Hepatitis C Virus Infection
Conditions
Brief summary
The primary objective of the PK Lead-in Phase of the study is to evaluate the steady state pharmacokinetics (PK) and confirm the dose of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) in hepatitis C virus (HCV)-infected pediatric participants. The PK Lead-in Phase will also evaluate the safety, tolerability, and antiviral activity of 10 days of dosing of LDV/SOF FDC in HCV-infected pediatric participants. The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate LDV/SOF FDC dosage levels. Participants from the PK Lead-in Phase will immediately rollover into the Treatment Phase with no interruption of study drug administration. The primary objective of the Treatment Phase is to evaluate the antiviral efficacy, safety, and tolerability of LDV/SOF FDC +/- ribavirin (RBV) for 12 or 24 weeks in pediatric participants with HCV. During screening, participants will receive placebo to match LDV/SOF FDC to assess ability to swallow tablets.
Interventions
DRUGLDV/SOF
LDV/SOF FDC administered orally once daily
DRUGRBV
Ribavirin (RBV) oral solution or capsules will be administered orally in a divided daily dose based on weight
Sponsors
Gilead Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Consent of parent or legal guardian required * Chronic HCV infection * Screening laboratory values within defined thresholds Key
Exclusion criteria
* History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol. * Co-infection with HIV, acute hepatitis A virus, or hepatitis B virus * Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage) * Pregnant or nursing females * Known hypersensitivity to study medication * Use of any prohibited concomitant medications as within 28 days of the Day 1 visit Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF), LDV, and SOF | Cohorts 1 and 2 (6 to < 18 years of age): predose, 0.5, 1, 2, 3, 4, 5, 8, and 12 hours postdose on Day 10; Cohort 3 (3 to < 6 years of age): predose, 0.5, 2, 4, 8, and 12 hours postdose on Day 10 | AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). |
| Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase | Up to 24 weeks | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4) | Posttreatment Week 4 | SVR4 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 4 weeks after stopping study treatment. |
| For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12) | Posttreatment Week 12 | SVR12 was defined as HCV RNA \< LLOQ at 12 weeks after stopping study treatment. |
| For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) | Posttreatment Week 24 | SVR24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment. |
| For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough | Up to 24 weeks | Viral breakthrough was defined as having confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment. |
| For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse | Up to Posttreatment Week 24 | Viral relapse was defined as having confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit. |
| For the Treatment Phase, Change From Baseline in HCV RNA | Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only) | — |
| For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only) | — |
| For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Week 4 | ALT normalization was defined as ALT \> the upper limit of normal (ULN) at baseline and ALT ≤ ULN at each visit. |
| For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Baseline; Weeks 1, 2, 4, 8, and 12 | — |
| For the Treatment Phase, Change From Baseline in Weight | Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24 | — |
| For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24 | Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented. |
| For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24 | Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented. |
| For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24 | Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented. |
| For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24 | Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented. |
| Acceptability of LDV/SOF Tablets as Measured by the Percentage of Participants Able/Unable to Swallow Placebo Tablet at Day 1 | Day 1 | Participants who were able/unable to swallow placebo tablets were assessed. Participants 12 to \< 18 years old were first asked to perform the swallowability assessment using the 90/400 mg placebo tablet. If they were unable to swallow this, they were then asked to perform the swallowability assessment with 22.5/100 mg placebo tablets. Participants 6 to \< 12 years old were to be assessed with the 22.5/100 mg placebo tablets. However, 8 participants were mistakenly assessed using the 90/400 mg placebo tablet. |
| Acceptability of LDV/SOF Granules as Measured by Palatability at Day 1 | Day 1 | Participants who were dosed with granules were asked if they tasted the study drug. If they tasted it, then they were asked to provide a number from 0 to 100 to rate the taste of the study drug, with higher scores indicating better taste. Data was then summarized as percentage of participants choosing the following palatability categories: 1) Did not taste the study drug, 2) Tasted drug with score \> 60 to 100, 3) Tasted drug with score 40 to 60, and 4) Tasted drug with score of 0 to \< 40. |
| For the Treatment Phase, Change From Baseline in Height | Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24 | — |
| Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase | Up to Day 10 | — |
Countries
Australia, New Zealand, United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled at study sites in the United States, United Kingdom, Australia, and New Zealand. The first participant was screened on 05 November 2014. The last study visit occurred on 24 August 2018.
