SPIRIT: switching to emtricitabine/rilpivirine/tenofovir DF single‐tablet regimen from boosted protease inhibitor maintains HIV suppression at week 48

Antiretroviral regimen simplification improves quality of life and medication adherence while reducing the risk of HIV virologic failure (VF) and long‐term drug‐related toxicities. Emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) is a well‐tolerated and efficacious once‐daily single‐tablet regimen (STR) treatment option. Here we report the Week 48 safety and efficacy results of SPIRIT, the first study to evaluate switching from boosted protease inhibitor (PI+RTV)‐based HAART to a simplified regimen of FTC/RPV/TDF STR. SPIRIT is a phase 3b, randomized, open‐label, multi‐center, international, 48‐week study to evaluate the safety and efficacy of switching from PI+RTV regimens to FTC/RPV/TDF in virologically‐suppressed HIV‐1 infected participants. Participants were randomized 2:1 to switch to FTC/RPV/TDF at baseline or maintain their current PI+RTV regimen with a delayed switch to FTC/RPV/TDF at Week 24. The primary endpoint was non‐inferiority (12% margin) of FTC/RPV/TDF relative to PI+RTV regimens in maintaining plasma HIV‐1 RNA