Hepatitis C Virus Infection
Conditions
Brief summary
The primary objective of this study is to evaluate the steady-state pharmacokinetics (PK) and confirm the age-appropriate dose of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) in pediatric participants with chronic hepatitis C virus (HCV) infection.
Detailed description
Participants will receive placebo to match SOF/VEL/VOX FDC to assess ability to swallow tablets at screening up to Day 1.
Interventions
DRUGSOF/VEL/VOX
Administered once daily with food.
Sponsors
Gilead Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Consent of parent or legal guardian required * Chronic HCV infection * Screening laboratory values within defined thresholds * Individuals must have a determination of prior treatment status: * DAA-naive is defined as either: * Treatment naive with no prior exposure to any interferon (IFN), ribavirin (RBV), or approved or experimental HCV-specific DAA * Treatment experienced with an IFN-based regimen and no prior exposure to an approved or experimental HCV-specific DAA * DAA-experienced is defined as prior exposure to a regimen including any DAA (eg, non-structural protein (NS)3/4A protease inhibitor, NS5A inhibitor, or NS5B nucleotide/nucleoside inhibitor) Key
Exclusion criteria
* History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol * Co-infection with human immunodeficiency virus (HIV), acute hepatitis A virus (HAV) or hepatitis B virus (HBV) * Clinical hepatic decompensation (eg, clinical ascites, encephalopathy, and/or variceal hemorrhage) * Pregnant or nursing females * Known hypersensitivity to study medication * Use of any prohibited concomitant medications as within 28 days of the Day 1 visit Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic (PK) Parameter: AUCtau of SOF, GS-331007 (Metabolite of SOF), VEL, and VOX | Sparse PK Sample (all participants): At Weeks 1 and 8 at any time, Weeks 2 and 4 (predose and between 15 minutes and 4 hours postdose). Intensive PK Sample [PK Substudy (N=14)]: Week 2 or Week 4 (0 (predose), 0.5, 1, 2, 3, 4, 6, 8, and 12 hours postdose) | AUCtau was defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). For participants with separate consent to participate in the optional intensive PK substudy, intensive serial PK blood samples were collected at Week 2 or Week 4. Sparse PK samples were collected from all participants at Weeks 1, 2, 4, and end of treatment/Week 8. Plasma concentration data from all PK samples (intensive and sparse) were combined and used to generate PK parameters of SOF, GS-331007, VEL, and VOX for all participants using a population PK modeling approach. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | Posttreatment Week 12 | SVR was defined as hepatitis C virus (HCV RNA) \< Lower limit of quantification (LLOQ) (ie, \< 15 IU/mL) 12 weeks after discontinuation of the study drug. |
| Percentage of Participants With HCV RNA < LLOQ 4 Weeks After Discontinuation of Therapy (SVR4) | Posttreatment Week 4 | SVR was defined as HCV RNA \< LLOQ (ie, \< 15 IU/mL) 4 weeks after discontinuation of the study drug. |
| Percentage of Participants With HCV RNA < LLOQ 24 Weeks After Discontinuation of Therapy (SVR24) | Posttreatment Week 24 | SVR was defined as HCV RNA \< LLOQ (ie, \< 15 IU/mL) 24 weeks after discontinuation of the study drug. |
| Percentage of Participants With Overall Virologic Failure | Up to Posttreatment Week 24 | Overall Virologic Failure comprises of on-treatment virologic failure and relapse. On-treatment virologic failure (breakthrough, rebound, and nonresponse) and relapse were defined as follows: Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), Rebound (confirmed \> 1 log10IU/mL increase in HCV RNA from nadir while on treatment), or Nonresponse (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) and Relapse (confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on treatment visit). |
| Percentage of Participants With HCV RNA < LLOQ on Treatment | Weeks 1, 2, 4, and 8 | Percentage of participants with HCV RNA \< LLOQ (15 IU/mL) while on treatment by analysis visit. |
| Percentage of Participants Who Developed Viral Resistance to SOF, VEL, and/or VOX During Treatment | Up to End of Treatment (Week 8) | 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 nonstructural protein (NS)3, NS5A, and NS5B deep sequencing analysis was performed for all participants. Sequencing for the HCV NS5A and NS5B regions was performed for all enrolled participants at baseline and for participants with virologic failure. |
| Percentage of Participants Who Developed Viral Resistance to SOF, VEL, and/or VOX When Treatment is Discontinued | Up to Posttreatment Week 24 | 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 nonstructural protein (NS)3, NS5A, and NS5B deep sequencing analysis was performed for all participants. Sequencing for the HCV NS5A and NS5B regions was performed for all enrolled participants at baseline and for participants with virologic failure. |
| Change in HCV RNA From Day 1 Through End of Treatment | Baseline (Day 1); Weeks 1, 2 ,4, and 8 | — |
| Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Baseline (Day 1); Week 1, 2, 4, 8, and Posttreatment/Follow-up Week 4 (FU-4) | ALT normalization was defined as ALT \> upper limit of normal (ULN) at baseline and ALT ≤ ULN at each visit. |
| Change From Baseline in Height Percentiles as a Measurement of Growth and Development | Baseline (Day 1); Weeks 1, 2, 4, 8, FU-4, Posttreatment/Follow-up Week 12 (FU-12), and Posttreatment/Follow-up Week 24 (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. |
| Change From Baseline in Weight Percentiles as a Measurement of Growth and Development | Baseline (Day 1); Weeks 1, 2, 4, 8, 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. |
| Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event | First dose date up to the last dose date (maximum: 8 Weeks) plus 30 days | Treatment-emergent Adverse Events (TEAE) were defined as events that met 1 or both of the following criteria as any AEs with onset dates on or after the study drug start date and no later than 30 days after the permanent discontinuation of study drug. It also includes the AEs that leads to premature discontinuation of study drug. |
| Change From Baseline in Radiographic Bone Age Assessment as a Measurement of Growth and Development | Baseline (Day 1); Week 8 | For radiographic bone age assessment, a single x-ray of the left wrist, hand, and fingers was performed and assessed by changes from baseline through end of treatment period. |
| Change From Baseline in C-Type Collagen Sequence (CTX) Bone Turn-Over Biochemical Marker as a Measurement of Growth and Development | Baseline (Day 1); FU-24 | Fasting blood samples for baseline values for bone age biomarkers CTX and change from baseline were recorded. |
| Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP) Bone Turn-Over Biochemical Marker as a Measurement of Growth and Development | Baseline (Day 1); FU-24 | Fasting blood samples for baseline values for bone age biomarkers P1NP and change from baseline were recorded. |
| Percentage of Participants in Each Swallowability Category of Able to Swallow or Unable to Swallow SOF/VEL/VOX 400/100/100 mg Size Tablets | Baseline (Day 1) | Swallowability for SOF/VEL/VOX FDC placebo to match (PTM) tablets was summarized based on the participants present in each swallowability category of Able to Swallow or Unable to Swallow a placebo tablet on one occasion during screening until Day 1. |
| Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant | Baseline (Day 1); Week 8 | A questionnaire was administered to participants to assess acceptability, including palatability, of the formulation. Acceptability and palatability were assessed by questions about how the study drug tasted, how easy it was to swallow the study drug, and also at the end of treatment about how it was to take the study drug and, as they all received a single tablet daily, how they felt about the number of tablets they had to swallow. |
| Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Parent/Legal Guardian | Week 8 | A questionnaire was administered to the parent/legal guardian of participants to assess acceptability, including palatability, of the formulation. Acceptability and palatability were assessed by questions about how the study drug tasted, how easy it was to swallow the study drug, about how it was to take the study drug and, as they all received a single tablet daily, how they felt about the number of tablets they had to swallow. |
| Neuropsychiatric Assessments Based on Questionnaire as Completed by Participant | Weeks 8, FU-12, and FU-24 | Neuropsychiatric safety assessment was done using the Pediatric Quality of Life (PedsQL™ 4.0 SF15). The PedsQL™ 4.0 SF15 Questionnaires was completed by all participants. It is a comprehensive and widely used patient-reported outcome survey designed to measure health-related quality of life in healthy children and adolescents. It is presented for each of the 4 domains of the SF-15 (physical functioning, emotional functioning, social functioning, and school functioning), the psychosocial health summary (emotional, social, and school functioning domains), physical health summary and the Total Score. Total scores as well as each of the subscale scores are transformed on a scale from 0 to 100. Higher scores in each case indicate better health-related quality of life (HRQOL). A positive change from end of treatment period indicates improvement. |
| Neuropsychiatric Assessments Based on Questionnaire as Completed by Parent/Legal Guardian | Weeks 8, FU-12, and FU-24 | Neuropsychiatric safety assessment was done using the Pediatric Quality of Life (PedsQL™ 4.0 SF15). The PedsQL™ 4.0 SF15 Questionnaires was completed by the parent/ legal guardian of the participants. It is a comprehensive and widely used patient-reported outcome survey designed to measure health-related quality of life in healthy children and adolescents. It is presented for each of the 4 domains of the SF-15 (physical functioning, emotional functioning, social functioning, and school functioning), the psychosocial health summary (emotional, social, and school functioning domains), physical health summary and the Total Score. Total scores as well as each of the subscale scores are transformed on a scale from 0 to 100. Higher scores in each case indicate better HRQOL. A positive change from end of treatment period indicates improvement. |
| Change From Baseline in Neuropsychiatric Assessments as Completed by Participant | Baseline (Day 1); Weeks 8, FU-12, and FU-24 | Neuropsychiatric safety assessment was done using the Pediatric Quality of Life (PedsQL™ 4.0 SF15). The PedsQL™ 4.0 SF15 Questionnaires was completed by all the participants. It is a comprehensive and widely used patient-reported outcome survey designed to measure health-related quality of life in healthy children and adolescents. It was presented for each of the 4 domains of the SF-15 (physical functioning, emotional functioning, social functioning, and school functioning), the psychosocial health summary (emotional, social, and school functioning domains), physical health summary and the Total Score. Total scores as well as each of the subscale scores are transformed on a scale from 0 to 100. Higher scores in each case indicate better HRQOL. A positive change from baseline indicates improvement. |
| Change From Baseline in Neuropsychiatric Assessments as Completed by Parent/Legal Guardian | Baseline (Day 1); Weeks 8, FU-12, and FU-24 | Neuropsychiatric safety assessment was done using the Pediatric Quality of Life (PedsQL™ 4.0 SF15). The PedsQL™ 4.0 SF15 Questionnaires was completed by the parent/ legal guardian of the participants. It is a comprehensive and widely used patient-reported outcome survey designed to measure health-related quality of life in healthy children and adolescents. It is presented for each of the 4 domains of the SF-15 (physical functioning, emotional functioning, social functioning, and school functioning), the psychosocial health summary (emotional, social, and school functioning domains), physical health summary and the Total Score. Total scores as well as each of the subscale scores are transformed on a scale from 0 to 100. Higher scores in each case indicate better HRQOL. A positive change from baseline indicates improvement. |
| Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Baseline (Day 1); Weeks 8, FU-12, and FU-24 | Tanner Pubertal Staging were 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 will be 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 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 and testes, Penis (10.5-12.5); 3: Enlargement of penis (11.5-14); 4: Penis size (13.5-15); 5: Genitalia adult in size and shape). |
Countries
Italy, Poland, United Kingdom
Participant flow
Recruitment details
Participants were enrolled at study sites in Europe. The first participant was screened on 28 January 2019. The last study visit occurred on 19 February 2020.
Pre-assignment details
The study was terminated because EMA granted Gilead a waiver for SOF/VEL/VOX in children less than 12 years old. Cohorts 2 and 3 were not enrolled. As per the protocol, participants could have received 8 or 12 weeks of treatment, depending on their prior treatment and disease status, however all participants received treatment for 8 weeks.
