth and Development as Measured by Weight Percentiles | Change From Baseline at FU-24 | -1.3 percentile |
Secondary
Treatment Phase: Change From Baseline in HCV RNA at Weeks 1, 4, 8, and 12
Time frame: Baseline; Weeks 1, 4, 8, and 12
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 12 to < 18 Years Old | Treatment Phase: Change From Baseline in HCV RNA at Weeks 1, 4, 8, and 12 | Change from Baseline at Week 8 | -4.91 log10 IU/mL | Standard Deviation 0.588 |
| 12 to < 18 Years Old | Treatment Phase: Change From Baseline in HCV RNA at Weeks 1, 4, 8, and 12 | Change from Baseline at Week 4 | -4.89 log10 IU/mL | Standard Deviation 0.578 |
| 12 to < 18 Years Old | Treatment Phase: Change From Baseline in HCV RNA at Weeks 1, 4, 8, and 12 | Baseline | 6.06 log10 IU/mL | Standard Deviation 0.585 |
| 12 to < 18 Years Old | Treatment Phase: Change From Baseline in HCV RNA at Weeks 1, 4, 8, and 12 | Change from Baseline at Week 1 | -4.46 log10 IU/mL | Standard Deviation 0.661 |
| 12 to < 18 Years Old | Treatment Phase: Change From Baseline in HCV RNA at Weeks 1, 4, 8, and 12 | Change from Baseline at Week 12 | -4.91 log10 IU/mL | Standard Deviation 0.588 |
| 6 to < 12 Years Old | Treatment Phase: Change From Baseline in HCV RNA at Weeks 1, 4, 8, and 12 | Change from Baseline at Week 4 | -4.64 log10 IU/mL | Standard Deviation 0.86 |
| 6 to < 12 Years Old | Treatment Phase: Change From Baseline in HCV RNA at Weeks 1, 4, 8, and 12 | Baseline | 5.87 log10 IU/mL | Standard Deviation 0.686 |
| 6 to < 12 Years Old | Treatment Phase: Change From Baseline in HCV RNA at Weeks 1, 4, 8, and 12 | Change from Baseline at Week 1 | -4.28 log10 IU/mL | Standard Deviation 0.632 |
| 6 to < 12 Years Old | Treatment Phase: Change From Baseline in HCV RNA at Weeks 1, 4, 8, and 12 | Change from Baseline at Week 8 | -4.69 log10 IU/mL | Standard Deviation 0.678 |
| 6 to < 12 Years Old | Treatment Phase: Change From Baseline in HCV RNA at Weeks 1, 4, 8, and 12 | Change from Baseline at Week 12 | -4.70 log10 IU/mL | Standard Deviation 0.683 |
| 3 to < 6 Years Old | Treatment Phase: Change From Baseline in HCV RNA at Weeks 1, 4, 8, and 12 | Change from Baseline at Week 12 | -4.56 log10 IU/mL | Standard Deviation 1.066 |
| 3 to < 6 Years Old | Treatment Phase: Change From Baseline in HCV RNA at Weeks 1, 4, 8, and 12 | Change from Baseline at Week 8 | -4.56 log10 IU/mL | Standard Deviation 1.066 |
| 3 to < 6 Years Old | Treatment Phase: Change From Baseline in HCV RNA at Weeks 1, 4, 8, and 12 | Baseline | 5.86 log10 IU/mL | Standard Deviation 1.057 |
| 3 to < 6 Years Old | Treatment Phase: Change From Baseline in HCV RNA at Weeks 1, 4, 8, and 12 | Change from Baseline at Week 4 | -4.49 log10 IU/mL | Standard Deviation 1.04 |
| 3 to < 6 Years Old | Treatment Phase: Change From Baseline in HCV RNA at Weeks 1, 4, 8, and 12 | Change from Baseline at Week 1 | -4.06 log10 IU/mL | Standard Deviation 0.914 |
Secondary
Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline
Tanner Pubertal Staging was assessed for pubic hair growth and genitalia development (males) and for pubic hair growth and breast development (females) in stages 1 to 5. Tanner stages were used to evaluate the onset and progression of pubertal changes from stage 1 (pre-pubertal) to stage 5 (adult). If a participant had reached Tanner stage 5, no further Tanner pubertal stage assessments were to be completed. Pubic hair growth: Tanner stages (1: No hair, 2: Downy hair, 3: More coarse and curly hair, 4: Adult-like hair quality; 5: Hair extends to the medial surface of the thighs); Breast development: Tanner stages (1: No glandular tissue, 2: Breast bud forms,3: More elevated, outside areola, 4: Increased breast size,5: Final adult-size breasts); Genitalia development: Tanner stages (1: Testes, scrotum, and penis about same size, 2: Enlargement of scrotum, testes and penis, 3: Enlargement of penis, 4: Penis size enlargement, 5: Genitalia adult in size and shape).
