Acquired Immune Deficiency Syndrome (AIDS), HIV Infections
Conditions
Keywords
Adolescents, HIV-1, HIV, Treatment-naive, Virologically suppressed, Children
Brief summary
The primary objectives of Cohort 1 are to evaluate the steady state pharmacokinetics (PK) for elvitegravir (EVG) and tenofovir alafenamide (TAF) and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) STR (Part A) and to evaluate the safety and tolerability of E/C/F/TAF STR through Week 24 (Part B) in human immunodeficiency virus - 1 (HIV-1) infected, antiretroviral (ARV) treatment-naive adolescents. The primary objectives of Cohort 2 are to evaluate the PK of EVG and TAF (Part A), and to evaluate the safety and tolerability of E/C/F/TAF through Week 24 (Part B) in virologically suppressed HIV-1 infection children 6 to \< 12 years weighing \>= 25 kg. The primary objectives of Cohort 3 are to evaluate the PK of EVG and TAF and confirm the dose of the STR, and to evaluate the safety and tolerability of E/C/F/TAF low dose (LD) STR in virologically suppressed HIV-1 infected children ≥ 2 years of age and weighing ≥ 14 to \< 25 kg.
Interventions
DRUGE/C/F/TAF
Tablets administered orally with food.
90/90/120/6 mg STR administered once daily orally with food.
Sponsors
Gilead Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Cohort 1 * Age at baseline: 12 years to \< 18 years old * Weight at screening: ≥ 35 kg (77 lbs) * Plasma HIV-1 ribonucleic acid (RNA) levels of ≥ 1,000 copies/mL at screening (Roche COBAS TaqMan v2.0) * Screening genotype report shows sensitivity to EVG, emtricitabine (FTC) and tenofovir (TFV) * No prior use of any approved or experimental anti-HIV-1 drug for any length of time * Cohort 2 * Age at baseline: 6 years to \< 12 years old * Weight at screening: ≥ 25 kg (55 lbs) * Plasma HIV-1 RNA of \< 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is \> 50 copies/mL) for ≥ 180 consecutive days (6 months) prior to screening on a stable antiretroviral regimen, without documented history of resistance to any component of E/C/F/TAF STR. * Cohort 3 * Age at baseline: ≥ 2 years old * Weight at screening: ≥ 14 kg (31 lbs) to \< 25 kg (55 lbs) * Plasma HIV-1 RNA: \< 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is \> 50 copies/mL) for ≥ 180 consecutive days (6 months) prior to screening on a stable antiretroviral regimen, without prior history of resistance to any component of E/C/F/TAF STR Key
Exclusion criteria
* Hepatitis B or hepatitis C virus infection * Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of the screening visit. * Individuals experiencing decompensated cirrhosis * Pregnant or lactating females Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic (PK) Parameter: AUCtau of Elvitegravir (EVG) (Cohort 1) | 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4 | AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval). |
| PK Parameter: AUCtau of EVG (Cohort 2) | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4 | AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval). |
| PK Parameter: AUCtau of EVG (Cohort 3) | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2 | AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval). |
| PK Parameter: AUClast of Tenofovir Alafenamide (TAF) (Cohort 1) | 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4 | AUClast is defined as the concentration of drug from time zero to the last observable concentration, area under the concentration time curve to last observation (AUClast). |
| PK Parameter: AUClast of TAF (Cohort 2) | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4 | AUClast is defined as the concentration of drug from time zero to the last observable concentration. |
| PK Parameter: AUCtau of TAF (Cohort 3) | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2 | AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval). |
| Cohort 1: Percentage of Participants With All Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs) | From first dose date up to Week 24 | Treatment-emergent adverse events (TEAEs) were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the Gilead Sciences Grading Scale for Severity of Adverse Events. An AE that met one or more of the following outcomes was classified as serious: * Fatal * Life-threatening * Disabling/incapacitating * Results in hospitalization or prolongs a hospital stay * A congenital abnormality * Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above. |
| Cohort 2: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs | From first dose date up to Week 24 | TEAEs were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the Gilead Sciences Grading Scale for Severity of Adverse Events. An AE that met one or more of the following outcomes was classified as serious: * Fatal * Life-threatening * Disabling/incapacitating * Results in hospitalization or prolongs a hospital stay * A congenital abnormality * Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above. |
| Cohort 3: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs | From first dose date up to Week 24 | TEAEs were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the Gilead Sciences Grading Scale for Severity of Adverse Events. An AE that met one or more of the following outcomes was classified as serious: * Fatal * Life-threatening * Disabling/incapacitating * Results in hospitalization or prolongs a hospital stay * A congenital abnormality * Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK Parameter: CL/F of EVG and TAF (Cohort 3) | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2 | CL/F is defined as the apparent clearance of the drug following oral administration. |
| PK Parameter: Vz/F of EVG and TAF (Cohort 1) | 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4 | Vz/F is defined as the apparent volume of distribution of the drug after oral administration. |
