TY - JOUR
T1 - Tuberculosis preventive treatment should be considered for all household contacts of pulmonary tuberculosis patients in India
AU - CTRIUMPh-RePORT India Study Team
AU - Paradkar, Mandar
AU - Padmapriyadarsini, Chandrasekaran
AU - Jain, Divyashri
AU - Shivakumar, Shri Vijay Bala Yogendra
AU - Thiruvengadam, Kannan
AU - Gupte, Akshay N.
AU - Thomas, Beena
AU - Kinikar, Aarti
AU - Sekar, Krithika
AU - Bharadwaj, Renu
AU - Dolla, Chandra Kumar
AU - Gaikwad, Sanjay
AU - Elilarasi, S.
AU - Lokhande, Rahul
AU - Reddy, Devarajulu
AU - Murali, Lakshmi
AU - Kulkarni, Vandana
AU - Pradhan, Neeta
AU - Hanna, Luke Elizabeth
AU - Pattabiraman, Sathyamurthi
AU - Kohli, Rewa
AU - Rani, S.
AU - Suryavanshi, Nishi
AU - Shrinivasa, B. M.
AU - Cox, Samyra R.
AU - Selvaraju, Sriram
AU - Gupte, Nikhil
AU - Mave, Vidya
AU - Gupta, Amita
AU - Bollinger, Robert C.
N1 - Funding Information:
Data in this manuscript were collected as part of the Regional Prospective Observational Research for Tuberculosis (RePORT) India Consortium. CTRIUMPH is part of the RePORT consortium funded with Federal funds from the Government of India's (GOI) Department of Biotechnology (DBT), the Indian Council of Medical Research (ICMR), the USA National Institutes of Health (NIH), the National Institute of Allergy and Infectious Diseases (NIAID), the Office of AIDS Research (OAR), and distributed in part by CRDF Global (USB1-31147-XX-13 to AG). This work was also supported by the National Institutes of Health (NIH 1R01A1I097494-01A1 to JG), the NIH funded Johns Hopkins Baltimore-Washington-India Clinical Trials Unit for NIAID Networks (UM1AI069465 to AG, VM, NG). Aarti Kinikar, Rajesh Kulkarni and Rahul Lokhande are supported by the BJGMC JHU HIV TB Program funded by the Fogarty International Center, NIH (D43TW009574 to RCB). The contents of this publication are solely the responsibility of the authors and do not represent the official views of the DBT, the ICMR, the NIH, or CRDF Global. Any mention of trade names, commercial projects or organizations does not imply endorsement by any of the sponsoring organizations. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Publisher Copyright:
© 2020 Paradkar et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
PY - 2020/7
Y1 - 2020/7
N2 - The World Health Organization (WHO) recently changed its guidance for tuberculosis (TB) preventive treatment (TPT) recommending TPT for all pulmonary TB (PTB) exposed household contacts (HHC) to prevent incident TB disease (iTBD), regardless of TB infection (TBI) status. However, this recommendation was conditional as the strength of evidence was not strong. We assessed risk factors for iTBD in recently-exposed adult and pediatric Indian HHC, to determine which HHC subgroups might benefit most from TPT. We prospectively enrolled consenting HHC of adult PTB patients in Pune and Chennai, India. They underwent clinical, microbiologic and radiologic screening for TB disease (TBD) and TBI, at enrollment, 4-6, 12 and 24 months. TBI testing was performed by tuberculin skin test (TST) and Quantiferon®- Gold-in-Tube (QGIT) assay. HHC without baseline TBD were followed for development of iTBI and iTBD. Using mixed-effect Poisson regression, we assessed baseline characteristics including TBI status, and incident TBI (iTBI) using several TST and/or QGIT cut-offs, as potential risk factors for iTBD. Of 1051 HHC enrolled, 42 (4%) with baseline TBD and 12 (1%) with no baseline TBI test available, were excluded. Of the remaining 997 HHC, 707 (71%) had baseline TBI (TST #x2265; 5 mm or QGIT #x2265; 0.35 IU/ml). Overall, 20 HHC (2%) developed iTBD (12 cases/1000 person-years, 95%CI: 8-19). HIV infection (aIRR = 29.08, 95% CI: 2.38-355.77, p = 0.01) and undernutrition (aIRR = 6.16, 95% CI: 1.89-20.03, p = 0.003) were independently associated with iTBD. iTBD was not associated with age, diabetes mellitus, smoking, alcohol, and baseline TBI, or iTBI, regardless of TST (#x2265; 5 mm, #x2265; 10 mm, #x2265; 6 mm increase) or QGIT (#x2265; 0.35 IU/ml, #x2265; 0.7 IU/ml) cut-offs. Given the high overall risk of iTBD among recently exposed HHCs, and the lack of association between TBI status and iTBD, our findings support the new WHO recommendation to offer TPT to all HHC of PTB patients residing in a high TB burden country such as India, and do not suggest any benefit of TBI testing at baseline or during follow-up to risk stratify recently-exposed HHC for TPT.
AB - The World Health Organization (WHO) recently changed its guidance for tuberculosis (TB) preventive treatment (TPT) recommending TPT for all pulmonary TB (PTB) exposed household contacts (HHC) to prevent incident TB disease (iTBD), regardless of TB infection (TBI) status. However, this recommendation was conditional as the strength of evidence was not strong. We assessed risk factors for iTBD in recently-exposed adult and pediatric Indian HHC, to determine which HHC subgroups might benefit most from TPT. We prospectively enrolled consenting HHC of adult PTB patients in Pune and Chennai, India. They underwent clinical, microbiologic and radiologic screening for TB disease (TBD) and TBI, at enrollment, 4-6, 12 and 24 months. TBI testing was performed by tuberculin skin test (TST) and Quantiferon®- Gold-in-Tube (QGIT) assay. HHC without baseline TBD were followed for development of iTBI and iTBD. Using mixed-effect Poisson regression, we assessed baseline characteristics including TBI status, and incident TBI (iTBI) using several TST and/or QGIT cut-offs, as potential risk factors for iTBD. Of 1051 HHC enrolled, 42 (4%) with baseline TBD and 12 (1%) with no baseline TBI test available, were excluded. Of the remaining 997 HHC, 707 (71%) had baseline TBI (TST #x2265; 5 mm or QGIT #x2265; 0.35 IU/ml). Overall, 20 HHC (2%) developed iTBD (12 cases/1000 person-years, 95%CI: 8-19). HIV infection (aIRR = 29.08, 95% CI: 2.38-355.77, p = 0.01) and undernutrition (aIRR = 6.16, 95% CI: 1.89-20.03, p = 0.003) were independently associated with iTBD. iTBD was not associated with age, diabetes mellitus, smoking, alcohol, and baseline TBI, or iTBI, regardless of TST (#x2265; 5 mm, #x2265; 10 mm, #x2265; 6 mm increase) or QGIT (#x2265; 0.35 IU/ml, #x2265; 0.7 IU/ml) cut-offs. Given the high overall risk of iTBD among recently exposed HHCs, and the lack of association between TBI status and iTBD, our findings support the new WHO recommendation to offer TPT to all HHC of PTB patients residing in a high TB burden country such as India, and do not suggest any benefit of TBI testing at baseline or during follow-up to risk stratify recently-exposed HHC for TPT.
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U2 - 10.1371/journal.pone.0236743
DO - 10.1371/journal.pone.0236743
M3 - Article
C2 - 32726367
AN - SCOPUS:85088852034
SN - 1932-6203
VL - 15
JO - PloS one
JF - PloS one
IS - 7 July
M1 - e0236743
ER -