Bedaquiline: a review of human pharmacokinetics and drug-drug interactions

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...

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Vydané v:Journal of antimicrobial chemotherapy Ročník 69; číslo 9; s. 2310
Hlavní autori: van Heeswijk, R P G, Dannemann, B, Hoetelmans, R M W
Médium: Journal Article
Jazyk:English
Vydavateľské údaje: England 01.09.2014
Predmet:
Antifungal Agents - pharmacology
Antitubercular Agents - pharmacokinetics
Antitubercular Agents - pharmacology
Antiviral Agents - pharmacology
Clinical Trials, Phase I as Topic
Clinical Trials, Phase II as Topic
Diarylquinolines - pharmacokinetics
Diarylquinolines - pharmacology
Drug Interactions
Humans
Tuberculosis, Multidrug-Resistant - drug therapy
CYP3A
clinical trials
HIV
tuberculosis
ISSN:1460-2091, 1460-2091
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Abstract 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.
AbstractList 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.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.
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.
Author Dannemann, B
Hoetelmans, R M W
van Heeswijk, R P G
Author_xml – sequence: 1
  givenname: R P G
  surname: van Heeswijk
  fullname: van Heeswijk, R P G
  email: rvheesw1@its.jnj.com
  organization: Janssen Infectious Diseases BVBA, Beerse, Belgium rvheesw1@its.jnj.com
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  surname: Dannemann
  fullname: Dannemann, B
  organization: Janssen Research & Development, LLC, Titusville, NJ, USA
– sequence: 3
  givenname: R M W
  surname: Hoetelmans
  fullname: Hoetelmans, R M W
  organization: Janssen Infectious Diseases BVBA, Beerse, Belgium
BackLink https://www.ncbi.nlm.nih.gov/pubmed/24860154$$D View this record in MEDLINE/PubMed
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Keywords CYP3A
clinical trials
HIV
tuberculosis
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Snippet Bedaquiline has recently been approved for the treatment of pulmonary multidrug-resistant tuberculosis (TB) as part of combination therapy in adults. It is...
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SubjectTerms Antifungal Agents - pharmacology
Antitubercular Agents - pharmacokinetics
Antitubercular Agents - pharmacology
Antiviral Agents - pharmacology
Clinical Trials, Phase I as Topic
Clinical Trials, Phase II as Topic
Diarylquinolines - pharmacokinetics
Diarylquinolines - pharmacology
Drug Interactions
Humans
Tuberculosis, Multidrug-Resistant - drug therapy
Title Bedaquiline: a review of human pharmacokinetics and drug-drug interactions
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