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Twelve-dose weekly rifapentine plus isoniazid for latent tuberculosis infection: A multicentre randomised controlled trial in Taiwan.
Tuberculosis (Edinb). 2018 07; 111:121-126.T

Abstract

Treatment of latent tuberculosis (TB) infection (LTBI) effectively prevents its progression to active TB. However, long treatment duration and drug-related hepatotoxicity limit the effectiveness of the 9-month daily isoniazid (9H). Data on the 3-month weekly rifapentine plus isoniazid (3 HP) in Asian populations are currently unavailable. We prospectively randomised the LTBI contacts aged ≥12 years with positive tuberculin skin test into 9H and 3 HP groups in four hospitals between January 2014 and May 2016 in Taiwan. The primary and secondary outcomes were treatment completion rate and adverse drug reactions (ADRs), respectively. Overall, 263 participants with LTBI were randomised into the 3 HP (n = 132) and 9H groups (n = 131); 14 (10.6%) and 29 (22.1%) participants in the 3 HP and 9H groups, respectively, discontinued therapy (p = 0.011). Discontinuation rates owing to ADRs were 9.1% (3 HP) and 5.3% (9H) (p = 0.241). Clinically relevant hepatotoxicity was more common in the 9H than in the 3 HP group (5.3% vs. 1.5%; p = 0.103), whereas systemic drug reaction was more common in the 3 HP than in the 9H group (3.8% vs. 0%; p = 0.060). Women had a significantly higher rate of Grade II fever than men (13.7% vs. 1.2%; p = 0.003). Compared with the 9H regimen, the 3 HP regimen had a higher completion rate with lower hepatotoxicity and well-tolerated ADR.

CLINICAL TRIALS REGISTRATION

number NCT02208427.

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Authors+Show Affiliations

Sun HY
Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.
Huang YW
Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan; Pulmonary and Critical Care Unit, Changhua Hospital, Department of Health, Changhua, Taiwan.
Huang WC
Division of Chest Medicine, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, 407, Taiwan; Department of Medical Technology, Jen-Teh Junior College of Medicine, Nursing and Management, Miaoli, 407, Taiwan; Department of Life Sciences, National Chung Hsing University, Taichung, 407, Taiwan.
Chang LY
Department of Internal Medicine, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan.
Chan PC
Department of Pediatrics, National Taiwan University Hospital and Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taiwan.
Chuang YC
Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.
Ruan SY
Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.
Wang JY
Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan. Electronic address: jywang@ntu.edu.tw.
Wang JT
Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.

MeSH

AdolescentAdultAgedAntibiotics, AntitubercularAntitubercular AgentsChildDrug Therapy, CombinationFemaleHumansIsoniazidLatent TuberculosisMaleMiddle AgedMycobacterium tuberculosisProspective StudiesRifampinTaiwanTime FactorsTreatment OutcomeYoung Adult

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

30029896

Clinical Trial Links

Clinical trial which this article describes

Citation

Sun, Hsin-Yun, et al. "Twelve-dose Weekly Rifapentine Plus Isoniazid for Latent Tuberculosis Infection: a Multicentre Randomised Controlled Trial in Taiwan." Tuberculosis (Edinburgh, Scotland), vol. 111, 2018, pp. 121-126.
Sun HY, Huang YW, Huang WC, et al. Twelve-dose weekly rifapentine plus isoniazid for latent tuberculosis infection: A multicentre randomised controlled trial in Taiwan. Tuberculosis (Edinb). 2018;111:121-126.
Sun, H. Y., Huang, Y. W., Huang, W. C., Chang, L. Y., Chan, P. C., Chuang, Y. C., Ruan, S. Y., Wang, J. Y., & Wang, J. T. (2018). Twelve-dose weekly rifapentine plus isoniazid for latent tuberculosis infection: A multicentre randomised controlled trial in Taiwan. Tuberculosis (Edinburgh, Scotland), 111, 121-126. https://doi.org/10.1016/j.tube.2018.05.013
Sun HY, et al. Twelve-dose Weekly Rifapentine Plus Isoniazid for Latent Tuberculosis Infection: a Multicentre Randomised Controlled Trial in Taiwan. Tuberculosis (Edinb). 2018;111:121-126. PubMed PMID: 30029896.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Twelve-dose weekly rifapentine plus isoniazid for latent tuberculosis infection: A multicentre randomised controlled trial in Taiwan. AU - Sun,Hsin-Yun, AU - Huang,Yi-Wen, AU - Huang,Wei-Chang, AU - Chang,Lih-Yu, AU - Chan,Pei-Chun, AU - Chuang,Yu-Chung, AU - Ruan,Sheng-Yuan, AU - Wang,Jann-Yuan, AU - Wang,Jann-Tay, Y1 - 2018/06/07/ PY - 2018/03/18/received PY - 2018/05/06/revised PY - 2018/05/20/accepted PY - 2018/7/22/entrez PY - 2018/7/22/pubmed PY - 2019/4/4/medline KW - Hepatotoxicity KW - Isoniazid KW - Latent tuberculosis infection KW - Preventive therapy KW - Rifapentine SP - 121 EP - 126 JF - Tuberculosis (Edinburgh, Scotland) JO - Tuberculosis (Edinb) VL - 111 N2 - : Treatment of latent tuberculosis (TB) infection (LTBI) effectively prevents its progression to active TB. However, long treatment duration and drug-related hepatotoxicity limit the effectiveness of the 9-month daily isoniazid (9H). Data on the 3-month weekly rifapentine plus isoniazid (3 HP) in Asian populations are currently unavailable. We prospectively randomised the LTBI contacts aged ≥12 years with positive tuberculin skin test into 9H and 3 HP groups in four hospitals between January 2014 and May 2016 in Taiwan. The primary and secondary outcomes were treatment completion rate and adverse drug reactions (ADRs), respectively. Overall, 263 participants with LTBI were randomised into the 3 HP (n = 132) and 9H groups (n = 131); 14 (10.6%) and 29 (22.1%) participants in the 3 HP and 9H groups, respectively, discontinued therapy (p = 0.011). Discontinuation rates owing to ADRs were 9.1% (3 HP) and 5.3% (9H) (p = 0.241). Clinically relevant hepatotoxicity was more common in the 9H than in the 3 HP group (5.3% vs. 1.5%; p = 0.103), whereas systemic drug reaction was more common in the 3 HP than in the 9H group (3.8% vs. 0%; p = 0.060). Women had a significantly higher rate of Grade II fever than men (13.7% vs. 1.2%; p = 0.003). Compared with the 9H regimen, the 3 HP regimen had a higher completion rate with lower hepatotoxicity and well-tolerated ADR. CLINICAL TRIALS REGISTRATION: number NCT02208427. SN - 1873-281X UR - https://www.unboundmedicine.com/medline/citation/30029896/Twelve_dose_weekly_rifapentine_plus_isoniazid_for_latent_tuberculosis_infection:_A_multicentre_randomised_controlled_trial_in_Taiwan_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1472-9792(18)30115-X DB - PRIME DP - Unbound Medicine ER -