Table 2.

Summary of studies that evaluated efficacy and tolerability of DRV/c

Study	N	Treatment	Results
COBI-boosted DRV in HIV-infected adults: week 48 results of a Phase IIIb, open-label, single-arm study39	Total =313 patients Treatment-naïve =295 (94%)	DRV/c 800/150 (single tablet) once daily in combination with NRTIs; TDF/FTC (96%)	Rate of grade 3 or 4 adverse events was 8% Virologic response by snapshot analysis (HIV RNA <50 copies/mL) was 83% in treatment-naïve patients One subject had virologic failure with DRV RAM Pharmacokinetics of DRV/c was comparable to DRV/ritonavir
DRV/c/FTC/TAF in STR formulation vs DRV boosted by COBI and FTC/TDF (fixed-dose combination) in HIV-infected treatment-naïve adults Double-blind, placebo-controlled trial41	N=153 patients	DRV/c/FTC/TAF, N=103 DRV boosted by COBI and FTC/TDF, N=50	At week 48, 76.7% randomized to TAF and 84.0% randomized to TDF had HIV RNA <50 copies/mL (FDA snapshot analysis), a nonsignificant difference (weighted difference: −6.2%; 95% confidence interval, −19.9% to 7.4%; P=0.35) Less unfavorable effects on bone density and proximal tubulopathy

Abbreviations: DRV/c, DRV-boosted COBI; COBI, cobicistat; DRV, darunavir; NRTIs, nucleoside/nucleotide reverse transcriptase inhibitors; TDF, tenofovir disoproxil fumarate; FTC, emtricitabine; TAF, tenofovir alfenamide; FDA, Food and Drug Administration; RAM, resistance-associated mutation; STR, single tablet regimen.