Purpose of review: Published articles from 1997 through May 2010 that reported findings on the relationship of soluble biomarkers with clinical outcomes among people infected with HIV were identified, and studies that examined the incremental value (over that of CD4+ cell count and HIV RNA level) that biomarkers had for predicting clinical outcomes were summarized.
Recent findings: Over 1500 articles were identified on MEDLINE databases that met selected medical subject heading terms. Thirty-eight met criteria for inclusion in the review. Fifteen of the articles were published since 2008. Most evaluated biomarkers reflecting inflammation and immune activation. For 25 studies, the relationship between the biomarker and all-cause mortality was evaluated. Samples stored in specimen repositories were used for many studies, and those that did not usually focused on biomarkers that are measured as part of routine care. Eight of the reports utilized a case–control design and most of these were nested within a cohort study or a clinical trial.
Summary: Establishing the relationship between a biomarker and a clinical outcome is an important step in biomarker evaluation. To advance research on biomarkers relevant to people with HIV, large studies with long follow-up, carefully documented clinical events, and specimen repositories will be needed.