The protease inhibitor (PI) darunavir (Prezista) was first approved in the U.S. in 2006, and it is often boosted with ritonavir (Norvir) or cobicistat (Tybost) to maximize its effect. Now, the drug is being investigated as a coformulated, single-tablet combination alongside cobicistat, emtricitabine (FTC, Emtriva) and tenofovir alafenamide (TAF, Vemlidy), and known by the abbreviation D/C/F/TAF. In the Phase III EMERALD trial, from which the latest data were presented on Oct. 6 by Joseph Eron, M.D., a professor of medicine at the University of North Carolina School of Medicine, people who switched to D/C/F/TAF from an already-suppressive regimen consisting of emtricitabine/tenofovir disoproxil fumarate (Truvada or FTC/TDF) plus a boosted protease inhibitor had non-inferior outcomes at week 48.
The primary objective of the trial was to gauge the non-inferiority of D/C/F/TAF versus a control regimen by measuring the proportion of patients experiencing virologic rebound. Eron noted that one interesting feature of the study design was that patients with prior virologic failure were permitted in the study, which creates a more real-world setting -- a design approach that he said is different than previous studies. Overall, 1,141 people were randomized; of those, 18% were women, 76% were white and 15% had failed a prior non-darunavir-based regimen. Participants switched to D/C/F/TAF saw high rates of suppression (95%), no drug resistance and better bone and renal outcomes.
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