Participants by arm
| Arm | Count |
|---|---|
| SOF/VEL/VOX FDC Direct-acting antiviral (DAA) - naive participants without cirrhosis (12 to \< 18 years old) received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose (FDC) combination (400/100/100 mg tablet) orally once daily in nonfasting state for 8 weeks. A single placebo to match tablet was administered during screening until Day 1 to confirm the participant was able to swallow SOF/VEL/VOX 400/100/100 mg tablets. | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | SOF/VEL/VOX FDC |
|---|---|
| Age, Continuous | 14 years STANDARD_DEVIATION 1.2 |
| Baseline Alanine aminotransferase (ALT) Category > 1.5 x ULN | 5 Participants |
| Baseline Alanine aminotransferase (ALT) Category ≤ 1.5 x (Upper Limit of Normal) ULN | 16 Participants |
| Baseline HCV Ribonucleic acid (RNA) | 5.9 log10 IU/mL STANDARD_DEVIATION 0.7 |
| Cirrhosis No | 21 Participants |
| Cirrhosis Yes | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 2 Participants |
| Race/Ethnicity, Customized Race Black or African American | 1 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Race Other | 2 Participants |
| Race/Ethnicity, Customized Race White | 16 Participants |
| Region of Enrollment Italy | 13 Participants |
| Region of Enrollment Poland | 4 Participants |
| Region of Enrollment United Kingdom | 4 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 13 / 21 |
| serious Total, serious adverse events | 1 / 21 |
Outcome results
Primary
Pharmacokinetic (PK) Parameter: AUCtau of SOF, GS-331007 (Metabolite of SOF), VEL, and VOX
AUCtau was defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). For participants with separate consent to participate in the optional intensive PK substudy, intensive serial PK blood samples were collected at Week 2 or Week 4. Sparse PK samples were collected from all participants at Weeks 1, 2, 4, and end of treatment/Week 8. Plasma concentration data from all PK samples (intensive and sparse) were combined and used to generate PK parameters of SOF, GS-331007, VEL, and VOX for all participants using a population PK modeling approach.
Time frame: Sparse PK Sample (all participants): At Weeks 1 and 8 at any time, Weeks 2 and 4 (predose and between 15 minutes and 4 hours postdose). Intensive PK Sample [PK Substudy (N=14)]: Week 2 or Week 4 (0 (predose), 0.5, 1, 2, 3, 4, 6, 8, and 12 hours postdose)
Population: The Pharmacokinetic Analysis Set included all enrolled adolescent participants who received at least 1 dose of study drug and for whom at least 1 nonmissing PK concentration value was available from all types of PK sampling.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOF/VEL/VOX FDC | Pharmacokinetic (PK) Parameter: AUCtau of SOF, GS-331007 (Metabolite of SOF), VEL, and VOX | SOF | 2474.8 hours•nanogram/milliliter | Standard Deviation 1247.28 |
| SOF/VEL/VOX FDC | Pharmacokinetic (PK) Parameter: AUCtau of SOF, GS-331007 (Metabolite of SOF), VEL, and VOX | GS- 331007 (metabolite of SOF) | 14890.2 hours•nanogram/milliliter | Standard Deviation 3126.35 |
| SOF/VEL/VOX FDC | Pharmacokinetic (PK) Parameter: AUCtau of SOF, GS-331007 (Metabolite of SOF), VEL, and VOX | VEL | 6773.0 hours•nanogram/milliliter | Standard Deviation 2367.3 |
| SOF/VEL/VOX FDC | Pharmacokinetic (PK) Parameter: AUCtau of SOF, GS-331007 (Metabolite of SOF), VEL, and VOX | VOX | 2205.8 hours•nanogram/milliliter | Standard Deviation 1403.45 |
Secondary
Change From Baseline in C-Type Collagen Sequence (CTX) Bone Turn-Over Biochemical Marker as a Measurement of Growth and Development
Fasting blood samples for baseline values for bone age biomarkers CTX and change from baseline were recorded.
Time frame: Baseline (Day 1); FU-24
Population: Participants in the Safety Analysis Set were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| SOF/VEL/VOX FDC | Change From Baseline in C-Type Collagen Sequence (CTX) Bone Turn-Over Biochemical Marker as a Measurement of Growth and Development | Baseline | 1.35 ng/mL |
| SOF/VEL/VOX FDC | Change From Baseline in C-Type Collagen Sequence (CTX) Bone Turn-Over Biochemical Marker as a Measurement of Growth and Development | Change at FU-24 | -0.22 ng/mL |
Secondary
Change From Baseline in Height Percentiles as a Measurement of Growth and Development
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 (Day 1); Weeks 1, 2, 4, 8, FU-4, Posttreatment/Follow-up Week 12 (FU-12), and Posttreatment/Follow-up Week 24 (FU-24)
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| SOF/VEL/VOX FDC | Change From Baseline in Height Percentiles as a Measurement of Growth and Development | Baseline | 47.9 percentile |
| SOF/VEL/VOX FDC | Change From Baseline in Height Percentiles as a Measurement of Growth and Development | Change at Week 8 | 0.0 percentile |
| SOF/VEL/VOX FDC | Change From Baseline in Height Percentiles as a Measurement of Growth and Development | Change at FU-12 | 0.0 percentile |
| SOF/VEL/VOX FDC | Change From Baseline in Height Percentiles as a Measurement of Growth and Development | Change at FU-24 | -0.2 percentile |
Secondary
Change From Baseline in Neuropsychiatric Assessments as Completed by Parent/Legal Guardian
Neuropsychiatric safety assessment was done using the Pediatric Quality of Life (PedsQL™ 4.0 SF15). The PedsQL™ 4.0 SF15 Questionnaires was completed by the parent/ legal guardian of the participants. It is a comprehensive and widely used patient-reported outcome survey designed to measure health-related quality of life in healthy children and adolescents. It is presented for each of the 4 domains of the SF-15 (physical functioning, emotional functioning, social functioning, and school functioning), the psychosocial health summary (emotional, social, and school functioning domains), physical health summary and the Total Score. Total scores as well as each of the subscale scores are transformed on a scale from 0 to 100. Higher scores in each case indicate better HRQOL. A positive change from baseline indicates improvement.
