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Observational Study
. 2019 Jan 16;16(1):1.
doi: 10.1186/s12981-019-0217-3.

HLA-B*57:01 screening and hypersensitivity reaction to abacavir between 1999 and 2016 in the OPERA® observational database: a cohort study

Karam Mounzer  1 , Ricky Hsu  2 , Jennifer S Fusco  3 , Laurence Brunet  4 , Cassidy E Henegar  5 , Vani Vannappagari  5 , Chris M Stainsby  6 , Mark S Shaefer  5 , Leigh Ragone  5 , Gregory P Fusco  4
Affiliations
Observational Study

HLA-B*57:01 screening and hypersensitivity reaction to abacavir between 1999 and 2016 in the OPERA® observational database: a cohort study

Karam Mounzer et al. AIDS Res Ther. .

Abstract

Background: HLA-B*57:01 screening was added to clinical care guidelines in 2008 to reduce the risk of hypersensitivity reaction from abacavir. The uptake of HLA-B*57:01 screening and incidence of hypersensitivity reaction were assessed in a prospective clinical cohort in the United States to evaluate the effectiveness of this intervention.

Methods: We included all patients initiating an abacavir-containing regimen for the first time in the pre-HLA-B*57:01 screening period (January 1, 1999 to June 14, 2008) or the post-HLA-B*57:01 screening period (June 15, 2008 to January 1, 2016). Yearly incidence of both HLA-B*57:01 screening and physician panel-adjudicated hypersensitivity reactions were calculated and compared.

Results: Of the 9619 patients eligible for the study, 33% initiated abacavir in the pre-screening period and 67% in the post-screening period. Incidence of HLA-B*57:01 screening prior to abacavir initiation increased from 43% in 2009 to 84% in 2015. The incidence of definite or probable hypersensitivity reactions decreased from 1.3% in the pre-screening period to 0.8% in 2009 and further to 0.2% in 2015 in the post-screening period.

Conclusions: Frequency of HLA-B*57:01 screening increased steadily since its first inclusion in treatment guidelines in the United States. This increase in screening was accompanied by a decreasing incidence of definite or probable hypersensitivity reactions over the same period. However, a considerable proportion of patients initiating abacavir were not screened, representing a failed opportunity to prevent hypersensitivity reactions. Where HLA-B*57:01 screening is standard of care, patients should be confirmed negative for this allele before starting abacavir treatment.

Keywords: Abacavir; Cohort; HIV; HLA-B*57:01 screening; Hypersensitivity reaction.

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Figures

Fig. 1
Fig. 1
Selection of eligible patients for analysis. 1As of July 31, 2016, 2Pre-screening period: 01 Jan 1999 to 14 June 2008, 3Post-screening period: 15 June 2008 to 31 July 2016
Fig. 2
Fig. 2
Trends in HLA-B*57:01 screening and physician-adjudicated HSR by calendar year
Fig. 3
Fig. 3
Time to definitive or probable hypersensitivity reaction within 6 weeks of abacavir initiation, by screening period
See this image and copyright information in PMC

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