| PK Parameter: Vz/F of EVG and TAF (Cohort 2) | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4 | Vz/F is defined as the apparent volume of distribution of the drug after oral administration. |
| PK Parameter: Vz/F of EVG and TAF (Cohort 3) | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2 | Vz/F is defined as the apparent volume of distribution of the drug after oral administration. |
| PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 1) | 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4 | AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval). |
| PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 2) | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4 | AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval). |
| PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 3) | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2 | AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval). |
| Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis | Week 24 | The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. |
| Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis | Week 48 | The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. |
| Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis | Week 24 | The percentage of participants with HIV-1 RNA \< 400 Copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. |
| Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis | Week 48 | The percentage of participants with HIV-1 RNA \< 400 Copies/mL at Weeks 24 and 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. |
| Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis | Week 24 | The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. |
| Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis | Week 48 | The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. |
| Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis | Week 24 | The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. |
| Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 24 | Baseline, Week 24 | — |
| Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis | Week 48 | The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. |
| Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses | Week 24 | The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed based on missing = failure analyses. |
| Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses | Week 48 | The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed based on missing = failure analyses. |
| Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses | Week 24 | The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed based on missing = failure analyses. |
| Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses | Week 48 | The percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 48 was analyzed based on missing = failure analyses. |
| Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses | Week 24 | The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed based on missing = failure analyses. |
| Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses | Week 48 | The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed based on missing = failure analyses. |
| Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses | Week 24 | The percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 24 was analyzed based on missing = failure analyses. |
| Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses | Week 48 | The percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 48 was analyzed based on missing = failure analyses. |
| Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses | Week 24 | The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed based on missing = failure analyses. |
| Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses | Week 48 | The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed based on missing = failure analyses. |
| Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses | Week 24 | The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed based on missing = excluded analyses. |
| Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses | Week 48 | The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed based on missing = excluded analyses. |
| Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses | Week 24 | The percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 24 was analyzed based on missing = excluded analyses. |
| Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses | Week 48 | The percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 48 was analyzed based on missing = excluded analyses. |
| Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses | Week 24 | The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed based on missing = excluded analyses. |
| Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses | Week 48 | The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed based on missing = excluded analyses. |
| Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 48 | Baseline, Week 48 | — |
| Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses | Week 48 | The percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 48 was analyzed based on missing = excluded analyses. |
| Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses | Week 24 | The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed based on missing = excluded analyses. |
| Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses | Week 48 | The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed based on missing = excluded analyses. |
| Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 24 | Baseline, Week 24 | — |
| Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 48 | Baseline, Week 48 | — |
