REALITY Study: raltegravir -intensified quadruple therapy in first-line antiretroviral therapy

Kityo C .PLoS Med. 2018 ; 15(12):e1002706

Type of ARV Trial
Head-to-head comparative trials for first line ART since 2006
» Intensification with INSTI
» EFV + 2 NRTI vs EFV + 2 NRTI + RAL
Drugs
RAL, EFV 600, 2 NRTI

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  • Standard triple ART (FTC/TDF + EFV) intensified with raltegravir
    for 12 weeks
    • Was well tolerated
    • Resulted in faster HIV RNA reduction through 24 weeks, and higher increase in CD4 at 48 weeks
    • But did not reduce mortality or WHO 3/4 events through either week 24 or 48

Design


Two other factorial randomisations: 12 weeks enhanced prophylaxis, 12 weeks supplementary food

Objective

  • Primary endpoint: 24-week mortality

Baseline characteristics

Mortality (left) & HIV RNA < 50 copies/mL (95% CI) (right)

Secondary/other outcomes (HR, 95% CI)