[Short-course isoniazid and rifampin compared with isoniazid for latent tuberculosis infection: a randomized clinical trial]. / Pauta corta de isoniazida y rifampicina comparada con isoniazida para la infección latente de tuberculosis. Ensayo clínico aleatorizado.

INTRODUCTION: The aim of this study was to compare the adherence to, and side effects of a 3-month short-course treatment for latent tuberculosis infection as compared to the standard 6-month course. METHODS: Prospective, comparative, randomized, open trial including patients with a positive tuberculin skin test and appropriate criteria for treatment in accordance with the CDC guidelines, and excluding patients with HIV infection. Group I (6H) was assigned to isoniazid 300 mg per day for 6 months and Group II (3HR) was assigned to isoniazid 300 mg per day plus rifampin 600 mg per day for 3 months. The patients were followed up for five years. RESULTS: A total of 105 patients were included, among which 9 refused treatment; 45 patients were placed in Group I and 51 patients in Group II. Both groups were comparable at baseline. Hepatotoxicity was 44% in Group 6H and 29% in Group 3HR (P = 0.07). Hepatotoxicity was severe in 6.7% of Group 6H and 5.8% of Group 3HR, requiring treatment interruption in 4.4% and 1.9%, respectively (P = NS). Among the total, 75.6% of patients in group 6H, and 90.2% in group 3HR completed the study treatment (P = 0.05). Tuberculous disease was detected in only one patient in the 6H group, occurring in the second month of treatment. CONCLUSION: In the treatment of latent tuberculosis infection, a 3-month course of isoniazid plus rifampin resulted in better adherence and a lower percentage of discontinued treatments than a 6-month isoniazid course. Tolerance was similar in the two regimens.

Pauta corta de isoniazida y rifampicina comparada con isoniazida para la infección latente de tuberculosis. Ensayo clínico aleatorizado / Short-course isoniazid and rifampin compared with isoniazid for latent tuberculosis infection: A randomized clinical trial

Introducción. El objetivo principal del estudio fue comparar la adherencia y tolerancia de una pauta corta de 3 meses con una pauta estándar de 6 meses para el tratamiento de la infección tuberculosa latente. Métodos. Ensayo clínico prospectivo, comparativo, aleatorizado y abierto de pacientes con derivado proteico purificado (PPD) positivo y criterios de tratamiento según normas de los Centers for Disease Control and Prevention (CDC), excluyendo infección por virus de la inmunodeficiencia humana (VIH). La pauta I consistía en isoniazida (H) en dosis de 300 mg/día, 6 meses (6H) y la pauta II en isoniazida en dosis de 300 mg/día con rifampicina (R) 600 mg/día, 3 meses (3HR). Los pacientes fueron seguidos durante 5 años. Resultados. Se han incluido 105 pacientes, 9 rechazaron el tratamiento; 45 pacientes en la pauta I y 51 pacientes en la pauta II. Los 2 grupos eran comparables a nivel basal. La hepatotoxicidad (HTX) fue del 44% en el grupo 6H, y 29% en el grupo 3HR (p 5 0,07). La HTX fue grave en 6,7% en pauta 6H y 5,8% en pauta 3HR; que obligó a suspender el tratamiento en el 4,4 y el 1,9%, respectivamente (p 5 NS). La proporción de pacientes que completaron el tratamiento fue 75,6% del grupo 6H, frente a 90,2% del grupo 3HR (p 5 0,05). Sólo un paciente en el segundo mes de 6H presentó enfermedad tuberculosa. Conclusión. Una pauta corta de 3 meses con isoniazida y rifampicina favorece una mejor adherencia con menor número de abandonos que la pauta de isoniazida 6 meses en el tratamiento de la infección latente tuberculosa. La tolerancia de las 2 pautas es similar (AU)

Introduction. The aim of this study was to compare the adherence to, and side effects of a 3-month short-course treatment for latent tuberculosis infection as compared to the standard 6-month course. Methods. Prospective, comparative, randomized, open trial including patients with a positive tuberculin skin test and appropriate criteria for treatment in accordance with the CDC guidelines, and excluding patients with HIV infection. Group I (6H) was assigned to isoniazid 300 mg per day for 6 months and Group II (3HR) was assigned to isoniazid 300 mg per day plus rifampin 600 mg per day for 3 months. The patients were followed up for five years. Results. A total of 105 patients were included, among which 9 refused treatment; 45 patients were placed in Group I and 51 patients in Group II. Both groups were comparable at baseline. Hepatotoxicity was 44% in Group 6H and 29% in Group 3HR (P 5 0.07). Hepatotoxicity was severe in 6.7% of Group 6H and 5.8% of Group 3HR, requiring treatment interruption in 4.4% and 1.9%, respectively (P 5 NS). Among the total, 75.6% of patients in group 6H, and 90.2% in group 3HR completed the study treatment (P 5 0.05). Tuberculous disease was detected in only one patient in the 6H group, occurring in the second month of treatment. Conclusion. In the treatment of latent tuberculosis infection, a 3-month course of isoniazid plus rifampin resulted in better adherence and a lower percentage of discontinued treatments than a 6-month isoniazid course. Tolerance was similar in the two regimens (AU)