Spinner, Christoph D., Kummerle, Tim, Schneider, Jochen, Cordes, Christiane, Heiken, Hans, Stellbrink, Hans-Jurgen, Krznaric, Ivanka, Scholten, Stephan, Jensen, Bjorn, Wyen, Christoph, Viehweger, Marin, Lehmann, Clara, Sprinzl, Martin, Stoehr, Albrecht, Bickel, Markus, Jessen, Heiko, Obst, Wilfried, Spornraft-Ragaller, Petra, Khaykin, Pavel, Wolf, Eva and Boesecke, Christoph (2020). 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. Open Forum Infect. Dis., 7 (9). CARY: OXFORD UNIV PRESS INC. ISSN 2328-8957

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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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Spinner, Christoph D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kummerle, TimUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schneider, JochenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cordes, ChristianeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Heiken, HansUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stellbrink, Hans-JurgenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Krznaric, IvankaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Scholten, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jensen, BjornUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wyen, ChristophUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Viehweger, MarinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lehmann, ClaraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sprinzl, MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stoehr, AlbrechtUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bickel, MarkusUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jessen, HeikoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Obst, WilfriedUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Spornraft-Ragaller, PetraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Khaykin, PavelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wolf, EvaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Boesecke, ChristophUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-320032
DOI: 10.1093/ofid/ofaa356
Journal or Publication Title: Open Forum Infect. Dis.
Volume: 7
Number: 9
Date: 2020
Publisher: OXFORD UNIV PRESS INC
Place of Publication: CARY
ISSN: 2328-8957
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
ANTIRETROVIRAL-NAIVE ADULTS; ONCE-DAILY DOLUTEGRAVIR; DOUBLE-BLIND; LOPINAVIR/RITONAVIR; RALTEGRAVIR; INHIBITOR; TOXICITYMultiple languages
Immunology; Infectious Diseases; MicrobiologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/32003

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