Long-term data on the efficacy and tolerability of lamivudine plus dolutegravir as a switch strategy in a multi-centre cohort of HIV-1-infected, virologically suppressed patients

被引:51
作者
Baldin, Gianmaria [1 ,2 ]
Ciccullo, Arturo [1 ]
Rusconi, Stefano [3 ]
Capetti, Amedeo [4 ]
Sterrantino, Gaetana [5 ]
Colafigli, Manuela [6 ]
d'Ettorre, Gabriella [7 ]
Giacometti, Andrea [8 ]
Cossu, Maria Vittoria [4 ]
Borghetti, Alberto [9 ]
Gennari, William [10 ]
Mussini, Cristina [11 ]
Borghi, Vanni [11 ]
Di Giambenedetto, Simona [1 ,9 ]
机构
[1] Univ Cattolica Sacro Cuore, Inst Infect Dis, Largo Francesco Vito 1, I-00168 Rome, Italy
[2] Mater Olbia Hosp, Olbia, Italy
[3] Univ Milan, DIBIC Luigi Sacco, Infect Dis Unit, Milan, Italy
[4] Luigi Sacco Univ Hosp, Dept Infect Dis, Div Infect Dis, Milan, Italy
[5] Univ Florence, Dept Clin & Expt Med, Infect Dis Unit, Florence, Italy
[6] IRCCS, IFO S Gallitano Inst, Infect Dermatol & Allergol Unit, Rome, Italy
[7] Azienda Policlin Umberto I, Dept Publ Hlth & Infect Dis, Rome, Italy
[8] Polytech Univ Marche, Dept Biomed Sci & Publ Hlth, Clin Infect Dis, Ancona, Italy
[9] Fdn Policlin Univ Agostino Gemelli IRCCS, UOC Malattie Infett, Rome, Italy
[10] Azienda Osped Univ Modena, Lab Microbiol & Virol, Modena, Italy
[11] Azienda Osped Univ Modena, Clin Malattie Infett & Trop, Modena, Italy
关键词
HIV; Two-drug regimen; ART; Simplification; Lamivudine; Dolutegravir; ANTIRETROVIRAL THERAPY; DUAL THERAPY; NON-INFERIORITY; TRIPLE THERAPY; OPEN-LABEL; SIMPLIFICATION; MAINTENANCE; EMTRICITABINE;
D O I
10.1016/j.ijantimicag.2019.09.002
中图分类号
R51 [传染病];
学科分类号
100401 ;
摘要
Background: Results from clinical trials and observational studies suggest that lamivudine plus dolute-gravir (3TC+ DTG) could be an effective and tolerated option for simplification in human immunodeficiency virus (HIV)-1-positive patients. Materials and methods: This observational study enrolled HIV-1-infected, virologically suppressed patients switching to 3TC+DTG. Kaplan-Meyer survival analysis was performed to evaluate time to virological failure (VF; defined by a single HIV-RNA determination >= 1000 copies/mL or by two consecutive HIV-RNA determinations >= 50 copies/mL) and time to treatment discontinuation (TD; defined as interruption of either 3TC or DTG), Cox regression was performed to assess predictors, and linear mixed model was performed for repeated measures to measure changes in immunological and metabolic parameters. Results: Five hundred and fifty-six patients were eligible for analysis. Their median CD4+ count at baseline was 668 cells/mm(3) and median time of virological suppression was 88 months. Estimated probabilities of maintaining virological suppression at 96 and 144 weeks of follow-up were 97.5% [standard deviation (SD) 0.8] and 96.5% (SD 1.0), respectively. Years since HIV diagnosis was the only predictor of VF. In patients with time of virological suppression <88 months, the rate of VF was higher in the presence of the M184V mutation. Estimated probabilities of remaining on 3TC+ DTG at 96 and 144 weeks of follow-up were 79.2% (SD 1.9) and 75.2% (SD 2.2), respectively. A significant increase in CD4 cell count (+ 44 cells/mm(3), P= 0.015), CD4/CD8 ratio (+ 0.10, P= 0.002) and high-density lipoprotein cholesterol (+ 5.4 mg/dL, P= 0.036) was found at 144 weeks of follow-up; meanwhile, total cholesterol (-9.1 mg/dL, P= 0.007) and triglycerides (-2.7, P=0.009) decreased significantly. Conclusions: These findings confirm the efficacy and tolerability of 3TC+ DTG in virologically suppressed patients. (C) 2019 Elsevier B.V. and International Society of Chemotherapy. All rights reserved.
引用
收藏
页码:728 / 734
页数:7
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