期刊
JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY
卷 69, 期 9, 页码 2310-2318出版社
OXFORD UNIV PRESS
DOI: 10.1093/jac/dku171
关键词
tuberculosis; clinical trials; CYP3A; HIV
资金
- Janssen Infectious Diseases BVBA (Belgium)
- Janssen Infectious Diseases BVBA
Bedaquiline has recently been approved for the treatment of pulmonary multidrug-resistant tuberculosis (TB) as part of combination therapy in adults. It is metabolized primarily by the cytochrome P450 isoenzyme 3A4 (CYP3A4) to a less-active N-monodesmethyl metabolite. Phase I and Phase II studies in healthy subjects and patients with drug-susceptible or multidrug-resistant TB have assessed the pharmacokinetics and drug-drug interaction profile of bedaquiline. Potential interactions have been assessed between bedaquiline and first-and second-line anti-TB drugs (rifampicin, rifapentine, isoniazid, pyrazinamide, ethambutol, kanamycin, ofloxacin and cycloserine), commonly used antiretroviral agents (lopinavir/ritonavir, nevirapine and efavirenz) and a potent CYP3A inhibitor (ketoconazole). This review summarizes the pharmacokinetic profile of bedaquiline as well as the results of the drug-drug interaction studies.
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