| Primary | Pharmacokinetic (PK) Parameter (Cohort 1): AUCtau of Tenofovir Alafenamide (TAF) | AUCtau is defined as the area under the drug concentration versus time curve over the dosing interval. | Participants in the Intensive PK (IPK) Analysis Set (participants who were enrolled in Cohort 1 for IPK evaluation, had received at least one dose of study medication, and had at least 1 non-missing PK concentration data for any analyte of interest (e.g., emtricitabine (FTC), TAF, and tenofovir (TFV))) with available data were analyzed. | Posted | | Mean | Standard Deviation | h*ng/mL | | Any time at Week 2 visit | | | | ID | Title | Description |
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| OG000 | F/TAF 200/10 mg+3rd ARV Agent (Cohort 1) | Participants between 12 to < 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV). The participants received the study drug up to a maximum of 438.9 weeks. | | OG001 | F/TAF 200/25 mg+3rd ARV Agent (Cohort 1) | Participants between 12 to < 18 years of age and ≥ 35 kg body weight received F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 438.9 weeks. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000139.9± 113.23
- OG001200.6± 83.80
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| |
| Primary | PK Parameter (Cohort 2: Part A - Groups 1 and 2): AUCtau of TAF | AUCtau is defined as the area under the drug concentration versus time curve over the dosing interval. | The IPK Analysis Set included all participants who were enrolled into the study, had received at least one dose of study medication, and had at least 1 non-missing PK concentration data for any analyte of interest (e.g., FTC, TAF, and TFV). | Posted | | Mean | Standard Deviation | h*ng/mL | | Any time at Week 2 or Week 4 visit, or within 7 days after the completion of Week 2 or Week 4 visits | | | | ID | Title | Description |
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| OG000 | F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1) | Participants between 6 to < 12 years of age and ≥ 25 kg body weight received F/TAF 200/25 mg FDC tablet orally once daily while continuing on their boosted PI for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted PIs: ATV, LPV or DRV). The participants received the study drug up to a maximum of 315.0 weeks. | | OG001 | F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2) | |
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| Primary | Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Through Week 24 | An AE is any untoward medical occurrence in a clinical study participant which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The TEAEs were defined as any AEs with an onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug. | The Safety Analysis Set included all participants who were enrolled in the study and had received at least one dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population. | Posted | | Number | | percentage of participants | | Baseline through Week 24 | | | | ID | Title | Description |
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| OG000 | F/TAF+3rd ARV Agent (Cohort 1) | Participants between 12 to < 18 years of age and ≥ 35 kg body weight received emtricitabine/tenofovir alafenamide (F/TAF) 200/10 mg fixed-dose combination (FDC) tablet (with boosted 3rd antiretroviral [ARV] agent) or F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: lopinavir [LPV], atazanavir [ATV], darunavir [DRV]; Allowed unboosted 3rd ARV agents: efavirenz [EFV], raltegravir [RAL], dolutegravir [DTG], or nevirapine [NVP]). The participants received the study drug up to a maximum of 438.9 weeks. |
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| Secondary | PK Parameter (Cohort 1): Cmax of TAF, FTC, and TFV | Cmax is defined as the maximum concentration of drug. | Participants in the IPK Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | Any time at Week 2 visit | | | | ID | Title | Description |
|---|
| OG000 | F/TAF 200/10 mg+3rd ARV Agent (Cohort 1) | Participants between 12 to < 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV). The participants received the study drug up to a maximum of 438.9 weeks. | | OG001 | F/TAF 200/25 mg+3rd ARV Agent (Cohort 1) | Participants between 12 to < 18 years of age and ≥ 35 kg body weight received F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 438.9 weeks. |
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| Secondary | PK Parameter (Cohort 2: Part A - Groups 1 and 2): Cmax of TAF, FTC, and TFV | Cmax is defined as the maximum concentration of drug. | Participants in the IPK Analysis Set were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | Any time at Week 2 or Week 4 visit, or within 7 days after the completion of Week 2 or Week 4 visits | | | | ID | Title | Description |
|---|
