Objective:

The aim of the trial was to evaluate in patients under antiretroviral therapy (ART) the effect of rosuvastatin on cellular and soluble markers of immune activation/inflammation, as well as to identify patients who better benefit from statin administration.

Methods:

IMEA-043-CESAR was a phase II open-label pilot trial that enrolled patients under suppressive ART and CD4< 500/mm 3. Patients received rosuvastatin (20 mg/d) for 12 weeks. The primary outcome was the variation at week 12 (W12) in the proportion of CD38+ HLA-DR+ CD8+ T lymphocytes. Secondary outcomes included evolution of other markers of T-cell activation and of inflammatory biomarkers between baseline, W12, and W24.

Results:

Fifty patients were enrolled; end points were available for 43 patients. When considering all patients, the proportion of CD38+ HLA-DR+ CD8+ T cells did not significantly decline throughout the follow-up. However, the proportion of CD38+ CD8+ T cells significantly decreased at W12 [median percentage change of− 22.2%(− 32.3;+ 1.4)]. Principal component analysis allowed identification of 3 groups of patients based on their baseline activation/inflammation profiles, 1 group with elevated levels of CD8 T-cell activation, and a small group with high levels of systemic inflammation and low levels of T-cell activation. Half of the patients exhibited relatively low levels of inflammation and activation. The proportion of activated CD8 T cells significantly decreased only in the particular group of patients with high baseline CD8 T-cell activation.

Conclusions:

This study shows that combining rosuvastatin with effective ART can result in a sustained decrease in CD8 T-cell activation and highlights the importance of identifying patients who can benefit from specific immunotherapeutic strategies.