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. 2025 Jul 1;80(7):1849-1859.
doi: 10.1093/jac/dkaf137.

Selected comorbidities and the probability of ART switch in PWH with undetectable HIV-RNA: a retrospective analysis in Italy

Alessandro Cozzi-Lepri  1 , Alessandro Tavelli  2   3 , Lucia Taramasso  4 , Giuseppe Lapadula  5   6 , Nicoletta Bobbio  7 , Stefania Piconi  8 , Giovanni Guaraldi  9 , Antonio Di Biagio  4 , Antonella Castagna  10 , Valentina Mazzotta  11 , Antonella d'Arminio Monforte  2 ; Icona Foundation Study group
Collaborators, Affiliations

Selected comorbidities and the probability of ART switch in PWH with undetectable HIV-RNA: a retrospective analysis in Italy

Alessandro Cozzi-Lepri et al. J Antimicrob Chemother. .

Abstract

Objectives: To estimate the incidence of comorbidities in persons with HIV (PWH) with a stable viral load (VL) of ≤50 copies/mL and evaluate the likelihood of treatment switch (TS) according to the new development of dyslipidaemia (DP), kidney disease and a weight change that determined overweight.

Methods: We carried out six case-control studies nested within the Icona Foundation Study cohort with the outcome of TS of the current regimen (due to intolerance/toxicity or simplification) and investigated the incident comorbidities. Conditional logistic regression models were employed.

Results: Overall, the median age of study participants was 45 years (IQR: 36-52), 19% were female, 48% were MSM and 17% were migrants. DP was confirmed to be the most frequent incident comorbidity [138 events; incidence rate (IR) = 28.4%; 95% CI: 22.7%-34%], followed by estimated glomerular filtration rate (eGFR) deterioration and BMI elevation. None of the studied factors was associated with the risk of TS because of simplification. TS because of toxicity was predicted by incident DP [adjusted OR (aOR) = 2.49, 95% CI: 1.19-5.19, P = 0.02] and by a decline in eGFR of >10 mL/min/1.73 m2 (aOR = 1.51, 95% CI: 0.98-2.32, P = 0.06). The association with DP was stronger in participants who were receiving a boosted PI-based regimen at baseline (aOR = 3.38, 95% CI: 1.11-10.30, P = 0.03). Therapy discontinuation because of toxicity/simplification has remained common in PWH with VL of ≤50 copies/mL in recent years.

Conclusions: The onset of DP and a decline in eGFR was associated with discontinuations due to toxicity. Interventions aiming to mitigate the risk of developing lipid abnormalities in PWH are likely to also reduce the number of ART changes, which can potentially affect future drug options.

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Figures

Figure 1.
Figure 1.
Study population and analysis design.
Figure 2.
Figure 2.
Distribution of the main reasons for modification due to toxicity/intolerance (eGFR exposure study).
Figure 3.
Figure 3.
Class of the anchor drug used at baseline and after ART modification (only cases after eGFR decline).
See this image and copyright information in PMC

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