Inflammatory biomarkers and plasma lipidomics after raltegravir plus TDF/FTC initiation in people with HIV: A longitudinal pilot study.

Persistent inflammation and altered lipid metabolism are linked to comorbidities in people with human immunodeficiency virus (HIV), yet their progression after initiating antiretroviral therapy (ART) is not fully understood. This exploratory, uncontrolled pilot study investigated longitudinal changes in biomarkers and plasma lipidomics in 11 ART-naïve adults starting raltegravir plus tenofovir disoproxil fumarate/emtricitabine. Circulating biomarkers were measured, and untargeted plasma lipidomics was performed using ultra-high-performance liquid chromatography-mass spectrometry at baseline and at a follow-up visit near week 48 (range: 47.7-61.9 weeks). Within-participant changes were analyzed using paired Wilcoxon signed-rank tests, with Benjamini-Hochberg false discovery rate (FDR) correction applied separately to biomarker and lipidomic datasets. Paired effect sizes and 95% confidence intervals were also estimated. All participants achieved virological suppression. After FDR correction, interleukin-10 (IL-10) concentrations increased, and soluble cluster of differentiation 163 (sCD163) concentrations decreased (both q = 0.019). However, none of the 490 lipid features remained significant after FDR correction. Twenty-six features showed large absolute paired Hedges' effect-size estimates (|gz| ≥ 0.80), with 24 positive and two negative estimates. These findings demonstrate longitudinal changes in IL-10 and sCD163 following ART initiation. The lipidomic results, however, are considered hypothesis-generating. Due to the absence of a comparator group, these changes cannot be definitively attributed to the specific ART regimen. Larger, controlled studies are necessary to confirm reproducibility and clinical relevance.