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Safety and feasibility of 1 month of daily rifapentine plus isoniazid to prevent tuberculosis in children and adolescents: a prospective cohort study.
Lancet Child Adolesc Health. 2021 05; 5(5):350-356.LC

Abstract

BACKGROUND

Shorter regimens for tuberculosis prevention can improve completion rates and protection against developing active tuberculosis disease after tuberculosis exposure. We aimed to assess the safety and feasibility of 1 month of daily isoniazid and rifapentine (1HP) in children and adolescents in a low-resource setting in south Asia with low prevalence of HIV.

METHODS

This prospective cohort study was done in eight tuberculosis facilities in Karachi, Pakistan. Eligible participants were aged 2-19 years and were household contacts of patients with drug-susceptible tuberculosis infection. After clinical, radiological, and laboratory evaluation to rule out tuberculosis disease, participants were prescribed 1HP as a preventive regimen. Isoniazid was administered as 100 mg or 300 mg oral tablets and rifapentine was administered as 150 mg oral tablets. Dosing was according to participant bodyweight. The primary endpoints were the cumulative probability of a household contact completing all stages of the preventive care cascade, assessed in all eligible participants, and the proportion of household contacts completing 1HP, assessed among all those who initiated the regimen. Safety was assessed in all household contacts who initiated the 1HP regimen.

FINDINGS

Between Dec 21, 2019, and March 20, 2020, 1395 household contacts of 253 patients with tuberculosis were identified, including 678 household contacts who were eligible to participate. 628 (93%) completed evaluation, of whom ten (2%) had active tuberculosis disease. Of the 618 individuals eligible for tuberculosis prevention, 408 (66%) initiated 1HP, 385 (94%) of whom completed the regimen. The median duration of 1HP was 31 days (IQR 30-32) in those who completed the regimen. The cumulative probability of completing all steps of the tuberculosis prevention cascade was 58%. A girl aged 11 years developed tuberculosis disease within 6 months of completing 1HP. A boy aged 14 years developed a burning sensation during 1HP therapy and discontinued the regimen. No other adverse events were observed.

INTERPRETATION

1HP can be safely and feasibly implemented as tuberculosis prevention in children and adolescents in programmatic settings.

FUNDING

The Global Fund to Fight AIDS, Tuberculosis and Malaria.

Authors+Show Affiliations

Global Health Directorate, Indus Health Network, Karachi, Pakistan; Interactive Research and Development Global, Singapore; Yale School of Medicine and Yale Institute for Global Health, Yale University, New Haven, CT, USA. Electronic address: amyn.malik@ird.global.Global Health Directorate, Indus Health Network, Karachi, Pakistan.Global Health Directorate, Indus Health Network, Karachi, Pakistan.Global Health Directorate, Indus Health Network, Karachi, Pakistan.Global Health Directorate, Indus Health Network, Karachi, Pakistan.Global Health Directorate, Indus Health Network, Karachi, Pakistan.Global Health Directorate, Indus Health Network, Karachi, Pakistan.The Indus Hospital, Karachi, Pakistan.Global Health Directorate, Indus Health Network, Karachi, Pakistan.Interactive Research and Development Global, Singapore; Harvard Medical School, Boston, MA, USA; Harvard Medical School Center for Global Health Delivery, Boston, MA, USA.Harvard Medical School, Boston, MA, USA; Harvard Medical School Center for Global Health Delivery, Boston, MA, USA; Division of Global Health Equity, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.Harvard Medical School, Boston, MA, USA; Harvard Medical School Center for Global Health Delivery, Boston, MA, USA; Partners In Health, Boston, MA, USA; Division of Global Health Equity, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.Interactive Research and Development Global, Singapore.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