Time frame: Baseline; EOT, FU-12 and FU-24
Population: Participants in the Safety Analysis Set with available data were analyzed. Overall Number of Participants Analyzed for each arm is the total of male plus female participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): Baseline, Stage 1 | 4 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): Baseline, Stage 2 | 3 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): Baseline, Stage 3 | 10 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): Baseline, Stage 4 | 14 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): Baseline, Stage 5 | 19 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): EOT, Stage 1 | 2 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): EOT, Stage 2 | 4 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): EOT, Stage 3 | 7 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): EOT, Stage 4 | 13 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): EOT, Stage 5 | 24 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): FU-12, Stage 1 | 1 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): FU-12, Stage 2 | 5 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): FU-12, Stage 3 | 6 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): FU-12, Stage 4 | 10 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): FU-12, Stage 5 | 25 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): FU-24, Stage 1 | 1 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): FU-24, Stage 2 | 4 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): FU-24, Stage 3 | 2 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): FU-24, Stage 4 | 13 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): FU-24, Stage 5 | 25 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): Baseline, Stage 1 | 4 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): Baseline, Stage 2 | 3 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): Baseline, Stage 3 | 8 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): Baseline, Stage 4 | 16 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): Baseline, Stage 5 | 19 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): EOT, Stage 1 | 2 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): EOT, Stage 2 | 3 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): EOT, Stage 3 | 7 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): EOT, Stage 4 | 15 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): EOT, Stage 5 | 23 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): FU-12, Stage 1 | 1 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): FU-12, Stage 2 | 4 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): FU-12, Stage 3 | 7 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): FU-12, Stage 4 | 11 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): FU-12, Stage 5 | 24 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): FU-24, Stage 1 | 1 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): FU-24, Stage 2 | 2 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): FU-24, Stage 3 | 4 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): FU-24, Stage 4 | 13 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): FU-24, Stage 5 | 25 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): Baseline, Stage 1 | 2 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): Baseline, Stage 2 | 3 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): Baseline, Stage 3 | 9 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): Baseline, Stage 4 | 16 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): Baseline, Stage 5 | 22 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): EOT, Stage 1 | 2 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): EOT, Stage 2 | 2 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): EOT, Stage 3 | 6 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): EOT, Stage 4 | 10 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): EOT, Stage 5 | 30 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): FU-12, Stage 1 | 2 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): FU-12, Stage 2 | 1 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): FU-12, Stage 3 | 8 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): FU-12, Stage 4 | 8 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): FU-12, Stage 5 | 32 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): FU-24, Stage 1 | 2 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): FU-24, Stage 2 | 0 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): FU-24, Stage 3 | 8 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): FU-24, Stage 4 | 9 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): FU-24, Stage 5 | 31 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): Baseline, Stage 1 | 1 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): Baseline, Stage 2 | 5 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): Baseline, Stage 3 | 6 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): Baseline, Stage 4 | 17 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): Baseline, Stage 5 | 23 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): EOT, Stage 1 | 1 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): EOT, Stage 2 | 2 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): EOT, Stage 3 | 6 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): EOT, Stage 4 | 14 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): EOT, Stage 5 | 27 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): FU-12, Stage 1 | 1 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): FU-12, Stage 2 | 2 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): FU-12, Stage 3 | 5 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): FU-12, Stage 4 | 15 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): FU-12, Stage 5 | 28 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): FU-24, Stage 1 | 1 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): FU-24, Stage 2 | 0 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): FU-24, Stage 3 | 6 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): FU-24, Stage 4 | 13 Participants |
| 12 to < 18 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): FU-24, Stage 5 | 30 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): FU-12, Stage 4 | 1 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): Baseline, Stage 1 | 31 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): Baseline, Stage 1 | 31 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): FU-12, Stage 4 | 0 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): Baseline, Stage 2 | 2 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): Baseline, Stage 4 | 0 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): FU-12, Stage 2 | 11 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): Baseline, Stage 3 | 1 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): Baseline, Stage 2 | 5 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): FU-12, Stage 5 | 0 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): Baseline, Stage 4 | 0 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): FU-12, Stage 1 | 26 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): EOT, Stage 3 | 2 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): Baseline, Stage 5 | 0 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): Baseline, Stage 3 | 2 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): FU-12, Stage 5 | 0 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): EOT, Stage 1 | 28 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): EOT, Stage 4 | 0 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): FU-24, Stage 1 | 24 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): EOT, Stage 2 | 3 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): Baseline, Stage 4 | 0 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): FU-24, Stage 4 | 2 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): EOT, Stage 3 | 1 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): FU-24, Stage 1 | 27 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): FU-24, Stage 3 | 3 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): EOT, Stage 4 | 0 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): Baseline, Stage 5 | 0 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): FU-24, Stage 2 | 6 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): EOT, Stage 5 | 0 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): Baseline, Stage 3 | 3 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): EOT, Stage 4 | 1 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): FU-12, Stage 1 | 26 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): EOT, Stage 1 | 29 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): FU-12, Stage 3 | 2 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): FU-12, Stage 2 | 3 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): EOT, Stage 1 | 25 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): FU-24, Stage 3 | 1 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): FU-12, Stage 3 | 1 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): FU-24, Stage 2 | 4 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): EOT, Stage 2 | 5 