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Low-level viremia linked to virological failure but not clinical events
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Download the PDF here
Download the PDF here
Bernal, Enriquea,b,c; Martínez-Rodríguez, Rodrigoa,b,c; Gómez, José Miguela,b,c; Tomás, Cristinaa,b,c; García-Villalba, Evaa,b,c; Valero, Salvadora,b,c; Muñoz, Ángelesa,b,c; Alcaraz, Antoniaa,b,c; Díez, Cristinad,e,f; García-Fraile, Lucio J.f,g; Gómez-García, Teresaf,h; Navarro-Marcotegui, Maríai; Alemán-Valls, María Remediosj; Olalla, Juliánk; Masiá, Marl; Gutiérrez, Félixl; and Cohort of the Spanish HIV/AIDS Research Network (CoRIS)
AIDS Sept 1 2025
Abstract
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.
Non-AIDS events
During follow-up, 769 individuals (6.19%) experienced NAE. 4.1% (n = 52; N = 1248) of individuals in the LLV1 group experienced a non-AIDS event compared to 6.7% (n = 717; N = 10,862) in the No-LLV group. Although there was a higher tendency to present NAE in the LLV groups, no significant differences were found in the analyses performed (Tables 3 and Fig. 1C).
In the competitive risk analysis (Table 3), LLV was not associated with NAE. However, it was observed that more recent initiation of ART (HR 0.79; 97.5% CI: 0.74-0.85; P < 0.001) and CD4+ cell counts at least 200 cells/mL (HR: 0.53; 97.5% CI: 0.46-0.61; P < 0.001) were significantly associated with a reduced risk of NAE.
In the No-LLV group (Table 1S, https://links.lww.com/QAD/D581, results not shown), the probability of experiencing a non-AIDS event rises from 0 to 14.28% at 15 years and in the LLV1 group, the risk increases to 16.4%. The probability of death without a non-AIDS event remains constant for all groups, at 1.41% for no LLV and 2.64% for LLV1. There were no statistically significant differences in the increase of NAE between individuals without LLV and those with LLV1 (P = 0.55) (Fig. 1c).
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.
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