Dataset Information

Efficacy and Safety of Switching to Dolutegravir With Boosted Darunavir in Virologically Suppressed Adults With HIV-1: A Randomized, Open-Label, Multicenter, Phase 3, Noninferiority Trial: The DUALIS Study.

ABSTRACT: 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 DTG?+?bDRV (2DR) with continuation of 2 nucleoside reverse transcriptase inhibitors (2NRTI)?+?bDRV (3DR). PWH with HIV RNA?<50 copies/mL taking 2NRTI?+?bDRV (3DR) for??24 weeks (1 accepted blip?<200 copies/mL) were randomized to either switch to DTG 50 mg?+?DRV 800 mg (boosted with 100 mg of ritonavir) or continue taking 3DR. The primary end point (PE) was the proportion of HIV RNA?<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 was??-10.0%. Results:In total, 263 subjects were randomized and treated (2DR n?=?131, 3DR n?=?132; 90.1% male; 89.7% Caucasian; median age [interquartile range], 48 [39-54] years). At W48, 86.3% (n?=?113/131) of the 2DR subject and 87.9% (n?=?116/132) of the 3DR subjects had HIV RNA?<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% [n?=?6]; 3DR, 0.8% [n?=?1]). Kaplan-Meier estimates of confirmed HIV RNA??50 copies/mL at W48 were 1.6% (n?=?2) in the 2DR and 3.1% (n?=?4) in the 3DR group. Development of treatment-emergent resistance was not observed. Conclusions:Switching to DTG?+?bDRV was noninferior to continuing 3DR in subjects already treated with bDRV.

SUBMITTER: Spinner CD

PROVIDER: S-EPMC7491710 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Efficacy and Safety of Switching to Dolutegravir With Boosted Darunavir in Virologically Suppressed Adults With HIV-1: A Randomized, Open-Label, Multicenter, Phase 3, Noninferiority Trial: The DUALIS Study.

Spinner Christoph D CD Kümmerle Tim T Schneider Jochen J Cordes Christiane C Heiken Hans H Stellbrink Hans-Jürgen HJ Krznaric Ivanka I Scholten Stephan S Jensen Björn B Wyen Christoph C Viehweger Marin M Lehmann Clara C Sprinzl Martin M Stoehr Albrecht A Bickel Markus M Jessen Heiko H Obst Wilfried W Spornraft-Ragaller Petra P Khaykin Pavel P Wolf Eva E Boesecke Christoph C

Open forum infectious diseases 20200813 9

<h4>Background</h4>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).<h4>Methods</h4>DUALIS, a randomized, open-label, phase 3b, noninferiority clinical trial, compared the switch to DTG + bDRV (2DR) with continuation of 2 nucleoside reverse transcriptase inhibitors (2NRTI) + bDRV (3DR). PWH with HIV RNA <50 copies/mL taking 2NRTI + bDRV (3DR) for ≥24 weeks (1 accepted blip <200 ...[more]

PMID: 32965277

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Dataset Information

Efficacy and Safety of Switching to Dolutegravir With Boosted Darunavir in Virologically Suppressed Adults With HIV-1: A Randomized, Open-Label, Multicenter, Phase 3, Noninferiority Trial: The DUALIS Study.

Publications

Efficacy and Safety of Switching to Dolutegravir With Boosted Darunavir in Virologically Suppressed Adults With HIV-1: A Randomized, Open-Label, Multicenter, Phase 3, Noninferiority Trial: The DUALIS Study.

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