Enrique Bernal, Rodrigo Martínez-Rodríguez, José Miguel Gómez, Cristina Tomás, Eva García-Villalba, Salvador Valero, Ángeles Muñoz, Antonia Alcaraz, Cristina Díez, Lucio J García-Fraile, Teresa Gómez-García, María Navarro-Marcotegui, María Remedios Alemán-Valls, Julián Olalla, Mar Masiá, Félix Gutiérrez
{"title":"低水平病毒血症与病毒学失败有关，但与临床事件无关：一项竞争风险研究。","authors":"Enrique Bernal, Rodrigo Martínez-Rodríguez, José Miguel Gómez, Cristina Tomás, Eva García-Villalba, Salvador Valero, Ángeles Muñoz, Antonia Alcaraz, Cristina Díez, Lucio J García-Fraile, Teresa Gómez-García, María Navarro-Marcotegui, María Remedios Alemán-Valls, Julián Olalla, Mar Masiá, Félix Gutiérrez","doi":"10.1097/QAD.0000000000004248","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Materials and methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":7502,"journal":{"name":"AIDS","volume":" ","pages":"1545-1557"},"PeriodicalIF":3.1000,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Low-level viremia linked to virological failure but not clinical events.\",\"authors\":\"Enrique Bernal, Rodrigo Martínez-Rodríguez, José Miguel Gómez, Cristina Tomás, Eva García-Villalba, Salvador Valero, Ángeles Muñoz, Antonia Alcaraz, Cristina Díez, Lucio J García-Fraile, Teresa Gómez-García, María Navarro-Marcotegui, María Remedios Alemán-Valls, Julián Olalla, Mar Masiá, Félix Gutiérrez\",\"doi\":\"10.1097/QAD.0000000000004248\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>The main objective of antiretroviral therapy (ART) for people with HIV (PWH) is to maintain an undetectable viral load. 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Statistical analyses involved Competing risk analysis and multinomial logistic regression.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>LLV (50-200 copies/ml) was associated with an increased risk of virological failure. 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引用次数: 0
摘要
对艾滋病毒感染者进行抗逆转录病毒治疗的主要目的是维持无法检测到的病毒载量。本研究评估了低水平病毒血症（50-200拷贝/mL）与病毒学失败、艾滋病和严重非艾滋病事件之间的关系，以及社会人口统计学和临床因素的影响。材料和方法：数据来自西班牙艾滋病毒/艾滋病研究网络（CoRIS），包括从西班牙47个中心招募的ART-naïve成年人。符合条件的参与者是那些达到病毒抑制（VL 51）的人，但结果：在12,110名参与者中，89.7%为No-LLV， 10.3%为LLV1。LLV组的中位年龄较高，CD4+计数较低。VF发生在12.3%的llv组，而无llv组为4.68% （p200细胞/ml为0.73 (97.5% CI 0.61-0.87)）。p结论：低水平病毒血症（50-200拷贝/ml）与病毒学失败风险增加相关。然而，它与更高的临床事件（艾滋病相关、非艾滋病相关或死亡）可能性无关。因此，虽然由于病毒学失败的风险，密切监测是必要的，但这些发现提供了保证，因为LLV不会转化为不良的临床结果。
Low-level viremia linked to virological failure but not clinical events.
Introduction: 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.
Materials and methods: 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.
Results: 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.
Conclusion: 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.
期刊介绍：
Publishing the very latest ground breaking research on HIV and AIDS. Read by all the top clinicians and researchers, AIDS has the highest impact of all AIDS-related journals. With 18 issues per year, AIDS guarantees the authoritative presentation of significant advances. The Editors, themselves noted international experts who know the demands of your work, are committed to making AIDS the most distinguished and innovative journal in the field. Submitted articles undergo a preliminary review by the editor. Some articles may be returned to authors without further consideration. Those being considered for publication will undergo further assessment and peer-review by the editors and those invited to do so from a reviewer pool.
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