Postorino Maria Concetta, Prosperi Mattia, Focà Emanuele, Quiros-Roldan Eugenia, Di Filippo Elisa, Maggiolo Franco, Borghetti Alberto, Ladisa Nicoletta, Di Pietro Massimo, Gori Andrea, Sighinolfi Laura, Pan Angelo, Mazzini Nicola, Torti Carlo
Infectious and Tropical Diseases Unit, Department of Medical and Surgical Sciences, University "Magna Graecia" of Catanzaro, Catanzaro, Italy.
Department of Epidemiology, College of Public Health and Health Professions & College of Medicine, University of Florida, Gainesville, USA.
BMC Infect Dis. 2017 Mar 15;17(1):212. doi: 10.1186/s12879-017-2322-z.
Atazanavir (ATV) not boosted by ritonavir (uATV) has been frequently used in the past for switching combination antiretroviral therapy (cART). However, the clinical outcomes and predictors of such strategy are unknown.
An observational study was carried out on the Italian MASTER, selecting HIV infected patients on cART switching to an uATV-containing regimen. Baseline was set as the last visit before uATV initiation. In the primary analysis, a composite clinical end-point was defined as the first occurring of any condition among: liver, cardiovascular, kidney, diabetes, non AIDS related cancer or death events. Incidence of AIDS events and incidence of composite clinical end-point were estimated. Kaplan-Meier and multivariable Cox regression analysis were used to assess predictors of the composite clinical end-point.
436 patients were observed. The majority of patients were males (61.5%) and Italians (85.3%), mean age was 42.7 years (IQR: 37.7-42), the most frequent route of transmission was heterosexual intercourse (47%), followed by injection drug use (25%) and homosexual contact (24%); the rate of HCV-Ab positivity was 16.3%. Patients were observed for a median time of 882 days (IQR: 252-1,769) under uATV. We recorded 93 clinical events (3 cardiovascular events, 20 kidney diseases, 33 liver diseases, 9 non AIDS related cancers, 21 diabetes, 7 AIDS events), and 19 deaths, accounting for an incidence of 3.7 (composite) events per 100 PYFU. At multivariable analysis, factors associated with the composite clinical end-point were intravenous drug use as risk factor for HIV acquisition vs. heterosexual intercourses [HR: 2.608, 95% CI 1.31-5.19, p = 0.0063], HIV RNA per Log copies/ml higher [HR: 1.612, 95% CI 1.278-2.034, p < 0.0001], number of switches in the nucleoside/nucleotide (NRTI) backbone of cART (performed to compose the uATV regimen under study or occurred in the past) per each more [HR: 1.085, 95% CI 1.025-1.15, p = 0.0051], Fib-4 score per unit higher [HR: 1.03, 95% CI 1.018-1.043, p < 0.0001] and Neutrophil/lymphocytes ratio (NLR inflammation score) per Log higher [HR: 1.319, 95% CI 1.047-1.662, p = 0.0188].
Intravenous drug users with high HIV RNA, high Fib-4 levels and more heavily exposed to antiretroviral drugs appeared to be more at risk of clinical events. Interestingly, high levels of inflammation measured through NLR, were also associated with clinical events. So, these patients should be monitored more strictly.
过去，未使用利托那韦增强的阿扎那韦（uATV）常用于转换联合抗逆转录病毒疗法（cART）。然而，这种策略的临床结局和预测因素尚不清楚。
在意大利的MASTER研究中开展了一项观察性研究，选取正在接受cART且转换为含uATV方案的HIV感染患者。将基线设定为开始使用uATV前的最后一次就诊。在主要分析中，复合临床终点定义为以下任何一种情况首次出现：肝脏、心血管、肾脏、糖尿病、非艾滋病相关癌症或死亡事件。估计艾滋病事件的发生率和复合临床终点的发生率。采用Kaplan-Meier法和多变量Cox回归分析来评估复合临床终点的预测因素。
观察了436例患者。大多数患者为男性（61.5%）且为意大利人（85.3%），平均年龄为42.7岁（四分位间距：37.7 - 42岁），最常见的传播途径是异性性行为（47%），其次是注射吸毒（25%）和同性接触（24%）；HCV-Ab阳性率为16.3%。在uATV治疗下，患者的中位观察时间为882天（四分位间距：252 - 1769天）。我们记录了93例临床事件（3例心血管事件、20例肾脏疾病、33例肝脏疾病、9例非艾滋病相关癌症、21例糖尿病、7例艾滋病事件）以及19例死亡，每100人年随访时间的发生率为3.7（复合）事件。在多变量分析中，与复合临床终点相关的因素包括：与异性性行为相比，静脉吸毒作为HIV感染的危险因素[风险比（HR）：2.608，95%置信区间（CI）1.31 - 5.19，p = 0.0063]、每增加1个对数拷贝/ml的HIV RNA水平更高[HR：1.612，95% CI 1.278 - 2.034，p < 0.0001]、cART的核苷/核苷酸（NRTI）骨干中的转换次数（为组成正在研究的uATV方案而进行或过去发生的）每增加1次[HR：1.085，95% CI 1.025 - 1.15，p = 0.0051]、每增加1个单位的Fib-4评分更高[HR：1.03，95% CI 1.018 - 1.043，p < 0.0001]以及每增加1个对数的中性粒细胞/淋巴细胞比值（NLR炎症评分）更高[HR：1.319，95% CI 1.047 - 1.
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