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HLA-B*5701 screening for hypersensitivity to abacavir.
Simon Mallal1, Elizabeth Phillips, Giampiero Carosi
1Royal Perth Hospital and Murdoch University, Perth, Australia. s.mallal@murdoch.edu.au
The New England Journal of Medicine
|February 8, 2008
Summary
Prospective HLA-B*5701 screening effectively prevents abacavir hypersensitivity reactions in HIV-1 patients. This pharmacogenetic approach significantly lowers the incidence of confirmed hypersensitivity reactions, demonstrating its clinical utility.
Area of Science:
- Pharmacogenetics
- Immunology
- HIV Medicine
Background:
- Abacavir hypersensitivity reactions (HSR) are a significant concern in HIV-1 treatment.
- The HLA-B*5701 allele is strongly associated with abacavir-induced HSR.
- Prospective screening for HLA-B*5701 aims to mitigate this risk.
Purpose of the Study:
- To evaluate the effectiveness of prospective HLA-B*5701 screening in preventing abacavir hypersensitivity reactions.
- To compare the incidence of confirmed HSR in patients undergoing screening versus standard care.
Main Methods:
- A double-blind, randomized controlled trial involving 1956 HIV-1 infected patients.
- Patients were assigned to either prospective HLA-B*5701 screening (with exclusion of positive patients from abacavir) or standard care.
- Immunological confirmation of HSR included epicutaneous patch testing with abacavir.
Main Results:
- The prevalence of HLA-B*5701 was 5.6%.
- Prospective screening eliminated immunologically confirmed HSR (0% vs. 2.7%, P<0.001) and significantly reduced clinically diagnosed HSR (3.4% vs. 7.8%, P<0.001).
- The negative predictive value of screening was 100%.
Conclusions:
- Prospective HLA-B*5701 screening is highly effective in preventing abacavir hypersensitivity reactions.
- In predominantly white populations, most patients (94%) do not carry the risk allele.
- Pharmacogenetic testing offers a viable strategy to prevent specific drug toxicities.
