Assessing Renal Outcomes After Switching from Tenofovir Disoproxil Fumarate to Tenofovir Alafenamide in People with HIV: Proteinuria Changes and Limits of Causal Attribution

Background: The total urinary protein-to-creatinine ratio (PCr) measures proteinuria but does not establish tubular injury or its recovery. Methods: We examined PCr changes after switching from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) in a single-centre retrospective cohort of 364 adults with human immunodeficiency virus (HIV) infection. Paired PCr values were available for 159 patients (43.7%). The primary descriptive endpoint was a PCr reduction below 20%, an operational, nonvalidated threshold. Analyses comprised paired rank-based comparisons, baseline-adjusted regression, threshold and influence sensitivity analyses, and nested cross-validation of ridge logistic regression using three predictor sets. Results: The median paired PCr change was −4.0 mg/g (interquartile range −41.5 to 11.5; signed-rank Benjamini–Hochberg-adjusted q = 0.0098); 99/159 patients (62.3%) had a reduction below 20%. Baseline log(1 + PCr) was positively associated with post-switch log(1 + PCr), while its coefficient in the corresponding change model was exactly one unit lower, illustrating mathematical coupling. The cross-validated area under the curve was 0.709 for baseline PCr alone, 0.475 for the other covariates, and 0.701 for all predictors. Conclusions: PCr changes were heterogeneous, and additional covariates did not improve discrimination over the baseline PCr alone. Missing outcomes, unavailable specimen dates, the absence of tubular-specific biomarkers and the uncontrolled design preclude conclusions about irreversible tubular injury, causal treatment effects or clinical prediction utility.

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Diseases
Published
2026-09-24
DOI
https://doi.org/10.3390/diseases14100353
Primary Topic
HIV/AIDS drug development and treatment
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article
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article

Assessing Renal Outcomes After Switching from Tenofovir Disoproxil Fumarate to Tenofovir Alafenamide in People with HIV: Proteinuria Changes and Limits of Causal Attribution

Marcello Trizzino, Claudia Gioè, Stefania Zerbo, Augusto Orlandi et al.
Diseases
HIV/AIDS drug development and treatment
article

Assessing Renal Outcomes After Switching from Tenofovir Disoproxil Fumarate to Tenofovir Alafenamide in People with HIV: Proteinuria Changes and Limits of Causal Attribution

Marcello Trizzino, Claudia Gioè, Stefania Zerbo, Augusto Orlandi, Antonio Cascio, Beatrice Belmonte, Antonina Argo, Tommaso D’Anna, Andrea Cicero
article en

Abstract

Background: The total urinary protein-to-creatinine ratio (PCr) measures proteinuria but does not establish tubular injury or its recovery. Methods: We examined PCr changes after switching from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) in a single-centre retrospective cohort of 364 adults with human immunodeficiency virus (HIV) infection. Paired PCr values were available for 159 patients (43.7%). The primary descriptive endpoint was a PCr reduction below 20%, an operational, nonvalidated threshold. Analyses comprised paired rank-based comparisons, baseline-adjusted regression, threshold and influence sensitivity analyses, and nested cross-validation of ridge logistic regression using three predictor sets. Results: The median paired PCr change was −4.0 mg/g (interquartile range −41.5 to 11.5; signed-rank Benjamini–Hochberg-adjusted q = 0.0098); 99/159 patients (62.3%) had a reduction below 20%. Baseline log(1 + PCr) was positively associated with post-switch log(1 + PCr), while its coefficient in the corresponding change model was exactly one unit lower, illustrating mathematical coupling. The cross-validated area under the curve was 0.709 for baseline PCr alone, 0.475 for the other covariates, and 0.701 for all predictors. Conclusions: PCr changes were heterogeneous, and additional covariates did not improve discrimination over the baseline PCr alone. Missing outcomes, unavailable specimen dates, the absence of tubular-specific biomarkers and the uncontrolled design preclude conclusions about irreversible tubular injury, causal treatment effects or clinical prediction utility.

DiseasesVol. 14(10)
University of Rome Tor Vergata (IT), Department of Health (ES), Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone" di Palermo (IT), University of Palermo (IT)
Reduced inequalities, Peace, Justice and strong institutions
Openalex Percentile: Top 12%
HIV/AIDS drug development and treatment
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