33770510

Citation

Malik, Amyn A., et al. "Safety and Feasibility of 1 Month of Daily Rifapentine Plus Isoniazid to Prevent Tuberculosis in Children and Adolescents: a Prospective Cohort Study." The Lancet. Child & Adolescent Health, vol. 5, no. 5, 2021, pp. 350-356.
Malik AA, Farooq S, Jaswal M, et al. Safety and feasibility of 1 month of daily rifapentine plus isoniazid to prevent tuberculosis in children and adolescents: a prospective cohort study. Lancet Child Adolesc Health. 2021;5(5):350-356.
Malik, A. A., Farooq, S., Jaswal, M., Khan, H., Nasir, K., Fareed, U., Shahbaz, S., Amanullah, F., Safdar, N., Khan, A. J., Keshavjee, S., Becerra, M. C., & Hussain, H. (2021). Safety and feasibility of 1 month of daily rifapentine plus isoniazid to prevent tuberculosis in children and adolescents: a prospective cohort study. The Lancet. Child & Adolescent Health, 5(5), 350-356. https://doi.org/10.1016/S2352-4642(21)00052-3
Malik AA, et al. Safety and Feasibility of 1 Month of Daily Rifapentine Plus Isoniazid to Prevent Tuberculosis in Children and Adolescents: a Prospective Cohort Study. Lancet Child Adolesc Health. 2021;5(5):350-356. PubMed PMID: 33770510.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and feasibility of 1 month of daily rifapentine plus isoniazid to prevent tuberculosis in children and adolescents: a prospective cohort study. AU - Malik,Amyn A, AU - Farooq,Saira, AU - Jaswal,Maria, AU - Khan,Hiba, AU - Nasir,Kumail, AU - Fareed,Usama, AU - Shahbaz,Shumail, AU - Amanullah,Farhana, AU - Safdar,Nauman, AU - Khan,Aamir J, AU - Keshavjee,Salmaan, AU - Becerra,Mercedes C, AU - Hussain,Hamidah, Y1 - 2021/03/24/ PY - 2020/12/23/received PY - 2021/02/08/revised PY - 2021/02/09/accepted PY - 2021/3/27/pubmed PY - 2021/5/7/medline PY - 2021/3/26/entrez SP - 350 EP - 356 JF - The Lancet. Child & adolescent health JO - Lancet Child Adolesc Health VL - 5 IS - 5 N2 - BACKGROUND: Shorter regimens for tuberculosis prevention can improve completion rates and protection against developing active tuberculosis disease after tuberculosis exposure. We aimed to assess the safety and feasibility of 1 month of daily isoniazid and rifapentine (1HP) in children and adolescents in a low-resource setting in south Asia with low prevalence of HIV. METHODS: This prospective cohort study was done in eight tuberculosis facilities in Karachi, Pakistan. Eligible participants were aged 2-19 years and were household contacts of patients with drug-susceptible tuberculosis infection. After clinical, radiological, and laboratory evaluation to rule out tuberculosis disease, participants were prescribed 1HP as a preventive regimen. Isoniazid was administered as 100 mg or 300 mg oral tablets and rifapentine was administered as 150 mg oral tablets. Dosing was according to participant bodyweight. The primary endpoints were the cumulative probability of a household contact completing all stages of the preventive care cascade, assessed in all eligible participants, and the proportion of household contacts completing 1HP, assessed among all those who initiated the regimen. Safety was assessed in all household contacts who initiated the 1HP regimen. FINDINGS: Between Dec 21, 2019, and March 20, 2020, 1395 household contacts of 253 patients with tuberculosis were identified, including 678 household contacts who were eligible to participate. 628 (93%) completed evaluation, of whom ten (2%) had active tuberculosis disease. Of the 618 individuals eligible for tuberculosis prevention, 408 (66%) initiated 1HP, 385 (94%) of whom completed the regimen. The median duration of 1HP was 31 days (IQR 30-32) in those who completed the regimen. The cumulative probability of completing all steps of the tuberculosis prevention cascade was 58%. A girl aged 11 years developed tuberculosis disease within 6 months of completing 1HP. A boy aged 14 years developed a burning sensation during 1HP therapy and discontinued the regimen. No other adverse events were observed. INTERPRETATION: 1HP can be safely and feasibly implemented as tuberculosis prevention in children and adolescents in programmatic settings. FUNDING: The Global Fund to Fight AIDS, Tuberculosis and Malaria. SN - 2352-4650 UR - https://www.unboundmedicine.com/medline/citation/33770510/Safety_and_feasibility_of_1_month_of_daily_rifapentine_plus_isoniazid_to_prevent_tuberculosis_in_children_and_adolescents:_a_prospective_cohort_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S2352-4642(21)00052-3 DB - PRIME DP - Unbound Medicine ER -