Pre-assignment details
240 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| 12 to < 18 Years Old - LDV/SOF 12 Weeks Participants 12 to \< 18 years of age with HCV genotype 1 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks. | 100 |
| 6 to < 12 Years Old - LDV/SOF 12 Weeks Participants 6 to \< 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks. | 89 |
| 6 to < 12 Years Old - LDV/SOF 24 Weeks Participants 6 to \< 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks. | 1 |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks Participants 6 to \< 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks. | 2 |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks Participants 3 to \< 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks. | 34 |
| Total | 226 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Treatment Phase | Lost to Follow-up | 4 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | 12 to < 18 Years Old - LDV/SOF 12 Weeks | Total | 3 to < 6 Years Old - LDV/SOF 12 Weeks | 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | 6 to < 12 Years Old - LDV/SOF 24 Weeks | 6 to < 12 Years Old - LDV/SOF 12 Weeks |
|---|---|---|---|---|---|---|
| Age, Continuous | 15 years STANDARD_DEVIATION 1.7 | 11 years STANDARD_DEVIATION 4.1 | 4 years STANDARD_DEVIATION 0.7 | 9 years STANDARD_DEVIATION 2.8 | 11 years | 9 years STANDARD_DEVIATION 1.6 |
| Cirrhosis Status No | 43 Participants | 92 Participants | 14 Participants | 2 Participants | 0 Participants | 33 Participants |
| Cirrhosis Status Unknown | 56 Participants | 131 Participants | 20 Participants | 0 Participants | 0 Participants | 55 Participants |
| Cirrhosis Status Yes | 1 Participants | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| HCV Genotype Genotype 1 | 100 Participants | 221 Participants | 33 Participants | 0 Participants | 1 Participants | 87 Participants |
| HCV Genotype Genotype 3 | 0 Participants | 2 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants |
| HCV Genotype Genotype 4 | 0 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| HCV RNA Category < 800,000 IU/mL | 45 Participants | 98 Participants | 15 Participants | 1 Participants | 0 Participants | 37 Participants |
| HCV RNA Category ≥ 800,000 IU/mL | 55 Participants | 128 Participants | 19 Participants | 1 Participants | 1 Participants | 52 Participants |
| IL28b Status CC | 24 Participants | 57 Participants | 10 Participants | 0 Participants | 0 Participants | 23 Participants |
| IL28b Status CT | 53 Participants | 124 Participants | 16 Participants | 2 Participants | 0 Participants | 53 Participants |
| IL28b Status Missing | 0 Participants | 3 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants |
| IL28b Status TT | 23 Participants | 42 Participants | 6 Participants | 0 Participants | 1 Participants | 12 Participants |
| Prior Treatment Experience Treatment-Experienced | 20 Participants | 40 Participants | 0 Participants | 2 Participants | 1 Participants | 17 Participants |
| Prior Treatment Experience Treatment-Naive | 80 Participants | 186 Participants | 34 Participants | 0 Participants | 0 Participants | 72 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 9 Participants | 2 Participants | 0 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized Black or African American | 7 Participants | 15 Participants | 1 Participants | 0 Participants | 0 Participants | 7 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 13 Participants | 28 Participants | 6 Participants | 0 Participants | 0 Participants | 9 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Not Disclosed | 2 Participants | 7 Participants | 0 Participants | 0 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 85 Participants | 191 Participants | 28 Participants | 2 Participants | 1 Participants | 75 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 9 Participants | 4 Participants | 0 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized White | 91 Participants | 191 Participants | 27 Participants | 2 Participants | 1 Participants | 70 Participants |
| Region of Enrollment Australia | 8 Participants | 17 Participants | 2 Participants | 0 Participants | 1 Participants | 6 Participants |
| Region of Enrollment New Zealand | 0 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants |
| Region of Enrollment United Kingdom | 1 Participants | 15 Participants | 3 Participants | 2 Participants | 0 Participants | 9 Participants |
| Region of Enrollment United States | 91 Participants | 190 Participants | 29 Participants | 0 Participants | 0 Participants | 70 Participants |
