Protective efficacy of 6-week regimen for latent tuberculosis infection treatment in rural China: 5-year follow-up of a randomised controlled trial
- Henan Xin1,4,
- Xuefang Cao1,4,
- Haoran Zhang1,4,
- Boxuan Feng1,
- Ying Du1,
- Bin Zhang2,
- Dakuan Wang2,
- Zisen Liu2,
- Ling Guan3,
- Fei Shen3,
- Xueling Guan3,
- Jiaoxia Yan2,
- Yijun He1,
- Yongpeng He1,
- Zhusheng Quan1,
- Shouguo Pan2,
- Jianmin Liu3,
- Qi Jin1 and
- Lei Gao1⇑
- 1NHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P.R. China
- 2Center for Diseases Control and Prevention of Zhongmu, Zhengzhou, China
- 3The Sixth People's Hospital of Zhengzhou, Zhengzhou, China
- 4Contributed equally
- Lei Gao (gaolei{at}ipbcams.ac.cn)
Abstract
Background Enlarging tuberculosis (TB) preventive treatment among at-risk populations is a critical component of the End TB Strategy. It is urgently needed to develop suitable latent tuberculosis infection (LTBI) testing and treatment tools according to local TB epidemic and available resources in worldwide.
Methods Based on an open-labeled randomised controlled trial conducted since 2015 among rural residents aged 50–70 years with LTBI, the protective efficacy of the 6-week twice-weekly regimen of rifapentine plus isoniazid was further evaluated in a 5-year follow-up survey.
Results A total of 1298 treated participants and 1151 untreated controls were included in the 5-year protective efficacy analysis. In the per-protocol analysis, the incidence rate was 0.49/100 person-years (95% confidence interval (CI): 0.30–0.67) in the untreated control group and 0.19/100 person-years (95% CI: 0.07–0.32) in the treated group, the protection rate was 61.22%. Subgroup analysis showed that the protection rate was 76.82% in the per-protocol analysis among participants with baseline IFN-γ levels in the highest quartile (≥3.25 IU·mL−1). The multiple logistic regression analysis indicated that participants with baseline BMI <18.5 kg·m−2 and with pulmonary fibrotic lesions had increased hazard of developing active disease with an adjusted hazard ratio (aHR) of 3.64 (95% CI: 1.20–11.00) and 5.99 (95% CI: 2.20–16.27), respectively. In addition, individuals with higher baseline IFN-γ levels showed an increased risk of TB occurrence (aHR 2.27, 95% CI 1.13–4.58).
Conclusions Our findings suggested the 6-week twice-weekly regimen of rifapentine plus isoniazid for LTBI treatment might be an optional tool for TB control in Chinese population.
Footnotes
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Conflict of interest: Henan Xin has nothing to disclose.
Conflict of interest: Xuefang Cao has nothing to disclose.
Conflict of interest: Haoran Zhang has nothing to disclose.
Conflict of interest: Boxuan Feng has nothing to disclose.
Conflict of interest: Ying Du has nothing to disclose.
Conflict of interest: Bin Zhang has nothing to disclose.
Conflict of interest: Dakuan Wang has nothing to disclose.
Conflict of interest: Zisen Liu has nothing to disclose.
Conflict of interest: Ling Guan has nothing to disclose.
Conflict of interest: Fei Shen has nothing to disclose.
Conflict of interest: Xueling Guan has nothing to disclose.
Conflict of interest: Jiaoxia Yan has nothing to disclose.
Conflict of interest: Yijun He has nothing to disclose.
Conflict of interest: Yongpeng He has nothing to disclose.
Conflict of interest: Zhusheng Quan has nothing to disclose.
Conflict of interest: Shouguo Pan has nothing to disclose.
Conflict of interest: Jianmin Liu has nothing to disclose.
Conflict of interest: Qi Jin has nothing to disclose.
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- Received August 31, 2021.
- Accepted November 1, 2021.
- Copyright ©The authors 2021. For reproduction rights and permissions contact permissions{at}ersnet.org