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): FU-12, Stage 4 | 0 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): FU-12, Stage 2 | 3 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): FU-24, Stage 2 | 10 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): FU-12, Stage 5 | 0 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): EOT, Stage 3 | 2 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): FU-24, Stage 4 | 4 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): FU-24, Stage 1 | 29 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): FU-12, Stage 5 | 0 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): EOT, Stage 5 | 0 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): FU-24, Stage 2 | 2 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): EOT, Stage 4 | 1 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): FU-24, Stage 3 | 1 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): FU-24, Stage 3 | 1 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): EOT, Stage 5 | 0 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): FU-24, Stage 5 | 0 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): FU-24, Stage 4 | 0 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): EOT, Stage 5 | 0 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): FU-24, Stage 1 | 20 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): FU-24, Stage 5 | 0 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): FU-24, Stage 4 | 0 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): FU-12, Stage 4 | 2 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): Baseline, Stage 1 | 31 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): FU-12, Stage 1 | 24 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): Baseline, Stage 1 | 29 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): Baseline, Stage 2 | 2 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): FU-12, Stage 3 | 1 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): FU-12, Stage 1 | 20 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): Baseline, Stage 3 | 1 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): FU-12, Stage 2 | 7 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): EOT, Stage 2 | 9 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): Baseline, Stage 4 | 0 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): FU-24, Stage 5 | 0 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): Baseline, Stage 2 | 6 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): Baseline, Stage 5 | 0 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): FU-12, Stage 3 | 3 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): EOT, Stage 3 | 1 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): EOT, Stage 1 | 28 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): Baseline, Stage 5 | 0 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): FU-24, Stage 5 | 0 Participants |
| 6 to < 12 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): EOT, Stage 2 | 3 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): FU-24, Stage 5 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): EOT, Stage 3 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): Baseline, Stage 3 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): EOT, Stage 4 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): EOT, Stage 5 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): FU-12, Stage 1 | 14 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): Baseline, Stage 4 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): FU-12, Stage 2 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): FU-12, Stage 5 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): FU-12, Stage 3 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): FU-12, Stage 4 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): Baseline, Stage 5 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): FU-12, Stage 5 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): FU-24, Stage 1 | 14 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): FU-24, Stage 2 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): EOT, Stage 1 | 21 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): FU-24, Stage 3 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): FU-24, Stage 4 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): FU-24, Stage 5 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): EOT, Stage 2 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): Baseline, Stage 1 | 24 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): FU-24, Stage 1 | 20 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): Baseline, Stage 2 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): Baseline, Stage 3 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): EOT, Stage 3 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): Baseline, Stage 4 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): FU-24, Stage 4 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): Baseline, Stage 5 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): EOT, Stage 1 | 21 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): EOT, Stage 4 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): EOT, Stage 2 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): EOT, Stage 3 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): EOT, Stage 4 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): EOT, Stage 5 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): EOT, Stage 5 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): FU-24, Stage 2 | 1 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): FU-12, Stage 1 | 21 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): FU-12, Stage 2 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): FU-12, Stage 1 | 21 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): FU-12, Stage 3 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): FU-24, Stage 5 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): Baseline, Stage 1 | 17 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): FU-12, Stage 4 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): Baseline, Stage 2 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): Baseline, Stage 3 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): Baseline, Stage 4 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): FU-12, Stage 5 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): Baseline, Stage 5 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): FU-12, Stage 2 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): EOT, Stage 1 | 13 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): EOT, Stage 2 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): FU-24, Stage 1 | 20 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): EOT, Stage 3 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): EOT, Stage 4 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): EOT, Stage 5 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): FU-24, Stage 2 | 1 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): FU-12, Stage 1 | 14 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): FU-12, Stage 2 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): FU-12, Stage 3 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): FU-24, Stage 3 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): FU-12, Stage 4 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): FU-12, Stage 3 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): FU-12, Stage 5 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): FU-24, Stage 1 | 14 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): FU-24, Stage 4 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): FU-24, Stage 2 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): FU-24, Stage 3 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): FU-24, Stage 3 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Male): FU-24, Stage 4 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Pubic Hair (Female): FU-24, Stage 5 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): EOT, Stage 2 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): Baseline, Stage 1 | 17 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): Baseline, Stage 2 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): Baseline, Stage 1 | 24 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): Baseline, Stage 3 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): FU-12, Stage 4 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): Baseline, Stage 4 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): Baseline, Stage 5 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Breasts (Female): Baseline, Stage 2 | 0 Participants |
| 3 to < 6 Years Old | Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline | Genitalia (Male): EOT, Stage 1 | 13 Participants |
Secondary
Treatment Phase: Growth and Development as Measured by Parental Height
Mid-parental height was calculated as the average of the biological father's and mother's heights. For boys, the sex-adjusted mid-parental height was calculated by adding 2.5 inches or 6.5 cm to the mean of the parents' heights. For girls, 2.5 inches or 6.5 cm was subtracted from the mean of the parents' heights.
