Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) is the only darunavir and F/TAF-containing single-tablet regimen in development for the treatment of patients with HIV-1 infection. EMERALD evaluated the efficacy and safety of switching to D/C/F/TAF 800/150/200/10 mg versus continuing use of a boosted protease inhibitor+emtricitabine/tenofovir disoproxil fumarate (control). We report Week 48 results in subgroups based on age, gender, and race.
EMERALD is a phase 3, randomized (2:1), non-inferiority trial of treatment experienced, virologically suppressed HIV-1–infected adults (viral load [VL] <50 copies [c]/mL for ≥2 months; 1 VL ≥50 and <200 c/mL allowed in 12 months before screening; previous non-darunavir virologic failure [VF] allowed). The primary endpoint was proportion of patients with virologic rebound (confirmed VL ≥50 c/mL or premature discontinuation with last VL ≥50 c/mL) cumulative through Week 48. Virologic response was defined as VL <50 c/mL (FDA snapshot). Safety was assessed by adverse events (AEs) and changes in bone mineral density and eGFR from baseline to Week 48. Results were evaluated in subgroups by age (≤50 vs >50 y), gender, and race (non-black/African American [AA] vs black/AA).
Of the 1141 patients randomized and treated, 382 (33.5%) were >50 y, 205 (18.0%) women, and 237 (20.8%) black/AA. Overall, virologic rebound rates were similar in the D/C/F/TAF and control arms (2.5% vs 2.1%); results were consistent across age, gender, and race subgroups (Table). Virologic response rates were similar for D/C/F/TAF (94.9%) and control (93.7%) in the total population and consistent across subgroups. No resistance to study drugs was observed. Overall rates of adverse events (AEs) and discontinuations due to an AE were generally similar for D/C/F/TAF and control, with no significant differences across subgroups. Consistent with the total population, improved bone safety (bone loss/atrophy AEs related to study drug; bone mineral density) and renal function (eGFR [serum cystatin C]) were seen with D/C/F/TAF versus control across subgroups.
In HIV-1–infected adults, switching to D/C/F/TAF led to low rates of cumulative virologic rebound over 48 weeks that was overall non-inferior to continuation of prior antiretroviral therapy. Low rebound rates, as well as improved bone safety and renal function, were observed with D/C/F/TAF versus control regardless of age, gender, or race.