Efectividad de la profilaxis para enfermedad tuberculosa en pacientes infectados por el virus de la inmunodeficiencia humana, Medellín, 2002-2005 / Effectiveness of prophylaxis against tuberculosis in patients infected with HIV

Introducción. La profilaxis para tuberculosis ha sido aceptada mundialmente para prevenir las formas activas de la enfermedad, especialmente, en pacientes positivos para VIH; pero en los países de alta prevalencia es aún controvertida su efectividad y sus indicaciones. Objetivo. Establecer en pacientes positivos para VIH el nivel de efectividad de dos esquemas de profilaxis contra la tuberculosis: con isoniacida durante nueve meses o pirazinamida/rifampicina durante 60 días, suministrados en forma autoadministrada, independientemente de la respuesta a la prueba de tuberculina. Materiales y métodos. Estudio observacional de cohorte. Se conformaron dos grupos, uno con 131 pacientes, quienes voluntariamente aceptaron recibir uno de los dos esquemas profilácticos, si el de pirazinamida/rifampicina no estaba contraindicado. El grupo control estuvo conformado por 200 pacientes seleccionados retrospectivamente, a partir de los registros de un programa de control de pacientes con VIH/sida. El seguimiento para ambos grupos se realizó durante dos años, mediante revisión de la historia clínica. Resultados. Los grupos no presentaron diferencias estadísticas significativas cuando se compararon sus características clínicas, ni demográficas. Una mayor proporción de pacientes del grupo control tuvieron recuento de CD4<200/ml y carga viral>100.000. En el grupo con profilaxis, 8 por ciento manifestó efectos adversos, una persona presentó tuberculosis (0,8 por ciento) y en el grupo control 10 (5 por ciento) [RR=0,15, IC95 por ciento 0,02-1,18, p=0,07], la protección de la profilaxis fue del 80 por ciento, independiente de CD4, carga viral y terapia antirretroviral recibida. Conclusión. La profilaxis para tuberculosis mostró ser efectiva en pacientes positivos para VIH, independientemente del estado inmune, virológico y el tratamiento antirretroviral recibido.

Introduction. Prophylaxis against tuberculosis has been recognized as important for preventing clinical forms of tuberculosis, mainly in HIV positive patients. However, in countries with high tuberculosis prevalence, prophylaxis application and effectiveness remains controversial. Objective. Effectiveness was established for two prophylaxis regimens -isoniazid treatment for nine months and pirazinamid/rifampin for 60 days. Materials and methods. Two cohort groups of patients diagnosed with HIV/AIDS were compared. One consisted of 131 volunteer patients, who received one of the two prophylactic regimens -pirazinamid/rifampin or isoniazid. The tuberculosis treatment drugs were self-administered and independent of tuberculin response tests. The second group consisted of 200 patients selected from the records of a HIV/AIDS control program. Follow up for both groups was conducted over a two-year period through clinical records. Results. The 2 groups were similar with respect to clinical and demographic variables. A higher proportion of patients in the control group had CD4 counts <200/ml and viral load >100,000 copies. In the prophylactic group, 8% of patients reported adverse effects due to the drug, and one person had tuberculosis in that group (0.8%). Ten persons in the control group contracted tuberculosis (5%) [RR=0.15, 95%CI 0.02-1.18, p=0.07]. The prophylaxis protective level was calculated to be 80%, after taking into account CD4, viral load, and effective antiretroviral therapy. Conclusion. The prophylaxis against tuberculosis was effective in HIV positive patients, independently of the immune status, viral load, and highly effective antiretroviral therapy.

Tendencia de la tuberculosis en cohortes de pacientes VIH positivos antes y después de la era HAART en instituciones de salud de Medellín (1996-2005) / Trends of tuberculosis in cohorts of positives HIV patient before and after of HAART era in health institutions of Medellin. (1996-2005)

