Li Shi1, Jingtao Gao2, Mengqiu Gao3, Ping Deng1, Shu Chen4, Minfu He4, Wenjun Feng1, Xiaoyun Yang1, Yunhui Huang1, Fang He1, Yumeng Hu1, Liping Lei1, Xuelian Li3, Juan Du5, Xiaomeng Hu5, Zhi Liu6, Peijun Tang7, Junfeng Han8, Hua Wang9, Yi Han9, Wei Shu2, Yuxian Sun2, Yi Pei10, Yuhong Liu11. 1. Department of Tuberculosis, Changsha Central Hospital, University of South China, Changsha, 410007, China. 2. Clinical Center on TB, Beijing Chest Hospital, Capital Medical University/Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing, 101149, China. 3. Department of Tuberculosis, Beijing Chest Hospital, Capital Medical University/Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing, 101149, China. 4. Beijing Innovation Alliance of TB Diagnosis and Treatment, Beijing, 101149, China. 5. Department of Tuberculosis, Wuhan Pulmonary Hospital, Wuhan, 430030, China. 6. Department of Tuberculosis, Shenzhen Third People's Hospital, Shenzhen, 518000, China. 7. The Fifth People's Hospital of Suzhou, Suzhou, 215000, China. 8. Tianjin Haihe Hospital, Tianjin, 300000, China. 9. Anhui Chest Hospital, Hefei, 230000, China. 10. Department of Tuberculosis, Changsha Central Hospital, University of South China, Changsha, 410007, China. 1113284116@qq.com. 11. Clinical Center on TB, Beijing Chest Hospital, Capital Medical University/Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing, 101149, China. liuyuhong0516@126.com.
Abstract
INTRODUCTION: Diabetes mellitus (DM), a common tuberculosis (TB) comorbidity, is associated with delayed bacillary clearance during anti-TB treatment and unfavorable outcomes. Bedaquiline (BDQ), when used as part of multidrug regimen for multidrug-resistant/extensively drug-resistant tuberculosis (MDR/XDR-TB), has been shown to be effective and safe although treatment outcome and risks for patients with MDR/XDR-TB and DM are unknown. A multicenter retrospective study was conducted to compared the safety and effectiveness of 24-week BDQ-containing anti-TB treatment for patients with MDR/XDR-TB with and without DM. METHODS: The study of patients with MDR/XDR-TB with or without DM (enrolled February 2018-September 2019, 21 Chinese hospitals) was supervised by the New Drug Introduction and Protection Program (NDIP). Of 640 patients with MDR/XDR-TB receiving BDQ-containing anti-TB treatments, two propensity score-matched groups (107 DM/107 non-DM) were compared for cumulative culture conversion rate, time to culture conversion, adverse events, and corrected QT interval. RESULTS: Body mass index was higher in patients with DM than patients without DM (23.29 ± 3.9 vs. 20.5 ± 3.6, P < 0.001); lung cavity prevalence (86.9% vs. 72.9%, P = 0.037) was also higher in patients with DM; the non-DM group had higher hepatitis prevalence (29.0% vs. 15.9%, P = 0.022). No significant intergroup differences were found for sputum culture conversion rate at week 8 (80.0% vs. 81.4%, P = 0.884), at week 24 (95.6% vs. 98.2%, P = 0.629), or for median time to sputum culture conversion [56 days (IQR 28-63) vs. 56 days (IQR 28-84) (P = 0.687)]. Favorable post-24-week treatment outcomes were presented by 90.7% and 93.5% in the DM group and non-DM group, respectively, without significant intergroup differences (P = 0.448). The DM adverse event rate exceeded non-DM rate (77.6% vs. 64.5%, P = 0.035). CONCLUSION: Despite some differences in baseline characteristics, Chinese patients with MDR/XDR-TB with or without DM had similar sputum culture conversion rates and favorable treatment outcomes post-24-week BDQ-containing anti-TB treatment. Low BMI but not DM is risk factor associated with unfavorable outcome of patients with MDR/XDR-TB.
