Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in Adults With HIV and M184V/I Mutation

Background The ability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) to maintain virologic suppression in participants with M184V and/or M184I resistance mutations from historical genotypic reports when switching from a tenofovir disoproxil fumarate (TDF)- or abacavir (ABC)-based regimen was investigated. Setting Phase IIIb, 48-week, open-label, single-arm, multicenter clinical trial (NCT02616029). Methods Virologically suppressed adults with HIV and documented M184V/I on historical genotypic records switched to E/C/F/TAF from a TDF- or ABC-based regimen. The primary endpoint was HIV-1 RNA Results M184V alone was reported in 82.8% of 64 participants; 9.4% and 7.8% had M184I and M184V/I, respectively, and 43.8% had archived M184V/I (baseline DNA). All (62/62 with available data, 100%, 95% confidence interval 94.2-100%) participants maintained PVR at weeks 12, 24, and 48. By FDA snapshot algorithm, one participant had HIV-1 RNA ≥50 copies/mL (week 12); confirmatory HIV-1 RNA was Conclusions The presence of the resistance mutations M184V/I did not jeopardize the efficacy of switching to E/C/F/TAF in virologically suppressed adults. High rates of virologic suppression were maintained throughout 48 weeks of therapy and treatment was well tolerated.