Selecting an appropriate all-oral short-course regimen for patients with multidrug-resistant or pre-extensive drug-resistant tuberculosis in China: A multicenter prospective cohort study
Objectives: Long, ineffective, and toxic regimens hinder the treatment of patients with multidrug-resistant tuberculosis (MDR-TB) and pre-extensive drug-resistant tuberculosis (pre-XDR-TB). Methods: We conducted a multicenter cohort study to prospectively evaluate the safety and efficacy of three 9-...
| Main Authors: | , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2023-10-01
|
| Series: | International Journal of Infectious Diseases |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1201971223006872 |
| _version_ | 1797674116508024832 |
|---|---|
| author | Liang Fu Xilin Zhang Juan Xiong Feng Sun Taoping Weng Yang Li Peize Zhang Hui Li Qianting Yang Yi Cai Hancheng Liang Qiuqi Chen Zhaoqing Wang Lei Liu Xinchun Chen Wenhong Zhang Guofang Deng |
| author_facet | Liang Fu Xilin Zhang Juan Xiong Feng Sun Taoping Weng Yang Li Peize Zhang Hui Li Qianting Yang Yi Cai Hancheng Liang Qiuqi Chen Zhaoqing Wang Lei Liu Xinchun Chen Wenhong Zhang Guofang Deng |
| author_sort | Liang Fu |
| collection | DOAJ |
| description | Objectives: Long, ineffective, and toxic regimens hinder the treatment of patients with multidrug-resistant tuberculosis (MDR-TB) and pre-extensive drug-resistant tuberculosis (pre-XDR-TB). Methods: We conducted a multicenter cohort study to prospectively evaluate the safety and efficacy of three 9-month, all-oral, 5-drug regimens. Regimen A (bedaquiline [Bdq]+linezolid [Lzd]+moxifloxacin [Mfx]+cycloserine [Cs]+pyrazinamide [Pza]) and Regimen B (Lzd+Mfx+Cs+clofazimine [Cfz]+Pza) were used to treat MDR-TB patients (Groups A and B, respectively, assigned according to the patient's treatment preference), while Regimen C (Bdq+Lzd+Cs+Cfz+Pza) was used to treat pre-XDR-TB patients (Group C). The primary endpoint was the occurrence of an unfavorable outcome within 12 months of treatment completion, regardless of regimen. Results: A total of 104 patients (34 in Group A, 46 in Group B, and 24 in Group C), with a median age of 35.5 (29.0-54.0) years, were included in the analysis population. At 12 months after treatment completion, five patients were deemed non-assessable. Of the remaining 99 participants, seven (7.1%) had an unfavorable outcome (including two deaths from any cause, four with treatment failure, and one loss to follow-up) and 92 (92.9%) had a favorable outcome. Culture conversion was achieved in 82.5% (80/97) of participants at month 2 and in 97.9% (94/97) of participants at month 6. Adverse events (AEs) resulting in drug adjustment occurred in 69.2% (72/104) of participants, mainly due to Lzd and Pza use. A QT interval prolongation of ≥ 500 ms occurred in 5.8% (6/104) of participants. Conclusion: The primary outcome of the three tailored, 9-month, all-oral, 5-drug regimens was satisfactory in the vast majority of MDR-TB and pre-XDR-TB patients, with manageable and reversible AEs. |
| first_indexed | 2024-03-11T21:54:28Z |
| format | Article |
| id | doaj.art-27a3d04a958b4e26942255aa5c84c63d |
| institution | Directory Open Access Journal |
| issn | 1201-9712 |
| language | English |
| last_indexed | 2024-03-11T21:54:28Z |
| publishDate | 2023-10-01 |
| publisher | Elsevier |
| record_format | Article |
| series | International Journal of Infectious Diseases |
| spelling | doaj.art-27a3d04a958b4e26942255aa5c84c63d2023-09-26T04:12:03ZengElsevierInternational Journal of Infectious Diseases1201-97122023-10-01135101108Selecting an appropriate all-oral short-course regimen for patients with multidrug-resistant or pre-extensive drug-resistant tuberculosis in China: A multicenter prospective cohort studyLiang Fu0Xilin Zhang1Juan Xiong2Feng Sun3Taoping Weng4Yang Li5Peize Zhang6Hui Li7Qianting Yang8Yi Cai9Hancheng Liang10Qiuqi Chen11Zhaoqing Wang12Lei Liu13Xinchun Chen14Wenhong Zhang15Guofang Deng16Division Two of Pulmonary Diseases Department, 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, ChinaTuberculosis Prevention and Control Department, The Fourth People's Hospital of Foshan, Foshan, ChinaHealth Science