Among HIV and AIDS treatment considerations, FDA recommends hla-b*57:01 screening for abacavir hypersensitivity to reduce incidence of adverse reactions 1,2
Abacavir is a nucleoside analog reverse transcriptase inhibitor (NRTI) used to treat HIV and AIDS, and is generally prescribed in combination with other antiretroviral drugs.1,2
The drug is well-tolerated and on the World Health Organization’s List of Essential Medicines.3 However, hypersensitivity reactions—which can be fatal—have been associated with abacavir therapy in approximately 5% of patients.4,5
Our genetic test allows you to screen patients quickly and effectively before starting or restarting abacavir treatment
The FDA, Clinical Pharmacogenomics Implementation Consortium (CPIC), and US Health and Human Services Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents recommend all patients be screened for the HLA-B*57:01 allele before starting or restarting treatment with abacavir or abacavir-containing medications due to increased risk for abacavir hypersensitivity.2, 7-8
Frequency of the HLA-B*57:01 allele varies with ethnicity, with a frequency of 4% to 8% in European populations, and up to 10% in Southwest Asian populations.9-11
Pharmacogenomics testing has been convincingly shown to reduce the incidence of abacavir hypersensitivity reactions,12 and is cost effective13-14
Pharmacogenomics testing for abacavir hypersensitivity is well-covered by insurances
Clinical management for positive hla-b*57:01 screen
- Abacavir is not recommended for use in patients screening positive for the HLA-B*57:01 allele8
- The US Health and Human Services Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents and the International Antiviral Society list alternative treatment considerations 8, 15
- Development of clinically suspected abacavir hypersensitivity requires immediate and permanent discontinuation of abacavir therapy in all patients, including patients negative for HLA-B*57:018