Time frame: Baseline (Day 1); Weeks 8, FU-12, and FU-24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Parent/Legal Guardian | Physical Functioning; Baseline | 85.3 score on a scale | Standard Deviation 22.56 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Parent/Legal Guardian | Physical Functioning; Change at Week 8 | 3.5 score on a scale | Standard Deviation 20.97 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Parent/Legal Guardian | Physical Functioning; Change at FU-12 | 2.1 score on a scale | Standard Deviation 20.9 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Parent/Legal Guardian | Physical Functioning; Change at FU-24 | 4.0 score on a scale | Standard Deviation 19.97 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Parent/Legal Guardian | Emotional Functioning; Baseline | 73.4 score on a scale | Standard Deviation 18.57 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Parent/Legal Guardian | Emotional Functioning; Change at Week 8 | 7.8 score on a scale | Standard Deviation 18.57 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Parent/Legal Guardian | Emotional Functioning; Change at FU-12 | 6.6 score on a scale | Standard Deviation 14.5 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Parent/Legal Guardian | Emotional Functioning; Change at FU-24 | 4.7 score on a scale | Standard Deviation 12.8 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Parent/Legal Guardian | Social Functioning; Baseline | 85.8 score on a scale | Standard Deviation 18.36 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Parent/Legal Guardian | Social Functioning; Change at Week 8 | 1.3 score on a scale | Standard Deviation 21.84 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Parent/Legal Guardian | Social Functioning; Change at FU-12 | 6.1 score on a scale | Standard Deviation 18.39 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Parent/Legal Guardian | Social Functioning; Change at FU-24 | 2.1 score on a scale | Standard Deviation 21.27 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Parent/Legal Guardian | School Functioning; Baseline | 72.5 score on a scale | Standard Deviation 27.59 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Parent/Legal Guardian | School Functioning; Change at Week 8 | 0.4 score on a scale | Standard Deviation 23.64 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Parent/Legal Guardian | School Functioning; Change at FU-12 | 3.9 score on a scale | Standard Deviation 22.8 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Parent/Legal Guardian | School Functioning; Change at FU-24 | 3.8 score on a scale | Standard Deviation 20.5 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Parent/Legal Guardian | Physical Health; Baseline | 85.3 score on a scale | Standard Deviation 22.56 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Parent/Legal Guardian | Physical Health; Change at Week 8 | 3.5 score on a scale | Standard Deviation 20.97 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Parent/Legal Guardian | Physical Health; Change at FU-12 | 2.1 score on a scale | Standard Deviation 20.9 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Parent/Legal Guardian | Physical Health, Change at FU-24 | 4.0 score on a scale | Standard Deviation 19.97 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Parent/Legal Guardian | Psychosocial Health; Baseline | 76.8 score on a scale | Standard Deviation 17.34 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Parent/Legal Guardian | Psychosocial Health; Change at Week 8 | 3.7 score on a scale | Standard Deviation 17.39 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Parent/Legal Guardian | Psychosocial Health; Change at FU-12 | 5.7 score on a scale | Standard Deviation 15.31 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Parent/Legal Guardian | Psychosocial Health; Change at FU-24 | 3.7 score on a scale | Standard Deviation 15.52 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Parent/Legal Guardian | Total Score; Baseline | 79.7 score on a scale | Standard Deviation 15.4 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Parent/Legal Guardian | Total Score; Change at Week 8 | 3.6 score on a scale | Standard Deviation 15.84 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Parent/Legal Guardian | Total Score; Change at FU-12 | 4.5 score on a scale | Standard Deviation 14.37 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Parent/Legal Guardian | Total Score; Change at FU-24 | 3.8 score on a scale | Standard Deviation 14.89 |
Secondary
Change From Baseline in Neuropsychiatric Assessments as Completed by Participant
Neuropsychiatric safety assessment was done using the Pediatric Quality of Life (PedsQL™ 4.0 SF15). The PedsQL™ 4.0 SF15 Questionnaires was completed by all the participants. It is a comprehensive and widely used patient-reported outcome survey designed to measure health-related quality of life in healthy children and adolescents. It was presented for each of the 4 domains of the SF-15 (physical functioning, emotional functioning, social functioning, and school functioning), the psychosocial health summary (emotional, social, and school functioning domains), physical health summary and the Total Score. Total scores as well as each of the subscale scores are transformed on a scale from 0 to 100. Higher scores in each case indicate better HRQOL. A positive change from baseline indicates improvement.
Time frame: Baseline (Day 1); Weeks 8, FU-12, and FU-24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Participant | Physical Functioning; Baseline | 90.7 score on a scale | Standard Deviation 13.81 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Participant | Physical Functioning; Change at Week 8 | -2.6 score on a scale | Standard Deviation 10.2 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Participant | Physical Functioning; Change at FU-12 | -3.3 score on a scale | Standard Deviation 11.87 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Participant | Physical Functioning; Change at FU-24 | -3.5 score on a scale | Standard Deviation 12.72 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Participant | Emotional Functioning; Baseline | 73.2 score on a scale | Standard Deviation 20.07 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Participant | Emotional Functioning; Change at Week 8 | 4.8 score on a scale | Standard Deviation 10.63 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Participant | Emotional Functioning; Change at FU-12 | 1.8 score on a scale | Standard Deviation 19.78 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Participant | Emotional Functioning; Change at FU-24 | 3.0 score on a scale | Standard Deviation 15.64 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Participant | Social Functioning; Baseline | 93.3 score on a scale | Standard Deviation 12.53 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Participant | Social Functioning; Change at Week 8 | 0.4 score on a scale | Standard Deviation 9.16 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Participant | Social Functioning; Change at FU-12 | -2.0 score on a scale | Standard Deviation 10.17 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Participant | Social Functioning; Change at FU-24 | -0.8 score on a scale | Standard Deviation 8.7 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Participant | School Functioning; Baseline | 75.0 score on a scale | Standard Deviation 24.58 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Participant | School Functioning; Change at Week 8 | 5.2 score on a scale | Standard Deviation 17.97 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Participant | School Functioning; Change at FU-12 | 0.4 score on a scale | Standard Deviation 12.21 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Participant | School Functioning; Change at FU-24 | 1.6 score on a scale | Standard Deviation 11.06 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Participant | Physical Health; Baseline | 90.7 score on a scale | Standard Deviation 13.81 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Participant | Physical Health; Change at Week 8 | -2.6 score on a scale | Standard Deviation 10.2 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Participant | Physical Health; Change at FU-12 | -3.3 score on a scale | Standard Deviation 11.87 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Participant | Physical Health, Change at FU-24 | -3.5 score on a scale | Standard Deviation 12.72 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Participant | Psychosocial Health; Baseline | 79.8 score on a scale | Standard Deviation 14.16 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Participant | Psychosocial Health; Change at Week 8 | 3.8 score on a scale | Standard Deviation 7.47 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Participant | Psychosocial Health; Change at FU-12 | 0.2 score on a scale | Standard Deviation 9.74 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Participant | Psychosocial Health; Change at FU-24 | 1.4 score on a scale | Standard Deviation 8.81 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Participant | Total Score; Baseline | 83.4 score on a scale | Standard Deviation 12.4 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Participant | Total Score; Change at Week 8 | 1.7 score on a scale | Standard Deviation 5.3 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Participant | Total Score; Change at FU-12 | -1.0 score on a scale | Standard Deviation 8.83 |
| SOF/VEL/VOX FDC | Change From Baseline in Neuropsychiatric Assessments as Completed by Participant | Total Score; Change at FU-24 | -0.2 score on a scale | Standard Deviation 8.58 |
Secondary
Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP) Bone Turn-Over Biochemical Marker as a Measurement of Growth and Development
Fasting blood samples for baseline values for bone age biomarkers P1NP and change from baseline were recorded.