| Sex: Female, Male Female | 63 Participants | 125 Participants | 24 Participants | 1 Participants | 1 Participants | 36 Participants |
| Sex: Female, Male Male | 37 Participants | 101 Participants | 10 Participants | 1 Participants | 0 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 89 | 0 / 1 | 0 / 2 | 0 / 34 |
| other Total, other adverse events | 62 / 100 | 54 / 89 | 1 / 1 | 2 / 2 | 22 / 34 |
| serious Total, serious adverse events | 0 / 100 | 1 / 89 | 0 / 1 | 0 / 2 | 0 / 34 |
Outcome results
Primary
For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF), LDV, and SOF
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Time frame: Cohorts 1 and 2 (6 to < 18 years of age): predose, 0.5, 1, 2, 3, 4, 5, 8, and 12 hours postdose on Day 10; Cohort 3 (3 to < 6 years of age): predose, 0.5, 2, 4, 8, and 12 hours postdose on Day 10
Population: Intensive PK Analysis Set included all participants in the PK lead-in phase who received at least 1 dose of study drug and for whom at least 1 nonmissing PK concentration value, during the intensive sampling period, was reported by the PK laboratory.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF), LDV, and SOF | LDV | 10202.4 h*ng/mL | Standard Deviation 5196.49 |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF), LDV, and SOF | GS-331007 (metabolite of SOF) | 12682.5 h*ng/mL | Standard Deviation 1732.66 |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF), LDV, and SOF | SOF | 2175.7 h*ng/mL | Standard Deviation 578.92 |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF), LDV, and SOF | LDV | 7288.3 h*ng/mL | Standard Deviation 4547.33 |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF), LDV, and SOF | GS-331007 (metabolite of SOF) | 8210.3 h*ng/mL | Standard Deviation 2542.42 |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF), LDV, and SOF | SOF | 1754.4 h*ng/mL | Standard Deviation 419.18 |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF), LDV, and SOF | GS-331007 (metabolite of SOF) | 11688.9 h*ng/mL | Standard Deviation 3400.79 |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF), LDV, and SOF | SOF | 2495.2 h*ng/mL | Standard Deviation 412.64 |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF), LDV, and SOF | LDV | 9316.3 h*ng/mL | Standard Deviation 3280.51 |
Comparison: AUCtau of GS-331007 for the 12 to \< 18 Years old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.90% CI: [90.61, 122.13]
Comparison: AUCtau of GS-331007 for the 6 to \< 12 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.90% CI: [56.62, 76.37]
Comparison: AUCtau of GS-331007 for the 3 to \< 6 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.90% CI: [82.51, 107.27]
Comparison: AUCtau of LDV for the 12 to \< 18 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.90% CI: [94.89, 170.45]
Comparison: AUCtau of LDV for the 6 to \< 12 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.90% CI: [61.34, 110.3]
Comparison: AUCtau of LDV for the 3 to \< 6 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.90% CI: [93.18, 155.73]
Comparison: AUCtau of SOF for the 12 to \< 18 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.90% CI: [137.89, 185.37]
Comparison: AUCtau of SOF for the 6 to \< 12 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.90% CI: [110.79, 151.32]
Comparison: AUCtau of SOF for the 3 to \< 6 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.90% CI: [143.41, 245.82]
Primary
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase
Time frame: Up to 24 weeks
Population: Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase | 0 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase | 0 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase | 0 percentage of participants |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase | 0 percentage of participants |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase | 2.9 percentage of participants |
Secondary
Acceptability of LDV/SOF Granules as Measured by Palatability at Day 1
Participants who were dosed with granules were asked if they tasted the study drug. If they tasted it, then they were asked to provide a number from 0 to 100 to rate the taste of the study drug, with higher scores indicating better taste. Data was then summarized as percentage of participants choosing the following palatability categories: 1) Did not taste the study drug, 2) Tasted drug with score \> 60 to 100, 3) Tasted drug with score 40 to 60, and 4) Tasted drug with score of 0 to \< 40.
