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- Titel:
Switching to a NRTI-free 2 drug regimen (2DR) -a sub-analysis of the 48 weeks DUALIS study on metabolic and renal changes.
- Dokumenttyp:
- Article
- Autor(en):
- Monin, Malte; Kuemmerle, Tim; Schneider, Jochen; Cordes, Christiane; Heiken, Hans; Stellbrink, Hans-Juergen; Krznaric, Ivanka; Scholten, Stefan; Jensen, Bjoern; Jessen, Heiko; Obst, Wilfried; Spornraft-Ragaller, Petra; Khaykin, Pavel; Balogh, Annamaria; Wolf, Eva; Bidner, Helen; Spinner, Christoph D.; Boesecke, Christoph
- 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/1.73m2 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.
- Zeitschriftentitel:
- HIV Res. Clin. Pract.
- Jahr:
- 2022
- Band / Volume:
- 23
- Heft / Issue:
- 1
- Seitenangaben Beitrag:
- 15-21
- Volltext / DOI:
- doi:10.1080/25787489.2021.2022825
- PubMed:
- http://view.ncbi.nlm.nih.gov/pubmed/35234092
- Print-ISSN:
- 2578-7489
- TUM Einrichtung:
- Klinik und Poliklinik für Innere Medizin II, Gastroenterologie; Kliniken und Institute
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