New TB drugs for the treatment of children and adolescents with rifampicin-resistant TB in Mumbai, India

Author:

Das M.1,Mamnoon F.2,Mansoor H.2,Meneguim A. C.2,Singh P.2,Shah I.3,Ravi S.2,Kalon S.2,Hossain F. N.2,Ferlazzo G.4,Isaakidis P.4,Furin J.5,Acharya S.6,Thakur H. P.7

Affiliation:

1. Médecins Sans Frontières, Mumbai, Tata Institute of Social Sciences, Mumbai

2. Médecins Sans Frontières, Mumbai

3. Bai Jerbai Wadia Hospital for Children, Mumbai, India

4. Southern Africa Medical Unit, Médecins Sans Frontières, Cape Town, South Africa

5. Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA

6. Mumbai Districts AIDS Control Society, Mumbai

7. Tata Institute of Social Sciences, Mumbai, National Institute of Health and Family Welfare, New Delhi, India

Abstract

SETTING: Médecins Sans Frontières (MSF) clinic in Mumbai, India.OBJECTIVE: To determine the final treatment outcomes, culture conversion and adverse events (AEs) during treatment among children and adolescents (0–19 years) with rifampicin-resistant tuberculosis (RR-TB) who received ambulatory injectable-free treatment, including bedaquiline (BDQ) and/or delamanid (DLM) during September 2014–January 2020.DESIGN: This was a retrospective cohort study based on review of routinely collected programme data.RESULTS: Twenty-four patients were included; the median age was 15.5 years (min-max 3–19) and 15 (63%) were females. None were HIV-coinfected. All had fluoroquinolone resistance. Twelve received treatment, including BDQ and DLM, 11 received DLM and one BDQ. The median exposure to BDQ (n = 13) and DLM (n = 23) was 82 (IQR 80–93) and 82 (IQR 77–96) weeks, respectively. Seventeen (94%) patients with positive culture at baseline (n = 18) had negative culture during treatment; median time for culture-conversion was 7 weeks (IQR 5–11). Twenty-three (96%) had successful treatment outcomes: cured (n = 16) or completed treatment (n = 7); one died. Eleven (46%) had 17 episodes of AEs. Two of 12 serious AEs were associated with new drugs (QTcF >500 ms).CONCLUSION: Based on one of the largest global cohorts of children and adolescents to receive new TB drugs, this study has shown that injectable-free regimens containing BDQ and/or DLM on ambulatory basis were effective and well-tolerated among children and adolescents and should be made routinely accessible to these vulnerable groups.

Publisher

International Union Against Tuberculosis and Lung Disease

Subject

Infectious Diseases,Pulmonary and Respiratory Medicine

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