| Cohort 1: Change From Baseline in Cluster of Differentiation (CD4+) Cell Count at Week 24 | Baseline, Week 24 | — |
| Cohort 1: Change From Baseline in CD4+ Cell Count at Week 48 | Baseline, Week 48 | — |
| Cohort 2: Change From Baseline in CD4+ Cell Count at Week 24 | Baseline, Week 24 | — |
| Cohort 2: Change From Baseline in CD4+ Cell Count at Week 48 | Baseline, Week 48 | — |
| Cohort 3: Change From Baseline in CD4+ Cell Count at Week 24 | Baseline, Week 24 | — |
| Cohort 3: Change From Baseline in CD4+ Cell Count at Week 48 | Baseline, Week 48 | — |
| Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 24 | Baseline, Week 24 | — |
| Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 48 | Baseline, Week 48 | — |
| Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 24 | Baseline, Week 24 | — |
| Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 48 | Baseline, Week 48 | — |
| Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses | Week 24 | The percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 24 was analyzed based on missing = excluded analyses. |
| PK Parameter: Ctau of EVG, Emtricitabine (FTC), Tenofovir (TFV), and Cobicistat (COBI) (Cohort 1) | 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4 | Ctau is defined as the observed drug concentration at the end of the dosing interval. |
| PK Parameter: Ctau of EVG, FTC, TFV and COBI (Cohort 2) | (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4 | Ctau is defined as the observed drug concentration at the end of the dosing interval. |
| PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 3) | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2 | Ctau is defined as the observed drug concentration at the end of the dosing interval. |
| PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 1) | 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4 | Cmax is defined as the maximum concentration of drug. |
| PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 2) | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4 | Cmax is defined as the maximum concentration of drug. |
| PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 3) | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2 | Cmax is defined as the maximum concentration of drug. |
| PK Parameter: CL/F of EVG and TAF (Cohort 1) | 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4 | Apparent oral clearance (CL/F) is defined as the apparent clearance of the drug following oral administration. |
| PK Parameter: CL/F of EVG and TAF (Cohort 2) | 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4 | CL/F is defined as the apparent clearance of the drug following oral administration. |
Countries
South Africa, Thailand, Uganda, United States, Zimbabwe
Participant flow
Recruitment details
Participants were enrolled at study sites in South Africa, Thailand, Uganda, United States of America, and Zimbabwe.
Pre-assignment details
155 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg Treatment naive adolescents (12 to \< 18 years of age) with human immunodeficiency virus (HIV) received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. | 50 |
| Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg Children (6 to \< 12 years of age weighing ≥ 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. | 52 |
| Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg Children (≥ 2 years of age weighing ≥ 14 to \< 25 kg) with HIV who were virologically suppressed received E/C/F/TAF (90/90/120/6 mg) FDC tablets, once daily orally with food for 48 weeks. Participants who attained a weight of ≥ 25 kg during the course of the study were switched to adult E/C/F/TAF (150/150/200/10 mg) tablets administered orally, once daily with food. Participants who completed 48 weeks of study treatment had the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turned 18 years old and E/C/F/TAF was commercially available for adults in the country in which the participant was enrolled; b) age-appropriate E/C/F/TAF became commercially available in participant's country. | 27 |
| Total | 129 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Extension Phase | Investigator's Discretion | 1 | 0 | 0 |
| Extension Phase | Lost to Follow-up | 1 | 0 | 0 |
| Extension Phase | Non-Compliance with study drug | 1 | 0 | 0 |
| Extension Phase | Pregnancy | 1 | 0 | 0 |
| Extension Phase | Withdrew consent | 0 | 1 | 0 |
| Treatment Phase (48 Weeks) | Lost to Follow-up | 1 | 0 | 0 |
| Treatment Phase (48 Weeks) | Withdrew consent | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg | Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg | Total |
|---|---|---|---|---|
| Age, Continuous | 15 years STANDARD_DEVIATION 1.9 | 10 years STANDARD_DEVIATION 1.2 | 6 years STANDARD_DEVIATION 1.9 | 11 years STANDARD_DEVIATION 3.7 |
| Age, Customized 12 to <18 Years | 50 Participants | 0 Participants | 0 Participants | 50 Participants |
| Age, Customized 2 to <6 Years | 0 Participants | 0 Participants | 11 Participants | 11 Participants |
| Age, Customized 6 to <12 Years | 0 Participants | 52 Participants | 16 Participants | 68 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants | 52 Participants | 27 Participants | 129 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 13 Participants | 3 Participants | 22 Participants |
| Race (NIH/OMB) Black or African American | 44 Participants | 37 Participants | 24 Participants | 105 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Region of Enrollment South Africa | 3 Participants | 0 Participants | 13 Participants | 16 Participants |
| Region of Enrollment Thailand | 6 Participants | 13 Participants | 1 Participants | 20 Participants |
| Region of Enrollment Uganda | 30 Participants | 27 Participants | 8 Participants | 65 Participants |
