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Tytuł:
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Efficacy and safety of weekly rifapentine and isoniazid for tuberculosis prevention in Chinese silicosis patients: a randomized controlled trial.
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Autorzy:
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Ruan QL; Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai 200040, China; National Clinical Research Centre for Aging and Medicine, Huashan Hospital, Fudan University, Shanghai 200040, China.
Huang XT; The First People's Hospital of Wengling, Zhejiang, China.
Yang QL; Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai 200040, China.
Liu XF; The First People's Hospital of Wengling, Zhejiang, China.
Wu J; Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai 200040, China; National Clinical Research Centre for Aging and Medicine, Huashan Hospital, Fudan University, Shanghai 200040, China.
Pan KC; The First People's Hospital of Wengling, Zhejiang, China.
Shen YJ; Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai 200040, China; State Key Laboratory of Genetic Engineering, School of Life Science, Fudan University, Shanghai 200438, China.
Cai LM; The First People's Hospital of Wengling, Zhejiang, China.
Ling Q; The First People's Hospital of Wengling, Zhejiang, China.
Jiang T; The First People's Hospital of Wengling, Zhejiang, China.
Hong JJ; The First People's Hospital of Wengling, Zhejiang, China.
Wang XD; The First People's Hospital of Wengling, Zhejiang, China.
Ma CL; The First People's Hospital of Wengling, Zhejiang, China.
Peng GQ; The First People's Hospital of Wengling, Zhejiang, China.
Wang XZ; The First People's Hospital of Wengling, Zhejiang, China.
Mao JC; The First People's Hospital of Wengling, Zhejiang, China.
Wu TZ; The First People's Hospital of Wengling, Zhejiang, China.
Lin MY; The First People's Hospital of Wengling, Zhejiang, China.
Shao LY; Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai 200040, China; National Clinical Research Centre for Aging and Medicine, Huashan Hospital, Fudan University, Shanghai 200040, China. Electronic address: .
Zhang WH; Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai 200040, China; National Clinical Research Centre for Aging and Medicine, Huashan Hospital, Fudan University, Shanghai 200040, China; Key Laboratory of Medical Molecular Virology (MOE/MOH) and Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, Shanghai 200032, China; State Key Laboratory of Genetic Engineering, School of Life Science, Fudan University, Shanghai 200438, China. Electronic address: .
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Źródło:
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Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases [Clin Microbiol Infect] 2021 Apr; Vol. 27 (4), pp. 576-582. Date of Electronic Publication: 2020 Jun 15.
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Typ publikacji:
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Journal Article; Randomized Controlled Trial
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Język:
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English
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Imprint Name(s):
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Publication: 2015- : London : Elsevier
Original Publication: Paris : Decker Europe, c1995-
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MeSH Terms:
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Antitubercular Agents/*pharmacology
Isoniazid/*pharmacology
Rifampin/*analogs & derivatives
Silicosis/*complications
Tuberculosis, Pulmonary/*prevention & control
Antitubercular Agents/administration & dosage ; Area Under Curve ; China ; Drug Administration Schedule ; Half-Life ; Humans ; Isoniazid/administration & dosage ; Male ; Medication Adherence ; Middle Aged ; Rifampin/administration & dosage ; Rifampin/pharmacokinetics ; Rifampin/pharmacology ; Tuberculosis, Pulmonary/complications
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Contributed Indexing:
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Keywords: Controlled clinical trial; Hepatoxicity; Isoniazid; Rifapentine; Systemic drug reactions; Tuberculosis
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Molecular Sequence:
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ClinicalTrials.gov NCT02430259
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Substance Nomenclature:
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0 (Antitubercular Agents)
V83O1VOZ8L (Isoniazid)
VJT6J7R4TR (Rifampin)
XJM390A33U (rifapentine)
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Entry Date(s):
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Date Created: 20200620 Date Completed: 20210825 Latest Revision: 20210825
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Update Code:
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20240105
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DOI:
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10.1016/j.cmi.2020.06.008
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PMID:
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32553881
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Objective: The aim was to evaluate the efficacy, safety and completion rate of 3-month, once-weekly rifapentine and isoniazid for tuberculosis (TB) prevention among Chinese silicosis patients.
Methods: Male silicosis patients without human immunodeficiency virus infection, aged 18 years to 65 years, with or without latent TB infection, were randomized 1:1 to receive rifapentine/isoniazid under direct observation (3RPT/INH group) or were untreated (observation group). Active TB incidence was compared between the two groups with 37 months of follow-up. Safety profile and complete rates were evaluated.
Results: A total of 1227 adults with silicosis were screened; 513 eligible participants were enrolled and assigned to 3RPT/INH (n = 254) vs. observation (n = 259). Twenty-eight participants were diagnosed with active TB, and 9 and 19 in the 3RPT/INH group and observation groups, respectively. In the intention-to-treat analysis, the cumulative active TB rate was 3.5% (9/254) in the 3RPT/INH group and 7.3% (19/259) in the observation group (log rank p 0.055). On per protocol analysis, the cumulative active TB rates were 0.7% (1/139) and 7.3% (19/259), respectively (log rank p 0.01). Owing to an unexpected high frequency of adverse events (70.4%) and Grade 3 or 4 AEs (7.9%), the completion rate of the 3RPT/INH regimen was 54.7% (139/254). Twenty-six (10.8%) participants had flu-like systemic drug reactions; five (2.1%) experienced hepatotoxicity.
Discussion: Weekly rifapentine/isoniazid prophylaxis prevented active TB among Chinese people with silicosis when taken, irrespective of LTBI screening; efficacy was reduced by lack of compliance. The regimen must be used with caution because of the high rates of adverse effects.
Clinical Trial Registration: ClinicalTrials.gov number: NCT02430259.
(Copyright © 2020. Published by Elsevier Ltd.)
