Research progress on pharmacokinetics and drug interaction of bedaquiline

doi:10.19982/j.issn.1000-6621.20220092

Abstract

Abstract:

As the new anti-tuberculosis drug, bedaquiline is often used in combination with other second-line anti-tuberculosis drugs. In view of the increasing literature on the pharmacokinetics of bedaquiline and the limited understanding of some clinicians about its pharmacokinetics, especially drug interactions, this review summarized the relevant literature on the pharmacokinetics, effect of covariates on pharmacokinetics and exposure-response relationship drug interactions, etc. It is expected that this paper can provide help for guiding clinicians to use drugs and researchers to carry out research.

Key words: Antitubercular agents, Tuberculosis, Pharmacokinetics, Review

CLC Number:

NIE Wen-juan, ZHOU Wen-qiang, CHU Nai-hui. Research progress on pharmacokinetics and drug interaction of bedaquiline[J]. Chinese Journal of Antituberculosis, 2022, 44(7): 716-719. doi: 10.19982/j.issn.1000-6621.20220092

References 24

[1]	World Health Organization. Global tuberculosis report 2021. Geneva: World Health Organization, 2021.
[2]	安军, 逄宇. 抗结核新药的临床应用:新希望与新挑战. 中国防痨杂志, 2022, 44(3):205-208. doi: 10.19982/j.issn.1000-6621.20220011. doi: 10.19982/j.issn.1000-6621.20220011
[3]	吴国兰, 高静韬, 陈晓红, 等. 含贝达喹啉方案治疗耐多药/广泛耐药结核病的近期疗效及安全性分析. 中国防痨杂志, 2021, 43(9):899-904. doi: 10.19982/j.issn.1000-6621.20220011. doi: 10.19982/j.issn.1000-6621.20220011
[4]	谢莉, 朱慧, 高静韬, 等. 贝达喹啉血药浓度在耐药肺结核治疗中的变化及其与QTc间期延长的相关性. 中国防痨杂志, 2022, 44(3):219-226. doi: 10.19982/j.issn.1000-6621.20210696. doi: 10.19982/j.issn.1000-6621.20210696
[5]	廖伟明, 付亮, 邓国防, 等. 含贝达喹啉方案治疗耐多药结核病的研究进展. 中国防痨杂志, 2021, 43(6):619-624. doi: 10.3969/j.issn.1000-6621.2021.06.017. doi: 10.3969/j.issn.1000-6621.2021.06.017
[6]	Liu K, Li F, Lu J, et al. Bedaquiline metabolism:enzymes and novel metabolites. Drug Metab Dispos, 2014, 42(5):863-866. doi: 10.1124/dmd.113.056119. doi: 10.1124/dmd.113.056119 pmid: 24513655
[7]	朱慧, 刘忠泉, 谢莉, 等. 应用高效液相色谱-质谱/质谱联用技术检测贝达喹啉血药浓度. 中国防痨杂志, 2018, 40(12):1319-1324. doi: 10.3969/j.issn.1000-6621.2018.12.015. doi: 10.3969/j.issn.1000-6621.2018.12.015
[8]	Tsuyuguchi K, Sasaki Y, Mitarai S, et al. Safety, efficacy, and pharmacokinetics of bedaquiline in Japanese patients with pulmonary multidrug-resistance tuberculosis: an interim analysis of an open-label phase 2 study. Resp Investig, 2019, 57(4):345-353. doi: 10.1016/j.resinv.2019.01.001. doi: 10.1016/j.resinv.2019.01.001
[9]	Salinger DH, Nedelman JR, Mendel C, et al. Daily dosing for bedaquiline in patients with tuberculosis. Antimicrob Agents Chemother, 2019, 63(11):e00463-19. doi: 10.1128/AAC00463-19. doi: 10.1128/AAC00463-19
[10]	Svensson EM, Dosne AG, Karlsson MO. Population pharmacokinetics of bedaquiline and metabolite M2 in patients with drug resistant tuberculosis: the effect of time-varying weight and albumin. CPT Pharmacometrics Syst Pharmacol, 2016, 5(12):682-691. doi: 10.1002/psp4.12147. doi: 10.1002/psp4.12147 URL
[11]	Alghamdi WA, Al-Shaer MH, Kipiani M, et al. Pharmacokinetics of bedaquiline, delamanid and clofazimine in patients with multidrug-resistant tuberculosis. J Antimicrob Chemother, 2021, 76(4):1019-1024. doi: 10.1093/jac/dkaa550. doi: 10.1093/jac/dkaa550 pmid: 33378452
[12]	McLeay SC, Vis P, van Heeswijk RP, et al. Population pharmacokinetics of bedaquiline (TMC207), a novel antituberculosis drug. Antimicrob Agents Chemother, 2014, 58(9):5315-5324. doi: 10.1128/AAC01418-013. doi: 10.1128/AAC.01418-13 pmid: 24957842