| Region of Enrollment United States | 11 Participants | 12 Participants | 3 Participants | 26 Participants |
| Region of Enrollment Zimbabwe | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Female | 28 Participants | 30 Participants | 17 Participants | 75 Participants |
| Sex: Female, Male Male | 22 Participants | 22 Participants | 10 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 50 | 0 / 52 | 0 / 27 |
| other Total, other adverse events | 47 / 50 | 45 / 52 | 25 / 27 |
| serious Total, serious adverse events | 10 / 50 | 7 / 52 | 1 / 27 |
Outcome results
Primary
Cohort 1: Percentage of Participants With All Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs)
Treatment-emergent adverse events (TEAEs) were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the Gilead Sciences Grading Scale for Severity of Adverse Events. An AE that met one or more of the following outcomes was classified as serious: * Fatal * Life-threatening * Disabling/incapacitating * Results in hospitalization or prolongs a hospital stay * A congenital abnormality * Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: From first dose date up to Week 24
Population: Participants in the Safety Analysis Set (all participants who received at least 1 dose of study drug) with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 1: Percentage of Participants With All Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs) | Any TEAEs | 81.3 percentage of participants |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 1: Percentage of Participants With All Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs) | SAEs | 8.3 percentage of participants |
Primary
Cohort 2: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs
TEAEs were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the Gilead Sciences Grading Scale for Severity of Adverse Events. An AE that met one or more of the following outcomes was classified as serious: * Fatal * Life-threatening * Disabling/incapacitating * Results in hospitalization or prolongs a hospital stay * A congenital abnormality * Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: From first dose date up to Week 24
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 2: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs | Any TEAEs | 73.9 percentage of participants |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 2: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs | SAEs | 0 percentage of participants |
Primary
Cohort 3: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs
TEAEs were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the Gilead Sciences Grading Scale for Severity of Adverse Events. An AE that met one or more of the following outcomes was classified as serious: * Fatal * Life-threatening * Disabling/incapacitating * Results in hospitalization or prolongs a hospital stay * A congenital abnormality * Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: From first dose date up to Week 24
Population: Participants in the Safety Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 3: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs | SAEs | 3.7 percentage of participants |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 3: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs | Any TEAEs | 70.4 percentage of participants |
Primary
Pharmacokinetic (PK) Parameter: AUCtau of Elvitegravir (EVG) (Cohort 1)
AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval).
Time frame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
Population: The PK Substudy Analysis Set included all enrolled and treated participants from Part A who had any nonmissing key PK parameters (AUCtau, AUClast, Cmax) from Week 4 intensive PK data for the respective analyte.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Pharmacokinetic (PK) Parameter: AUCtau of Elvitegravir (EVG) (Cohort 1) | 23840.1 hr*ng/mL | Standard Deviation 6076.15 |
Primary
PK Parameter: AUClast of TAF (Cohort 2)
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Time frame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4
Population: Participants in the PK Substudy Analysis set were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: AUClast of TAF (Cohort 2) | 332.9 hr*ng/mL | Standard Deviation 149.12 |
Primary
PK Parameter: AUClast of Tenofovir Alafenamide (TAF) (Cohort 1)
AUClast is defined as the concentration of drug from time zero to the last observable concentration, area under the concentration time curve to last observation (AUClast).
Time frame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
Population: Participants in the PK Substudy Analysis Set were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: AUClast of Tenofovir Alafenamide (TAF) (Cohort 1) | 188.9 hr*ng/mL | Standard Deviation 105.45 |
Primary
PK Parameter: AUCtau of EVG (Cohort 2)
AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval).
Time frame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4
Population: Participants in the PK Substudy Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: AUCtau of EVG (Cohort 2) | 33813.9 hr*ng/mL | Standard Deviation 19536.3 |
Primary
PK Parameter: AUCtau of EVG (Cohort 3)
AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval).
Time frame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2
Population: The Intensive PK Analysis Set included all enrolled and treated participants who had any nonmissing key PK parameters (AUCtau, AUClast, Cmax) from Week 2 intensive PK data for the respective analyte.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: AUCtau of EVG (Cohort 3) | 33245.6 hr*ng/mL | Standard Deviation 15499.22 |
Primary
PK Parameter: AUCtau of TAF (Cohort 3)
AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval).
