E Burhan, J Sugiharto, M Soemarno, A Juan, Y Runtu, A Yuvensia, R Ramadhani, J Sabono, A Lailiyah, F Fenni, M Farikha, T Pakasi, I Pambudi, M Mbenga, I Koppelaar, V Mirtskhulava, F Wares, D Jerene, J K Jung, J S Lee, S Foraida, S Juneja, M Diachenko, A Gebhard
{"title":"在前瞻性BPaL队列研究中，治疗成功率和培养转化时间。","authors":"E Burhan, J Sugiharto, M Soemarno, A Juan, Y Runtu, A Yuvensia, R Ramadhani, J Sabono, A Lailiyah, F Fenni, M Farikha, T Pakasi, I Pambudi, M Mbenga, I Koppelaar, V Mirtskhulava, F Wares, D Jerene, J K Jung, J S Lee, S Foraida, S Juneja, M Diachenko, A Gebhard","doi":"10.5588/ijtldopen.24.0524","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>In July 2022, Indonesia implemented the 6-month BPaL (bedaquiline, pretomanid, linezolid) regimen under operational research (OR) for selected drug-resistant tuberculosis patients. The study aimed to assess treatment success rate (TSR) and time to sputum culture conversion (TSCC).</p><p><strong>Methods: </strong>A prospective cohort study in fifteen sites between July 2022 and March 2023 enrolled patients with rifampicin-resistant/multidrug-resistant TB with additional fluoroquinolone resistance or intolerance/failures of previous second-line TB treatment. TSR was descriptively analysed, and Kaplan-Meier and Cox proportional-hazards analyses were used to evaluate TSCC.</p><p><strong>Results: </strong>A total of 87 patients were enrolled, 3 were withdrawn, and 84 completed treatment and had outcomes; 82 (97.6%) patients had successful treatment, 1 (1.2%) died, and 1 (1.2%) had failure. Overall, 61 (72.6%) patients had positive cultures at baseline, and favourable outcomes were included in the TSCC analysis; all 61 (100%) converted within the first 3 months (median 32 days of treatment, IQR 30.0-56.0). None of the six variables were statistically associated with conversion time.</p><p><strong>Conclusion: </strong>The Indonesian BPaL OR showed a highly promising TSR of 97.6%, with 100% sputum conversion within 3 months. The lack of observed statistical differences in the TSCC across variables shows that the BPaL treatment will be equally effective in all patient groups.</p>","PeriodicalId":519984,"journal":{"name":"IJTLD open","volume":"2 5","pages":"284-290"},"PeriodicalIF":0.0000,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12068447/pdf/","citationCount":"0","resultStr":"{\"title\":\"Treatment success rate and time to culture conversion under a prospective BPaL cohort study.\",\"authors\":\"E Burhan, J Sugiharto, M Soemarno, A Juan, Y Runtu, A Yuvensia, R Ramadhani, J Sabono, A Lailiyah, F Fenni, M Farikha, T Pakasi, I Pambudi, M Mbenga, I Koppelaar, V Mirtskhulava, F Wares, D Jerene, J K Jung, J S Lee, S Foraida, S Juneja, M Diachenko, A Gebhard\",\"doi\":\"10.5588/ijtldopen.24.0524\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>In July 2022, Indonesia implemented the 6-month BPaL (bedaquiline, pretomanid, linezolid) regimen under operational research (OR) for selected drug-resistant tuberculosis patients. The study aimed to assess treatment success rate (TSR) and time to sputum culture conversion (TSCC).</p><p><strong>Methods: </strong>A prospective cohort study in fifteen sites between July 2022 and March 2023 enrolled patients with rifampicin-resistant/multidrug-resistant TB with additional fluoroquinolone resistance or intolerance/failures of previous second-line TB treatment. TSR was descriptively analysed, and Kaplan-Meier and Cox proportional-hazards analyses were used to evaluate TSCC.</p><p><strong>Results: </strong>A total of 87 patients were enrolled, 3 were withdrawn, and 84 completed treatment and had outcomes; 82 (97.6%) patients had successful treatment, 1 (1.2%) died, and 1 (1.2%) had failure. Overall, 61 (72.6%) patients had positive cultures at baseline, and favourable outcomes were included in the TSCC analysis; all 61 (100%) converted within the first 3 months (median 32 days of treatment, IQR 30.0-56.0). None of the six variables were statistically associated with conversion time.</p><p><strong>Conclusion: </strong>The Indonesian BPaL OR showed a highly promising TSR of 97.6%, with 100% sputum conversion within 3 months. The lack of observed statistical differences in the TSCC across variables shows that the BPaL treatment will be equally effective in all patient groups.</p>\",\"PeriodicalId\":519984,\"journal\":{\"name\":\"IJTLD open\",\"volume\":\"2 5\",\"pages\":\"284-290\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-05-12\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12068447/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"IJTLD open\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.5588/ijtldopen.24.0524\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/5/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"IJTLD open","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.5588/ijtldopen.24.0524","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/5/1 0:00:00","PubModel":"eCollection","JCR":"","JCRName":"","Score":null,"Total":0}
Treatment success rate and time to culture conversion under a prospective BPaL cohort study.
Background: In July 2022, Indonesia implemented the 6-month BPaL (bedaquiline, pretomanid, linezolid) regimen under operational research (OR) for selected drug-resistant tuberculosis patients. The study aimed to assess treatment success rate (TSR) and time to sputum culture conversion (TSCC).
Methods: A prospective cohort study in fifteen sites between July 2022 and March 2023 enrolled patients with rifampicin-resistant/multidrug-resistant TB with additional fluoroquinolone resistance or intolerance/failures of previous second-line TB treatment. TSR was descriptively analysed, and Kaplan-Meier and Cox proportional-hazards analyses were used to evaluate TSCC.
Results: A total of 87 patients were enrolled, 3 were withdrawn, and 84 completed treatment and had outcomes; 82 (97.6%) patients had successful treatment, 1 (1.2%) died, and 1 (1.2%) had failure. Overall, 61 (72.6%) patients had positive cultures at baseline, and favourable outcomes were included in the TSCC analysis; all 61 (100%) converted within the first 3 months (median 32 days of treatment, IQR 30.0-56.0). None of the six variables were statistically associated with conversion time.
Conclusion: The Indonesian BPaL OR showed a highly promising TSR of 97.6%, with 100% sputum conversion within 3 months. The lack of observed statistical differences in the TSCC across variables shows that the BPaL treatment will be equally effective in all patient groups.
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