Insignificant difference in culture conversion between bedaquiline-containing and bedaquiline-free all-oral short regimens for multidrug-resistant tuberculosis
Background: Multidrug-resistant tuberculosis (MDR-TB) patients have been suffering long, ineffective, and toxic treatment until short-course injectable-free regimens emerged. However, the new WHO-recommended regimens might be less feasible in the real-world setting. Here, we evaluated two optimized...
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| Language: | English |
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Elsevier
2021-10-01
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| Series: | International Journal of Infectious Diseases |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S1201971221006883 |
| _version_ | 1830189011863339008 |
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| author | Liang Fu Taoping Weng Feng Sun Peize Zhang Hui Li Yang Li Qianting Yang Yi Cai Xilin Zhang Hancheng Liang Xinchun Chen Zhaoqin Wang Lei Liu Wenhong Zhang Guofang Deng |
| author_facet | Liang Fu Taoping Weng Feng Sun Peize Zhang Hui Li Yang Li Qianting Yang Yi Cai Xilin Zhang Hancheng Liang Xinchun Chen Zhaoqin Wang Lei Liu Wenhong Zhang Guofang Deng |
| author_sort | Liang Fu |
| collection | DOAJ |
| description | Background: Multidrug-resistant tuberculosis (MDR-TB) patients have been suffering long, ineffective, and toxic treatment until short-course injectable-free regimens emerged. However, the new WHO-recommended regimens might be less feasible in the real-world setting. Here, we evaluated two optimized all-oral short-course regimens in China. Methods: From April 2019 to August 2020, we conducted a prospective nonrandomized controlled trial and consecutively included 103 MDR-TB patients diagnosed with pulmonary MDR-TB in Shenzhen, China. A 4-5 drug regimen of 9-12 months was tailored to the strain's resistance patterns, patients' affordability, and tolerance to drugs. This was an interim analysis, focusing on the early treatment period. Results: 53.4% (55/103) of patients were prescribed linezolid, fluoroquinolone (FQ), clofazimine, cycloserine, and pyrazinamide, followed by a regimen in which clofazimine was replaced by bedaquiline (35/103, 34.0%). The culture conversion rate was 83.1% and 94.4% at two and four months, respectively, with no significant difference between bedaquiline-free and bedaquiline-containing cases and between FQ-susceptible and FQ-resistant cases. Among 41 patients who completed treatment, 40 (97.6%) patients had a favorable outcome and no relapse was observed. Peripheral neuropathy and arthralgia/myalgia were the most frequent AEs (56.3%, 58/103). 18 AEs caused permanent discontinuation of drugs, mostly due to pyrazinamide and linezolid. Conclusion: Optimized all-oral short-course regimens showed satisfactory efficacy and safety in early treatment stage. Further research is needed to confirm these results. |
| first_indexed | 2024-12-17T22:55:32Z |
| format | Article |
| id | doaj.art-feb4b25d0f9048098eacf77f796f6671 |
| institution | Directory Open Access Journal |
| issn | 1201-9712 |
| language | English |
| last_indexed | 2024-12-17T22:55:32Z |
| publishDate | 2021-10-01 |
| publisher | Elsevier |
| record_format | Article |
| series | International Journal of Infectious Diseases |
| spelling | doaj.art-feb4b25d0f9048098eacf77f796f66712022-12-21T21:29:33ZengElsevierInternational Journal of Infectious Diseases1201-97122021-10-01111138147Insignificant difference in culture conversion between bedaquiline-containing and bedaquiline-free all-oral short regimens for multidrug-resistant tuberculosisLiang Fu0Taoping Weng1Feng Sun2Peize Zhang3Hui Li4Yang Li5Qianting Yang6Yi Cai7Xilin Zhang8Hancheng Liang9Xinchun Chen10Zhaoqin Wang11Lei Liu12Wenhong Zhang13Guofang Deng14Pulmonary Diseases Department Two, National Clinical Research Center for Infectious Disease (Shenzhen), Guangdong Provincial Clinical Research Center for Infectious Diseases (Tuberculosis), Shenzhen Third People's Hospital, Southern University of Science and Technology, Shenzhen, 518112, ChinaDepartments of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai, 200040, ChinaDepartments of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai, 200040, ChinaPulmonary Diseases Department Two, National Clinical Research Center for Infectious Disease (Shenzhen), Guangdong Provincial Clinical Research Center for Infectious Diseases (Tuberculosis), Shenzhen Third People's Hospital, Southern University of Science and Technology, Shenzhen, 518112, ChinaPulmonary Diseases Department Two, National Clinical Research Center for Infectious Disease (Shenzhen), Guangdong Provincial Clinical Research Center for Infectious Diseases (Tuberculosis), Shenzhen Third People's Hospital, Southern University of Science and Technology, Shenzhen, 518112, ChinaDepartments of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai, 200040, ChinaGuangdong Key Lab for Diagnosis &Treatment of Emerging Infectious Disease, Shenzhen Third People's Hospital, National clinical research center for