Time frame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2
Population: Participants in the Intensive PK Analysis Set (all enrolled and treated participants who had any nonmissing key PK parameters \[AUCtau, AUClast, Cmax\] from Week 2 intensive PK data for the respective analyte) with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: AUCtau of TAF (Cohort 3) | 366.4 hr*ng/mL | Standard Deviation 144.91 |
Secondary
Cohort 1: Change From Baseline in CD4+ Cell Count at Week 48
Time frame: Baseline, Week 48
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 1: Change From Baseline in CD4+ Cell Count at Week 48 | Baseline | 471 cells/μL | Standard Deviation 212.2 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 1: Change From Baseline in CD4+ Cell Count at Week 48 | Change at Week 48 | 224 cells/μL | Standard Deviation 170.3 |
Secondary
Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 24
Time frame: Baseline, Week 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 24 | Baseline | 23.6 percentage of CD4+ cell | Standard Deviation 8.8 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 24 | Change at Week 24 | 7.7 percentage of CD4+ cell | Standard Deviation 4.77 |
Secondary
Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 48
Time frame: Baseline, Week 48
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 48 | Baseline | 23.6 percentage of CD4+ cell | Standard Deviation 8.8 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 48 | Change at Week 48 | 9.3 percentage of CD4+ cell | Standard Deviation 5.19 |
Secondary
Cohort 1: Change From Baseline in Cluster of Differentiation (CD4+) Cell Count at Week 24
Time frame: Baseline, Week 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 1: Change From Baseline in Cluster of Differentiation (CD4+) Cell Count at Week 24 | Baseline | 471 cells/μL | Standard Deviation 212.2 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 1: Change From Baseline in Cluster of Differentiation (CD4+) Cell Count at Week 24 | Change at Week 24 | 191 cells/μL | Standard Deviation 175.2 |
Secondary
Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 24
Time frame: Baseline, Week 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 24 | Baseline | 4.62 copies/mL | Standard Deviation 0.587 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 24 | Change at Week 24 | -3.25 copies/mL | Standard Deviation 0.645 |
Secondary
Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 48
Time frame: Baseline, Week 48
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 48 | Baseline | 4.62 copies/mL | Standard Deviation 0.587 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 48 | Change at Week 48 | -3.26 copies/mL | Standard Deviation 0.712 |
Secondary
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis
The percentage of participants with HIV-1 RNA \< 400 Copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time frame: Week 24
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis | 94.0 percentage of participants |
Secondary
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses
The percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 24 was analyzed based on missing = excluded analyses.
Time frame: Week 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses | 97.9 percentage of participants |
Secondary
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed based on missing = failure analyses.
Time frame: Week 24
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses | 94.0 percentage of participants |
Secondary
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis
The percentage of participants with HIV-1 RNA \< 400 Copies/mL at Weeks 24 and 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time frame: Week 48
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis | 94.0 percentage of participants |
Secondary
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses
The percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 48 was analyzed based on missing = excluded analyses.
Time frame: Week 48
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses | 97.9 percentage of participants |
Secondary
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses
The percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 48 was analyzed based on missing = failure analyses.
Time frame: Week 48
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses | 94.0 percentage of participants |
Secondary
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time frame: Week 24
Population: The Full analysis set included all participants who were enrolled in the study and had received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis | 90.0 percentage of participants |
Secondary
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed based on missing = excluded analyses.
Time frame: Week 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses | 93.8 percentage of participants |
Secondary
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed based on missing = failure analyses.
Time frame: Week 24
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses | 90.0 percentage of participants |
Secondary
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time frame: Week 48
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis | 92.0 percentage of participants |
Secondary
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed based on missing = excluded analyses.
Time frame: Week 48
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses | 95.8 percentage of participants |
Secondary
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed based on missing = failure analyses.