INTRODUCTION:Diabetes mellitus (DM), a common tuberculosis (TB) comorbidity, is associated with delayed bacillary clearance during anti-TB treatment and unfavorable outcomes. Bedaquiline (BDQ), when used as part of multidrug regimen for multidrug-resistant/extensively drug-resistant tuberculosis (MDR/XDR-TB), has been shown to be effective and safe although treatment outcome and risks for patients with MDR/XDR-TB and DM are unknown. A multicenter retrospective study was conducted to compared the safety and effectiveness of 24-week BDQ-containing anti-TB treatment for patients with MDR/XDR-TB with and without DM. METHODS: The study of patients with MDR/XDR-TB with or without DM (enrolled February 2018-September 2019, 21 Chinese hospitals) was supervised by the New Drug Introduction and Protection Program (NDIP). Of 640 patients with MDR/XDR-TB receiving BDQ-containing anti-TB treatments, two propensity score-matched groups (107 DM/107 non-DM) were compared for cumulative culture conversion rate, time to culture conversion, adverse events, and corrected QT interval. RESULTS: Body mass index was higher in patients with DM than patients without DM (23.29 ± 3.9 vs. 20.5 ± 3.6, P < 0.001); lung cavity prevalence (86.9% vs. 72.9%, P = 0.037) was also higher in patients with DM; the non-DM group had higher hepatitis prevalence (29.0% vs. 15.9%, P = 0.022). No significant intergroup differences were found for sputum culture conversion rate at week 8 (80.0% vs. 81.4%, P = 0.884), at week 24 (95.6% vs. 98.2%, P = 0.629), or for median time to sputum culture conversion [56 days (IQR 28-63) vs. 56 days (IQR 28-84) (P = 0.687)]. Favorable post-24-week treatment outcomes were presented by 90.7% and 93.5% in the DM group and non-DM group, respectively, without significant intergroup differences (P = 0.448). The DM adverse event rate exceeded non-DM rate (77.6% vs. 64.5%, P = 0.035). CONCLUSION: Despite some differences in baseline characteristics, Chinese patients with MDR/XDR-TB with or without DM had similar sputum culture conversion rates and favorable treatment outcomes post-24-week BDQ-containing anti-TB treatment. Low BMI but not DM is risk factor associated with unfavorable outcome of patients with MDR/XDR-TB.
Authors: M Gao; J Gao; L Xie; G Wu; W Chen; Y Chen; Y Pei; G Li; Y Liu; W Shu; L Fan; Q Wu; J Du; X Chen; P Tang; Y Xiong; M Li; Q Cai; L Jin; Z Mei; Y Pang; L Li Journal: Clin Microbiol Infect Date: 2020-06-15 Impact factor: 8.067
Authors: J W C Alffenaar; S L Stocker; L Davies Forsman; A Garcia-Prats; S K Heysell; R E Aarnoutse; O W Akkerman; A Aleksa; R van Altena; W Arrazola de Oñata; P K Bhavani; N Van't Boveneind-Vrubleuskaya; A C C Carvalho; R Centis; J M Chakaya; D M Cirillo; J G Cho; L D Ambrosio; M P Dalcolmo; P Denti; K Dheda; G J Fox; A C Hesseling; H Y Kim; C U Köser; B J Marais; I Margineanu; A G Märtson; M Munoz Torrico; H M Nataprawira; C W M Ong; R Otto-Knapp; C A Peloquin; D R Silva; R Ruslami; P Santoso; R M Savic; R Singla; E M Svensson; A Skrahina; D van Soolingen; S Srivastava; M Tadolini; S Tiberi; T A Thomas; Z F Udwadia; D H Vu; W Zhang; S G Mpagama; T Schön; G B Migliori Journal: Int J Tuberc Lung Dis Date: 2022-06-01 Impact factor: 3.427