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Methods Patients on stable ART with HIV-RNA (VL) <200 copies/ mL for ≥3 months were stratified by NNRTIor PI-based ART, and randomized (2:1) to switch to EFV/FTC/TDF or continue SBR. The primary end-point was maintenance of VL < 200 copies/mL at 48 weeks by time to loss of virologic response (TLOVR) algorithm (intent-to-treat, noncompleters = failure [ITT, NC = F], Δ = 15%); efficacy was also assessed by VL <50 copies/mL (TLOVR; ITT, NC = F), pure virologic response (non-responders defined as two consecutive VL ≥50 copies/mL or one VL ≥50 copies/mL followed by study discontinuation; PVR – by Kaplan Meier); and by last observation carried forward (LOCF) analysis where early discontinuations for an adverse event (AE) were considered failures.

Simplification of therapy (ART) with efavirenz/emtricitabine/tenofovir DF single tablet regimen vs. continued ART in suppressed, HIV-infected patients