Time frame: Week 48
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses | 92.0 percentage of participants |
Secondary
Cohort 2: Change From Baseline in CD4+ Cell Count at Week 24
Time frame: Baseline, Week 24
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 2: Change From Baseline in CD4+ Cell Count at Week 24 | Baseline | 961 cells/μL | Standard Deviation 275.5 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 2: Change From Baseline in CD4+ Cell Count at Week 24 | Change at Week 24 | -118 cells/μL | Standard Deviation 194.1 |
Secondary
Cohort 2: Change From Baseline in CD4+ Cell Count at Week 48
Time frame: Baseline, Week 48
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 2: Change From Baseline in CD4+ Cell Count at Week 48 | Baseline | 961 cells/µL | Standard Deviation 275.5 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 2: Change From Baseline in CD4+ Cell Count at Week 48 | Change at Week 48 | -66 cells/µL | Standard Deviation 203.6 |
Secondary
Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 24
Time frame: Baseline, Week 24
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 24 | Baseline | 38.2 percentage of CD4+ cell | Standard Deviation 6.44 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 24 | Change at Week 24 | -0.8 percentage of CD4+ cell | Standard Deviation 3.97 |
Secondary
Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 48
Time frame: Baseline, Week 48
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 48 | Change at Week 48 | -0.6 percentage of CD4+ cell | Standard Deviation 4.37 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 48 | Baseline | 38.2 percentage of CD4+ cell | Standard Deviation 6.44 |
Secondary
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses
The percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 24 was analyzed based on missing = excluded analyses.
Time frame: Week 24
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses | 100.0 percentage of participants |
Secondary
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses
The percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 24 was analyzed based on missing = failure analyses.
Time frame: Week 24
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses | 100.0 percentage of participants |
Secondary
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses
The percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 48 was analyzed based on missing = excluded analyses.
Time frame: Week 48
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses | 100.0 percentage of participants |
Secondary
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses
The percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 48 was analyzed based on missing = failure analyses.
Time frame: Week 48
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses | 100.0 percentage of participants |
Secondary
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time frame: Week 24
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis | 100.0 percentage of participants |
Secondary
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed based on missing = excluded analyses.
Time frame: Week 24
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses | 100.0 percentage of participants |
Secondary
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed based on missing = failure analyses.
Time frame: Week 24
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses | 100.0 percentage of participants |
Secondary
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time frame: Week 48
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis | 98.1 percentage of participants |
Secondary
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed based on missing = excluded analyses.
Time frame: Week 48
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses | 100.0 percentage of participants |
Secondary
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed based on missing = failure analyses.
Time frame: Week 48
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses | 100.0 percentage of participants |
Secondary
Cohort 3: Change From Baseline in CD4+ Cell Count at Week 24
Time frame: Baseline, Week 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 3: Change From Baseline in CD4+ Cell Count at Week 24 | Baseline | 1153 cells/μL | Standard Deviation 459.9 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 3: Change From Baseline in CD4+ Cell Count at Week 24 | Change at Week 24 | -137 cells/μL | Standard Deviation 278.3 |
Secondary
Cohort 3: Change From Baseline in CD4+ Cell Count at Week 48
Time frame: Baseline, Week 48
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 3: Change From Baseline in CD4+ Cell Count at Week 48 | Baseline | 1153 cells/µL | Standard Deviation 459.9 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 3: Change From Baseline in CD4+ Cell Count at Week 48 | Change at Week 48 | -179 cells/µL | Standard Deviation 319.2 |
Secondary
Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 24
Time frame: Baseline, Week 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 24 | Baseline | 35.9 percentage of CD4+ cell | Standard Deviation 6.73 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 24 | Change at Week 24 | 0.0 percentage of CD4+ cell | Standard Deviation 4.4 |
Secondary
Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 48
Time frame: Baseline, Week 48
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 48 | Baseline | 35.9 percentage of CD4+ cell | Standard Deviation 6.73 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 48 | Change at Week 48 | 0.2 percentage of CD4+ cell | Standard Deviation 3.78 |
Secondary
Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time frame: Week 24
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis | 96.3 percentage of participants |
Secondary
Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed based on missing = excluded analyses.
Time frame: Week 24
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses | 96.3 percentage of participants |
Secondary
Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed based on missing = failure analyses.