Time frame: Day 1
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 12 to < 18 Years Old | Treatment Phase: Growth and Development as Measured by Parental Height | 170.5 cm |
| 6 to < 12 Years Old | Treatment Phase: Growth and Development as Measured by Parental Height | 170.0 cm |
| 3 to < 6 Years Old | Treatment Phase: Growth and Development as Measured by Parental Height | 168.7 cm |
Secondary
Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1
Acceptability was assessed by numeric response marked on line between numbers 0 - 100. Higher scores indicate better acceptability and/or palatability.
Time frame: Day 1
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 12 to < 18 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Taste, Participants Who Did Not Taste Study Drug | 61 Participants |
| 12 to < 18 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Easy to Take, Participants Who Marked > 60 to 100 | 82 Participants |
| 12 to < 18 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Taste, Participants Who Marked > 60 to 100 | 16 Participants |
| 12 to < 18 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Easy to Take, Participants Who Marked 0 to < 40 | 2 Participants |
| 12 to < 18 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Taste, Participants Who Marked 40 to 60 | 11 Participants |
| 12 to < 18 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Easy to Take, Participants Who Marked 40 to 60 | 5 Participants |
| 12 to < 18 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Taste, Participants Who Marked 0 to < 40 | 3 Participants |
| 6 to < 12 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Taste, Participants Who Marked > 60 to 100 | 3 Participants |
| 6 to < 12 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Taste, Participants Who Marked 0 to < 40 | 2 Participants |
| 6 to < 12 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Taste, Participants Who Marked 40 to 60 | 1 Participants |
| 6 to < 12 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Easy to Take, Participants Who Marked > 60 to 100 | 9 Participants |
| 6 to < 12 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Taste, Participants Who Did Not Taste Study Drug | 5 Participants |
| 6 to < 12 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Easy to Take, Participants Who Marked 0 to < 40 | 1 Participants |
| 6 to < 12 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Easy to Take, Participants Who Marked 40 to 60 | 1 Participants |
| 3 to < 6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Taste, Participants Who Marked 40 to 60 | 6 Participants |
| 3 to < 6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Taste, Participants Who Marked > 60 to 100 | 11 Participants |
| 3 to < 6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Taste, Participants Who Did Not Taste Study Drug | 42 Participants |
| 3 to < 6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Easy to Take, Participants Who Marked > 60 to 100 | 60 Participants |
| 3 to < 6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Easy to Take, Participants Who Marked 40 to 60 | 3 Participants |
| 3 to < 6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Taste, Participants Who Marked 0 to < 40 | 12 Participants |
| 3 to < 6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Easy to Take, Participants Who Marked 0 to < 40 | 8 Participants |
| 6 to <12 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Taste, Participants Who Marked 0 to < 40 | 1 Participants |
| 6 to <12 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Taste, Participants Who Did Not Taste Study Drug | 0 Participants |
| 6 to <12 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Taste, Participants Who Marked > 60 to 100 | 0 Participants |
| 6 to <12 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Taste, Participants Who Marked 40 to 60 | 0 Participants |
| 6 to <12 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Easy to Take, Participants Who Marked > 60 to 100 | 0 Participants |
| 6 to <12 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Easy to Take, Participants Who Marked 40 to 60 | 0 Participants |
| 6 to <12 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Easy to Take, Participants Who Marked 0 to < 40 | 1 Participants |
| 3 to < 6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Taste, Participants Who Marked 40 to 60 | 4 Participants |
| 3 to < 6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Taste, Participants Who Marked > 60 to 100 | 6 Participants |
| 3 to < 6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Easy to Take, Participants Who Marked 0 to < 40 | 10 Participants |
| 3 to < 6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Taste, Participants Who Did Not Taste Study Drug | 8 Participants |
| 3 to < 6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Easy to Take, Participants Who Marked 40 to 60 | 4 Participants |
| 3 to < 6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Taste, Participants Who Marked 0 to < 40 | 9 Participants |
| 3 to < 6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Easy to Take, Participants Who Marked > 60 to 100 | 13 Participants |
| 3 to <6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Easy to Take, Participants Who Marked 0 to < 40 | 6 Participants |
| 3 to <6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Easy to Take, Participants Who Marked > 60 to 100 | 4 Participants |
| 3 to <6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Taste, Participants Who Marked 40 to 60 | 1 Participants |
| 3 to <6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Taste, Participants Who Marked > 60 to 100 | 3 Participants |
| 3 to <6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Easy to Take, Participants Who Marked 40 to 60 | 2 Participants |
| 3 to <6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Taste, Participants Who Did Not Taste Study Drug | 5 Participants |
| 3 to <6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1 | Taste, Participants Who Marked 0 to < 40 | 3 Participants |
Secondary
Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12
Acceptability was assessed by numeric response marked on line between numbers 0 - 100. Higher scores indicate better acceptability and/or palatability.