Time frame: Day 1
Population: Participants between 3 to \<6 years old in the Safety Analysis Set who performed the palatability test were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | Acceptability of LDV/SOF Granules as Measured by Palatability at Day 1 | Did not taste the study drug | 41.2 percentage of participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | Acceptability of LDV/SOF Granules as Measured by Palatability at Day 1 | Tasted drug with score > 60 to 100 | 17.6 percentage of participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | Acceptability of LDV/SOF Granules as Measured by Palatability at Day 1 | Tasted drug with score 40 to 60 | 11.8 percentage of participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | Acceptability of LDV/SOF Granules as Measured by Palatability at Day 1 | Tasted drug with score of 0 to < 40 | 29.4 percentage of participants |
Secondary
Acceptability of LDV/SOF Tablets as Measured by the Percentage of Participants Able/Unable to Swallow Placebo Tablet at Day 1
Participants who were able/unable to swallow placebo tablets were assessed. Participants 12 to \< 18 years old were first asked to perform the swallowability assessment using the 90/400 mg placebo tablet. If they were unable to swallow this, they were then asked to perform the swallowability assessment with 22.5/100 mg placebo tablets. Participants 6 to \< 12 years old were to be assessed with the 22.5/100 mg placebo tablets. However, 8 participants were mistakenly assessed using the 90/400 mg placebo tablet.
Time frame: Day 1
Population: Participants between 6 to \<18 years old in the Safety Analysis Set who performed the swallowability assessment were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | Acceptability of LDV/SOF Tablets as Measured by the Percentage of Participants Able/Unable to Swallow Placebo Tablet at Day 1 | Able to Swallow 90/400 mg Placebo Tablet | 89.0 percentage of participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | Acceptability of LDV/SOF Tablets as Measured by the Percentage of Participants Able/Unable to Swallow Placebo Tablet at Day 1 | Unable to Swallow 90/400 mg Placebo Tablet | 11.0 percentage of participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | Acceptability of LDV/SOF Tablets as Measured by the Percentage of Participants Able/Unable to Swallow Placebo Tablet at Day 1 | Able to Swallow 22.5/100 mg Placebo Tablet | 72.7 percentage of participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | Acceptability of LDV/SOF Tablets as Measured by the Percentage of Participants Able/Unable to Swallow Placebo Tablet at Day 1 | Unable to Swallow 22.5/100 mg Placebo Tablet | 27.3 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | Acceptability of LDV/SOF Tablets as Measured by the Percentage of Participants Able/Unable to Swallow Placebo Tablet at Day 1 | Unable to Swallow 22.5/100 mg Placebo Tablet | 1.2 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | Acceptability of LDV/SOF Tablets as Measured by the Percentage of Participants Able/Unable to Swallow Placebo Tablet at Day 1 | Able to Swallow 90/400 mg Placebo Tablet | 100.0 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | Acceptability of LDV/SOF Tablets as Measured by the Percentage of Participants Able/Unable to Swallow Placebo Tablet at Day 1 | Able to Swallow 22.5/100 mg Placebo Tablet | 98.8 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | Acceptability of LDV/SOF Tablets as Measured by the Percentage of Participants Able/Unable to Swallow Placebo Tablet at Day 1 | Unable to Swallow 90/400 mg Placebo Tablet | 0 percentage of participants |
Secondary
For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA
Time frame: Baseline; Weeks 1, 2, 4, 8, and 12
Population: Participants who were enrolled in the PK lead-in phase with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 8 | -4.73 log10 IU/mL | Standard Deviation 0.667 |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 4 | -4.73 log10 IU/mL | Standard Deviation 0.667 |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 1 | -4.34 log10 IU/mL | Standard Deviation 0.621 |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 2 | -4.71 log10 IU/mL | Standard Deviation 0.651 |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 12 | -4.73 log10 IU/mL | Standard Deviation 0.667 |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 4 | -4.75 log10 IU/mL | Standard Deviation 0.702 |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 1 | -4.29 log10 IU/mL | Standard Deviation 0.518 |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 2 | -4.55 log10 IU/mL | Standard Deviation 0.636 |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 8 | -4.76 log10 IU/mL | Standard Deviation 0.71 |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 12 | -4.76 log10 IU/mL | Standard Deviation 0.71 |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 12 | -4.92 log10 IU/mL | Standard Deviation 0.715 |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 8 | -4.92 log10 IU/mL | Standard Deviation 0.715 |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 1 | -4.32 log10 IU/mL | Standard Deviation 0.616 |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 4 | -4.92 log10 IU/mL | Standard Deviation 0.715 |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Change at Week 2 | -4.87 log10 IU/mL | Standard Deviation 0.724 |
Secondary
For the Treatment Phase, Change From Baseline in HCV RNA
Time frame: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)
