What the FDA Relabeling of Abacavir Means for You and Your Patient

Clinical Utility³

November 2008

In patients who have clinically-suspected hypersensitivity reaction, the sensitivity approximately 46% and the specificity is about 98%. The negative predictive value is exceedingly high and is about 100%, where the absence of HLA-B*5701 correlates with absence of abacavir hypersensitivity reaction. The positive predictive value is approximately 61% and this correlates with individuals with the HLA-B*5701 allele who had a suspected hypersensitivity reaction with abacavir.

Immunologically-confirmed hypersensitivity reactions, however, show higher sensitivity and specificity. The negative predictive value is still 100% and the positive predictive value is about 48% with individuals who have the alleles and had a confirmed hypersensitivity reaction.

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Jump to section:

• Introduction
• Highly Active Antiretroviral Therapy
• Abacavir
• FDA Caution and Relabeling
• Abacavir Hypersensitivity
• Abacavir HSR and HLA Gene
• HLA-B Antigens and Alleles
• Naming Conventions - HLA-B*5701
• Chromosome 6
• Detecting HLA Alleles
• HLA-B*5701 Correlations
• HLA-B*5701 Correlations
• Clinical Utility³
• Problems
• If HSR Symptoms are Present⁴
• If HSR Symptoms are Present⁴
• Recommendations for Physicians⁵
• Recommendations for Physicians⁵
• Information for Patients⁵
• Information for Patients⁵
• HLA-B*5701 Genotyping
• References
• Questions?