infectious disease, Southern University of Science and Technology, Shenzhen, 518112, ChinaDepartment of Pathogen Biology, Guangdong Key Laboratory of Regional Immunity and Diseases, Shenzhen University School of Medicine, Shenzhen, 518060, ChinaThe Fourth People's Hospital of Foshan, Foshan, 528000, ChinaTuberculosis Diseases Department Two, The Sixth People's Hospital of Dongguan, Dongguan, 523000, ChinaDepartment of Pathogen Biology, Guangdong Key Laboratory of Regional Immunity and Diseases, Shenzhen University School of Medicine, Shenzhen, 518060, ChinaPulmonary Diseases Department Two, National Clinical Research Center for Infectious Disease (Shenzhen), Guangdong Provincial Clinical Research Center for Infectious Diseases (Tuberculosis), Shenzhen Third People's Hospital, Southern University of Science and Technology, Shenzhen, 518112, ChinaPulmonary Diseases Department Two, National Clinical Research Center for Infectious Disease (Shenzhen), Guangdong Provincial Clinical Research Center for Infectious Diseases (Tuberculosis), Shenzhen Third People's Hospital, Southern University of Science and Technology, Shenzhen, 518112, China; Correspondence to.Departments of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai, 200040, China; Correspondence to.Pulmonary Diseases Department Two, National Clinical Research Center for Infectious Disease (Shenzhen), Guangdong Provincial Clinical Research Center for Infectious Diseases (Tuberculosis), Shenzhen Third People's Hospital, Southern University of Science and Technology, Shenzhen, 518112, China; Correspondence to.Background: Multidrug-resistant tuberculosis (MDR-TB) patients have been suffering long, ineffective, and toxic treatment until short-course injectable-free regimens emerged. However, the new WHO-recommended regimens might be less feasible in the real-world setting. Here, we evaluated two optimized all-oral short-course regimens in China. Methods: From April 2019 to August 2020, we conducted a prospective nonrandomized controlled trial and consecutively included 103 MDR-TB patients diagnosed with pulmonary MDR-TB in Shenzhen, China. A 4-5 drug regimen of 9-12 months was tailored to the strain's resistance patterns, patients' affordability, and tolerance to drugs. This was an interim analysis, focusing on the early treatment period. Results: 53.4% (55/103) of patients were prescribed linezolid, fluoroquinolone (FQ), clofazimine, cycloserine, and pyrazinamide, followed by a regimen in which clofazimine was replaced by bedaquiline (35/103, 34.0%). The culture conversion rate was 83.1% and 94.4% at two and four months, respectively, with no significant difference between bedaquiline-free and bedaquiline-containing cases and between FQ-susceptible and FQ-resistant cases. Among 41 patients who completed treatment, 40 (97.6%) patients had a favorable outcome and no relapse was observed. Peripheral neuropathy and arthralgia/myalgia were the most frequent AEs (56.3%, 58/103). 18 AEs caused permanent discontinuation of drugs, mostly due to pyrazinamide and linezolid. Conclusion: Optimized all-oral short-course regimens showed satisfactory efficacy and safety in early treatment stage. Further research is needed to confirm these results.http://www.sciencedirect.com/science/article/pii/S1201971221006883Multidrug-resistanttuberculosistreatmentoutcomesafetyclinical trials |
| spellingShingle | Liang Fu Taoping Weng Feng Sun Peize Zhang Hui Li Yang Li Qianting Yang Yi Cai Xilin Zhang Hancheng Liang Xinchun Chen Zhaoqin Wang Lei Liu Wenhong Zhang Guofang Deng Insignificant difference in culture conversion between bedaquiline-containing and bedaquiline-free all-oral short regimens for multidrug-resistant tuberculosis International Journal of Infectious Diseases Multidrug-resistant tuberculosis treatment outcome safety clinical trials |
| title | Insignificant difference in culture conversion between bedaquiline-containing and bedaquiline-free all-oral short regimens for multidrug-resistant tuberculosis |
| title_full | Insignificant difference in culture conversion between bedaquiline-containing and bedaquiline-free all-oral short regimens for multidrug-resistant tuberculosis |
| title_fullStr | Insignificant difference in culture conversion between bedaquiline-containing and bedaquiline-free all-oral short regimens for multidrug-resistant tuberculosis |
| title_full_unstemmed | Insignificant difference in culture conversion between bedaquiline-containing and bedaquiline-free all-oral short regimens for multidrug-resistant tuberculosis |
| title_short | Insignificant difference in culture conversion between bedaquiline-containing and bedaquiline-free all-oral short regimens for multidrug-resistant tuberculosis |
| title_sort | insignificant difference in culture conversion between bedaquiline containing and bedaquiline free all oral short regimens for multidrug resistant tuberculosis |
| topic | Multidrug-resistant tuberculosis treatment outcome safety clinical trials |
| url | http://www.sciencedirect.com/science/article/pii/S1201971221006883 |
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