RESUMO
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%.
Assuntos
Fármacos Anti-HIV/efeitos adversos , Didesoxinucleosídeos/efeitos adversos , Hipersensibilidade a Drogas/genética , Antígenos HLA-B/genética , Farmacogenética/métodos , Hipersensibilidade a Drogas/prevenção & controle , Predisposição Genética para Doença , Infecções por HIV/tratamento farmacológico , Humanos , Programas de Rastreamento , Estudos Prospectivos , Sensibilidade e EspecificidadeRESUMO
El ensayo PREDICT-1 tuvo como objetivo comprobar la utilidad clínica del test farmacogenético que determina el HLA-B*5701 para reducir la incidencia de reacción de hipersensibilidad (RHS) a abacavir (ABC) diagnosticada clínicamente y con confirmación inmunológica, así como para reducir el abandono injustificado de este fármaco. En el estudio PREDICT-1 se aleatorizó a 1.956 pacientes a ser sometidos a cribado de HLA-B*5701 previo a la instauración de tratamiento con ABC (excluyendo a los sujetos positivos), o bien a recibir ABC con el desconocimiento de su HLA-B*5701 bajo vigilancia clínica convencional. La prevalencia de positividad para HLA-B*5701 fue del 5,7%. En el grupo en que se realizó el cribado prospectivo no se observó ningún caso de RHS a ABC confirmada inmunológicamente (con test epicutáneo positivo) frente a una incidencia de 2,7% en el grupo con vigilancia estándar. La sensibilidad del cribado prospectivo para predecir la RHS a ABC confirmada inmunológicamente fue 100% y su valor predictivo negativo también fue del 100%. La RHS a ABC sospechada clínicamente también fue inferior en el grupo sometido a cribado; 3,4 frente a 7,8% en el grupo de seguimiento convencional. La realización del test epicutáneo como prueba de confirmación inmunológica demostró una sensibilidad del 100%(AU)
The aim of the PREDICT-1 study was to determine the clinical utility of the pharmacogenetic test identifying HLAB* 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 HLAB* 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%(AU)
