Acceptability of a new child-friendly dispersible tablet for drug-sensitive pulmonary tuberculosis in children

<b>Introduction:</b> One of the problems in the treatment of children with tuberculosis is the lack of pediatric dosages of anti-TB drugs. It is relevant today to use of child-friendly Fixed Dose Combination (FDC), also supported by the World Health Organization (WHO). FDC have been proven to present therapeutic advantage compared to loose tablets, due to increased compliance and error avoidance. <b>Objective:</b> To investigate for safety and efficiency of a 3-FDC (isoniazid(H) 150 mg + pyrazinamide(Z) 375 mg+ rifampicin(R) 150 mg) dispersible tablet. <b>Methods:</b> We conducted a prospective comparative study for safety and efficiency of 3-FDC dispersible tablet for drug-sensitive pulmonary tuberculosis in the intensive phase of treatment (2-3 months). The study enrolled and randomized in total 146 patients. Patient groups were comparable by gender, age, clinical, radiological and laboratory. In I group (n = 73) 3-FDC dispersible tablets in combination with ethambutol(E) daily for 2-3 months and in II group (n = 73) single tablets (ST) of H, R, Z and E for 2-3 months were taking into account age-related dosages. <b>Results:</b> Hepatotoxic related side effects in I group were observed in 7 patients and in 12 patients in II group (9.6% and 16.4%, χ2= 1.5, p &lt;0.05). Effectiveness was not different between FDC and ST regimens. The using drugs in the intensive phase in I group halved bills with II group. <b>Conclusions:</b> Both regimens showed similar safety and efficiency profiles. 3-FDC dispersible tablet in combination with E was a safety, efficiency and easily administered treatment in intensive phase treatment regimen, also patient acceptability improved with dispersible form.