Switching to a NRTI-free 2 drug regimen (2DR) -a sub-analysis of the 48 weeks DUALIS study on metabolic and renal changes
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/1.73m2 and 0.4 (-8.8 to +5.7) mL/min/1.73m2 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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:23 |
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| Enthalten in: |
HIV research & clinical practice - 23(2021), 1 vom: 23. Dez., Seite 15-21 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Monin, Malte [VerfasserIn] |
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| Anmerkungen: |
Date Completed 02.05.2022 Date Revised 09.06.2022 published: Print-Electronic Citation Status MEDLINE |
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| Förderinstitution / Projekttitel: |
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NLM337653593 |
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| 100 | 1 | |a Monin, Malte |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Switching to a NRTI-free 2 drug regimen (2DR) -a sub-analysis of the 48 weeks DUALIS study on metabolic and renal changes |
| 264 | 1 | |c 2021 | |
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| 500 | |a Date Revised 09.06.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a 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/1.73m2 and 0.4 (-8.8 to +5.7) mL/min/1.73m2 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Dolutegravir | |
| 650 | 4 | |a HIV | |
| 650 | 4 | |a NRTI-sparing | |
| 650 | 4 | |a darunavir | |
| 650 | 4 | |a kidney function test | |
| 650 | 4 | |a lipid metabolism | |
| 650 | 4 | |a switch | |
| 650 | 7 | |a Anti-HIV Agents |2 NLM | |
| 650 | 7 | |a Ritonavir |2 NLM | |
| 650 | 7 | |a O3J8G9O825 |2 NLM | |
| 650 | 7 | |a Darunavir |2 NLM | |
| 650 | 7 | |a YO603Y8113 |2 NLM | |
| 700 | 1 | |a Kümmerle, Tim |e verfasserin |4 aut | |
| 700 | 1 | |a Schneider, Jochen |e verfasserin |4 aut | |
| 700 | 1 | |a Cordes, Christiane |e verfasserin |4 aut | |
| 700 | 1 | |a Heiken, Hans |e verfasserin |4 aut | |
| 700 | 1 | |a Stellbrink, Hans-Jürgen |e verfasserin |4 aut | |
| 700 | 1 | |a Krznaric, Ivanka |e verfasserin |4 aut | |
| 700 | 1 | |a Scholten, Stefan |e verfasserin |4 aut | |
| 700 | 1 | |a Jensen, Björn |e verfasserin |4 aut | |
| 700 | 1 | |a Jessen, Heiko |e verfasserin |4 aut | |
| 700 | 1 | |a Obst, Wilfried |e verfasserin |4 aut | |
| 700 | 1 | |a Spornraft-Ragaller, Petra |e verfasserin |4 aut | |
| 700 | 1 | |a Khaykin, Pavel |e verfasserin |4 aut | |
| 700 | 1 | |a Balogh, Annamaria |e verfasserin |4 aut | |
| 700 | 1 | |a Wolf, Eva |e verfasserin |4 aut | |
| 700 | 1 | |a Bidner, Helen |e verfasserin |4 aut | |
| 700 | 1 | |a Spinner, Christoph D |e verfasserin |4 aut | |
| 700 | 1 | |a Boesecke, Christoph |e verfasserin |4 aut | |
| 700 | 0 | |a DUALIS STUDY GROUP |e verfasserin |4 aut | |
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