Bernal Enrique, Martínez-Rodríguez Rodrigo, Gómez José Miguel, Tomás Cristina, García-Villalba Eva, Valero Salvador, Muñoz Ángeles, Alcaraz Antonia, Díez Cristina, García-Fraile Lucio J, Gómez-García Teresa, Navarro-Marcotegui María, Alemán-Valls María Remedios, Olalla Julián, Masiá Mar, Gutiérrez Félix
Unidad de Enfermedades Infecciosas, Hospital General Universitario Reina Sofía.
Instituto Murciano de Investigación Biosanitaria Pascual Parrilla.
AIDS. 2025 Sep 1;39(11):1545-1557. doi: 10.1097/QAD.0000000000004248. Epub 2025 Jun 2.
The main objective of antiretroviral therapy (ART) for people with HIV (PWH) is to maintain an undetectable viral load. This study evaluates the association between low-level viremia (LLV) (50-200 copies/ml) and virological failure, AIDS, and severe non-AIDS events, as well as the impact of sociodemographic and clinical factors.
Data were collected from the Spanish HIV/AIDS research network (CoRIS), comprising ART-naive adults recruited from 47 centers across Spain. Eligible participants were those who achieved viral suppression (viral load <200 copies/ml) within 3-9 months post-ART initiation and had follow-up data. Participants were classified into two groups: No-LLV (viral load ≤50 copcies/ml or a single measurement >51 but <1000 copies/ml) and LLV1 (51-199 copies/ml in two consecutive measurements). The outcomes included virological failure, AIDS, and severe non-AIDS events (NAE). Statistical analyses involved Competing risk analysis and multinomial logistic regression.
Of 12 110 participants, 89.7% were No-LLV and 10.3% LLV1. LLV groups had higher median age and lower CD4 + counts. Virological failure occurred in 12.3% of LLV1 compared to 4.68% in the No-LLV group ( P < 0.001). In the competitive risk analysis, the hazard ratio for virological failure of LLV1 was 1.39 [97.5% confidence interval (CI) 1.28-1.53, P < 0.0001], ART from 2016 to 2021 was 0.70 (97.5% CI 0.64-0.77, P < 0.001), ART with protease inhibitor was 1.09 (97.5% CI 1.01-1.19, P < 0.001), HIV viral load at least 100 000 copies/ml 1.17 (97.5% CI, 1.01-1.35; P = 0.036) and CD4 + cell count greater than 200 cells/μl was 0.73 (97.5% CI 0.61-0.87, P < 0.001). LLV1 were not associated with an increased risk of AIDS, mortality or NAE.
LLV (50-200 copies/ml) was associated with an increased risk of virological failure. However, it was not linked to a higher likelihood of clinical events (AIDS-related, non-AIDS-related, or death). Therefore, while close monitoring is necessary due to the risk of virological failure, these findings provide reassurance as LLV does not translate into adverse clinical outcomes.
对感染人类免疫缺陷病毒（HIV）的患者（PWH）进行抗逆转录病毒治疗（ART）的主要目标是维持病毒载量检测不到。本研究评估低水平病毒血症（LLV）（50 - 200拷贝/毫升）与病毒学失败、获得性免疫缺陷综合征（AIDS）和严重非AIDS事件之间的关联，以及社会人口统计学和临床因素的影响。
数据收集自西班牙HIV/AIDS研究网络（CoRIS），该网络包含从西班牙47个中心招募的初治成人。符合条件的参与者是那些在ART启动后3 - 9个月内实现病毒抑制（病毒载量<200拷贝/毫升）且有随访数据的人。参与者被分为两组：无LLV组（病毒载量≤50拷贝/毫升或单次测量>51但<1000拷贝/毫升）和LLV1组（连续两次测量为51 - 199拷贝/毫升）。结局包括病毒学失败、AIDS和严重非AIDS事件（NAE）。统计分析采用竞争风险分析和多项逻辑回归。
在12110名参与者中，89.7%为无LLV组，10.3%为LLV1组。LLV组的年龄中位数较高，CD4 +细胞计数较低。LLV1组的病毒学失败发生率为12.3%，而无LLV组为4.68%（P<0.001）。在竞争风险分析中，LLV1组病毒学失败的风险比为1.39 [97.5%置信区间（CI）1.28 - 1.53，P<0.0001]，2016年至2021年的ART为0.70（97.5% CI 0.64 - 0.77，P<0.001），使用蛋白酶抑制剂的ART为1.09（97.5% CI 1.01 - 1.19，P<0.001），HIV病毒载量至少100000拷贝/毫升为1.17（97.5% CI，1.01 - 1.35；P = 0.036），CD4 +细胞计数大于200个/微升为0.73（97.5% CI 0.61 - 0.87，P<0.001）。LLV1与AIDS、死亡率或NAE风险增加无关。
LLV（50 - 200拷贝/毫升）与病毒学失败风险增加相关。然而，它与临床事件（AIDS相关、非AIDS相关或死亡）的较高可能性无关。因此，虽然由于病毒学失败风险需要密切监测，但这些发现令人安心，因为LLV不会转化为不良临床结局。
