Virological outcomes of EVG/COBI/FTC/TDF and EVG/COBI/FTC/TAF in antiretroviral-naive HIV-1-infected participants with baseline HIV-1 RNA ≥1,000,000 copies/ml: A post hoc analysis of Phase III clinical trials
We address a data gap identified by Adams et al., of virological efficacy outcomes and emergent drug resistance in HIV-1-infected, antiretroviral treatment (ART)-naive participants with baseline (BL) viral loads (VL) >1,000,000 copies/ml. Initial ART regimens including an integrase strand transfer inhibitor (INSTI) cause a rapid decline in VL. In two cases described, the VL response on the single tablet regimen (STR) of co-formulated elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF) was <2 log10 copies/ml and associated with emergent drug resistance [1]. Double-blind, Phase III studies of EVG/COBI/FTC/TDF (Studies 102/103 and 128), and co-formulated elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide (EVG/COBI/FTC/TAF; Studies 104/111), have investigated the efficacy and safety of both EVG-containing STRs in ART-naive participants [2–10]. We present a post hoc analysis of efficacy of these STRs in participants with VL ≥1,000,000 copies/ml
