Diagnostic Accuracy of HLA-B*57:01 Screening for The Prediction of Abacavir Hypersensitivity and Clinical Utility of the Test: A Meta-Analytic Review

Abstract

Aim: To determine diagnostic accuracy of HLA-B*57:01 testing for prediction of abacavir-induced hypersensitivity and to quantify the clinical benefit of pretreatment screening through a meta-analytic review of published studies. Methods: A comprehensive search was performed up to June 2013. The methodological quality of relevant studies was assessed by the QUADAS-2 tool. The pooled diagnostic estimates were calculated using a random effect model. Results: Despite the presence of heterogeneity in sensitivity or specificity estimates, the pooled diagnostic odds ratio to detect abacavir-induced hypersensitivity on the basis of clinical criteria was 33.07 (95% CI: 22.33–48.97, I²: 13.9%), while diagnostic odds ratio for detection of immunologically confirmed abacavir hypersensitivity was 1141 (95% CI: 409–3181, I²: 0%). Pooled analysis of risk ratio showed that prospective HLA-B*57:01 testing significantly reduced the incidence of abacavir-induced hypersensitivity. Conclusion: This meta-analysis demonstrates an excellent diagnostic accuracy of HLA-B*57:01 testing to detect immunologically confirmed abacavir hypersensitivity and corroborates existing recommendations.

Original submitted 29 January 2014; Revision submitted 13 March 2014

Keywords::

• abacavir hypersensitivity
• clinical utility
• diagnostic accuracy
• HLA-B*57:01
• meta-analysis

Acknowledgements

The authors acknowledge B Gallo and M Bassotto for their invaluable bibliographic support.

Financial & competing interests disclosure

S Cargnin holds a PhD fellowship supported by the Compagnia di San Paolo. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.

Additional information

Funding

S Cargnin holds a PhD fellowship supported by the Compagnia di San Paolo. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript