EARLY-SIMPLIFIED Study: DTG monotherapy for maintenance

Braun DL, Clin Infect Dis 2019, Janv 2, Epub ahead of print

Type of ARV Trial
Switch studies in virologically suppressed patients
» Switch to DTG-containing regimen
» DTG monotherapy

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  • In patients who initiated cART < 180 days after the estimated day of a document primary HIV-1 infection and had HIV-1 RNA < 50 c/mL for more than 48 weeks, DTG monotherapy was non-inferior to cART

Design

Objective

  • Primary: % HIV RNA < 50 c/mL at W48, by ITT, LOCF ; non-inferiority if upper margin of a one-sided 95% CI for the difference = 10%, power 80%

Baseline characteristics and patient disposition

HIV RNA < 50 c/mL at W48

  • Non inferiority achieved at W48

Adverse events