RESUMO
BACKGROUND: Dolutegravir (DTG) and boosted darunavir (bDRV) are potent antiretrovirals with a high resistance barrier and might be valuable switch options for people with HIV (PWH). METHODS: DUALIS, a randomized, open-label, phase 3b, noninferiority clinical trial, compared the switch to DTGâ +â bDRV (2DR) with continuation of 2 nucleoside reverse transcriptase inhibitors (2NRTI)â +â bDRV (3DR). PWH with HIV RNAâ <50 copies/mL taking 2NRTIâ +â bDRV (3DR) forâ ≥24 weeks (1 accepted blipâ <200 copies/mL) were randomized to either switch to DTG 50 mgâ +â DRV 800 mg (boosted with 100 mg of ritonavir) or continue taking 3DR. The primary end point (PE) was the proportion of HIV RNAâ <50 copies/mL at week (W) 48. Change in NRTI backbone was not classified as failure. The estimated sample size for PE analysis was 292; the noninferiority margin wasâ ≤-10.0%. RESULTS: In total, 263 subjects were randomized and treated (2DR nâ =â 131, 3DR nâ =â 132; 90.1% male; 89.7% Caucasian; median age [interquartile range], 48 [39-54] years). At W48, 86.3% (nâ =â 113/131) of the 2DR subject and 87.9% (nâ =â 116/132) of the 3DR subjects had HIV RNAâ <50 copies/mL; the difference between arms was -1.6% (95.48% CI, based on the adjusted alpha level accounting for the interim analysis at W24, -9.9% to +6.7%; discontinuations due to adverse events: 2DR, 4.6% [nâ =â 6]; 3DR, 0.8% [nâ =â 1]). Kaplan-Meier estimates of confirmed HIV RNAâ ≥50 copies/mL at W48 were 1.6% (nâ =â 2) in the 2DR and 3.1% (nâ =â 4) in the 3DR group. Development of treatment-emergent resistance was not observed. CONCLUSIONS: Switching to DTGâ +â bDRV was noninferior to continuing 3DR in subjects already treated with bDRV.