Distinct Lipid-Lowering Kinetics Following Single-Pill Rosuvastatin/Ezetimibe in People Living with HIV: A Comparative Study with HIV-Negative Controls

Abstract

Background: People living with HIV (PLWH) have increased cardiovascular disease (CVD) risk, and dyslipidemia remains a major modifiable factor. Achieving recommended low-density lipoprotein cholesterol (LDL-C) targets can be challenging. Objective: To evaluate the real-world effectiveness and safety of fixed-dose low-dose rosuvastatin/ezetimibe in virologically stable PLWH and explore lipid-lowering kinetics versus an unmatched HIV-negative control cohort. Methods: This retrospective single-center study included 32 PLWH and 43 HIV-negative outpatients receiving rosuvastatin 5 mg plus ezetimibe 10 mg daily. Lipid parameters, CVD risk scores, and safety markers were assessed at baseline, 3 months, and 6 months. Results: In PLWH, LDL-C decreased from 170.7 ± 35.1 to 87.8 ± 24.6 mg/dL at 6 months (p<0.001), and 53.1% reached guideline-recommended LDL targets. CVD risk scores improved and correlated with LDL-C reduction (D:A:D, r=0.74). Mixed-design ANOVA showed significant group×time interactions for total, LDL, and non-HDL cholesterol: controls achieved most lipid reduction by 3 months, whereas PLWH showed a more progressive decline through 6 months. No treatment-limiting adverse events or viro-immunological deterioration occurred. Conclusions: Fixed-dose rosuvastatin/ezetimibe was effective and well tolerated in PLWH. The exploratory comparison suggests distinct lipid-lowering kinetics in PLWH versus HIV-negative controls; demographic differences between cohorts warrant cautious interpretation.

Keywords: HIV; Dyslipidemia; Rosuvastatin; Ezetimibe; LDL cholesterol; Cardiovascular risk

List of Abbreviations: PLWH: People living with HIV; CVD: cardiovascular disease; cART: combination antiretroviral therapy; LDL: low-density lipoprotein cholesterol; DAD: Data Collection on Adverse events of Anti-HIV Drugs; SCORE2: Systematic COronary Risk Evaluation 2; HDL: High-Density Lipoprotein; EACS: European AIDS Clinical Society; ESC: European Society of Cardiology; AST: aspartate aminotransferase; ALT: alanine aminotransferase; CK: creatine kinase; CRP: C-reactive protein; BUN: blood urea nitrogen; γGT: gamma glutamyl transpeptidase, LDH: dehydrogenated lactate, SD: standard deviation; INSTI: Integrase Strand Transfer Inhibitors; BMI: body mass index; STR: single-tablet regimen.