Time frame: Week 24
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses | 96.3 percentage of participants |
Secondary
Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time frame: Week 48
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis | 96.3 percentage of participants |
Secondary
Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed based on missing = excluded analyses.
Time frame: Week 48
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses | 96.3 percentage of participants |
Secondary
Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed based on missing = failure analyses.
Time frame: Week 48
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses | 96.3 percentage of participants |
Secondary
PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 1)
AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval).
Time frame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
Population: Participants in the PK Substudy Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 1) | TFV | 287.6 hr*ng/mL | Standard Deviation 54.09 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 1) | COBI | 8240.8 hr*ng/mL | Standard Deviation 2972.94 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 1) | FTC | 14424.4 hr*ng/mL | Standard Deviation 3452.88 |
Secondary
PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 2)
AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval).
Time frame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4
Population: Participants in the PK Substudy Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 2) | FTC | 20629.2 hr*ng/mL | Standard Deviation 3906.01 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 2) | TFV | 440.2 hr*ng/mL | Standard Deviation 92.13 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 2) | COBI | 15890.7 hr*ng/mL | Standard Deviation 8208.78 |
Secondary
PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 3)
AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval).
Time frame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2
Population: Participants in the Intensive PK Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 3) | FTC | 19468.1 hr*ng/mL | Standard Deviation 5635.74 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 3) | TFV | 334.9 hr*ng/mL | Standard Deviation 76.77 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 3) | COBI | 14485.2 hr*ng/mL | Standard Deviation 7166.1 |
Secondary
PK Parameter: CL/F of EVG and TAF (Cohort 1)
Apparent oral clearance (CL/F) is defined as the apparent clearance of the drug following oral administration.
Time frame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
Population: Participants in the PK Substudy Analysis Set with available data were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: CL/F of EVG and TAF (Cohort 1) | EVG | 6.7 L/hr | Standard Deviation 1.74 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: CL/F of EVG and TAF (Cohort 1) | TAF | 68.6 L/hr | Standard Deviation 52.64 |
Secondary
PK Parameter: CL/F of EVG and TAF (Cohort 2)
CL/F is defined as the apparent clearance of the drug following oral administration.
Time frame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4
Population: Participants in the PK Substudy Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: CL/F of EVG and TAF (Cohort 2) | EVG | 6.3 L/hr | Standard Deviation 5.11 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: CL/F of EVG and TAF (Cohort 2) | TAF | 31.9 L/hr | Standard Deviation 11.21 |
Secondary
PK Parameter: CL/F of EVG and TAF (Cohort 3)
CL/F is defined as the apparent clearance of the drug following oral administration.
Time frame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2
Population: Participants in the Intensive PK Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: CL/F of EVG and TAF (Cohort 3) | EVG | 3.4 L/hr | Standard Deviation 1.79 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: CL/F of EVG and TAF (Cohort 3) | TAF | 18.5 L/hr | Standard Deviation 6.27 |
Secondary
PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 1)
Cmax is defined as the maximum concentration of drug.
Time frame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
Population: Participants in the PK Substudy Analysis Set were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 1) | EVG | 2229.6 ng/mL | Standard Deviation 427.93 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 1) | TAF | 166.8 ng/mL | Standard Deviation 107.44 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 1) | FTC | 2265.0 ng/mL | Standard Deviation 510.55 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 1) | TFV | 17.6 ng/mL | Standard Deviation 4.18 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 1) | COBI | 1202.4 ng/mL | Standard Deviation 421.21 |
Secondary
PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 2)
Cmax is defined as the maximum concentration of drug.
Time frame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4
Population: Participants in the PK Substudy Analysis Set were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 2) | EVG | 3055.2 ng/mL | Standard Deviation 1180.9 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 2) | TAF | 313.3 ng/mL | Standard Deviation 191.68 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 2) | FTC | 3397.4 ng/mL | Standard Deviation 916.06 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 2) | TFV | 26.1 ng/mL | Standard Deviation 5.43 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 2) | COBI | 2079.4 ng/mL | Standard Deviation 970.81 |
Secondary
PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 3)
Cmax is defined as the maximum concentration of drug.
