Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Adolescents

Key Inclusion Criteria:

- Currently on a stable antiretroviral regimen for ≥ 6 consecutive months

- Weight ≥ 35 kg (77 lbs.)

- Plasma HIV-1 RNA levels < 50 copies/mL for ≥ 6 months

- CD4+ cell count > 100 cells/μL

- No resistance to elvitegravir (EVG), emtricitabine (FTC), lamivudine (3TC) or
tenofovir (TFV)

- Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)

- No evidence of current hepatitis B virus (HBV) infection

- No evidence of current hepatitis C virus (HCV) infection

Note: participants from Gilead Study GS-US-162-0112 were allowed to roll over into this
Study GS-US-292-1515 even if they were 18 years or older at the time of screening.

Key Exclusion Criteria:

- A new AIDS-defining condition diagnosed within the 30 days prior to Screening

- Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months
of screening

- Pregnant or lactating subjects

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