Bedaquiline for multidrug-resistant TB in paediatric patients
| Autor: | R. Moodliar, V. Aksenova, M. V. G. Frias, J. van de Logt, S. Rossenu, E. Birmingham, S. Zhuo, G. Mao, N. Lounis, C. Kambili, N. Bakare, null on behalf of the TMC207-C211 study group |
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| Rok vydání: | 2021 |
| Předmět: |
Adult
Pulmonary and Respiratory Medicine medicine.medical_specialty Adolescent medicine.drug_class Extensively Drug-Resistant Tuberculosis Antitubercular Agents MDR-TB Antimycobacterial chemistry.chemical_compound Pharmacokinetics Internal medicine Tuberculosis Multidrug-Resistant BDQ/TMC207 Humans Medicine Diarylquinolines Child Paediatric patients business.industry Original Articles children/adolescents Treatment Outcome Infectious Diseases chemistry Tolerability safety/tolerability Cohort Multidrug-Resistant TB Bedaquiline business pharmacokinetics Dose selection |
| Zdroj: | The International Journal of Tuberculosis and Lung Disease |
| ISSN: | 1027-3719 |
| DOI: | 10.5588/ijtld.21.0022 |
| Popis: | BACKGROUND: TMC207-C211 (NCT02354014) is a Phase 2, open-label, multicentre, single-arm study to evaluate pharmacokinetics, safety/tolerability, antimycobacterial activity and dose selection of bedaquiline (BDQ) in children (birth to METHODS: Patients received 24 weeks’ BDQ with an anti-MDR-TB background regimen (BR), followed by 96 weeks of safety follow-up. Results of the primary analysis are presented based on data up to 24 weeks for Cohort 1 (≥12–RESULTS: Both cohorts had 15 patients, of whom respectively 53% and 40% of Cohort 1 and Cohort 2 children had confirmed/probable pulmonary MDR-TB. Most patients completed 24 weeks´ BDQ/BR treatment (Cohort 1: 93%; Cohort 2: 67%). Geometric mean BDQ area under the curve 168h values of 119,000 ng.h/mL (Cohort 1) and 118,000 ng.h/mL (Cohort 2) at Week 12 were within 60–140% (86,200–201,000 ng.h/mL) of adult target values. Few adverse event (AE) related discontinuations or serious AEs, and no QTcF >460 ms during BDQ/BR treatment or deaths occurred. Of MGIT-evaluable patients, 6/8 (75%) Cohort 1 and 3/3 (100%) Cohort 2 culture converted.CONCLUSION: In children and adolescents aged ≥5– |
| Databáze: | OpenAIRE |
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