Time frame: Baseline (Day 1); FU-24
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| SOF/VEL/VOX FDC | Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP) Bone Turn-Over Biochemical Marker as a Measurement of Growth and Development | Baseline | 383.25 ng/mL |
| SOF/VEL/VOX FDC | Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP) Bone Turn-Over Biochemical Marker as a Measurement of Growth and Development | Change at FU-24 | -101.50 ng/mL |
Secondary
Change From Baseline in Radiographic Bone Age Assessment as a Measurement of Growth and Development
For radiographic bone age assessment, a single x-ray of the left wrist, hand, and fingers was performed and assessed by changes from baseline through end of treatment period.
Time frame: Baseline (Day 1); Week 8
Population: Participants in the Safety Analysis Set were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| SOF/VEL/VOX FDC | Change From Baseline in Radiographic Bone Age Assessment as a Measurement of Growth and Development | Baseline | 14.5 years |
| SOF/VEL/VOX FDC | Change From Baseline in Radiographic Bone Age Assessment as a Measurement of Growth and Development | Change at Week 8 | 0.0 years |
Secondary
Change From Baseline in Weight Percentiles as a Measurement of Growth and Development
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 (Day 1); Weeks 1, 2, 4, 8, FU-4, FU-12, and FU-24
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| SOF/VEL/VOX FDC | Change From Baseline in Weight Percentiles as a Measurement of Growth and Development | Baseline | 54.0 percentile |
| SOF/VEL/VOX FDC | Change From Baseline in Weight Percentiles as a Measurement of Growth and Development | Change at Week 8 | -2.5 percentile |
| SOF/VEL/VOX FDC | Change From Baseline in Weight Percentiles as a Measurement of Growth and Development | Change at FU-12 | -2.7 percentile |
| SOF/VEL/VOX FDC | Change From Baseline in Weight Percentiles as a Measurement of Growth and Development | Change at FU-24 | -1.6 percentile |
Secondary
Change in HCV RNA From Day 1 Through End of Treatment
Time frame: Baseline (Day 1); Weeks 1, 2 ,4, and 8
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOF/VEL/VOX FDC | Change in HCV RNA From Day 1 Through End of Treatment | Change at Week 1 | -4.55 log10 IU/mL | Standard Deviation 0.525 |
| SOF/VEL/VOX FDC | Change in HCV RNA From Day 1 Through End of Treatment | Change at Week 2 | -4.65 log10 IU/mL | Standard Deviation 0.621 |
| SOF/VEL/VOX FDC | Change in HCV RNA From Day 1 Through End of Treatment | Change at Week 4 | -4.71 log10 IU/mL | Standard Deviation 0.661 |
| SOF/VEL/VOX FDC | Change in HCV RNA From Day 1 Through End of Treatment | Change at Week 8 | -4.77 log10 IU/mL | Standard Deviation 0.698 |
Secondary
Neuropsychiatric Assessments Based on Questionnaire as Completed by Parent/Legal Guardian
Neuropsychiatric safety assessment was done using the Pediatric Quality of Life (PedsQL™ 4.0 SF15). The PedsQL™ 4.0 SF15 Questionnaires was completed by the parent/ legal guardian of the participants. It is a comprehensive and widely used patient-reported outcome survey designed to measure health-related quality of life in healthy children and adolescents. It is presented for each of the 4 domains of the SF-15 (physical functioning, emotional functioning, social functioning, and school functioning), the psychosocial health summary (emotional, social, and school functioning domains), physical health summary and the Total Score. Total scores as well as each of the subscale scores are transformed on a scale from 0 to 100. Higher scores in each case indicate better HRQOL. A positive change from end of treatment period indicates improvement.
Time frame: Weeks 8, FU-12, and FU-24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Parent/Legal Guardian | Physical Functioning; Week 8 | 87.4 score on a scale | Standard Deviation 17.29 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Parent/Legal Guardian | Physical Functioning; Change at FU-12 | -2.5 score on a scale | Standard Deviation 9.39 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Parent/Legal Guardian | Physical Functioning; Change at FU-24 | -1.7 score on a scale | Standard Deviation 12.97 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Parent/Legal Guardian | Emotional Functioning; Week 8 | 78.6 score on a scale | Standard Deviation 21.06 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Parent/Legal Guardian | Emotional Functioning; Change at FU-12 | -0.3 score on a scale | Standard Deviation 22.53 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Parent/Legal Guardian | Emotional Functioning; Change at FU-24 | -2.4 score on a scale | Standard Deviation 17.95 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Parent/Legal Guardian | Social Functioning; Week 8 | 87.7 score on a scale | Standard Deviation 17.8 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Parent/Legal Guardian | Social Functioning; Change at FU-12 | 4.2 score on a scale | Standard Deviation 18.04 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Parent/Legal Guardian | Social Functioning; Change at FU-24 | 0.8 score on a scale | Standard Deviation 14.41 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Parent/Legal Guardian | School Functioning; Week 8 | 74.2 score on a scale | Standard Deviation 27.63 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Parent/Legal Guardian | School Functioning; Change at FU-12 | 3.3 score on a scale | Standard Deviation 20.84 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Parent/Legal Guardian | School Functioning; Change at FU-24 | 3.2 score on a scale | Standard Deviation 16.77 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Parent/Legal Guardian | Physical Health; Week 8 | 87.4 score on a scale | Standard Deviation 17.29 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Parent/Legal Guardian | Physical Health ; Change at FU-12 | -2.5 score on a scale | Standard Deviation 9.39 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Parent/Legal Guardian | Physical Health; Change at FU-24 | -1.7 score on a scale | Standard Deviation 12.97 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Parent/Legal Guardian | Psychosocial Health; Week 8 | 80.0 score on a scale | Standard Deviation 17.46 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Parent/Legal Guardian | Psychosocial Health; Change at FU-12 | 2.1 score on a scale | Standard Deviation 15.82 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Parent/Legal Guardian | Psychosocial Health; Change at FU-24 | 0.2 score on a scale | Standard Deviation 9.61 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Parent/Legal Guardian | Total Score; Week 8 | 82.5 score on a scale | Standard Deviation 16.1 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Parent/Legal Guardian | Total Score; Change at FU-12 | 0.6 score on a scale | Standard Deviation 12.67 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Parent/Legal Guardian | Total Score; Change at FU-24 | -0.4 score on a scale | Standard Deviation 7.87 |
Secondary
Neuropsychiatric Assessments Based on Questionnaire as Completed by Participant
Neuropsychiatric safety assessment was done using the Pediatric Quality of Life (PedsQL™ 4.0 SF15). The PedsQL™ 4.0 SF15 Questionnaires was completed by all participants. It is a comprehensive and widely used patient-reported outcome survey designed to measure health-related quality of life in healthy children and adolescents. It is presented for each of the 4 domains of the SF-15 (physical functioning, emotional functioning, social functioning, and school functioning), the psychosocial health summary (emotional, social, and school functioning domains), physical health summary and the Total Score. Total scores as well as each of the subscale scores are transformed on a scale from 0 to 100. Higher scores in each case indicate better health-related quality of life (HRQOL). A positive change from end of treatment period indicates improvement.
