Preventive tuberculosis treatment effect on QuantiFERON TB-Gold in-tube testing in a high tuberculosis-endemic country: A clinical trial. (February 2020)

• Record Type: Journal Article
• Authors: Yang, Qingluan; Ruan, Qiaoling; Liu, Xuefeng; Shen, Yaojie; Jiang, Tian; Wu, Jing; Cai, Limin; Pan, Kechuan; Lin, Miaoyao; Huang, Xitian; Shao, Lingyun; Zhang, Wenhong
• Is Part Of: International journal of infectious diseases. Volume 91(2020)
• Page Start: 182
• Page End: 187
• Publication Date: 2020-02
• Subjects: QuantiFERON TB-Gold in-tube -- Tuberculosis preventive treatment -- Serial tests -- Randomized clinical trial; Communicable diseases -- Periodicals; Communicable Diseases -- Periodicals; Communicable diseases; Periodicals; Electronic journals; 616.9
• DOI: 10.1016/j.ijid.2019.11.023
• Languages: English
• ISSNs: 1201-9712

Abstract

Highlights: This study was a prospective, randomized controlled trial to evaluate the changes of QFT-GIT under the influence of preventive treatment. This study was the largest scale and the longest-term follow-up to date to evaluate QFT-GIT performance before and after preventive treatment. Preventive tuberculosis treatment has no effect on interferon-γ responses measuring by serial QFT-GIT in a high tuberculosis-endemic country. QFT-GIT may not be an appropriate biomarker for preventative treatment efficacy in high-endemic TB settings. Abstract: Background: Whether T-cell interferon-γ responses to Mycobacterium tuberculosis- specific antigens can be influenced by tuberculosis preventive treatment in a high-endemic country is uncertain. Methods: In this prospective, open-label, controlled study, 513 individuals with silicosis were randomly selected for TB preventive treatment with rifapentine and isoniazid or for observation. QuantiFERON-TB Gold in-tube (QFT-GIT) assay was used to measure IFN-γ response to M. tuberculosis antigens at baseline (T0) and at 6 (T1) and 33 (T2) months after completion of therapy. Results: A total of 220 subjects were included in the final analysis: 105 and 115 in the prevention and observation arms, respectively. The proportions of QFT-GIT reversion from baseline to T1 were similar in the prevention and observation arms (18.4% vs 12.8%, P = 0.566). However, reversion from baseline to T2 was more frequent in the prevention arm than in the observation arm, but the difference was not significant (24.2% vs 6.3%, P = 0.881). No significant difference was observed in the quantitative responses of QFT-GIT between the two arms during follow-up at T1 ( P = 0.648) and T2 ( P = 0.918). Conclusions: Preventive tuberculosis treatment has no effect on interferon-γ responses measured by serial QFT-GIT assays in a high tuberculosis-endemic country. Clinical Trials Registration: http://www.clinicaltrials.gov NCT02430259.