Literature DB >> 21521028

Novel sensitive, specific and rapid pharmacogenomic test for the prediction of abacavir hypersensitivity reaction: HLA-B*57:01 detection by real-time PCR.

Cinzia Dello Russo1, Lucia Lisi, Alessia Lofaro, Simona Di Giambenedetto, Bruno Federico, Giordano Madeddu, Marianna Salerno, Maria Stella Mura, Antonella Pirazzoli, Andrea de Luca, Roberto Cauda, Pierluigi Navarra.   

Abstract

AIM: International HIV treatment guidelines recommend HLA-B*57:01 typing before abacavir administration, in order to reduce the incidence of abacavir hypersensitivity reactions, the major cause of early therapy discontinuation. A fast, sensitive and specific test for HLA-B*57:01 detection has been developed in the present study. MATERIALS &
METHODS: Two sets of sequence-specific primers were designed, and amplification rapidly detected by real-time PCR.
RESULTS: A total of 108 samples were analyzed in a single-blind fashion, and 41 samples were identified as positive. Complete agreement, with κ = 1 (standard error = 0.0962, p < 0.0001), was found, with a validated methodology used in the EPI109367 clinical trial funded by GlaxoSmithKline, and consisting of low-resolution sequence-specific oligonucleotide PCR, followed by high-resolution sequence-specific oligonucleotide PCR carried out on the HLA-B*57-positive samples.
CONCLUSION: We provided a detailed characterization of a novel HLA-B*57:01 screening test, which can be easily implemented by those laboratories already involved in the detection of viral load and virus genotyping. Original submitted 26 October 2010; Revision submitted 13 December 2010.

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Year:  2011        PMID: 21521028     DOI: 10.2217/pgs.10.208

Source DB:  PubMed          Journal:  Pharmacogenomics        ISSN: 1462-2416            Impact factor:   2.533


  12 in total

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