Experience of Fixed-Dose Combinations of Anti-Tuberculosis Drugs for Preventive Treatment in Children

The objective: to evaluate the effectiveness and safety of preventive treatment with fixed-dose combination of anti-tuberculosis drugs (FDCs) in children from groups at high risk of developing tuberculosis.

Subjects and Methods. Effectiveness of preventive treatment was analyzed in 318 children from groups at high risk of developing tuberculosis. Also, we studied the possibility of successful completion of the full course of treatment using FDCs and preventive treatment regimens containing at least two single drugs. Inclusion criteria were as follows: the child at high risk of developing tuberculosis; no clinical and radiological signs of active tuberculosis; lack of information about the resistance to first-line drugs at the suspected source of infection; and negative HIV status. A group of children (172 people) underwent preventive treatment using FDCs, of them 126 patients received FDCs containing isoniazid 150 mg + pyrazinamide 500 mg + pyridoxine hydrochloride 15 mg, and 46 patients received FDCs containing isoniazid 150 mg + ethambutol 400 mg + pyridoxine hydrochloride 15 mg. The comparison group (CG) included 146 children who received preventive treatment with single drugs: 111 children received isoniazid and pyrazinamide, and 35 children received isoniazid and ethambutol.

Results. When assessing the safety and effectiveness, no statistically significant differences were found when using FDCs and single-drug regimens. 91.9% of children receiving FDCs and 86.3% of children receiving single-drug regimens successfully completed the full course of treatment. When taking FDCs, there was a tendency to lower incidence of adverse events. With the FDC (isoniazid 150 mg + pyrazinamide 500 mg + pyridoxine hydrochloride 15 mg), the proportion of adverse events did not exceed 4.0%. There were no adverse events with the FDC (isoniazid 150 mg + ethambutol 400 mg + pyridoxine hydrochloride 15 mg).

Conclusion. Preventive treatment of children with tuberculosis infection with FDC is a modern and effective technology.

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