B/F/TAF FDC in HIV-1 Infected Virologically Suppressed Adolescents and Children

Key Inclusion Criteria:

Cohort 1: HIV-1 infected adolescents (12 to < 18 years of age and screening weight ≥ 35 kg)
who are virologically suppressed for ≥ 6 months prior to screening.

Cohort 2: HIV-1 infected children (6 to < 12 years of age and screening weight ≥ 25 kg) who
are virologically suppressed for ≥ 6 months prior to screening.

Cohort 3: HIV-1 infected children (≥ 2 years of age and screening weight of ≥ 14 to < 25
kg) who are virologically suppressed for ≥ 6 months prior to screening.

- Documented plasma HIV-1 RNA < 50 copies/mL on a stable regimen (or undetectable HIV-1
RNA level according to the local assay being used if the limit of detection is ≥ 50
copies/mL) for ≥ 6 months preceding the Screening visit. Unconfirmed virologic
elevations of ≥ 50 copies/mL (transient detectable viremia, or "blip") prior to
screening are acceptable. If the lower limit of detection of the local HIV-1 RNA assay
is < 50 copies/mL (eg, < 20 copies/mL), the plasma HIV-1 RNA level cannot exceed 50
copies/mL on two consecutive HIV-1 RNA tests.

- Stable antiretroviral regimen of 2 nucleoside reverse transcriptase inhibitors (NRTIs)
in combination with a third agent for a minimum of 6 months prior to the screening
visit. Individuals undergoing dose modifications to their antiretroviral regimen for
growth or who are switching medication formulation(s) are considered to be on a stable
antiretroviral regimen.

- Estimated glomerular filtration rate (GFR) ≥ 90 mL/min/1.73 m^2 according to the
Schwartz Formula

- No documented or suspected resistance to emtricitabine (FTC), tenofovir (TFV), or
integrase strand transfer inhibitors (INSTIs) including, but not limited to, the
reverse transcriptase resistance mutations K65R and M184V/I

Note: Other protocol defined Inclusion/Exclusion criteria may apply.