BackgroundHypersensitivity reaction to abacavir is strongly associated with the presence of the HLA-B*5701 allele. This study was designed to establish the effectiveness of prospective HLA-B*5701 screening to prevent the hypersensitivity reaction to abacavir. MethodsThis double-blind, prospective, randomized study involved 1956 patients from 19 countries, who were infected with human immunodeficiency virus type 1 and who had not previously received abacavir. We randomly assigned patients to undergo prospective HLA-B*5701 screening, with exclusion of HLA-B*5701-positive patients from abacavir treatment (prospective-screening group), or to undergo a standard-of-care approach of abacavir use without prospective HLA-B*5701 screening (control group). All patients who started abacavir were observed for 6 weeks. To immunologically confirm, and enhance the specificity of, the clinical diagnosis of hypersensitivity reaction to abacavir, we performed epicutaneous patch testing with the use of abacavir. ResultsThe prevalence of HLA-B*5701 was 5.6% (109 of 1956 patients). Of the patients receiving abacavir, 72% were men, 84% were white, and 18% had not previously received antiretroviral therapy. Screening eliminated immunologically confirmed hypersensitivity reaction (0% in the prospective-screening group vs. 2.7% in the control group, P<0.001), with a negative predictive value of 100% and a positive predictive value of 47.9%. Hypersensitivity reaction was clinically diagnosed in 93 patients, with a significantly lower incidence in the prospective-screening group (3.4%) than in the control group (7.8%) (P<0.001). ConclusionsHLA-B*5701 screening reduced the risk of hypersensitivity reaction to abacavir. In predominantly white populations, similar to the one in this study, 94% of patients do not carry the HLA-B*5701 allele and are at low risk for hypersensitivity reaction to abacavir. Our results show that a pharmacogenetic test can be used to prevent a specific toxic effect of a drug. (ClinicalTrials.gov number, NCT00340080.) Abacavir is a nucleoside reverse-transcriptase inhibitor with activity against the human immunodeficiency virus (HIV), available for oncedaily use in combination with other antiretroviral agents, that has shown efficacy, few drug interactions, and a favorable long-term toxicity profile. The most important adverse effect of abacavir that limits its use in therapy and mandates a high degree of clinical vigilance is an immunologically mediated hypersensitivity reaction affecting 5 to 8% of patients during the first 6 weeks of treatment. 2,3 Symptoms of a hypersensitivity reaction to abacavir include combinations of fever, rash, constitutional symptoms, gastrointestinal tract symptoms, and respiratory symptoms that become more severe with continued dosing. Immediate and permanent discontinuation of abacavir is mandated, resulting in a rapid reversal of symptoms. Subsequent rechallenge with abacavir is contraindicated, since it can result in a more severe, rapid, and potentially life-threatening reaction. 2 ...
INTRODUCCIÓNLas mujeres constituyen el 40% de los casos de infección por VIH en el mundo. Si analizamos el grupo de las mujeres declaradas con SIDA en España nos encontramos que desde 1981 se han notificado 13.300 casos (19,7% del total). La razón hombre/mujer fue de 4/1 incluso en 2003. El 76% de ellas tienen edades comprendidas entre los 20 y los 34 años, siendo la media de edad menor que en los varones, y constituyen la gran mayoría de los casos de SIDA por transmisión heterosexual en adolescentes y adultos jóvenes. La incidencia de casos fue ascendente hasta 1994, pero desde 1996 y con la introducción del TARGA (tratamiento antirretroviral de gran actividad) se ha registrado una disminución global [0212-7199 (2007) RESUMENObjetivo: Valorar la eficacia del tratamiento antirretroviral en mujeres con infección por VIH, evaluar la evolución de la enfermedad y establecer la supervivencia.Diseño: Estudio retrospectivo que comprende desde el año 1985 hasta Diciembre de 2004. Incluye 75 mujeres elegidas aleatoriamente de entre todas las pacientes del Servicio de Consultas Externas del Hospital Arnau de Vilanova, mayores de 18 años, con infección por VIH y con tratamiento antirretroviral. Las pacientes se han dividido en dos grupos en función de la fecha de inicio de la terapia, antes o después de 1997, ya que a partir de este año se produjo un cambio significativo en la terapia antirretroviral.Método: Se realizó una comparación del perfil epidemiológico y demográfico, del tratamiento inicial y final, de la eficacia del tratamiento antirretroviral, de la evolución de la infección y de la supervivencia en los dos grupos de pacientes.Resultados: Un 66.7% de las pacientes del primer grupo y un 85.2% de las pacientes del segundo tuvieron cargas virales negativas al final del estudio. El 47,9% de las pacientes que iniciaron tratamiento antes de 1997 consiguieron mantener recuentos de linfocitos CD4 superior a 500 células/ml frente al 59,3% de las pacientes que iniciaron tratamiento a partir de 1997. Sólo hubo 6 fallecidos correspondiendo al primer grupo de las pacientes.Conclusiones: los datos obtenidos en nuestro estudio sugieren que el tratamiento antirretroviral ha sido eficaz en los dos grupos de pacientes lo que ha permitido una buena evolución de las mismas y prolongar su supervivencia.
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