La tuberculosis continúa siendo una de las enfermedades con mayor impacto sobre la salud pública, el cual ha aumentado mediante la coinfección con el virus de inmunodeficiencia adquirida. El papel preventivo de la terapia antirretroviral altamente efectiva (HAART), para que ocurra la tuberculosis activa, se considera insuficiente si no se brinda de una manera regular y con un nivel de adherencia por parte de los pacientes. Desde la implementación mundial de esta terapia HAART, la morbilidad por la coinfección tuberculosa ha disminuido de manera importante, pero no es el único factor para controlar la TB en este grupo de alto riesgo. Objetivos: determinar la tendencia de la enfermedad tuberculosa en pacientes VIH positivos durante los años de implementación del tratamiento antirretroviral en dos cohortes de pacientes VIH positivos provenientes de diferentes centros de salud de la ciudad de Medellín. Metodología: estudio descriptivo basado en los registros de la base de datos del programa de atención para VIH en un programa de referencia para manejo de pacientes con VIH/sida de diferentes instituciones de salud durante los años 1996 a 2002 y una cohorte retrospectiva conformada para evaluar la incidencia de la TB, en comparación con pacientes que recibían quimioprofilaxis en un estudio realizado durante los años 2003 a 2005. Resultados: se encontró una tendencia progresiva al aumento de la proporción de terapia HAART en el período de estudio, con suministro irregular de esta terapia de 60% entre los años 2003-2005. Se presentó una incidencia anual de TB entre 0,1 y 5,1%. La proporción de casos de TB entre quienes no recibieron HAART fue significativamente mayor: 29,5% en el período 1996-2001. El nivel de efectividad contra la tuberculosis de esta terapia fue de 60% (RR = 0,4). Conclusión: se debe garantizar una terapia altamente efectiva a los pacientes con VIH/sida en el momento en que se les indique por el alto riesgo de desarrollar TB. ...

Tuberculosis (TB) is still an important disease with public health impact. Which has increased since HIV epidemic emergence. The preventive role of highly effective antiretroviral (HAART) against TB disease is not enough to control TB because it requires regular administration and adherence to therapy. Since HAART implementation around the world, de TB, co morbidity has decreased, but is no the only factor to control it. Objectives: to determine TB trend in HIV infected patients, during HAART implementation in two patient cohorts coming from different health centers of Medellín. Methods: a descriptive study was conducted based on registries and data bases from a referral program to care HIV/AIDS patiens in different health centers in the city during 1996 to 2002, and a retrospective cohort of HIV patients with data from clinical registries which was comprised in order to compare TB risk in a prophylaxis study during 2003-2005. Results: we report an increasing trend of HAART therapy use during the period of study, with 60% of HIV patients with irregular therapy during the last period (2003-2005). The annual TB incidence was between 0.1 to 5.1%. The TB proportion among the HIV patients who did not received haart effectiviness was 60% (RR=0.4). Conclusion: HAART therapy must be administered at each HIV/AIDS patients when the risk of developing TB is high, according to this results, HAART therapy is effective but is not the only factor to control TB in this population.

[Effectiveness of prophylaxis against tuberculosis in patients infected with HIV]. / Efectividad de la profilaxis para enfermedad tuberculosa en pacientes infectados por el virus de la inmunodeficiencia humana, Medellín, 2002-2005.

INTRODUCTION: Prophylaxis against tuberculosis has been recognized as important for preventing clinical forms of tuberculosis, mainly in HIV positive patients. However, in countries with high tuberculosis prevalence, prophylaxis application and effectiveness remains controversial. OBJECTIVE: Effectiveness was established for two prophylaxis regimens -isoniazid treatment for nine months and pirazinamid/rifampin for 60 days. MATERIALS AND METHODS: Two cohort groups of patients diagnosed with HIV/AIDS were compared. One consisted of 131 volunteer patients, who received one of the two prophylactic regimens -pirazinamid/rifampin or isoniazid. The tuberculosis treatment drugs were self-administered and independent of tuberculin response tests. The second group consisted of 200 patients selected from the records of a HIV/AIDS control program. Follow up for both groups was conducted over a two-year period through clinical records. RESULTS: The 2 groups were similar with respect to clinical and demographic variables. A higher proportion of patients in the control group had CD4 counts <200/ml and viral load >100,000 copies. In the prophylactic group, 8% of patients reported adverse effects due to the drug, and one person had tuberculosis in that group (0.8%). Ten persons in the control group contracted tuberculosis (5%) RR=0.15, 95%CI 0.02-1.18, p=0.07. The prophylaxis protective level was calculated to be 80%, after taking into account CD4, viral load, and effective antiretroviral therapy. CONCLUSION: The prophylaxis against tuberculosis was effective in HIV positive patients, independently of the immune status, viral load, and highly effective antiretroviral therapy.