Time frame: Week 12
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 12 to < 18 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Taste, Participants Who Marked 0 to < 40 | 7 Participants |
| 12 to < 18 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Taste, Participants Who Marked 40 to 60 | 10 Participants |
| 12 to < 18 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Feel About Taking Pills, Who Marked 0 to < 40 | 3 Participants |
| 12 to < 18 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Feel About Taking Pills, Who Marked 40 to 60 | 3 Participants |
| 12 to < 18 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Feel About Taking Pills, Who Marked > 60 to 100 | 82 Participants |
| 12 to < 18 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Easy to Take, Participants Who Marked 0 to < 40 | 3 Participants |
| 12 to < 18 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Taste, Participants Who Marked > 60 to 100 | 24 Participants |
| 12 to < 18 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Taste, Participants Who Did Not Taste Study Drug | 49 Participants |
| 12 to < 18 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Easy to Take, Participants Who Marked 40 to 60 | 3 Participants |
| 12 to < 18 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Easy to Take, Participants Who Marked > 60 to 100 | 83 Participants |
| 6 to < 12 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Taste, Participants Who Marked > 60 to 100 | 5 Participants |
| 6 to < 12 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Taste, Participants Who Did Not Taste Study Drug | 2 Participants |
| 6 to < 12 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Taste, Participants Who Marked 40 to 60 | 1 Participants |
| 6 to < 12 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Taste, Participants Who Marked 0 to < 40 | 3 Participants |
| 6 to < 12 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Easy to Take, Participants Who Marked > 60 to 100 | 9 Participants |
| 6 to < 12 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Easy to Take, Participants Who Marked 40 to 60 | 0 Participants |
| 6 to < 12 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Easy to Take, Participants Who Marked 0 to < 40 | 2 Participants |
| 6 to < 12 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Feel About Taking Pills, Who Marked > 60 to 100 | 8 Participants |
| 6 to < 12 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Feel About Taking Pills, Who Marked 40 to 60 | 1 Participants |
| 6 to < 12 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Feel About Taking Pills, Who Marked 0 to < 40 | 2 Participants |
| 3 to < 6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Taste, Participants Who Marked 0 to < 40 | 11 Participants |
| 3 to < 6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Feel About Taking Pills, Who Marked > 60 to 100 | 60 Participants |
| 3 to < 6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Taste, Participants Who Did Not Taste Study Drug | 33 Participants |
| 3 to < 6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Easy to Take, Participants Who Marked > 60 to 100 | 65 Participants |
| 3 to < 6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Taste, Participants Who Marked 40 to 60 | 12 Participants |
| 3 to < 6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Taste, Participants Who Marked > 60 to 100 | 14 Participants |
| 3 to < 6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Easy to Take, Participants Who Marked 40 to 60 | 5 Participants |
| 3 to < 6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Feel About Taking Pills, Who Marked 40 to 60 | 7 Participants |
| 3 to < 6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Feel About Taking Pills, Who Marked 0 to < 40 | 3 Participants |
| 3 to < 6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Easy to Take, Participants Who Marked 0 to < 40 | 0 Participants |
| 6 to <12 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Easy to Take, Participants Who Marked 0 to < 40 | 0 Participants |
| 6 to <12 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Feel About Taking Pills, Who Marked > 60 to 100 | NA Participants |
| 6 to <12 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Taste, Participants Who Marked > 60 to 100 | 0 Participants |
| 6 to <12 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Feel About Taking Pills, Who Marked 0 to < 40 | NA Participants |
| 6 to <12 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Feel About Taking Pills, Who Marked 40 to 60 | NA Participants |
| 6 to <12 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Taste, Participants Who Did Not Taste Study Drug | 0 Participants |
| 6 to <12 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Easy to Take, Participants Who Marked 40 to 60 | 0 Participants |
| 6 to <12 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Easy to Take, Participants Who Marked > 60 to 100 | 1 Participants |
| 6 to <12 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Taste, Participants Who Marked 0 to < 40 | 0 Participants |
| 6 to <12 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Taste, Participants Who Marked 40 to 60 | 1 Participants |
| 3 to < 6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Easy to Take, Participants Who Marked 0 to < 40 | 2 Participants |
| 3 to < 6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Taste, Participants Who Marked 0 to < 40 | 7 Participants |
| 3 to < 6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Easy to Take, Participants Who Marked > 60 to 100 | 20 Participants |
| 3 to < 6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Easy to Take, Participants Who Marked 40 to 60 | 1 Participants |
| 3 to < 6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Taste, Participants Who Did Not Taste Study Drug | 8 Participants |
| 3 to < 6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Feel About Taking Pills, Who Marked > 60 to 100 | NA Participants |
| 3 to < 6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Feel About Taking Pills, Who Marked 0 to < 40 | NA Participants |
| 3 to < 6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Feel About Taking Pills, Who Marked 40 to 60 | NA Participants |
| 3 to < 6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Taste, Participants Who Marked 40 to 60 | 4 Participants |
| 3 to < 6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Taste, Participants Who Marked > 60 to 100 | 4 Participants |
| 3 to <6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Easy to Take, Participants Who Marked 40 to 60 | 1 Participants |
| 3 to <6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Feel About Taking Pills, Who Marked 0 to < 40 | NA Participants |
| 3 to <6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Taste, Participants Who Marked > 60 to 100 | 1 Participants |
| 3 to <6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Taste, Participants Who Marked 40 to 60 | 3 Participants |
| 3 to <6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Easy to Take, Participants Who Marked > 60 to 100 | 6 Participants |
| 3 to <6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Easy to Take, Participants Who Marked 0 to < 40 | 1 Participants |
| 3 to <6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Taste, Participants Who Marked 0 to < 40 | 2 Participants |
| 3 to <6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Feel About Taking Pills, Who Marked > 60 to 100 | NA Participants |
| 3 to <6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Taste, Participants Who Did Not Taste Study Drug | 2 Participants |
| 3 to <6 Years Old | Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12 | Feel About Taking Pills, Who Marked 40 to 60 | NA Participants |
Secondary
Treatment Phase: Percentage of Participants Who Develop Viral Resistance to SOF and/or VEL During Treatment and After Discontinuation of Treatment
Drug-resistant substitutions were analyzed as part of the Virology Study. Plasma samples were collected and stored for potential HCV sequencing. Impact on the treatment outcomes of SVR12 and SVR24 were observed during the study. Baseline deep sequencing of the HCV nonstructural protein (NS)5A and NS5B genes was performed for all participants at the first time point after virologic failure if the plasma or serum sample was available. Pretreatment full-length NS5A deep sequencing data were obtained at a 15% assay cutoff for the Resistance Analysis Population which covered all NS5A and NS5B nucleoside inhibitor (NI) resistance-associated variants (RAVs).