Population: Participants in the Full Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Change at Weeks 16, 20, and 24 because they were only treated for 12 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 1 | -4.34 log10 IU/mL | Standard Deviation 0.634 |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 2 | -4.74 log10 IU/mL | Standard Deviation 0.585 |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 8 | -4.85 log10 IU/mL | Standard Deviation 0.556 |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 12 | -4.85 log10 IU/mL | Standard Deviation 0.556 |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 4 | -4.84 log10 IU/mL | Standard Deviation 0.557 |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 8 | -4.89 log10 IU/mL | Standard Deviation 0.597 |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 12 | -4.89 log10 IU/mL | Standard Deviation 0.597 |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 2 | -4.73 log10 IU/mL | Standard Deviation 0.544 |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 1 | -4.27 log10 IU/mL | Standard Deviation 0.592 |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 4 | -4.87 log10 IU/mL | Standard Deviation 0.592 |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 24 | -5.09 log10 IU/mL | — |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 12 | -5.09 log10 IU/mL | — |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 8 | -5.09 log10 IU/mL | — |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 4 | -5.09 log10 IU/mL | — |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 1 | -4.30 log10 IU/mL | — |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 20 | -5.09 log10 IU/mL | — |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 2 | -5.09 log10 IU/mL | — |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 16 | -5.09 log10 IU/mL | — |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 24 | -4.54 log10 IU/mL | Standard Deviation 0.308 |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 1 | -4.54 log10 IU/mL | Standard Deviation 0.308 |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 2 | -4.54 log10 IU/mL | Standard Deviation 0.308 |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 4 | -4.54 log10 IU/mL | Standard Deviation 0.308 |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 8 | -4.54 log10 IU/mL | Standard Deviation 0.308 |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 12 | -4.54 log10 IU/mL | Standard Deviation 0.308 |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 16 | -4.54 log10 IU/mL | Standard Deviation 0.308 |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 20 | -4.54 log10 IU/mL | Standard Deviation 0.308 |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 2 | -4.80 log10 IU/mL | Standard Deviation 0.628 |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 4 | -4.85 log10 IU/mL | Standard Deviation 0.628 |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 1 | -4.25 log10 IU/mL | Standard Deviation 0.505 |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 12 | -4.86 log10 IU/mL | Standard Deviation 0.633 |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in HCV RNA | Change at Week 8 | -4.86 log10 IU/mL | Standard Deviation 0.633 |
Secondary
For the Treatment Phase, Change From Baseline in Height
Time frame: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24
Population: Participants in the Safety Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Change at Weeks 16, 20, and 24 because they were only treated for 12 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Posttreatment Week 12 | 1.2 centimeters | Standard Deviation 1.82 |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 2 | 0.0 centimeters | Standard Deviation 0.7 |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 4 | 0.1 centimeters | Standard Deviation 0.84 |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 12 | 0.5 centimeters | Standard Deviation 1.1 |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Posttreatment Week 4 | 0.8 centimeters | Standard Deviation 1.46 |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 1 | 0.1 centimeters | Standard Deviation 0.68 |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 8 | 0.4 centimeters | Standard Deviation 1.04 |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Posttreatment Week 24 | 1.8 centimeters | Standard Deviation 2.31 |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 2 | 0.3 centimeters | Standard Deviation 0.73 |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Posttreatment Week 4 | 1.8 centimeters | Standard Deviation 1.04 |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Posttreatment Week 24 | 4.1 centimeters | Standard Deviation 1.39 |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 4 | 0.5 centimeters | Standard Deviation 0.79 |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 1 | 0.1 centimeters | Standard Deviation 0.83 |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 8 | 0.8 centimeters | Standard Deviation 0.79 |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 12 | 1.3 centimeters | Standard Deviation 0.83 |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Posttreatment Week 12 | 2.7 centimeters | Standard Deviation 0.97 |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 20 | 4.3 centimeters | — |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 8 | 1.3 centimeters | — |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Posttreatment Week 24 | 7.6 centimeters | — |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Posttreatment Week 12 | 5.0 centimeters | — |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 2 | 0.5 centimeters | — |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 16 | 3.2 centimeters | — |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 12 | 2.1 centimeters | — |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 4 | 1.2 centimeters | — |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 24 | 4.3 centimeters | — |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 1 | 0.3 centimeters | — |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Posttreatment Week 4 | 4.3 centimeters | — |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 20 | 1.6 centimeters | Standard Deviation 0.85 |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 1 | 0.7 centimeters | Standard Deviation 1.13 |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 2 | 0.5 centimeters | Standard Deviation 0.85 |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 4 | 0.6 centimeters | Standard Deviation 0.92 |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 8 | 0.8 centimeters | Standard Deviation 0.92 |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 12 | 1.1 centimeters | Standard Deviation 1.41 |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 16 | 1.4 centimeters | Standard Deviation 1.06 |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 24 | 2.5 centimeters | Standard Deviation 1.48 |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Posttreatment Week 4 | 2.4 centimeters | Standard Deviation 1.27 |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Posttreatment Week 12 | 3.4 centimeters | Standard Deviation 1.56 |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Posttreatment Week 24 | 5.6 centimeters | Standard Deviation 0.85 |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 8 | 1.0 centimeters | Standard Deviation 0.82 |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Posttreatment Week 24 | 4.7 centimeters | Standard Deviation 1.31 |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Posttreatment Week 12 | 3.3 centimeters | Standard Deviation 1.18 |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 4 | 0.7 centimeters | Standard Deviation 0.79 |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 2 | 0.3 centimeters | Standard Deviation 0.72 |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 1 | 0.2 centimeters | Standard Deviation 1.24 |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Posttreatment Week 4 | 2.1 centimeters | Standard Deviation 1.13 |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Height | Change at Week 12 | 1.6 centimeters | Standard Deviation 0.98 |
Secondary
For the Treatment Phase, Change From Baseline in Weight
Time frame: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24
Population: Participants in the Safety Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Change at Weeks 16, 20, and 24 because they were only treated for 12 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 1 | 0.1 kilograms | Standard Deviation 1 |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 2 | 0.3 kilograms | Standard Deviation 1.11 |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Posttreatment Week 4 | 0.9 kilograms | Standard Deviation 2.7 |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 4 | 0.4 kilograms | Standard Deviation 1.44 |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Posttreatment Week 12 | 1.6 kilograms | Standard Deviation 3.48 |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Posttreatment Week 24 | 3.2 kilograms | Standard Deviation 4.38 |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 12 | 0.6 kilograms | Standard Deviation 2.32 |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 8 | 0.5 kilograms | Standard Deviation 1.9 |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Posttreatment Week 24 | 3.5 kilograms | Standard Deviation 2.75 |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 8 | 0.8 kilograms | Standard Deviation 0.84 |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Posttreatment Week 12 | 2.1 kilograms | Standard Deviation 1.87 |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 12 | 1.1 kilograms | Standard Deviation 1.27 |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 2 | 0.4 kilograms | Standard Deviation 0.54 |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 1 | 0.3 kilograms | Standard Deviation 0.51 |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 4 | 0.5 kilograms | Standard Deviation 0.64 |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Posttreatment Week 4 | 1.4 kilograms | Standard Deviation 1.48 |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Posttreatment Week 12 | 3.1 kilograms | — |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Posttreatment Week 24 | 4.5 kilograms | — |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 2 | 0.0 kilograms | — |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 4 | 0.5 kilograms | — |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 1 | -0.5 kilograms | — |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 8 | 1.3 kilograms | — |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 12 | 2.1 kilograms | — |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 16 | 1.6 kilograms | — |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 20 | 2.2 kilograms | — |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 24 | 3.1 kilograms | — |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Posttreatment Week 4 | 1.8 kilograms | — |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 2 | 0.3 kilograms | Standard Deviation 1.77 |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 20 | 1.8 kilograms | Standard Deviation 3.96 |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Posttreatment Week 24 | 5.7 kilograms | Standard Deviation 1.41 |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 24 | 2.4 kilograms | Standard Deviation 3.68 |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 8 | 0.6 kilograms | Standard Deviation 2.33 |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 4 | 0.7 kilograms | Standard Deviation 1.91 |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Posttreatment Week 12 | 3.7 kilograms | Standard Deviation 2.9 |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 12 | 0.9 kilograms | Standard Deviation 2.9 |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 1 | 0.3 kilograms | Standard Deviation 1.34 |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Posttreatment Week 4 | 2.2 kilograms | Standard Deviation 3.68 |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 16 | 1.2 kilograms | Standard Deviation 3.68 |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Posttreatment Week 24 | 2.0 kilograms | Standard Deviation 1.57 |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 1 | 0.1 kilograms | Standard Deviation 0.39 |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 2 | 0.2 kilograms | Standard Deviation 0.44 |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 4 | 0.3 kilograms | Standard Deviation 0.64 |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 8 | 0.5 kilograms | Standard Deviation 0.66 |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Week 12 | 0.6 kilograms | Standard Deviation 0.7 |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Posttreatment Week 4 | 1.1 kilograms | Standard Deviation 1.09 |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Change From Baseline in Weight | Change at Posttreatment Week 12 | 1.2 kilograms | Standard Deviation 0.93 |
Secondary
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development
Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.