| OG000 | F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1) | Participants between 6 to < 12 years of age and ≥ 25 kg body weight received F/TAF 200/25 mg FDC tablet orally once daily while continuing on their boosted PI for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted PIs: ATV, LPV or DRV). The participants received the study drug up to a maximum of 315.0 weeks. | | OG001 | F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2) | Participants between 2 to < 12 years of age and 17 to < 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 103.1 weeks. |
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| Secondary | PK Parameter (Cohort 1): Clast of TAF | Clast is defined as the last observable concentration of drug. | Participants in the IPK Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | Any time at Week 2 visit | | | | ID | Title | Description |
|---|
| OG000 | F/TAF 200/10 mg+3rd ARV Agent (Cohort 1) | Participants between 12 to < 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV). The participants received the study drug up to a maximum of 438.9 weeks. | | OG001 | F/TAF 200/25 mg+3rd ARV Agent (Cohort 1) | Participants between 12 to < 18 years of age and ≥ 35 kg body weight received F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 438.9 weeks. |
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| Secondary | PK Parameter (Cohort 2: Part A - Groups 1 and 2): Clast of TAF | Clast is defined as the last observable concentration of drug. | Participants in the IPK Analysis Set were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | Any time at Week 2 or Week 4 visit, or within 7 days after the completion of Week 2 or Week 4 visits | | | | ID | Title | Description |
|---|
| OG000 | F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1) | Participants between 6 to < 12 years of age and ≥ 25 kg body weight received F/TAF 200/25 mg FDC tablet orally once daily while continuing on their boosted PI for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted PIs: ATV, LPV or DRV). The participants received the study drug up to a maximum of 315.0 weeks. | | OG001 | F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2) | Participants between 2 to < 12 years of age and 17 to < 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 103.1 weeks. |
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| Secondary | PK Parameter (Cohort 1): CL/F of TAF | CL/F is defined as the apparent clearance following oral administration of the drug. | Participants in the IPK Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | L/hr | | Any time at Week 2 visit | | | | ID | Title | Description |
|---|
| OG000 | F/TAF 200/10 mg+3rd ARV Agent (Cohort 1) | Participants between 12 to < 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV). The participants received the study drug up to a maximum of 438.9 weeks. | | OG001 | F/TAF 200/25 mg+3rd ARV Agent (Cohort 1) | Participants between 12 to < 18 years of age and ≥ 35 kg body weight received F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 438.9 weeks. |
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| Secondary | PK Parameter (Cohort 2: Part A - Groups 1 and 2): CL/F of TAF | CL/F is defined as the apparent clearance following oral administration of the drug. | Participants in the IPK Analysis Set were analyzed. | Posted | | Mean | Standard Deviation | L/hr | | Any time at Week 2 or Week 4 visit, or within 7 days after the completion of Week 2 or Week 4 visits | | | | ID | Title | Description |
|---|
| OG000 | F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1) | Participants between 6 to < 12 years of age and ≥ 25 kg body weight received F/TAF 200/25 mg FDC tablet orally once daily while continuing on their boosted PI for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted PIs: ATV, LPV or DRV). The participants received the study drug up to a maximum of 315.0 weeks. | | OG001 | F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2) | Participants between 2 to < 12 years of age and 17 to < 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 103.1 weeks. |
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| Secondary | PK Parameter (Cohort 1): Vz/F of TAF | Vz/F is defined as the apparent volume of distribution of the drug following oral administration. | Participants in the IPK Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | liters | | Any time at Week 2 visit | | | | ID | Title | Description |
|---|
| OG000 | F/TAF 200/10 mg+3rd ARV Agent (Cohort 1) | Participants between 12 to < 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV). The participants received the study drug up to a maximum of 438.9 weeks. | | OG001 | F/TAF 200/25 mg +3rd ARV Agent (Cohort 1) | Participants between 12 to < 18 years of age and ≥ 35 kg body weight received F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 438.9 weeks. |