Time frame: First dose date up to Posttreatment Week 24
Population: The Resistance Analysis Population with all adolescent or pediatric participants in the Safety Analysis Set with a virologic outcome with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 12 to < 18 Years Old | Treatment Phase: Percentage of Participants Who Develop Viral Resistance to SOF and/or VEL During Treatment and After Discontinuation of Treatment | Pretreatment NS5A NI RAVs | 16.3 percentage of participants |
| 12 to < 18 Years Old | Treatment Phase: Percentage of Participants Who Develop Viral Resistance to SOF and/or VEL During Treatment and After Discontinuation of Treatment | Pretreatment NS5B NI RAVs | 5.1 percentage of participants |
| 6 to < 12 Years Old | Treatment Phase: Percentage of Participants Who Develop Viral Resistance to SOF and/or VEL During Treatment and After Discontinuation of Treatment | Pretreatment NS5A NI RAVs | 10.2 percentage of participants |
| 6 to < 12 Years Old | Treatment Phase: Percentage of Participants Who Develop Viral Resistance to SOF and/or VEL During Treatment and After Discontinuation of Treatment | Pretreatment NS5B NI RAVs | 0.0 percentage of participants |
| 3 to < 6 Years Old | Treatment Phase: Percentage of Participants Who Develop Viral Resistance to SOF and/or VEL During Treatment and After Discontinuation of Treatment | Pretreatment NS5A NI RAVs | 18.1 percentage of participants |
| 3 to < 6 Years Old | Treatment Phase: Percentage of Participants Who Develop Viral Resistance to SOF and/or VEL During Treatment and After Discontinuation of Treatment | Pretreatment NS5B NI RAVs | 3.0 percentage of participants |
Secondary
Treatment Phase: Percentage of Participants With HCV RNA < LLOQ On Treatment
Percentage of participants with HCV RNA \< LLOQ while on treatment by analysis visit.
Time frame: Weeks 1, 4, 8, and 12
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 12 to < 18 Years Old | Treatment Phase: Percentage of Participants With HCV RNA < LLOQ On Treatment | Week 1 | 44.1 percentage of participants |
| 12 to < 18 Years Old | Treatment Phase: Percentage of Participants With HCV RNA < LLOQ On Treatment | Week 4 | 96.1 percentage of participants |
| 12 to < 18 Years Old | Treatment Phase: Percentage of Participants With HCV RNA < LLOQ On Treatment | Week 8 | 100.0 percentage of participants |
| 12 to < 18 Years Old | Treatment Phase: Percentage of Participants With HCV RNA < LLOQ On Treatment | Week 12 | 100.0 percentage of participants |
| 6 to < 12 Years Old | Treatment Phase: Percentage of Participants With HCV RNA < LLOQ On Treatment | Week 12 | 98.6 percentage of participants |
| 6 to < 12 Years Old | Treatment Phase: Percentage of Participants With HCV RNA < LLOQ On Treatment | Week 1 | 39.7 percentage of participants |
| 6 to < 12 Years Old | Treatment Phase: Percentage of Participants With HCV RNA < LLOQ On Treatment | Week 8 | 98.6 percentage of participants |
| 6 to < 12 Years Old | Treatment Phase: Percentage of Participants With HCV RNA < LLOQ On Treatment | Week 4 | 94.4 percentage of participants |
| 3 to < 6 Years Old | Treatment Phase: Percentage of Participants With HCV RNA < LLOQ On Treatment | Week 12 | 100.0 percentage of participants |
| 3 to < 6 Years Old | Treatment Phase: Percentage of Participants With HCV RNA < LLOQ On Treatment | Week 4 | 91.4 percentage of participants |
| 3 to < 6 Years Old | Treatment Phase: Percentage of Participants With HCV RNA < LLOQ On Treatment | Week 8 | 100.0 percentage of participants |
| 3 to < 6 Years Old | Treatment Phase: Percentage of Participants With HCV RNA < LLOQ On Treatment | Week 1 | 36.8 percentage of participants |
Secondary
Treatment Phase: Percentage of Participants With Sustained Virologic Response (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: The Full Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug (SOF/VEL FDC).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 12 to < 18 Years Old | Treatment Phase: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) | 95.1 percentage of participants |
| 6 to < 12 Years Old | Treatment Phase: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) | 93.2 percentage of participants |
| 3 to < 6 Years Old | Treatment Phase: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) | 82.9 percentage of participants |
Secondary
Treatment Phase: Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
SVR 24 was defined as HCV RNA \< LLOQ (ie, 15 IU/mL) 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) |
|---|---|---|
| 12 to < 18 Years Old | Treatment Phase: Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) | 95.1 percentage of participants |
| 6 to < 12 Years Old | Treatment Phase: Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) | 93.2 percentage of participants |
| 3 to < 6 Years Old | Treatment Phase: Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) | 82.9 percentage of participants |