Time frame: Weeks 8, FU-12, and FU-24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Participant | Physical Functioning; Week 8 | 88.1 score on a scale | Standard Deviation 17.06 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Participant | Physical Functioning; Change at FU-12 | -0.7 score on a scale | Standard Deviation 7.29 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Participant | Physical Functioning; Change at FU-24 | -0.9 score on a scale | Standard Deviation 6.4 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Participant | Emotional Functioning; Week 8 | 78.0 score on a scale | Standard Deviation 19.33 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Participant | Emotional Functioning; Change at FU-12 | -3.0 score on a scale | Standard Deviation 21.43 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Participant | Emotional Functioning; Change at FU-24 | -1.8 score on a scale | Standard Deviation 18.56 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Participant | Social Functioning; Week 8 | 95.0 score on a scale | Standard Deviation 10.95 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Participant | Social Functioning; Change at FU-12 | -2.9 score on a scale | Standard Deviation 8.67 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Participant | Social Functioning; Change at FU-24 | -0.4 score on a scale | Standard Deviation 6.88 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Participant | School Functioning; Week 8 | 80.2 score on a scale | Standard Deviation 22.89 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Participant | School Functioning; Change at FU-12 | -4.8 score on a scale | Standard Deviation 18.37 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Participant | School Functioning; Change at FU-24 | -3.6 score on a scale | Standard Deviation 16.15 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Participant | Physical Health; Week 8 | 88.1 score on a scale | Standard Deviation 17.06 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Participant | Physical Health ; Change at FU-12 | -0.7 score on a scale | Standard Deviation 7.29 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Participant | Physical Health; Change at FU-24 | -0.9 score on a scale | Standard Deviation 6.4 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Participant | Psychosocial Health; Week 8 | 83.6 score on a scale | Standard Deviation 15.04 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Participant | Psychosocial Health; Change at FU-12 | -3.6 score on a scale | Standard Deviation 12.38 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Participant | Psychosocial Health; Change at FU-24 | -2.4 score on a scale | Standard Deviation 11.51 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Participant | Total Score; Week 8 | 85.1 score on a scale | Standard Deviation 14.13 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Participant | Total Score; Change at FU-12 | -2.6 score on a scale | Standard Deviation 9.32 |
| SOF/VEL/VOX FDC | Neuropsychiatric Assessments Based on Questionnaire as Completed by Participant | Total Score; Change at FU-24 | -1.9 score on a scale | Standard Deviation 8.83 |
Secondary
Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development
Tanner Pubertal Staging were 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 will be 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 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 and testes, Penis (10.5-12.5); 3: Enlargement of penis (11.5-14); 4: Penis size (13.5-15); 5: Genitalia adult in size and shape).
Time frame: Baseline (Day 1); Weeks 8, FU-12, and FU-24
Population: Participants in the Safety Analysis Set were analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Male); Baseline | Stage 1 | 1 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Male); Baseline | Stage 2 | 1 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Male); Baseline | Stage 3 | 0 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Male); Baseline | Stage 4 | 4 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Male); Baseline | Stage 5 | 2 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Male); Week 8 | Stage 1 | 0 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Male); Week 8 | Stage 2 | 2 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Male); Week 8 | Stage 3 | 0 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Male); Week 8 | Stage 4 | 4 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Male); Week 8 | Stage 5 | 2 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Male); FU-12 | Stage 1 | 0 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Male); FU-12 | Stage 2 | 2 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Male); FU-12 | Stage 3 | 0 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Male); FU-12 | Stage 4 | 3 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Male); FU-12 | Stage 5 | 3 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Male); FU-24 | Stage 1 | 0 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Male); FU-24 | Stage 2 | 1 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Male); FU-24 | Stage 3 | 1 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Male); FU-24 | Stage 4 | 2 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Male); FU-24 | Stage 5 | 4 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Genitalia (Male); Baseline | Stage 1 | 1 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Genitalia (Male); Baseline | Stage 2 | 1 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Genitalia (Male); Baseline | Stage 3 | 0 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Genitalia (Male); Baseline | Stage 4 | 4 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Genitalia (Male); Baseline | Stage 5 | 2 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Genitalia (Male); Week 8 | Stage 1 | 0 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Genitalia (Male); Week 8 | Stage 2 | 2 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Genitalia (Male); Week 8 | Stage 3 | 0 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Genitalia (Male); Week 8 | Stage 4 | 4 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Genitalia (Male); Week 8 | Stage 5 | 2 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Genitalia (Male); FU-12 | Stage 1 | 0 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Genitalia (Male); FU-12 | Stage 2 | 2 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Genitalia (Male); FU-12 | Stage 3 | 0 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Genitalia (Male); FU-12 | Stage 4 | 3 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Genitalia (Male); FU-12 | Stage 5 | 3 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Genitalia (Male); FU-24 | Stage 1 | 0 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Genitalia (Male); FU-24 | Stage 2 | 1 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Genitalia (Male); FU-24 | Stage 3 | 1 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Genitalia (Male); FU-24 | Stage 4 | 2 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Genitalia (Male); FU-24 | Stage 5 | 4 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Female); Baseline | Stage 1 | 0 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Female); Baseline | Stage 2 | 2 