[13]	Svensson EM, Karlsson MO. Modelling of mycobacterial load reveals bedaquiline’s exposure-response relationship in patients with drug-resistant TB. J Antimicrob Chemother, 2017, 72(12):3398-3405. doi: 10.1093/jac/dkx317. doi: 10.1093/jac/dkx317 pmid: 28961790
[14]	Tanneau L, Karlsson MO, Svensson EM. Understanding the drug-exposure relationship of bedaquiline to predict efficacy for novel dosing regimens in the treatment of multidrug resistant tuberculosis. Br J Clin Pharmacol, 2020, 86(5):913-922. doi: 10.1111/bcp.14199. doi: 10.1111/bcp.14199 pmid: 31840278
[15]	Winter H, Egizi E, Murray S, et al. Evaluation of the pharmacokinetic interaction between repeated doses of rifapentine or rifampin and a single dose of bedaquiline in healthy adult subjects. Antimicrob Agents Chemother, 2015, 59(2):1219-1224. doi: 10.1128/AAC04171-14. doi: 10.1128/AAC.04171-14 pmid: 25512422
[16]	Svensson EM, Murray S, Karlsson MO, et al. Rifampicin and rifapentine significantly reduce concentrations of bedaquiline a new TB drug. J Antimicrob Chemother, 2015, 70(4):1106-1114. doi: 10.1093/jac/dku504. doi: 10.1093/jac/dku504 pmid: 25535219
[17]	Healan AM, Griffiss JM, Proskin HM, et al. Impact of rifabutin or rifampin on bedaquiline safety, tolerability, and pharmacokinetics assessed in a randomized clinical trial with healthy adult volunteers. Antimicrob Agents Chemother, 2018, 62(1):e00855-17. doi: 10.1128/AAC.00855-17. doi: 10.1128/AAC.00855-17
[18]	Healan AM, Salata RA, Griffiss JM, et al. Effects of rifamycin coadministration on bedaquiline desmethylation in healthy adult volunteers. Clin Pharmacol Drug Dev, 2019, 8(4):436-442. doi: 10.1002/cpdd.639. doi: 10.1002/cpdd.639 URL
[19]	Dooley KE, Park JG, Swindells S, et al. Safety, tolerability, and pharmacokinetic interactions of the antituberculosis agent TMC207 (bedaquiline) with efavirenz in healthy volunteers: AIDS Clinical Trials Group study A5267. J Acquir Immune Defic Syndr, 2012, 59(5):455-462. doi: 10.1097/QAI.0b013e3182 410503. doi: 10.1097/QAI.0b013e3182410503 pmid: 22126739
[20]	Svensson EM, Aweeka F, Park JG, et al. Model-based estimates of the effects of efavirenz on bedaquiline pharmacokinetics and suggested dose adjustments for patients coinfected with HIV and tuberculosis. Antimicrob Agents Chemother, 2013, 57(6):2780-2787. doi: 10.1128/AAC00 191-113. doi: 10.1128/AAC.00191-13 pmid: 23571542
[21]	O’Donnell MR, Padayatchi N, Daftary A, et al. Antiretroviral switching and bedaquiline treatment of drug-resistant tuberculosis HIV co-infection. Lancet HIV, 2019, 6(3):e201-204. doi: 10.1016/S2352-3018(19) 30035-9. doi: 10.1016/S2352-3018(19) 30035-9 URL
[22]	Svensson EM, Dooley KE, Karlsson MO. Impact of lopinavir-ritonavir or nevirapine on bedaquiline exposures and potential implications for patients with tuberculosis-HIV coinfection. Antimicrob Agents Chemother, 2014, 58(11):6406-6412. doi: 10.1128/AAC03246-14. doi: 10.1128/AAC.03246-14 pmid: 25114140
[23]	Maartens G, Brill MJE, Pandie M, et al. Pharmacokinetic interaction between bedaquiline and clofazmine in patients with drug-resistant tuberculosis. Int J Tuberc Lung Dis, 2018, 22(1):26-29. doi: 10.5588/ijtld.17.0615. doi: 10.5588/ijtld.17.0615 pmid: 29145924
[24]	Yao R, Wang B, Fu L, et al. Sudapyridine (WX-081), a Novel Compound against Mycobacterium tuberculosis. Microbiol Spectr, 2022, 10(1):e0247721. doi: 10.1128/spectrum.02477-21. doi: 10.1128/spectrum.02477-21 URL