One-month daily and three-month weekly rifapentine plus isoniazid are comparable in completion rate and safety for latent tuberculosis infection in non-HIV Population: a randomized controlled trial

Hung Ling Huang, Meng Rui Lee, Chih Hsin Lee, Meng Hsuan Cheng, Po Liang Lu, Chau Chyun Sheu, Jann Yuan Wang, Inn Wen Chong, Jinn Moon Yang

Research output: Contribution to journalArticlepeer-review

3 Citations (Scopus)

Abstract

Objectives: The weekly rifapentine plus isoniazid for 3 months (3HP) improves completion rate of latent tuberculosis infection treatment, but flu-like symptoms are common. The novel 1HP regimen, involving daily rifapentine plus isoniazid for 28 days, has demonstrated low toxicity in HIV-infected populations. We aimed to investigate whether 1HP has a lower incidence rate of systemic drug reaction (SDR) compared with 3HP during treatment in non-HIV populations. Methods: This randomized, multicentre trial compared the completion rate and risks of SDRs of 1HP and 3HP in aged ≥13 years non-HIV subjects with latent tuberculosis infection between September 2019 and September 2023 (ClinicalTrials.gov: NCT04094012). We also investigated associations between SDRs and plasma levels of drugs and their metabolites. Results: A total of 251 and 239 individuals were randomly assigned to 1HP and 3HP groups, respectively, with completion rates of 82.9% (208/251) and 84.5% (202/239), respectively. Among them, 12.7% (32/251) and 10.9% (26/239) of 1HP and 3HP groups experienced SDRs, respectively (p 0.522), predominantly urticaria in 1HP group (59.4% [19/32]) and flu-like syndrome in 3HP group (80.8% [21/26]). Among participants experiencing SDRs, 43.8% (14/32) and 34.6% (9/26) in 1HP and 3HP groups, respectively, completed treatment (p 0.470). Cutaneous reactions were more common in 1HP than 3HP group (32.7% [82/251] vs. 13.0% [31/239], p < 0.001). In 1HP group, urticaria was associated with a higher plasma desacetyl-rifapentine level (ug/mL) at both 2 (median [interquartile range]: 36.06 [17.46–50.79] vs. 22.94 [14.67–31.65], p 0.018) and 6 hours (26.13 [15.80–53.06] vs. 29.83 [18.13–34.01], p 0.047) after dosing. Discussion: In non-HIV population, the incidence rate of SDR under 1HP is not lower than 3HP. Notably, urticaria, rather than flu-like syndrome, was the predominant SDR associated 1HP. The findings of this study underscore the feasibility of 1HP regimen in non-HIV populations with a high-completion rate exceeding 80%.

Original languageEnglish
Pages (from-to)1410-1417
Number of pages8
JournalClinical Microbiology and Infection
Volume30
Issue number11
DOIs
Publication statusAccepted/In press - Jul 10 2024

Keywords

  • Latent tuberculosis infection
  • Preventive therapy
  • Rifapentine
  • Safety
  • Systemic drug reaction
  • Urticaria

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

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