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

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.