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| Secondary | PK Parameter (Cohort 2: Part A - Groups 1 and 2): Vz/F of TAF | Vz/F is defined as the apparent volume of distribution of the drug following oral administration. | Participants in the IPK Analysis Set were analyzed. | Posted | | Mean | Standard Deviation | liters | | Any time at Week 2 or Week 4 visit, or within 7 days after the completion of Week 2 or Week 4 visits | | | | ID | Title | Description |
|---|
| OG000 | F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1) | Participants between 6 to < 12 years of age and ≥ 25 kg body weight received F/TAF 200/25 mg FDC tablet orally once daily while continuing on their boosted PI for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted PIs: ATV, LPV or DRV). The participants received the study drug up to a maximum of 315.0 weeks. | | OG001 | F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2) | Participants between 2 to < 12 years of age and 17 to < 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 103.1 weeks. |
|
| Secondary | PK Parameter (Cohort 1): AUCtau of FTC and TFV | AUCtau is defined as the area under the drug concentration versus time curve over the dosing interval. | Participants in the IPK Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | h*ng/mL | | Any time at Week 2 visit | | | | ID | Title | Description |
|---|
| OG000 | F/TAF 200/10 mg+3rd ARV Agent (Cohort 1) | Participants between 12 to < 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV). The participants received the study drug up to a maximum of 438.9 weeks. | | OG001 | F/TAF 200/25 mg+3rd ARV Agent (Cohort 1) | Participants between 12 to < 18 years of age and ≥ 35 kg body weight received F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 438.9 weeks. |
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| Secondary | PK Parameter (Cohort 2: Part A - Groups 1 and 2): AUCtau of FTC and TFV | AUCtau is defined as the area under the drug concentration versus time curve over the dosing interval. | Participants in the IPK Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | h*ng/mL | | Any time at Week 2 or Week 4 visit, or within 7 days after the completion of Week 2 or Week 4 visits | | | | ID | Title | Description |
|---|
| OG000 | F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1) | Participants between 6 to < 12 years of age and ≥ 25 kg body weight received F/TAF 200/25 mg FDC tablet orally once daily while continuing on their boosted PI for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted PIs: ATV, LPV or DRV). The participants received the study drug up to a maximum of 315.0 weeks. | | OG001 | F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2) | Participants between 2 to < 12 years of age and 17 to < 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 103.1 weeks. |
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| Secondary | PK Parameter (Cohort 1): Ctau of FTC and TFV | Ctau is defined as the observed drug concentration at the end of the dosing interval. | Participants in the IPK Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | Any time at Week 2 visit | | | | ID | Title | Description |
|---|
| OG000 | F/TAF 200/10 mg+3rd ARV Agent (Cohort 1) | Participants between 12 to < 18 years of age and ≥ 35 kg body weight received F/TAF 200/10 mg FDC tablet (with boosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV). The participants received the study drug up to a maximum of 438.9 weeks. | | OG001 | F/TAF 200/25 mg+3rd ARV Agent (Cohort 1) | Participants between 12 to < 18 years of age and ≥ 35 kg body weight received F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in an extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 438.9 weeks. |
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| Secondary | PK Parameter (Cohort 2: Part A - Groups 1 and 2): Ctau of FTC and TFV | Ctau is defined as the observed drug concentration at the end of the dosing interval. | Participants in the IPK Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | Any time at Week 2 or Week 4 visit, or within 7 days after the completion of Week 2 or Week 4 visits | | | | ID | Title | Description |
|---|
| OG000 | F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 1) | Participants between 6 to < 12 years of age and ≥ 25 kg body weight received F/TAF 200/25 mg FDC tablet orally once daily while continuing on their boosted PI for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted PIs: ATV, LPV or DRV). The participants received the study drug up to a maximum of 315.0 weeks. | | OG001 | F/TAF+3rd ARV Agent (Cohort 2, Part A - Group 2) | Participants between 2 to < 12 years of age and 17 to < 25 kg body weight received F/TAF 120/15 mg FDC orally once daily while continuing on their 3rd ARV agent for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: LPV, ATV, DRV; Allowed unboosted 3rd ARV agents: EFV, RAL, DTG, or NVP). The participants received the study drug up to a maximum of 103.1 weeks. |