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Female); Baseline | Stage 3 | 2 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Female); Baseline | Stage 4 | 5 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Female); Baseline | Stage 5 | 4 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Female); Week 8 | Stage 1 | 0 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Female); Week 8 | Stage 2 | 2 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Female); Week 8 | Stage 3 | 1 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Female); Week 8 | Stage 4 | 5 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Female); Week 8 | Stage 5 | 5 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Female); FU-12 | Stage 1 | 0 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Female); FU-12 | Stage 2 | 2 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Female); FU-12 | Stage 3 | 1 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Female); FU-12 | Stage 4 | 5 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Female); FU-12 | Stage 5 | 5 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Female); FU-24 | Stage 1 | 0 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Female); FU-24 | Stage 2 | 1 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Female); FU-24 | Stage 3 | 2 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Female); FU-24 | Stage 4 | 4 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Pubic Hair (Female); FU-24 | Stage 5 | 6 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Breasts (Female); Baseline | Stage 1 | 0 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Breasts (Female); Baseline | Stage 2 | 2 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Breasts (Female); Baseline | Stage 3 | 2 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Breasts (Female); Baseline | Stage 4 | 4 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Breasts (Female); Baseline | Stage 5 | 5 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Breasts (Female); Week 8 | Stage 1 | 0 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Breasts (Female); Week 8 | Stage 2 | 2 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Breasts (Female); Week 8 | Stage 3 | 1 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Breasts (Female); Week 8 | Stage 4 | 5 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Breasts (Female); Week 8 | Stage 5 | 5 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Breasts (Female); FU-12 | Stage 1 | 0 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Breasts (Female); FU-12 | Stage 2 | 2 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Breasts (Female); FU-12 | Stage 3 | 1 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Breasts (Female); FU-12 | Stage 4 | 5 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Breasts (Female); FU-12 | Stage 5 | 5 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Breasts (Female); FU-24 | Stage 1 | 0 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Breasts (Female); FU-24 | Stage 2 | 1 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Breasts (Female); FU-24 | Stage 3 | 2 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Breasts (Female); FU-24 | Stage 4 | 4 Participants |
| SOF/VEL/VOX FDC | Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development | Breasts (Female); FU-24 | Stage 5 | 6 Participants |
Secondary
Percentage of Participants in Each Swallowability Category of Able to Swallow or Unable to Swallow SOF/VEL/VOX 400/100/100 mg Size Tablets
Swallowability for SOF/VEL/VOX FDC placebo to match (PTM) tablets was summarized based on the participants present in each swallowability category of Able to Swallow or Unable to Swallow a placebo tablet on one occasion during screening until Day 1.
Time frame: Baseline (Day 1)
Population: Participants in the Safety Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SOF/VEL/VOX FDC | Percentage of Participants in Each Swallowability Category of Able to Swallow or Unable to Swallow SOF/VEL/VOX 400/100/100 mg Size Tablets | Able to Swallow PTM Tablet | 100.0 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants in Each Swallowability Category of Able to Swallow or Unable to Swallow SOF/VEL/VOX 400/100/100 mg Size Tablets | Unable to Swallow PTM Tablet | 0 percentage of participants |
Secondary
Percentage of Participants Who Developed Viral Resistance to SOF, VEL, and/or VOX During Treatment
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 nonstructural protein (NS)3, NS5A, and NS5B deep sequencing analysis was performed for all participants. Sequencing for the HCV NS5A and NS5B regions was performed for all enrolled participants at baseline and for participants with virologic failure.
Time frame: Up to End of Treatment (Week 8)
Population: Resistance Analysis Population was defined as all participants in the Safety Analysis Set with a virologic outcome. No on-treatment virologic breakthrough or relapse was observed. Therefore, no participants qualified for resistance testing.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF/VEL/VOX FDC | Percentage of Participants Who Developed Viral Resistance to SOF, VEL, and/or VOX During Treatment | 0 percentage of participants |
Secondary
Percentage of Participants Who Developed Viral Resistance to SOF, VEL, and/or VOX When Treatment is Discontinued
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 nonstructural protein (NS)3, NS5A, and NS5B deep sequencing analysis was performed for all participants. Sequencing for the HCV NS5A and NS5B regions was performed for all enrolled participants at baseline and for participants with virologic failure.
Time frame: Up to Posttreatment Week 24
Population: Resistance Analysis Population was defined as all participants in the Safety Analysis Set with a virologic outcome. No on-treatment virologic breakthrough or relapse was observed through posttreatment Week 12 or posttreatment Week 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF/VEL/VOX FDC | Percentage of Participants Who Developed Viral Resistance to SOF, VEL, and/or VOX When Treatment is Discontinued | 0 percentage of participants |
Secondary
Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event
Treatment-emergent Adverse Events (TEAE) were defined as events that met 1 or both of the following criteria as any AEs with onset dates on or after the study drug start date and no later than 30 days after the permanent discontinuation of study drug. It also includes the AEs that leads to premature discontinuation of study drug.
Time frame: First dose date up to the last dose date (maximum: 8 Weeks) plus 30 days
Population: The Safety Analysis Set included participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF/VEL/VOX FDC | Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event | 0 percentage of participants |
Secondary
Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Parent/Legal Guardian
A questionnaire was administered to the parent/legal guardian of participants to assess acceptability, including palatability, of the formulation. Acceptability and palatability were assessed by questions about how the study drug tasted, how easy it was to swallow the study drug, about how it was to take the study drug and, as they all received a single tablet daily, how they felt about the number of tablets they had to swallow.