Time frame: Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24
Population: Female participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | End of Treatment | Increase | 8 Participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 24 | Increase | 18 Participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 12 | Decrease | 0 Participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | End of Treatment | No Change | 53 Participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 24 | Decrease | 0 Participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 12 | Increase | 11 Participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | End of Treatment | Decrease | 1 Participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 24 | No Change | 43 Participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 12 | No Change | 49 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 12 | No Change | 25 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 12 | Increase | 8 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 12 | Decrease | 1 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 24 | No Change | 21 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 24 | Increase | 14 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 24 | Decrease | 0 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | End of Treatment | No Change | 31 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | End of Treatment | Increase | 5 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | End of Treatment | Decrease | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | End of Treatment | No Change | 21 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 24 | No Change | 21 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 12 | Increase | 1 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | End of Treatment | Increase | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 12 | Decrease | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 12 | No Change | 21 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 24 | Decrease | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Posttreatment Week 24 | Increase | 1 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | End of Treatment | Decrease | 0 Participants |
Secondary
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair
Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.
Time frame: Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24
Population: Female participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | No Change | 45 Participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | Decrease | 0 Participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | Decrease | 0 Participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | Increase | 15 Participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | No Change | 52 Participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | Increase | 21 Participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | Decrease | 1 Participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | Increase | 9 Participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | No Change | 40 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | Increase | 3 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | No Change | 34 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | Increase | 2 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | Decrease | 0 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | No Change | 31 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | Decrease | 0 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | No Change | 27 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | Increase | 8 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | Decrease | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | Decrease | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | No Change | 21 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | No Change | 22 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | Increase | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | Decrease | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | Increase | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | No Change | 22 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | Increase | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | Decrease | 0 Participants |
Secondary
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development
Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.
Time frame: Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24
Population: Male participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | End of Treatment | Decrease | 0 Participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 24 | Decrease | 0 Participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 24 | No Change | 29 Participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | End of Treatment | Increase | 1 Participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 24 | Increase | 6 Participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 12 | Increase | 2 Participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 12 | No Change | 33 Participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | End of Treatment | No Change | 34 Participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 12 | Decrease | 0 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | End of Treatment | Decrease | 1 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 12 | No Change | 50 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 12 | Increase | 4 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 12 | Decrease | 0 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 24 | No Change | 47 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 24 | Increase | 6 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 24 | Decrease | 0 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | End of Treatment | No Change | 52 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | End of Treatment | Increase | 1 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | End of Treatment | Decrease | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 24 | Decrease | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 12 | Increase | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | End of Treatment | Increase | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | End of Treatment | No Change | 10 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 24 | No Change | 10 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 12 | No Change | 9 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 24 | Increase | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Posttreatment Week 12 | Decrease | 0 Participants |
Secondary
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair
Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.
Time frame: Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24
Population: Male participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | No Change | 32 Participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | Decrease | 0 Participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | Decrease | 0 Participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | Increase | 3 Participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | No Change | 35 Participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | Increase | 7 Participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | Decrease | 0 Participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | Increase | 1 Participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | No Change | 28 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | Increase | 2 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | No Change | 52 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | Increase | 1 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | Decrease | 1 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | No Change | 51 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | Decrease | 1 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | No Change | 48 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | Increase | 4 Participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | Decrease | 1 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | Decrease | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | No Change | 10 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | No Change | 9 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | End of Treatment | Increase | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | Decrease | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | Increase | 0 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | No Change | 9 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 24 | Increase | 1 Participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Posttreatment Week 12 | Decrease | 0 Participants |
Secondary
For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough
Viral breakthrough was defined as having confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment.
