Toward Evidence-based Recommendations for Laboratory Monitoring for Adolescents and Adults on Antiretroviral Therapy

We reviewed prominent national and international guidelines to compare recommendations for laboratory monitoring for persons on antiretroviral therapy. The United States Department of Health and Human Services guidelines recommend more frequent CD4 count, viral load, hematologic, renal, and liver tests than other guidelines. To evaluate the evidence base for these recommendations, we reviewed phase 3 trials of currently recommended antiretroviral regimens and large cohort studies. Cohort studies have consistently shown that persons with sustained viral suppression have stable or increasing CD cell counts, so it is not clear how continued CD4 count monitoring contributes to clinical care. Long-term safety data from trials and observational cohorts show little evidence to support hematologic, hepatic, or renal monitoring (apart from persons on tenofovir disoproxil fumarate). It is time to use the available data from clinical trials and cohort studies to develop evidence-based recommendations for laboratory monitoring tests for persons with viral suppression.