Time frame: Week 8
Population: Participants in the Safety Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Parent/Legal Guardian | Take (Very Easy) | 23.8 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Parent/Legal Guardian | Did Not Taste Study Drug | 61.9 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Parent/Legal Guardian | Taste (Very Bad) | 0 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Parent/Legal Guardian | Taste (Bad) | 23.8 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Parent/Legal Guardian | Taste (Maybe Bad/ Maybe Good) | 9.5 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Parent/Legal Guardian | Taste (Good) | 4.8 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Parent/Legal Guardian | Taste (Very Good) | 0 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Parent/Legal Guardian | Swallow (Very Hard) | 4.8 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Parent/Legal Guardian | Swallow (Hard) | 9.5 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Parent/Legal Guardian | Swallow (Maybe Hard/ Maybe Easy) | 14.3 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Parent/Legal Guardian | Swallow (Easy) | 33.3 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Parent/Legal Guardian | Swallow (Very Easy) | 38.1 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Parent/Legal Guardian | Take (Very Hard) | 0 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Parent/Legal Guardian | Take (Hard) | 9.5 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Parent/Legal Guardian | Take (Maybe Hard/ Maybe Easy) | 19.0 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Parent/Legal Guardian | Take (Easy) | 47.6 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Parent/Legal Guardian | Number of Tablets (Very Hard) | 0 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Parent/Legal Guardian | Number of Tablets (Hard) | 4.8 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Parent/Legal Guardian | Number of Tablets (Maybe Hard/Maybe Easy) | 28.6 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Parent/Legal Guardian | Number of Tablets (Easy) | 47.6 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Parent/Legal Guardian | Number of Tablets (Very Easy) | 19.0 percentage of participants |
Secondary
Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant
A questionnaire was administered to participants to assess acceptability, including palatability, of the formulation. Acceptability and palatability were assessed by questions about how the study drug tasted, how easy it was to swallow the study drug, and also at the end of treatment about how it was to take the study drug and, as they all received a single tablet daily, how they felt about the number of tablets they had to swallow.
Time frame: Baseline (Day 1); Week 8
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant | Did Not Taste Study Drug; Day 1 | 23.8 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant | Taste (Very Bad); Day 1 | 9.5 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant | Taste (Bad); Day 1 | 9.5 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant | Taste (Maybe Bad/ Maybe Good); Day 1 | 38.1 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant | Taste (Good); Day 1 | 19.0 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant | Taste (Very Good); Day 1 | 0 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant | Swallow (Very Hard); Day 1 | 9.5 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant | Swallow (Hard); Day 1 | 9.5 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant | Swallow (Maybe Hard/ Maybe Easy); Day 1 | 9.5 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant | Swallow (Easy); Day 1 | 23.8 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant | Swallow (Very Easy); Day 1 | 47.6 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant | Did Not Taste Study Drug; Week 8 | 25.0 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant | Taste (Very Bad); Week 8 | 0 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant | Taste (Bad); Week 8 | 25.0 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant | Taste (Maybe Bad/ Maybe Good); Week 8 | 40.0 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant | Taste (Good); Week 8 | 5.0 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant | Taste (Very Good); Week 8 | 5.0 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant | Swallow (Very Hard); Week 8 | 0 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant | Swallow (Hard); Week 8 | 5.0 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant | Swallow (Maybe Hard/ Maybe Easy); Week 8 | 20.0 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant | Swallow (Easy); Week 8 | 25.0 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant | Swallow (Very Easy); Week 8 | 50.0 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant | Take (Very Hard); Week 8 | 0 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant | Take (Hard); Week 8 | 0 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant | Take (Maybe Hard/Maybe Easy); Week 8 | 25.0 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant | Take (Easy); Week 8 | 50.0 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant | Take (Very Easy); Week 8 | 25.0 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant | Number of Tablets(Very Hard); Week 8 | 0 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant | Number of Tablets(Hard); Week 8 | 0 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant | Number of Tablets( Maybe Hard/ Maybe Easy); Week 8 | 45.0 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant | Number of Tablets(Easy); Week 8 | 25.0 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant | Number of Tablets(Very Easy); Week 8 | 30.0 percentage of participants |
Secondary
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
ALT normalization was defined as ALT \> upper limit of normal (ULN) at baseline and ALT ≤ ULN at each visit.
Time frame: Baseline (Day 1); Week 1, 2, 4, 8, and Posttreatment/Follow-up Week 4 (FU-4)
Population: Participants in the Full Analysis Set with available data were analyzed. It includes participants with ALT \>ULN at Baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SOF/VEL/VOX FDC | Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 1 | 50.0 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 2 | 75.0 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 4 | 100.0 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 8 | 100.0 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | FU-4 | 100.0 percentage of participants |
Secondary
Percentage of Participants With HCV RNA < LLOQ 24 Weeks After Discontinuation of Therapy (SVR24)
SVR was defined as HCV RNA \< LLOQ (ie, \< 15 IU/mL) 24 weeks after discontinuation of the study drug.
Time frame: Posttreatment Week 24
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF/VEL/VOX FDC | Percentage of Participants With HCV RNA < LLOQ 24 Weeks After Discontinuation of Therapy (SVR24) | 100.0 percentage of participants |
Secondary
Percentage of Participants With HCV RNA < LLOQ 4 Weeks After Discontinuation of Therapy (SVR4)
SVR was defined as HCV RNA \< LLOQ (ie, \< 15 IU/mL) 4 weeks after discontinuation of the study drug.
Time frame: Posttreatment Week 4
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF/VEL/VOX FDC | Percentage of Participants With HCV RNA < LLOQ 4 Weeks After Discontinuation of Therapy (SVR4) | 100.0 percentage of participants |
Secondary
Percentage of Participants With HCV RNA < LLOQ on Treatment
Percentage of participants with HCV RNA \< LLOQ (15 IU/mL) while on treatment by analysis visit.
Time frame: Weeks 1, 2, 4, and 8
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SOF/VEL/VOX FDC | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 1 | 52.4 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 2 | 81.0 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 4 | 90.5 percentage of participants |
| SOF/VEL/VOX FDC | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 8 | 100.0 percentage of participants |
Secondary
Percentage of Participants With Overall Virologic Failure
Overall Virologic Failure comprises of on-treatment virologic failure and relapse. On-treatment virologic failure (breakthrough, rebound, and nonresponse) and relapse were defined as follows: Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), Rebound (confirmed \> 1 log10IU/mL increase in HCV RNA from nadir while on treatment), or Nonresponse (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) and 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) |
|---|---|---|
| SOF/VEL/VOX FDC | Percentage of Participants With Overall Virologic Failure | 0 percentage of participants |
Secondary
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR was defined as hepatitis C virus (HCV RNA) \< Lower limit of quantification (LLOQ) (ie, \< 15 IU/mL) 12 weeks after discontinuation of the study drug.
Time frame: Posttreatment Week 12
Population: The Full Analysis Set included all adolescent participants 12 to \< 18 years old who were enrolled into the study and took at least 1 dose of study drug (SOF/VEL/VOX FDC).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF/VEL/VOX FDC | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 100.0 percentage of participants |