Abacavir

Pharmacogenomic Information in the Context of the FDA-Approved Drug Label*

The FDA recommends, but does not require, genetic testing prior to initiating or reinitiating treatment with abacavir.

Excerpt from the abacavir drug label:

"WARNING: RISK OF HYPERSENSITIVITY REACTIONS . . . Patients who carry the HLA-B*5701 allele are at high risk for experiencing a hypersensitivity reaction to abacavir. Prior to initiating therapy with abacavir, screening for the HLA-B*5701 allele is recommended; this approach has been found to decrease the risk of hypersensitivity reaction. Screening is also recommended prior to reinitiation of abacavir in patients of unknown HLA-B*5701 status who have previously tolerated abacavir. . . ."

In the CNA106030 (PRECICT-1) study of 1650 HIV-infected adults, it was found that pre-screening for the HLA-B*5701 allele reduced the incidence of suspected hypersensitivity reactions from 7.8% to 3.4%. Based on this study, it is estimated that 61% of patients carrying the HLA-B*5701 allele will develop a hypersensitivity reaction to abacavir, vs. 4% of patients who do not have this allele.

For the complete drug label text with sections containing pharmacogenetic information highlighted, see the Abacavir drug label PDF.

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