Center, Shenzhen University, Shenzhen, ChinaDepartment of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai, ChinaDepartment of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai, ChinaDepartment of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai, ChinaDivision Two of Pulmonary Diseases Department, 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, ChinaDivision Two of Pulmonary Diseases Department, 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, 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, ChinaDepartment of Pathogen Biology, Guangdong Key Laboratory of Regional Immunity and Diseases, Shenzhen University School of Medicine, Shenzhen, ChinaDivision Two of Tuberculosis Diseases Department, The Sixth People's Hospital of Dongguan, Dongguan, ChinaGraduate School of Guangdong Medical University, Zhanjiang, ChinaDivision Two of Pulmonary Diseases Department, 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, ChinaDivision Two of Pulmonary Diseases Department, 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, ChinaDepartment of Pathogen Biology, Guangdong Key Laboratory of Regional Immunity and Diseases, Shenzhen University School of Medicine, Shenzhen, ChinaDepartment of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai, ChinaDivision Two of Pulmonary Diseases Department, 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, China; Corresponding author: (G. Deng). Tel: +86-13530027001Objectives: Long, ineffective, and toxic regimens hinder the treatment of patients with multidrug-resistant tuberculosis (MDR-TB) and pre-extensive drug-resistant tuberculosis (pre-XDR-TB). Methods: We conducted a multicenter cohort study to prospectively evaluate the safety and efficacy of three 9-month, all-oral, 5-drug regimens. Regimen A (bedaquiline [Bdq]+linezolid [Lzd]+moxifloxacin [Mfx]+cycloserine [Cs]+pyrazinamide [Pza]) and Regimen B (Lzd+Mfx+Cs+clofazimine [Cfz]+Pza) were used to treat MDR-TB patients (Groups A and B, respectively, assigned according to the patient's treatment preference), while Regimen C (Bdq+Lzd+Cs+Cfz+Pza) was used to treat pre-XDR-TB patients (Group C). The primary endpoint was the occurrence of an unfavorable outcome within 12 months of treatment completion, regardless of regimen. Results: A total of 104 patients (34 in Group A, 46 in Group B, and 24 in Group C), with a median age of 35.5 (29.0-54.0) years, were included in the analysis population. At 12 months after treatment completion, five patients were deemed non-assessable. Of the remaining 99 participants, seven (7.1%) had an unfavorable outcome (including two deaths from any cause, four with treatment failure, and one loss to follow-up) and 92 (92.9%) had a favorable outcome. Culture conversion was achieved in 82.5% (80/97) of participants at month 2 and in 97.9% (94/97) of participants at month 6. Adverse events (AEs) resulting in drug adjustment occurred in 69.2% (72/104) of participants, mainly due to Lzd and Pza use. A QT interval prolongation of ≥ 500 ms occurred in 5.8% (6/104) of participants. Conclusion: The primary outcome of the three tailored, 9-month, all-oral, 5-drug regimens was satisfactory in the vast majority of MDR-TB and pre-XDR-TB patients, with manageable and reversible AEs.http://www.sciencedirect.com/science/article/pii/S1201971223006872Multidrug-resistant tuberculosisPre-extensive drug-resistant tuberculosisTreatmentShort-courseSafety |
| spellingShingle | Liang Fu Xilin Zhang Juan Xiong Feng Sun Taoping Weng Yang Li Peize Zhang Hui Li Qianting Yang Yi Cai Hancheng Liang Qiuqi Chen Zhaoqing Wang Lei Liu Xinchun Chen Wenhong Zhang Guofang Deng Selecting an appropriate all-oral short-course regimen for patients with multidrug-resistant or pre-extensive drug-resistant tuberculosis in China: A multicenter prospective cohort study International Journal of Infectious Diseases Multidrug-resistant tuberculosis Pre-extensive drug-resistant tuberculosis Treatment Short-course Safety |
| title | Selecting an appropriate all-oral short-course regimen for patients with multidrug-resistant or pre-extensive drug-resistant tuberculosis in China: A multicenter prospective cohort study |
