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

Area of Science:

• Pediatric infectious diseases
• Pharmacokinetics and drug dosing
• Tuberculosis treatment

Background:

• The one-month daily rifapentine plus isoniazid (1HP) regimen is a novel approach to reduce active tuberculosis (TB) incidence.
• Optimal dosing of rifapentine in pediatric populations remains under investigation, particularly in China.
• This study addresses the need for data on 1HP regimen feasibility and safety in young Chinese children with tuberculosis infection (TBI).

Purpose of the Study:

• To evaluate the feasibility and safety of the 1HP regimen in young Chinese children diagnosed with TBI.
• To analyze rifapentine concentrations within this pediatric cohort.
• To inform and potentially refine pediatric dosing strategies for rifapentine.

Main Methods:

• An open-label, prospective, single-arm clinical trial.
• Inclusion criteria: participants aged 14 years or younger.
• Analysis focused on treatment completion rates, adverse events, and plasma rifapentine concentrations.

Main Results:

• High treatment completion rate of 98.75% (79/80 children).
• Low incidence of grade ≥3 adverse events (6.25%), with no serious adverse events or deaths.
• Rifapentine concentrations were lowest in children under 2 years old and weighing less than 15kg.

Conclusions:

• The 1HP regimen demonstrates safety and feasibility for treating TBI in young Chinese children.
• Current weight-based rifapentine dosing (10-15 mg/Kg) may be insufficient for very young children (under 2 years) and those weighing less than 15kg.
• Further research into optimized dosing is recommended for specific pediatric subgroups to ensure therapeutic efficacy.