Treatment outcomes of bedaquiline-based longer oral antitubercular regimens in Indian children above five years of age
Background and Objective: This study evaluates the treatment outcomes and adverse drug reactions (ADRs) of longer oral bedaquiline (BDQ)-based (without delamanid) antitubercular therapy (ATT) regimens in children aged 5–18 years. Methods: A retrospective study was conducted between June 2021 and Feb...
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| Format: | Article |
| Language: | English |
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Wolters Kluwer Medknow Publications
2025-07-01
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| Series: | Lung India |
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| Online Access: | https://journals.lww.com/10.4103/lungindia.lungindia_609_24 |
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| author | Ira Shah Dhruv N. Gandhi Ramsha Ansari Himanshu Warse Sachi Kalawadia Tsering Yangchen Daksha Shah Varsha Puri Sanjay Mattoo Minnie Bodhanwala |
| author_facet | Ira Shah Dhruv N. Gandhi Ramsha Ansari Himanshu Warse Sachi Kalawadia Tsering Yangchen Daksha Shah Varsha Puri Sanjay Mattoo Minnie Bodhanwala |
| author_sort | Ira Shah |
| collection | DOAJ |
| description | Background and Objective:
This study evaluates the treatment outcomes and adverse drug reactions (ADRs) of longer oral bedaquiline (BDQ)-based (without delamanid) antitubercular therapy (ATT) regimens in children aged 5–18 years.
Methods:
A retrospective study was conducted between June 2021 and February 2024. We included 105 children diagnosed with drug-resistant tuberculosis (DR-TB) and treated with longer oral BDQ-based regimens. Duration of treatment was based on clinico-radiological resolution and multiple ADRs. Data on demographics, clinical features, resistance patterns, treatment regimens, outcomes, and adverse effects were analyzed.
Results:
Mean age was 11.29 ± 3.20 years, with a male-to-female ratio of 0.42:1. Prior ATT exposure was reported in 61 (58.1%), with previous treatment failure in 34 (55.7% of those with prior exposure) patients. BDQ was administered for a median duration of 6 months, with 14 (13.33%) requiring extension. BMLCC (bedaquiline–moxifloxacin–linezolid–cycloserine–clofazimine) regimen was received by 61 (58.1%), and BLCC ± additional drugs (bedaquiline–linezolid–clofazimine–cycloserine) regimen was received by 30 (28.6%) patients. Treatment completion was achieved in 75 (71.43%) patients with a mean duration of 22.50 ± 7.50 months, of which 35 (46.67%) required treatment for 18 months, 32 (42.67%) required treatment for more than 18 months, and 8 (10.67%) patients required treatment stoppage before 18 months in view of multiple ADRs. Fifty-one (48.6%) patients had ADRs, including QTc prolongation in 25 (23.8%), psychosis 11 (10.5%), and vomiting 7 (6.7%).
Conclusion:
BDQ-based regimens are effective in treating pediatric DR-TB, with high treatment completion rates. However, the duration of treatment is 18 months or longer in most patients based on clinico-radiological resolution. ADRs, particularly QTcF prolongation, warrant close monitoring and follow-up. |
| format | Article |
| id | doaj-art-499438a3f6c6402ca87da61d56f8e07c |
| institution | Kabale University |
| issn | 0970-2113 0974-598X |
| language | English |
| publishDate | 2025-07-01 |
| publisher | Wolters Kluwer Medknow Publications |
| record_format | Article |
| series | Lung India |
| spelling | doaj-art-499438a3f6c6402ca87da61d56f8e07c2025-08-20T03:29:44ZengWolters Kluwer Medknow PublicationsLung India0970-21130974-598X2025-07-0142433033610.4103/lungindia.lungindia_609_24Treatment outcomes of bedaquiline-based longer oral antitubercular regimens in Indian children above five years of ageIra ShahDhruv N. GandhiRamsha AnsariHimanshu WarseSachi KalawadiaTsering YangchenDaksha ShahVarsha PuriSanjay MattooMinnie BodhanwalaBackground and Objective: This study evaluates the treatment outcomes and adverse drug reactions (ADRs) of longer oral bedaquiline (BDQ)-based (without delamanid) antitubercular therapy (ATT) regimens in children aged 5–18 years. Methods: A retrospective study was conducted between June 2021 and February 2024. We included 105 children diagnosed with drug-resistant tuberculosis (DR-TB) and treated with longer oral BDQ-based regimens. Duration of treatment was based on clinico-radiological resolution and multiple ADRs. Data on demographics, clinical features, resistance patterns, treatment regimens, outcomes, and adverse effects were analyzed. Results: Mean age was 11.29 ± 3.20 years, with a male-to-female ratio of 0.42:1. Prior ATT exposure was reported in 61 (58.1%), with previous treatment failure in 34 (55.7% of those with prior exposure) patients. BDQ was administered for a median duration of 6 months, with 14 (13.33%) requiring extension. BMLCC (bedaquiline–moxifloxacin–linezolid–cycloserine–clofazimine) regimen was received by 61 (58.1%), and BLCC ± additional drugs (bedaquiline–linezolid–clofazimine–cycloserine) regimen was received by 30 (28.6%) patients. Treatment completion was achieved in 75 (71.43%) patients with a mean duration of 22.50 ± 7.50 months, of which 35 (46.67%) required treatment for 18 months, 32 (42.67%) required treatment for more than 18 months, and 8 (10.67%) patients required treatment stoppage before 18 months in view of multiple ADRs. Fifty-one (48.6%) patients had ADRs, including QTc prolongation in 25 (23.8%), psychosis 11 (10.5%), and vomiting 7 (6.7%). Conclusion: BDQ-based regimens are effective in treating pediatric DR-TB, with high treatment completion rates. However, the duration of treatment is 18 months or longer in most patients based on clinico-radiological resolution. ADRs, particularly QTcF prolongation, warrant close monitoring and follow-up.https://journals.lww.com/10.4103/lungindia.lungindia_609_24antitubercular therapychildhood tuberculosisdrug-resistant tuberculosislong dr-tb regimenspediatric tuberculosisqt prolongation |
| spellingShingle | Ira Shah Dhruv N. Gandhi Ramsha Ansari Himanshu Warse Sachi Kalawadia Tsering Yangchen Daksha Shah Varsha Puri Sanjay Mattoo Minnie Bodhanwala Treatment outcomes of bedaquiline-based longer oral antitubercular regimens in Indian children above five years of age Lung India antitubercular therapy childhood tuberculosis drug-resistant tuberculosis long dr-tb regimens pediatric tuberculosis qt prolongation |
| title | Treatment outcomes of bedaquiline-based longer oral antitubercular regimens in Indian children above five years of age |
| title_full | Treatment outcomes of bedaquiline-based longer oral antitubercular regimens in Indian children above five years of age |
| title_fullStr | Treatment outcomes of bedaquiline-based longer oral antitubercular regimens in Indian children above five years of age |
| title_full_unstemmed | Treatment outcomes of bedaquiline-based longer oral antitubercular regimens in Indian children above five years of age |
| title_short | Treatment outcomes of bedaquiline-based longer oral antitubercular regimens in Indian children above five years of age |
| title_sort | treatment outcomes of bedaquiline based longer oral antitubercular regimens in indian children above five years of age |
| topic | antitubercular therapy childhood tuberculosis drug-resistant tuberculosis long dr-tb regimens pediatric tuberculosis qt prolongation |
| url | https://journals.lww.com/10.4103/lungindia.lungindia_609_24 |
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