Secondary
Treatment Phase: Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA \< LLOQ (ie, 15 IU/mL) 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) |
|---|---|---|
| 12 to < 18 Years Old | Treatment Phase: Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) | 96.1 percentage of participants |
| 6 to < 12 Years Old | Treatment Phase: Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) | 94.5 percentage of participants |
| 3 to < 6 Years Old | Treatment Phase: Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) | 82.9 percentage of participants |
Secondary
Treatment Phase: Percentage of Participants With Virologic Failure
Virologic failure was defined as: On-treatment virologic failure - Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment); Virologic relapse: 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) |
|---|---|---|
| 12 to < 18 Years Old | Treatment Phase: Percentage of Participants With Virologic Failure | 1.0 percentage of participants |
| 6 to < 12 Years Old | Treatment Phase: Percentage of Participants With Virologic Failure | 1.4 percentage of participants |
| 3 to < 6 Years Old | Treatment Phase: Percentage of Participants With Virologic Failure | 0.0 percentage of participants |
Secondary
Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey
To evaluate the effect of treatment with SOF/VEL on general and disease-specific health-related QoL, the PedsQL™ Pediatric QoL Inventory V4.0 Short Form (SF15) was completed at Day 1, end of treatment, early termination (if applicable), and posttreatment Weeks 12 and 24. The SF15 questionnaire represented 4 domains: physical, emotional, social, and school functioning, with the emotional, social, and school functioning domains representing the psychosocial health summary. Neuropsychiatric assessment was conducted using the PedsQL™ Pediatric QoL Inventory V4.0 SF15 psychosocial domain-related scores. Items were calculated and transformed into an overall score with a range of 0 to 100 points, with more points indicating better QoL.
Time frame: Baseline; Week 12, End of Treatment (EOT), Posttreatment/Follow-up (FU) Week-12 (FU-12), and FU Week-24 (FU-24)
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 12 to < 18 Years Old | Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey | Parents Reports, Total Score at Baseline | 80.0 score on a scale | Standard Deviation 17.71 |
| 12 to < 18 Years Old | Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey | Parents Reports, Total Score at Week 12 | 82.4 score on a scale | Standard Deviation 18.13 |
| 12 to < 18 Years Old | Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey | Parents Reports, Total Score at EOT | 82.4 score on a scale | Standard Deviation 18.13 |
| 12 to < 18 Years Old | Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey | Parents Reports, Total Score at Follow Up-12 | 81.7 score on a scale | Standard Deviation 17.39 |
| 12 to < 18 Years Old | Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey | Parents Reports, Total Score at Follow Up-24 | 80.8 score on a scale | Standard Deviation 18.65 |
| 12 to < 18 Years Old | Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey | Participants Reports, Total Score at Baseline | 79.9 score on a scale | Standard Deviation 15.22 |
| 12 to < 18 Years Old | Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey | Participants Reports, Total Score at Week 12 | 80.9 score on a scale | Standard Deviation 16.38 |
| 12 to < 18 Years Old | Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey | Participants Reports, Total Score at EOT | 80.9 score on a scale | Standard Deviation 16.38 |
| 12 to < 18 Years Old | Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey | Participants Reports, Total Score at Follow Up-12 | 82.5 score on a scale | Standard Deviation 15.41 |
| 12 to < 18 Years Old | Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey | Participants Reports, Total Score at Follow Up-24 | 81.4 score on a scale | Standard Deviation 16.34 |
| 6 to < 12 Years Old | Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey | Participants Reports, Total Score at Follow Up-12 | 81.1 score on a scale | Standard Deviation 13.32 |
| 6 to < 12 Years Old | Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey | Parents Reports, Total Score at Baseline | 79.7 score on a scale | Standard Deviation 15.58 |
| 6 to < 12 Years Old | Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey | Participants Reports, Total Score at Baseline | 77.9 score on a scale | Standard Deviation 13.33 |
| 6 to < 12 Years Old | Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey | Parents Reports, Total Score at Follow Up-24 | 79.7 score on a scale | Standard Deviation 15.3 |
| 6 to < 12 Years Old | Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey | Parents Reports, Total Score at Week 12 | 82.8 score on a scale | Standard Deviation 14.26 |
