ABSTRACT
INTRODUCTION: Treatment interruptions may be an alternative to HAART in the management of chronically infected HIV-patients. We designed this study in an attempt to assess the predictability of this strategy. METHODS: We recruited HIV-infected patients whose treatment had been suspended. Interruption was due to the patient's own decision, or toxicity, or because the patient had started the treatment with more than 350 CD41 cells/microL (immunologic criteria). RESULTS: Forty-one consecutive patients were included, with a median follow-up of 13 months. Failure was associated with the reason for interruption (p 5 0.0063). Failure occurred in 14.3% of those who interrupted treatment due to immunological criteria and in 40% of those who interrupted treatment due to their own decision or toxicity. The reasons for interruption were: toxicity in 11 patients (26.8%), personal decision in 9 (21.9%) and immunological criteria in 21 (51.2%). In the univariate analysis, the nadir CD41 cell count < 350 cél./microL [OR 16 (p = 0.054)] was statistically significant in the patients who stopped treatment due to immunological criteria, while treatment with protease inhibitors [OR 14 (p = 0.032)] was statistically significant in the remaining patients. In the multivariable analysis only nadir CD41 < 350 cél./microL was independently related with failure. CONCLUSIONS: Failure was related to interruption criteria and was greater in patients who stopped due their own decision or toxicity. When interruption was due to immunological criteria, the factor predicting failure was nadir CD41 cell count < 350 cél./microL. In the remaining patients, none of the variables was related to failure.
Subject(s)
Anti-HIV Agents/administration & dosage , Antiretroviral Therapy, Highly Active , HIV Infections/drug therapy , AIDS-Related Opportunistic Infections/epidemiology , Adult , Algorithms , Anti-HIV Agents/adverse effects , Anti-HIV Agents/therapeutic use , Antiretroviral Therapy, Highly Active/adverse effects , CD4 Lymphocyte Count , Chemical and Drug Induced Liver Injury/etiology , Cohort Studies , Drug Administration Schedule , Female , Follow-Up Studies , HIV-1 , HIV-Associated Lipodystrophy Syndrome/chemically induced , Humans , Male , Multivariate Analysis , Patient Dropouts , Prospective Studies , ROC Curve , Treatment Failure , Viral Load , Withholding TreatmentABSTRACT
INTRODUCCIÓN. La interrupción del tratamiento puede ser una alternativa terapéutica al tratamiento antirretroviral en el manejo de la infección crónica por el virus de la inmunodeficiencia humana. Para estudiar esta opción, se ha diseñado un estudio de predicibilidad. MÉTODOS. Se incluyeron a pacientes que pararon el tratamiento por abandono de la medicación, toxicidad o por haber iniciado el tratamiento con una cifra de CD4+ > 350 cél./ml (criterio inmunológico).RESULTADOS. Se seleccionaron de forma prospectiva41 pacientes y la mediana de seguimiento fue de 13 meses. El fracaso se relacionó con el criterio de suspensión(p = 0,0063). En aquellos que abandonaron el tratamiento por criterio inmunológico el fracaso fue del 14,3% y en los que pararon por toxicidad o por abandono, el 40%. Las causas que motivaron la suspensión fueron: 11 (26,8%) por toxicidad; 9 (21,9%) por abandono y 21 (51,2%) por criterio inmunológico. Aunque en el análisis univariado, en el grupo que paró el tratamiento por criterio inmunológico la variable CD4+ nadir inferior a 350 cél./ml (odds ratio[OR] 16; p = 0,054) fue estadísticamente significativa, y en los otros pacientes lo fue el tratamiento con inhibidores de proteasa (OR 14; p = 0,032), en el análisis multivariable sólo CD4+ nadir inferior a 350 cél./ml se asoció de forma independiente con el fracaso. CONCLUSIONES. El fracaso se relacionó con el criterio de suspensión, y fue mayor cuando se suspendió por toxicidad o por abandono. El factor que predijo el fracaso en los pacientes que pararon por criterio inmunológico fue una cifra de CD4+ nadir inferior a 350 cél./ml. En el otro grupo de pacientes, ninguna variable se relacionó con el fracaso (AU)
INTRODUCTION. Treatment interruptions may be an alternative to HAART in the management of chronically infected HIV-patients. We designed this study in an attempt to assess the predictability of this strategy. METHODS. We recruited HIV-infected patients whose treatment had been suspended. Interruption was due to the patients own decision, or toxicity, or because the patient had started the treatment with more than 350 CD4+ cells/mL (immunologic criteria).RESULTS. Forty-one consecutive patients were included, with a median follow-up of 13 months. Failure was associated with the reason for interruption (p = 0.0063).Failure occurred in 14.3% of those who interrupted treatment due to immunological criteria and in 40% of those who interrupted treatment due to their own decision or toxicity. The reasons for interruption were: toxicity in 11 patients (26.8%), personal decision in 9 (21.9%) and immunological criteria in 21 (51.2%). In the univariate analysis, the nadir CD4+ cell count < 350 cél./mL[OR 16 (p = 0.054)] was statistically significant in the patients who stopped treatment due to immunological criteria, while treatment with protease inhibitors [OR14 (p = 0.032)] was statistically significant in there maining patients. In the multivariable analysis only nadir CD4+ < 350 cél./mL was independently related with failure. CONCLUSIONS. Failure was related to interruption criteria and was greater in patients who stopped due their own decision or toxicity. When interruption was due to immunological criteria, the factor predicting failure was nadir CD4+ cell count < 350 cél./mL. In the remaining patients, none of the variables was related to failure (AU)
