Insignificant difference in culture conversion between bedaquiline-containing and bedaquiline-free all-oral short regimens for multidrug-resistant tuberculosis

Fu，Liang1; Weng，Taoping2; Sun，Feng2; Zhang，Peize1; Li，Hui1; Li，Yang2; Yang，Qianting3; Cai，Yi4; Zhang，Xilin5; Liang，Hancheng6; Chen，Xinchun4; Wang，Zhaoqin1; Liu，Lei1; Zhang，Wenhong2; Deng，Guofang1

2021-10-01

10.1016/j.ijid.2021.08.055

INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES   影响因子和分区

1201-9712

1878-3511

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.

clinical trials Multidrug-resistant outcome safety treatment tuberculosis

SCI

英语

第一 ; 通讯

National Key Research and Development Plan["2020YFA0907200","2019YFC0840602"] ; Guangdong Foundation for Basic and Applied Basic Research[2019B1515120041] ; Guangdong Science and Technology Plan[2020B1111170014] ; Shenzhen Scientific and Technological Foundation[KCXFZ2020020110 07083] ; Summit Plan for Foshan High-level Hospital Construction[FSSYKF-2020001] ; Clinical Research Plan of SHDC[SHDC2020CR1011B]

Infectious Diseases

Infectious Diseases

WOS:000706974100023

ELSEVIER SCI LTD

IMMUNOLOGY

2-s2.0-85114951706

Scopus

1.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
2.Departments of Infectious Diseases,Huashan Hospital,Fudan University,200040,China
3.Guangdong 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,China
4.Department of Pathogen Biology,Guangdong Key Laboratory of Regional Immunity and Diseases,Shenzhen University School of Medicine,Shenzhen,518060,China
5.The Fourth People's Hospital of Foshan,Foshan,528000,China
6.Tuberculosis Diseases Department Two,The Sixth People's Hospital of Dongguan,Dongguan,523000,China

Fu，Liang,Weng，Taoping,Sun，Feng,et al. Insignificant difference in culture conversion between bedaquiline-containing and bedaquiline-free all-oral short regimens for multidrug-resistant tuberculosis[J]. INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES,2021,111:138-147.

Fu，Liang.,Weng，Taoping.,Sun，Feng.,Zhang，Peize.,Li，Hui.,...&Deng，Guofang.(2021).Insignificant difference in culture conversion between bedaquiline-containing and bedaquiline-free all-oral short regimens for multidrug-resistant tuberculosis.INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES,111,138-147.

Fu，Liang,et al."Insignificant difference in culture conversion between bedaquiline-containing and bedaquiline-free all-oral short regimens for multidrug-resistant tuberculosis".INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES 111(2021):138-147.