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

Recommendations for Physicians⁵

November 2008

These are the following recommendations for providers who care for patients with HIV infection and providing abacavir therapy. Prior to starting, all patients should be screened for the HLA-B *5701 allele to reduce risk of hypersensitivity reaction to this drug.

Screening for this allele is recommended prior to reinitiation, as these would be patients who have had some sort of hypersensitivity reaction, but it is not known whether it is due to abacavir. So if upon restarting abacavir therapy, there is a hypersensitivity reaction, then these patients should avoid abacavir permanently.

Finally, if a patient is HLA-B*5701-positive, abacavir treatment regimens are not recommended and should be considered “only under exceptional circumstances when the potential benefit outweighs the risk.”

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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?