[Prospective validation of a pharmacogenetic test: the PREDICT-1 study].
The aim of the PREDICT-1 study was to determine the clinical utility of the pharmacogenetic test identifying HLA-B*5701 to reduce the incidence of hypersensitivity reaction to abacavir, diagnosed clinically and with immunological confirmation, as well as to reduce unwarranted withdrawal of this drug. In the PREDICT-1 study, 1,956 patients were randomized to be screened for HLA-B*5701 before starting abacavir treatment (excluding participants who were HLA-B*5701-positive) or to receive abacavir without knowing their HLA-B*5701 status under conventional clinical monitoring. The prevalence of HLA-B*5701-positivity was 5.7%. In the group that underwent prospective screening, no hypersensitivity tests with immunological confirmation (by positive epicutaneous patch testing) were observed compared with an incidence of 2.7% in the group undergoing standard follow-up. The sensitivity of prospective screening in predicting immunologically confirmed hypersensitivity reaction to abacavir was 100% and its negative predictive value was 100%. The number of clinically suspected hypersensitivity reactions to abacavir was also lower in the screened group (3.4% versus 7.8% in the group undergoing conventional follow-up). The sensitivity of epicutaneous patch testing for immunological confirmation was 100%.
Muñoz de Benito
Rosa M
RM
Servicio de Medicina Interna, Hospital del Norte, San Sebastián de los Reyes, Madrid, España.
Arribas López
José Ramón
JR
D019380:Anti-HIV Agents / Q000009:adverse effects*; D015224:Dideoxynucleosides / Q000009:adverse effects*; D004342:Drug Hypersensitivity / Q000235:genetics* / Q000517:prevention & control; D020022:Genetic Predisposition to Disease; D015658:HIV Infections / Q000188:drug therapy; D015235:HLA-B Antigens / Q000235:genetics*; D006801:Humans; D008403:Mass Screening; D010597:Pharmacogenetics / Q000379:methods*; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D000099227:Abacavir
D019380:Anti-HIV Agents; D015224:Dideoxynucleosides; D015235:HLA-B Antigens; D000099227:Abacavir