Real-world challenges of 4-month rifapentine-moxifloxacin TB regimen: High hyperbilirubinemia in Thailand
Abstract
Background: The four-month rifapentine-moxifloxacin (HPMZ) regimen is an alternative to the standard six-month tuberculosis treatment. While clinical trials confirm its efficacy, real-world data, especially in Asian populations, are limited. This study evaluates the effectiveness and tolerability of HPMZ in Thailand.
Methods: A prospective study was conducted at the Central Chest Institute of Thailand (September 2023-June 2025) in drug-susceptible TB patients. The HPMZ regimen included daily rifapentine 1200 mg, moxifloxacin 400 mg, isoniazid 300 mg, and weight-based pyrazinamide for eight weeks, followed by rifapentine, moxifloxacin, and isoniazid for nine weeks. Patients were monitored for adverse events (AEs).
Results: Fourteen participants (median age 54 years, weight 55.35 kg) received a mean rifapentine dose of 21.26 mg/kg. Hyperbilirubinemia was the most common AEs, leading to treatment discontinuation in 78.57%. Grade 3 hyperbilirubinemia occurred in 57.14%, with a mean peak bilirubin level of 3.03 mg/dL. Rifapentine overexposure was observed, with five patients showing a mean maximum plasma concentration (Cmax) of 41.89 ± 10.42 μg/mL.
Conclusion: The high incidence of hyperbilirubinemia suggests a fixed 1200 mg rifapentine dose may not be suitable for lower-weight populations. Weight-based rifapentine dosing and standardized ADR management are crucial for broader implementation. Larger studies are needed to refine dosing and evaluate effectiveness and tolerability.
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