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| Secondary | Percentage of Participants Experiencing TEAEs and SAEs Through Week 48 | An AE is any untoward medical occurrence in a clinical study participant which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The TEAEs were defined as any AEs with an onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug. | Participants in the Safety Analysis Set were analyzed. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population. | Posted | | Number | | percentage of participants | | Baseline through Week 48 | | | | ID | Title | Description |
|---|
| OG000 | F/TAF+3rd ARV Agent (Cohort 1) | Participants between 12 to < 18 years of age and ≥ 35 kg body weight received emtricitabine/tenofovir alafenamide (F/TAF) 200/10 mg fixed-dose combination (FDC) tablet (with boosted 3rd antiretroviral [ARV] agent) or F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: lopinavir [LPV], atazanavir [ATV], darunavir [DRV]; Allowed unboosted 3rd ARV agents: efavirenz [EFV], raltegravir [RAL], dolutegravir [DTG], or nevirapine [NVP]). The participants received the study drug up to a maximum of 438.9 weeks. |
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| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined 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. | The Full Analysis Set included all participants who were enrolled in the study and had received at least one dose of study medication. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population. | Posted | | Number | | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | F/TAF+3rd ARV Agent (Cohort 1) | Participants between 12 to < 18 years of age and ≥ 35 kg body weight received emtricitabine/tenofovir alafenamide (F/TAF) 200/10 mg fixed-dose combination (FDC) tablet (with boosted 3rd antiretroviral [ARV] agent) or F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: lopinavir [LPV], atazanavir [ATV], darunavir [DRV]; Allowed unboosted 3rd ARV agents: efavirenz [EFV], raltegravir [RAL], dolutegravir [DTG], or nevirapine [NVP]). The participants received the study drug up to a maximum of 438.9 weeks. |
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| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the US FDA-Defined Snapshot Algorithm | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defined 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. | Participants in the Full Analysis Set were analyzed. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population. | Posted | | Number | | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | F/TAF+3rd ARV Agent (Cohort 1) | Participants between 12 to < 18 years of age and ≥ 35 kg body weight received emtricitabine/tenofovir alafenamide (F/TAF) 200/10 mg fixed-dose combination (FDC) tablet (with boosted 3rd antiretroviral [ARV] agent) or F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: lopinavir [LPV], atazanavir [ATV], darunavir [DRV]; Allowed unboosted 3rd ARV agents: efavirenz [EFV], raltegravir [RAL], dolutegravir [DTG], or nevirapine [NVP]). The participants received the study drug up to a maximum of 438.9 weeks. |
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| Secondary | Change From Baseline in CD4+ Cell Count at Week 24 | | Participants in the Full Analysis Set with available data were analyzed. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population. | Posted | | Mean | Standard Deviation | cells/µL | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | F/TAF+3rd ARV Agent (Cohort 1) | Participants between 12 to < 18 years of age and ≥ 35 kg body weight received emtricitabine/tenofovir alafenamide (F/TAF) 200/10 mg fixed-dose combination (FDC) tablet (with boosted 3rd antiretroviral [ARV] agent) or F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: lopinavir [LPV], atazanavir [ATV], darunavir [DRV]; Allowed unboosted 3rd ARV agents: efavirenz [EFV], raltegravir [RAL], dolutegravir [DTG], or nevirapine [NVP])The participants received the study drug up to a maximum of 438.9 weeks. | | OG001 |
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| Secondary | Change From Baseline in CD4+ Cell Count at Week 48 | | Participants in the Full Analysis Set with available data were analyzed. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population. | Posted | | Mean | Standard Deviation | cells/µL | | Baseline, Week 48 | | | | ID | Title | Description |
|---|
| OG000 | F/TAF+3rd ARV Agent (Cohort 1) | Participants between 12 to < 18 years of age and ≥ 35 kg body weight received emtricitabine/tenofovir alafenamide (F/TAF) 200/10 mg fixed-dose combination (FDC) tablet (with boosted 3rd antiretroviral [ARV] agent) or F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: lopinavir [LPV], atazanavir [ATV], darunavir [DRV]; Allowed unboosted 3rd ARV agents: efavirenz [EFV], raltegravir [RAL], dolutegravir [DTG], or nevirapine [NVP]). The participants received the study drug up to a maximum of 438.9 weeks. | | OG001 |