Time frame: Up to 24 weeks
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough | 0 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough | 0 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough | 0 percentage of participants |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough | 0 percentage of participants |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough | 0 percentage of participants |
Secondary
For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse
Viral relapse was defined as having confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.
Time frame: Up to Posttreatment Week 24
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse | 0 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse | 1.1 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse | 0 percentage of participants |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse | 0 percentage of participants |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse | 0 percentage of participants |
Secondary
For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
ALT normalization was defined as ALT \> the upper limit of normal (ULN) at baseline and ALT ≤ ULN at each visit.
Time frame: Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Week 4
Population: Participants in the Full Analysis Set with ALT \> ULN at Baseline with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Weeks 16, 20, and 24 because they were only treated for 12 weeks.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 2 | 89.8 percentage of participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 12 | 93.3 percentage of participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Posttreatment Week 4 | 90.2 percentage of participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 1 | 72.3 percentage of participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 8 | 91.3 percentage of participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 4 | 93.8 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 4 | 93.1 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 2 | 84.8 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 12 | 95.5 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 8 | 90.1 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 1 | 75.7 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Posttreatment Week 4 | 98.4 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 20 | 100.0 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 1 | 0 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 4 | 0 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 2 | 0 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 16 | 100.0 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 12 | 100.0 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 8 | 0 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 24 | 100.0 percentage of participants |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 16 | 100.0 percentage of participants |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 1 | 50.0 percentage of participants |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 2 | 50.0 percentage of participants |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 20 | 100.0 percentage of participants |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 24 | 100.0 percentage of participants |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Posttreatment Week 4 | 100.0 percentage of participants |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 4 | 100.0 percentage of participants |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 8 | 100.0 percentage of participants |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 12 | 100.0 percentage of participants |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 4 | 96.0 percentage of participants |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 2 | 84.0 percentage of participants |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 1 | 63.0 percentage of participants |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 12 | 91.7 percentage of participants |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Posttreatment Week 4 | 91.3 percentage of participants |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | Week 8 | 92.0 percentage of participants |
Secondary
For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment
Time frame: Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)
Population: Participants in the Full Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Weeks 16, 20, and 24 because they were only treated for 12 weeks.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 8 | 100.0 percentage of participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 2 | 75.0 percentage of participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 1 | 40.0 percentage of participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 4 | 97.0 percentage of participants |
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 12 | 100.0 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 1 | 30.3 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 4 | 96.6 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 8 | 100.0 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 2 | 71.9 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 12 | 100.0 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 20 | 100.0 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 8 | 100.0 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 24 | 100.0 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 1 | 0 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 16 | 100.0 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 12 | 100.0 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 2 | 100.0 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 4 | 100.0 percentage of participants |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 12 | 100.0 percentage of participants |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 16 | 100.0 percentage of participants |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 1 | 100.0 percentage of participants |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 2 | 100.0 percentage of participants |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 4 | 100.0 percentage of participants |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 20 | 100.0 percentage of participants |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 24 | 100.0 percentage of participants |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 8 | 100.0 percentage of participants |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 8 | 100.0 percentage of participants |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 4 | 97.0 percentage of participants |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 2 | 78.8 percentage of participants |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 1 | 29.4 percentage of participants |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Week 12 | 100.0 percentage of participants |
Secondary
For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 4 weeks after stopping study treatment.
Time frame: Posttreatment Week 4
Population: Full Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4) | 98.0 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4) | 98.9 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4) | 100.0 percentage of participants |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4) | 100.0 percentage of participants |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4) | 97.1 percentage of participants |
Secondary
For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA \< LLOQ at 12 weeks after stopping study treatment.
Time frame: Posttreatment Week 12
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12) | 98.0 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12) | 98.9 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12) | 100.0 percentage of participants |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12) | 100.0 percentage of participants |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12) | 97.1 percentage of participants |
Secondary
For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
SVR24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment.
Time frame: Posttreatment Week 24
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) | 98.0 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) | 98.9 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) | 100.0 percentage of participants |
| 6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks | For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) | 100.0 percentage of participants |
| 3 to < 6 Years Old - LDV/SOF 12 Weeks | For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) | 97.1 percentage of participants |
Secondary
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase
Time frame: Up to Day 10
Population: Participants who were enrolled in the PK lead-in phase were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase | 0 percentage of participants |
| PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase | 0 percentage of participants |
| PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase | 5.9 percentage of participants |