| 6 to < 12 Years Old | Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey | Participants Reports, Total Score at Follow Up-24 | 81.7 score on a scale | Standard Deviation 15.43 |
| 6 to < 12 Years Old | Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey | Participants Reports, Total Score at EOT | 79.7 score on a scale | Standard Deviation 14.13 |
| 6 to < 12 Years Old | Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey | Parents Reports, Total Score at EOT | 82.2 score on a scale | Standard Deviation 14.95 |
| 6 to < 12 Years Old | Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey | Participants Reports, Total Score at Week 12 | 80.0 score on a scale | Standard Deviation 14.21 |
| 6 to < 12 Years Old | Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey | Parents Reports, Total Score at Follow Up-12 | 81.5 score on a scale | Standard Deviation 15.34 |
| 3 to < 6 Years Old | Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey | Participants Reports, Total Score at EOT | 83.3 score on a scale | Standard Deviation 11.62 |
| 3 to < 6 Years Old | Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey | Parents Reports, Total Score at Follow Up-12 | 87.7 score on a scale | Standard Deviation 14.11 |
| 3 to < 6 Years Old | Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey | Parents Reports, Total Score at Follow Up-24 | 88.3 score on a scale | Standard Deviation 9.79 |
| 3 to < 6 Years Old | Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey | Participants Reports, Total Score at Baseline | 82.2 score on a scale | Standard Deviation 12.47 |
| 3 to < 6 Years Old | Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey | Participants Reports, Total Score at Follow Up-12 | 80.5 score on a scale | Standard Deviation 14.18 |
| 3 to < 6 Years Old | Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey | Participants Reports, Total Score at Week 12 | 83.3 score on a scale | Standard Deviation 11.62 |
| 3 to < 6 Years Old | Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey | Parents Reports, Total Score at Baseline | 86.5 score on a scale | Standard Deviation 12.43 |
| 3 to < 6 Years Old | Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey | Participants Reports, Total Score at Follow Up-24 | 82.1 score on a scale | Standard Deviation 12.56 |
| 3 to < 6 Years Old | Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey | Parents Reports, Total Score at Week 12 | 87.3 score on a scale | Standard Deviation 11.31 |
| 3 to < 6 Years Old | Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey | Parents Reports, Total Score at EOT | 87.0 score on a scale | Standard Deviation 11.65 |
Secondary
Treatment Phase: Swallowability of SOF/VEL as Assessed by the Participant's Ability to Swallow SOF/VEL Placebo Tablets at Baseline
A SOF/VEL FDC swallowability assessment was performed using placebo tablets at baseline.
Time frame: Baseline
Population: Participants in the Full Analysis Set with available data were analyzed. Swallowability assessment was performed in 12 to \<18 years old and 6 to \< 12 Years old only.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 12 to < 18 Years Old | Treatment Phase: Swallowability of SOF/VEL as Assessed by the Participant's Ability to Swallow SOF/VEL Placebo Tablets at Baseline | SOF/VEL 400/100mg Placebo Tablet, Able to Swallow | 92 Participants |
| 12 to < 18 Years Old | Treatment Phase: Swallowability of SOF/VEL as Assessed by the Participant's Ability to Swallow SOF/VEL Placebo Tablets at Baseline | SOF/VEL 400/100mg Placebo, Not Able to Swallow | 10 Participants |
| 12 to < 18 Years Old | Treatment Phase: Swallowability of SOF/VEL as Assessed by the Participant's Ability to Swallow SOF/VEL Placebo Tablets at Baseline | SOF/VEL 200/50mg Placebo, Able to Swallow | 10 Participants |
| 12 to < 18 Years Old | Treatment Phase: Swallowability of SOF/VEL as Assessed by the Participant's Ability to Swallow SOF/VEL Placebo Tablets at Baseline | SOF/VEL 200/50mg Placebo, Not Able to Swallow | 0 Participants |
| 6 to < 12 Years Old | Treatment Phase: Swallowability of SOF/VEL as Assessed by the Participant's Ability to Swallow SOF/VEL Placebo Tablets at Baseline | SOF/VEL 200/50mg Placebo, Not Able to Swallow | 1 Participants |
| 6 to < 12 Years Old | Treatment Phase: Swallowability of SOF/VEL as Assessed by the Participant's Ability to Swallow SOF/VEL Placebo Tablets at Baseline | SOF/VEL 400/100mg Placebo Tablet, Able to Swallow | 1 Participants |
| 6 to < 12 Years Old | Treatment Phase: Swallowability of SOF/VEL as Assessed by the Participant's Ability to Swallow SOF/VEL Placebo Tablets at Baseline | SOF/VEL 200/50mg Placebo, Able to Swallow | 72 Participants |
| 6 to < 12 Years Old | Treatment Phase: Swallowability of SOF/VEL as Assessed by the Participant's Ability to Swallow SOF/VEL Placebo Tablets at Baseline | SOF/VEL 400/100mg Placebo, Not Able to Swallow | 0 Participants |