Comparison of Individual Regimen Containing Bedaquiline with Delamanid and Bedaquiline without Delamanid on Efficacy and Safety in Multidrug-resistant Tuberculosis Patients: Implementation in Dr. Soetomo General Academic Hospital, Indonesia.
Humans
Nitroimidazoles
/ therapeutic use
Diarylquinolines
/ therapeutic use
Oxazoles
/ therapeutic use
Tuberculosis, Multidrug-Resistant
/ drug therapy
Antitubercular Agents
/ therapeutic use
Retrospective Studies
Female
Adult
Male
Middle Aged
Indonesia
Treatment Outcome
Young Adult
Drug Therapy, Combination
Mycobacterium tuberculosis
/ drug effects
Adolescent
Aged
Journal
International journal of mycobacteriology
ISSN: 2212-554X
Titre abrégé: Int J Mycobacteriol
Pays: India
ID NLM: 101615660
Informations de publication
Date de publication:
01 Apr 2024
01 Apr 2024
Historique:
received:
18
04
2024
accepted:
28
05
2024
medline:
25
6
2024
pubmed:
25
6
2024
entrez:
25
6
2024
Statut:
ppublish
Résumé
Bedaquiline is one of the core drugs used to treat multidrug-resistant TB (MDR-TB). Delamanid is one of the companion drugs in group C which is used to complete the treatment regimen when drugs in groups A and B can not be used. This study was conducted to analyze the efficacy and safety between individual regimens containing bedaquiline with delamanid and bedaquiline without delamanid. This was an observational analytic study with a retrospective design in MDR-TB patients treated with individual regimens containing bedaquiline with delamanid (bedaquiline-delamanid group) and bedaquiline without delamanid (bedaquiline group). Efficacy was measured according to the time to Acid Fast Bacilli (AFB) conversion and Mycobacterium tuberculosis culture conversion, while safety was measured specifically on QTc interval prolongation. The median (range) time to AFB conversion in bedaquiline-delamanid group was faster than bedaquiline group, although there was no significant difference (1.5 (1-4) months vs. 1 (1-6) months, P=0.429), the median time to culture conversion in bedaquiline-delamanid group also faster than bedaquiline group, although there was no significant difference (1 (1-6) months vs. 2 (1-6) months, P=0.089). The incidence of QTc interval prolongation in bedaquiline-delamanid group was less than bedaquiline group, although there was no significant difference (26.9% vs. 40.3%, P=0.223). Individual regimens containing bedaquiline with delamanid was proven to provide similar efficacy and safety profiles with individual regimens containing bedaquiline without delamanid. Delamanid should be preferred when selecting drugs to complete the treatment regimen when drugs in groups A and B can not be used.
Sections du résumé
BACKGROUND
BACKGROUND
Bedaquiline is one of the core drugs used to treat multidrug-resistant TB (MDR-TB). Delamanid is one of the companion drugs in group C which is used to complete the treatment regimen when drugs in groups A and B can not be used. This study was conducted to analyze the efficacy and safety between individual regimens containing bedaquiline with delamanid and bedaquiline without delamanid.
METHODS
METHODS
This was an observational analytic study with a retrospective design in MDR-TB patients treated with individual regimens containing bedaquiline with delamanid (bedaquiline-delamanid group) and bedaquiline without delamanid (bedaquiline group). Efficacy was measured according to the time to Acid Fast Bacilli (AFB) conversion and Mycobacterium tuberculosis culture conversion, while safety was measured specifically on QTc interval prolongation.
RESULTS
RESULTS
The median (range) time to AFB conversion in bedaquiline-delamanid group was faster than bedaquiline group, although there was no significant difference (1.5 (1-4) months vs. 1 (1-6) months, P=0.429), the median time to culture conversion in bedaquiline-delamanid group also faster than bedaquiline group, although there was no significant difference (1 (1-6) months vs. 2 (1-6) months, P=0.089). The incidence of QTc interval prolongation in bedaquiline-delamanid group was less than bedaquiline group, although there was no significant difference (26.9% vs. 40.3%, P=0.223).
CONCLUSIONS
CONCLUSIONS
Individual regimens containing bedaquiline with delamanid was proven to provide similar efficacy and safety profiles with individual regimens containing bedaquiline without delamanid. Delamanid should be preferred when selecting drugs to complete the treatment regimen when drugs in groups A and B can not be used.
Identifiants
pubmed: 38916383
doi: 10.4103/ijmy.ijmy_88_24
pii: 01929415-202413020-00004
doi:
Substances chimiques
bedaquiline
78846I289Y
Nitroimidazoles
0
Diarylquinolines
0
Oxazoles
0
Antitubercular Agents
0
OPC-67683
0
Types de publication
Journal Article
Observational Study
Comparative Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
140-146Informations de copyright
Copyright © 2024 Copyright: © 2024 International Journal of Mycobacteriology.
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