| title_full | Selecting an appropriate all-oral short-course regimen for patients with multidrug-resistant or pre-extensive drug-resistant tuberculosis in China: A multicenter prospective cohort study |
| title_fullStr | Selecting an appropriate all-oral short-course regimen for patients with multidrug-resistant or pre-extensive drug-resistant tuberculosis in China: A multicenter prospective cohort study |
| title_full_unstemmed | Selecting an appropriate all-oral short-course regimen for patients with multidrug-resistant or pre-extensive drug-resistant tuberculosis in China: A multicenter prospective cohort study |
| title_short | Selecting an appropriate all-oral short-course regimen for patients with multidrug-resistant or pre-extensive drug-resistant tuberculosis in China: A multicenter prospective cohort study |
| title_sort | selecting an appropriate all oral short course regimen for patients with multidrug resistant or pre extensive drug resistant tuberculosis in china a multicenter prospective cohort study |
| topic | Multidrug-resistant tuberculosis Pre-extensive drug-resistant tuberculosis Treatment Short-course Safety |
| url | http://www.sciencedirect.com/science/article/pii/S1201971223006872 |
| work_keys_str_mv | AT liangfu selectinganappropriatealloralshortcourseregimenforpatientswithmultidrugresistantorpreextensivedrugresistanttuberculosisinchinaamulticenterprospectivecohortstudy AT xilinzhang selectinganappropriatealloralshortcourseregimenforpatientswithmultidrugresistantorpreextensivedrugresistanttuberculosisinchinaamulticenterprospectivecohortstudy AT juanxiong selectinganappropriatealloralshortcourseregimenforpatientswithmultidrugresistantorpreextensivedrugresistanttuberculosisinchinaamulticenterprospectivecohortstudy AT fengsun selectinganappropriatealloralshortcourseregimenforpatientswithmultidrugresistantorpreextensivedrugresistanttuberculosisinchinaamulticenterprospectivecohortstudy AT taopingweng selectinganappropriatealloralshortcourseregimenforpatientswithmultidrugresistantorpreextensivedrugresistanttuberculosisinchinaamulticenterprospectivecohortstudy AT yangli selectinganappropriatealloralshortcourseregimenforpatientswithmultidrugresistantorpreextensivedrugresistanttuberculosisinchinaamulticenterprospectivecohortstudy AT peizezhang selectinganappropriatealloralshortcourseregimenforpatientswithmultidrugresistantorpreextensivedrugresistanttuberculosisinchinaamulticenterprospectivecohortstudy AT huili selectinganappropriatealloralshortcourseregimenforpatientswithmultidrugresistantorpreextensivedrugresistanttuberculosisinchinaamulticenterprospectivecohortstudy AT qiantingyang selectinganappropriatealloralshortcourseregimenforpatientswithmultidrugresistantorpreextensivedrugresistanttuberculosisinchinaamulticenterprospectivecohortstudy AT yicai selectinganappropriatealloralshortcourseregimenforpatientswithmultidrugresistantorpreextensivedrugresistanttuberculosisinchinaamulticenterprospectivecohortstudy AT hanchengliang selectinganappropriatealloralshortcourseregimenforpatientswithmultidrugresistantorpreextensivedrugresistanttuberculosisinchinaamulticenterprospectivecohortstudy AT qiuqichen selectinganappropriatealloralshortcourseregimenforpatientswithmultidrugresistantorpreextensivedrugresistanttuberculosisinchinaamulticenterprospectivecohortstudy AT zhaoqingwang selectinganappropriatealloralshortcourseregimenforpatientswithmultidrugresistantorpreextensivedrugresistanttuberculosisinchinaamulticenterprospectivecohortstudy AT leiliu selectinganappropriatealloralshortcourseregimenforpatientswithmultidrugresistantorpreextensivedrugresistanttuberculosisinchinaamulticenterprospectivecohortstudy AT xinchunchen selectinganappropriatealloralshortcourseregimenforpatientswithmultidrugresistantorpreextensivedrugresistanttuberculosisinchinaamulticenterprospectivecohortstudy AT wenhongzhang selectinganappropriatealloralshortcourseregimenforpatientswithmultidrugresistantorpreextensivedrugresistanttuberculosisinchinaamulticenterprospectivecohortstudy AT guofangdeng selectinganappropriatealloralshortcourseregimenforpatientswithmultidrugresistantorpreextensivedrugresistanttuberculosisinchinaamulticenterprospectivecohortstudy |