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| Secondary | Change From Baseline in CD4 Percentage at Week 24 | | Participants in the Full Analysis Set with available data were analyzed. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population. | Posted | | Mean | Standard Deviation | percentage of lymphocytes | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | F/TAF+3rd ARV Agent (Cohort 1) | Participants between 12 to < 18 years of age and ≥ 35 kg body weight received emtricitabine/tenofovir alafenamide (F/TAF) 200/10 mg fixed-dose combination (FDC) tablet (with boosted 3rd antiretroviral [ARV] agent) or F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: lopinavir [LPV], atazanavir [ATV], darunavir [DRV]; Allowed unboosted 3rd ARV agents: efavirenz [EFV], raltegravir [RAL], dolutegravir [DTG], or nevirapine [NVP]). The participants received the study drug up to a maximum of 438.9 weeks. | | OG001 |
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| Secondary | Change From Baseline in CD4 Percentage at Week 48 | | Participants in the Full Analysis Set with available data were analyzed. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population. | Posted | | Mean | Standard Deviation | percentage of lymphocytes | | Baseline, Week 48 | | | | ID | Title | Description |
|---|
| OG000 | F/TAF+3rd ARV Agent (Cohort 1) | Participants between 12 to < 18 years of age and ≥ 35 kg body weight received emtricitabine/tenofovir alafenamide (F/TAF) 200/10 mg fixed-dose combination (FDC) tablet (with boosted 3rd antiretroviral [ARV] agent) or F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: lopinavir [LPV], atazanavir [ATV], darunavir [DRV]; Allowed unboosted 3rd ARV agents: efavirenz [EFV], raltegravir [RAL], dolutegravir [DTG], or nevirapine [NVP]). The participants received the study drug up to a maximum of 438.9 weeks. | | OG001 |
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| Secondary | Number of Participants With Palatability of F/TAF Formulation | Palatability was reported based on the pleasant product taste as 'Yes' or 'No'. Data has been reported for Participant Response (PR) and Guardian Response (GR). Participants with missing data were reported as N/A. | Participants in the Safety Analysis Set were analyzed. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population. | Posted | | Count of Participants | | Participants | | Week 2 (for Cohort 1), Week 2 and Week 4 (for Cohort 2) | | | | ID | Title | Description |
|---|
| OG000 | F/TAF+3rd ARV Agent (Cohort 1) | Participants between 12 to < 18 years of age and ≥ 35 kg body weight received emtricitabine/tenofovir alafenamide (F/TAF) 200/10 mg fixed-dose combination (FDC) tablet (with boosted 3rd antiretroviral [ARV] agent) or F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: lopinavir [LPV], atazanavir [ATV], darunavir [DRV]; Allowed unboosted 3rd ARV agents: efavirenz [EFV], raltegravir [RAL], dolutegravir [DTG], or nevirapine [NVP]). The participants received the study drug up to a maximum of 438.9 weeks. |
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| Secondary | Number of Participants With Acceptability of F/TAF Formulation | Acceptability has been reported for categories medication size, shape and difficulty swallowing as 'Yes' or 'No' for Participant Response (PR) and Guardian Response (GR). Participants with missing data were reported as N/A. | Participants in the Safety Analysis Set with available data were analyzed. It was prespecified to analyze data from Cohort 1 together because both treatments (F/TAF 200/10 mg with boosted 3rd ARV and F/TAF 200/25 mg with unboosted 3rd ARV) were expected to have a similar effect on the efficacy and safety for the target population. | Posted | | Count of Participants | | Participants | | Baseline up to Week 4 | | | | ID | Title | Description |
|---|
| OG000 | F/TAF+3rd ARV Agent (Cohort 1) | Participants between 12 to < 18 years of age and ≥ 35 kg body weight received emtricitabine/tenofovir alafenamide (F/TAF) 200/10 mg fixed-dose combination (FDC) tablet (with boosted 3rd antiretroviral [ARV] agent) or F/TAF 200/25 mg FDC tablet (with unboosted 3rd ARV agent) orally once daily for 48 weeks. After completion of 48 weeks, all participants were given the option to participate in the extension phase of the study to continue with F/TAF+3rd ARV agent. Gilead provided F/TAF until a) the participant turned 18 and F/TAF was commercially available for use in adults in the country in which the participant was enrolled or, b) F/TAF became commercially available for pediatric use in the country in which the participant was enrolled or, c) Gilead Sciences elected to terminate development of F/TAF in the applicable country. (Allowed boosted 3rd ARV agents: lopinavir [LPV], atazanavir [ATV], darunavir [DRV]; Allowed unboosted 3rd ARV agents: efavirenz [EFV], raltegravir [RAL], dolutegravir [DTG], or nevirapine [NVP]). The participants received the study drug up to a maximum of 438.9 weeks. |
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