ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2026
Fixed-Dose Rifapentine-Isoniazid (1HP) for Tuberculosis Preventive Treatment in Chinese Adults: A Prospective Real-World Safety and Pharmacokinetic Study.
Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundThe World Health Organization recommends 1 month of daily rifapentine plus isoniazid (1HP) for tuberculosis preventive treatment (TPT). Real-world safety and feasibility data remain scarce, particularly for East Asian populations, and the performance of fixed-dose 1HP in routine clinical practice requires prospective evaluation.
methodsWe conducted a prospective study at a tuberculosis referral center in Shenzhen, China, enrolling 136 non-human immunodeficiency virus adults (body weight 42-90 kg) with tuberculosis infection between October 2024 and July 2025. All participants received fixed-dose 1HP. Outcomes included treatment completion (defined as taking ≥23 doses within 40 days), adverse events graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0, and 12-hour postdose rifapentine concentrations measured by liquid chromatography-tanden mass spectrometry.
resultsTreatment completion reached 76.5% (104/136; 95% confidence interval [CI], 68.7%-82.8%). Adverse events occurred in 26.5% of participants, most commonly neutropenia (14.7%) and rash (6.6%); grade ≥ 3 events were observed in only 1.5% (2/136), both in patients receiving concurrent methotrexate. Median rifapentine concentration was 21.8 mg/L (interquartile range [IQR], 14.8-28.4), and 91.9% of participants exceeded the model-informed 10 mg/L threshold. Body weight demonstrated a modest inverse correlation with rifapentine concentrations (ρ = -0.24; P = .005), accounting for only 7.1% of interindividual variability.
conclusionsFixed-dose 1HP exhibited good tolerability and achieved acceptable completion rate in Chinese adult population. Pharmacokinetic results confirmed adequate rifapentine exposure across the studied weight range, lending support to fixed-dose 1HP for programmatic scale-up.
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