Time frame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2
Population: Participants in the Intensive PK Analysis Set were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 3) | EVG | 3297.2 ng/mL | Standard Deviation 1720.38 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 3) | TAF | 286.6 ng/mL | Standard Deviation 206.97 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 3) | FTC | 3007.4 ng/mL | Standard Deviation 1138.1 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 3) | TFV | 19.6 ng/mL | Standard Deviation 4.72 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 3) | COBI | 1525.5 ng/mL | Standard Deviation 788.12 |
Secondary
PK Parameter: Ctau of EVG, Emtricitabine (FTC), Tenofovir (TFV), and Cobicistat (COBI) (Cohort 1)
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Time frame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
Population: Participants in the PK Substudy Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: Ctau of EVG, Emtricitabine (FTC), Tenofovir (TFV), and Cobicistat (COBI) (Cohort 1) | TFV | 10.0 ng/mL | Standard Deviation 2.13 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: Ctau of EVG, Emtricitabine (FTC), Tenofovir (TFV), and Cobicistat (COBI) (Cohort 1) | COBI | 25.0 ng/mL | Standard Deviation 44.97 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: Ctau of EVG, Emtricitabine (FTC), Tenofovir (TFV), and Cobicistat (COBI) (Cohort 1) | EVG | 300.8 ng/mL | Standard Deviation 243.69 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: Ctau of EVG, Emtricitabine (FTC), Tenofovir (TFV), and Cobicistat (COBI) (Cohort 1) | FTC | 102.4 ng/mL | Standard Deviation 39.85 |
Secondary
PK Parameter: Ctau of EVG, FTC, TFV and COBI (Cohort 2)
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Time frame: (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4
Population: Participants in the PK Substudy Analysis Set were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: Ctau of EVG, FTC, TFV and COBI (Cohort 2) | EVG | 370.0 ng/mL | Standard Deviation 438.52 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: Ctau of EVG, FTC, TFV and COBI (Cohort 2) | FTC | 114.9 ng/mL | Standard Deviation 27.7 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: Ctau of EVG, FTC, TFV and COBI (Cohort 2) | TFV | 15.1 ng/mL | Standard Deviation 3.77 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: Ctau of EVG, FTC, TFV and COBI (Cohort 2) | COBI | 96.0 ng/mL | Standard Deviation 162.01 |
Secondary
PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 3)
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Time frame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2
Population: Participants in the Intensive PK Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 3) | EVG | 277.5 ng/mL | Standard Deviation 223.43 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 3) | FTC | 82.5 ng/mL | Standard Deviation 26.47 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 3) | TFV | 11.4 ng/mL | Standard Deviation 2.65 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 3) | COBI | 23.0 ng/mL | Standard Deviation 23.02 |
Secondary
PK Parameter: Vz/F of EVG and TAF (Cohort 1)
Vz/F is defined as the apparent volume of distribution of the drug after oral administration.
Time frame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
Population: Participants in the PK Substudy Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: Vz/F of EVG and TAF (Cohort 1) | EVG | 60.5 liters | Standard Deviation 18.77 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: Vz/F of EVG and TAF (Cohort 1) | TAF | 49.7 liters | Standard Deviation 32.54 |
Secondary
PK Parameter: Vz/F of EVG and TAF (Cohort 2)
Vz/F is defined as the apparent volume of distribution of the drug after oral administration.
Time frame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4
Population: Participants in the PK Substudy Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: Vz/F of EVG and TAF (Cohort 2) | EVG | 46.8 liters | Standard Deviation 36.02 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: Vz/F of EVG and TAF (Cohort 2) | TAF | 28.6 liters | Standard Deviation 25.74 |
Secondary
PK Parameter: Vz/F of EVG and TAF (Cohort 3)
Vz/F is defined as the apparent volume of distribution of the drug after oral administration.
Time frame: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2
Population: Participants in the Intensive PK Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: Vz/F of EVG and TAF (Cohort 3) | EVG | 28.5 liters | Standard Deviation 28.3 |
| Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg | PK Parameter: Vz/F of EVG and TAF (Cohort 3) | TAF | 16.3 liters | Standard Deviation 11.07 |