Comparison of the effectiveness, safety, compliance, and cost of the 6-month isoniazid vs 3-month isoniazid-rifampicin regimen for latent tuberculosis in children.

Abstract

Background: Tuberculosis remains to be a major cause of morbidity in children and treatment of latent tuberculosis is important to prevent children from developing active tuberculosis. This study aimed to compare the effectiveness, safety, compliance, and cost of the currently available Latent Tuberculosis Infection treatment regimens, 6 months isoniazid (6H) and 3 months isoniazid plus rifampicin (3HR), based on the 2020 Department of Health National Tuberculosis Control Program Tuberculosis Preventive Treatment guidelines for children. Methodology: In this open label randomized controlled trial pilot study, 30 participants were assigned to receive either 6H or 3HR. Medications were administered daily by either participants (with direct supervision of treatment supporters) or treatment supporters (for younger participants). Data on outcome measures in terms of effectiveness, safety, and compliance were obtained. Direct cost of treatment was computed per patient’s weight category. Independent Z-test for proportion (for effectiveness, safety, and compliance) and mean (for cost) at 5% level of significance was used to compare the outcomes for each treatment group. Results: Twelve subjects (67%) in the 6H group completed per-protocol therapy, compared to 10 subjects (87%) in the 3HR group. The proportion of adverse events was higher in the 6H group (22%) compared to the 3HR group (8%), but statistical tests showed no significant difference for both compliance and frequency of adverse events. No participant developed active TB disease in both groups. The cost of the 6H treatment regimen was 2,180.18 Php while the cost of the 3HR treatment regimen was 1,526.41 Php, with a p-value of 0.0470 which was statistically significant. Conclusions: Both 6H and 3HR are effective treatments for latent TB infection in patients 0-18 years old. Both treatments were comparable in terms of safety and ease of compliance, but overall cost was higher in the 6H treatment regimen.