TY - JOUR
T1 - Comparison of Individual Regimen Containing Bedaquiline with Delamanid and Bedaquiline without Delamanid on Efficacy and Safety in Multidrug‑resistant Tuberculosis Patients
T2 - Implementation in Dr. Soetomo General Academic Hospital, Indonesia
AU - Soedarsono, Soedarsono
AU - Mertaniasih, Ni Made
AU - Kusmiati, Tutik
AU - Permatasari, Ariani
AU - Subay, Susi
AU - Adiono, Suko Hari
N1 - Publisher Copyright:
© 2024 International Journal of Mycobacteriology | Published by Wolters Kluwer - Medknow.
PY - 2024
Y1 - 2024
N2 - 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: 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: 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: 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.
AB - 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: 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: 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: 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.
KW - Acid‑fast bacilli conversion
KW - Mycobacterium tuberculosis culture conversion
KW - QTc interval prolongation
KW - bedaquiline
KW - delamanid
KW - individual regimen
KW - multidrug‑resistant tuberculosis
UR - http://www.scopus.com/inward/record.url?scp=85196711441&partnerID=8YFLogxK
U2 - 10.4103/ijmy.ijmy_88_24
DO - 10.4103/ijmy.ijmy_88_24
M3 - Article
AN - SCOPUS:85196711441
SN - 2212-5531
VL - 13
SP - 140
EP - 146
JO - International Journal of Mycobacteriology
JF - International Journal of Mycobacteriology
IS - 2
ER -