Switching to a NRTI-free 2 drug regimen (2DR) –a sub-analysis of the 48 weeks DUALIS study on metabolic and renal changes. Issue 1 (23rd December 2021)

• Record Type: Journal Article
• Authors: Monin, Malte; Kümmerle, Tim; Schneider, Jochen; Cordes, Christiane; Heiken, Hans; Stellbrink, Hans-Jürgen; Krznaric, Ivanka; Scholten, Stefan; Jensen, Björn; Jessen, Heiko; Obst, Wilfried; Spornraft-Ragaller, Petra; Khaykin, Pavel; Balogh, Annamaria; Wolf, Eva; Bidner, Helen; Spinner, Christoph D.; Boesecke, Christoph
• Is Part Of: HIV research & clinical practice. Volume 23:Issue 1(2022)
• Page Start: 15
• Page End: 21
• Publication Date: 2021-12-23
• Subjects: Dolutegravir -- darunavir -- HIV -- lipid metabolism -- NRTI-sparing -- kidney function test -- switch; HIV Infections -- therapy; Acquired Immunodeficiency Syndrome -- therapy; Clinical Trials as Topic; Clinical Medicine; AIDS (Disease) -- Treatment -- Periodicals; AIDS (Disease) -- Treatment; Periodicals; Periodical; 616.9792
• DOI: Https://www.tandfonline.com/doi/10.1080/25787489.2021.2022825
• Languages: English
• ISSNs: 2578-7489

Abstract

Abstract: Background/Aims: Switching from a three-drug regimen (3DR: boosted darunavir [bDRV] and two nucleoside reverse transcriptase inhibitors [NRTIs]) to a two-drug regimen (2DR: bDRV and dolutegravir [DTG]) demonstrated non-inferiority with regard to viral suppression in people living with HIV (PLWH) in the DUALIS study. This sub-analysis focuses on changes in metabolic and renal parameters when sparing the NRTI backbone. Methods: DUALIS was a randomized, open-label, multicenter (27) phase 3-trial. Participants were virologically suppressed (HIV-RNA < 50 copies/mL) on 3DR for at least 24 weeks. Subjects were either switched to DTG 50 mg + bDRV 800 mg (with ritonavir 100 mg) (2DR) or continued their regimen consisting of two NRTIs in combination with ritonavir-bDRV (3DR) once daily. Data of metabolic and renal parameters at baseline and week 48 were compared. Results: The LDL-fraction increased by + 13.3 (−3.0 to +31.3) mg/dL on 2DRs and was stable (−14.0 to +18.0 mg/dL) on 3DRs ( p < 0.0010). PLWH gained +2.0 (−0.2 to +4.0) kg and +0.2 (−1.9 to +2.1) kg in body weight on 2DRs and 3DRs, respectively 3 ( p = 0.0006). The MDRD eGFR decreased by −7, 8 (−17.4 to −0.3) mL/min/1.73m 2 and 0.4 (−8.8 to +5.7) mL/min/1.73m 2 on 2DRs and 3DRs, respectively ( p = 0.0002), while serum levels of cystatin C were stable in both arms (2DR: −0.1 to +0.1 mg/L; 3DR: 0.0 to +0.1 mg/L). Conclusions: While being non-inferior in terms of viral suppression, sparing the NRTI backbone showed a non-favorable profile in metabolic or renal parameters over 48 weeks.