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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.
Huang, Hung-Ling; Lee, Meng-Rui; Lee, Chih-Hsin; Cheng, Meng-Hsuan; Lu, Po-Liang; Sheu, Chau-Chyun; Wang, Jann-Yuan; Chong, Inn-Wen; Yang, Jinn-Moon.
Afiliação
  • Huang HL; Department of Internal Medicine, Kaohsiung Municipal Ta-Tung Hospital, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan; Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan; Department of Internal Medicin
  • Lee MR; Department of Internal Medicine, National Taiwan University Hospital, Hsinchu Branch, Hsinchu, Taiwan; Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; National Taiwan University, College of Medicine, Taipei, Taiwan.
  • Lee CH; Division of Pulmonary Medicine and Pulmonary Research Center, Wanfang Hospital, Taipei Medical University, Taipei, Taiwan.
  • Cheng MH; Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan; Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan; School of Medicine, Graduate Institute of Medicine, College of Medic
  • Lu PL; Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan; Center for Liquid Biopsy and Cohort Research, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.
  • Sheu CC; Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan; Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan; School of Medicine, Graduate Institute of Medicine, College of Medic
  • Wang JY; Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; National Taiwan University, College of Medicine, Taipei, Taiwan. Electronic address: jywang@ntu.edu.tw.
  • Chong IW; Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan; Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan; School of Medicine, Graduate Institute of Medicine, College of Medic
  • Yang JM; Department of Biological Science and Technology, National Chiao Tung University, Hsinchu, Taiwan; Institute of Bioinformatics and Systems Biology, National Chiao Tung University, Hsinchu, Taiwan; Center for Intelligent Drug Systems and Smart Bio-devices, National Chiao Tung University, Hsinchu, Taiw
Clin Microbiol Infect ; 30(11): 1410-1417, 2024 Nov.
Article em En | MEDLINE | ID: mdl-38996972
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%.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Rifampina / Tuberculose Latente / Isoniazida / Antituberculosos Idioma: En Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Rifampina / Tuberculose Latente / Isoniazida / Antituberculosos Idioma: En Ano de publicação: 2024 Tipo de documento: Article