Safety, Feasibility, and Rifapentine Plasma Concentration in Chinese Children With 1 Month of Daily Rifapentine Plus Isoniazid for Tuberculosis Infection.

BACKGROUND: One month of daily rifapentine plus isoniazid (1HP) is a new regimen for tuberculosis (TB) infection to lower the incidence of active TB. However, it has not been prescribed for Chinese children, and the optimal dosage of daily rifapentine for children remains controversial. We aimed to assess the feasibility and safety of 1HP in young Chinese children with TB infection and to provide evidence for extrapolating dosing strategies to children.

METHODS: An open-label, prospective, single-arm clinical trial was conducted among eligible participants (aged ≤14 years). Completion rate, safety, and rifapentine concentrations of the 1HP regimen were analyzed.

RESULTS: Eighty children were enrolled in our study; 79 of the participants (98.75%) completed the treatment, with only 1 case of noncompletion (1.25%) in the age group 6-14 years because of rash. Five of 80 participants (6.25%) experienced grade ≥3 adverse events, with no serious adverse events or deaths reported. The relationship between rifapentine concentration (mg/L) and time (days) in children stratified by age and weight demonstrated the lowest rifapentine concentration in participants ≤2 years old and those weighing ≤15 kg when compared to the other subgroups.

CONCLUSIONS: The 1HP regimen is safe and feasible for young Chinese children with TB infection. Weight-based daily rifapentine (10-15 mg/kg) might not be enough for young children, particularly for those aged ≤2 years or weighing ≤15 kg.

CLINICAL TRIALS REGISTRATION: ChiCTR2200066411.