Tenofovir Disoproxil Fumarate and Emtricitabine Maintenance Strategy in Virologically Controlled Adults with Low HIV-1 DNA: 48 Week Results from a Randomized, Open-Label, Non-Inferiority Trial

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Prazuck, Thierry | Verdon, Renaud | Le Moal, Gwenael | Ajana, Faiza | Bernard, Louis | Sunder, Simon | Roncato-Saberan, Mariam | Ponscarme, Diane | Etienne, Manuel | Viard, Jean-Paul | Pasdeloup, Thierry | Darasteanu, Iuliana | Pialoux, Gilles | Blanchardière, Arnaud, de La | Avettand-Fenoël, Véronique | Parienti, Jean-Jacques | Hocqueloux, Laurent

Edité par CCSD ; Oxford University Press (OUP) -

International audience. Abstract Objectives Low HIV reservoirs may be associated with viral suppression under a lower number of antiretroviral drugs. We investigated tenofovir disoproxil fumarate/emtricitabine as a maintenance strategy in people living with HIV (PLHIV) with low HIV-DNA. Methods TRULIGHT (NCT02302547) was a multicentre, open-label, randomized trial comparing a simplification to tenofovir disoproxil fumarate/emtricitabine versus a triple regimen continuation (tenofovir disoproxil fumarate/emtricitabine with a third agent, control arm) in virologically suppressed adults with HIV-DNA <2.7\,log10 copies/106 PBMCs and no prior virological failure (VF). The primary endpoint (non-inferiority margin 12%) was the percentage of participants with a plasma viral load (pVL) <50\,copies/mL in ITT (Snapshot approach) and PP analyses at Week 48 (W48). Results Of the 326 participants screened, 223 (68%) were randomized to the tenofovir disoproxil fumarate/emtricitabine arm (n\,=\,113) or control arm (n\,=\,110). At W48, the tenofovir disoproxil fumarate/emtricitabine and control arms maintained a pVL\,<\,50\,copies/mL in 100/113 (88.5%) and 100/110 (90.9%) participants, respectively (ITT difference 2.4%, 95% CI \textendash 5.9 to 10.7; PP difference 3.4%, 95% CI \textendash 4.2 to 11.0). Six VFs occurred in the tenofovir disoproxil fumarate/emtricitabine arm (two with emerging mutations M184V and K65R) versus two in the control arm (ITT difference 3.5%, 95% CI \textendash 1.9 to 9.4). All VFs were resuppressed after treatment modification. Conclusions Although non-inferiority was shown, simplification to tenofovir disoproxil fumarate/emtricitabine should not be used for most PLHIV because of a low risk of VF with resistance.

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