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What is an abacavir HSR?
Abacavir is associated with a risk for hypersensitivity reactions (HSR) characterised by fever and/or rash with other symptoms indicating multi-organ involvement.
An abacavir hypersensitivity reaction (HSR) is an idiosyncratic reaction.
The approximate reporting rate of abacavir HSR in clinical trials was:
- 1% in trials that excluded subjects testing positive for the HLA-B*5701 allele1
- 5% in trials where HLA-B*5701 screening was not performed2
Abacavir HSR is clinically well characterised:3
- Most HSR include fever and/or rash
- Other symptoms include respiratory, gastrointestinal and constitutional symptoms such as lethargy and malaise.
- Multiple symptoms are typical in most cases of hypersensitivity
Diagnosis is complicated by:4
- Variable presentation with nonspecific symptoms
- Concomitant use of other antiretroviral medications whose adverse event profiles overlap
- Calculated from published data for four Marketing Authorisation Holder clinical trials: Post F et al. JAIDS. 2010; 55(1): 49-57*, Young B et al. AIDS. 2008; 22: 1673-1675*, Wohl DA et al. PLoS One. 2014; 9(5): e96187*, Walmsley SL et al. N Engl J Med. 2013; 369(19): 1807-1818*
- Cutrell et al. Ann Pharmacother. 2004; 38: 2171-2172.*
- Hernandez et al. Abstract presented at: 15th International AIDS Conference; July 11-16, 2004; Bangkok, Thailand. Note: Symptomatology was evaluated from clinical trials where HLA B*5701 screening was not performed.
- Hughes et al. Pharmacogenomics J. 2008; 8: 365-374.*
* ViiV Healthcare does not recommend, endorse or accept liability for sites controlled by third parties.