TY - JOUR
T1 - Bedaquiline Drug Resistance Emergence Assessment in Multidrug-Resistant Tuberculosis (MDR-TB)
T2 - a 5-Year Prospective in Vitro Surveillance Study of Bedaquiline and Other Second-Line Drug Susceptibility Testing in MDR-TB Isolates
AU - Kaniga, Koné
AU - Hasan, Rumina
AU - Jou, Ruwen
AU - Vasiliauskienė, Edita
AU - Chuchottaworn, Charoen
AU - Ismail, Nazir
AU - Metchock, Beverly
AU - Miliauskas, Skaidrius
AU - Nhung, Nguyen Viet
AU - Rodrigues, Camilla
AU - Shin, Soyoun
AU - Simsek, Hulya
AU - Smithtikarn, Saijai
AU - Le Thi Ngoc, Anh
AU - Boonyasopun, Jirakan
AU - Kazi, Mubin
AU - Kim, Seungmo
AU - Kamolwat, Phalin
AU - Musteikiene, Greta
AU - Sacopon, Catherine Ann
AU - Tahseen, Sabira
AU - Vasiliauskaitė, Laima
AU - Wu, Mei Hua
AU - Omar, Shaheed Vally
N1 - Publisher Copyright:
Copyright © 2022 Kaniga et al. This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International license.
PY - 2022/1
Y1 - 2022/1
N2 - Bedaquiline Drug Resistance Emergence Assessment in Multidrug-resistant tuberculosis (MDR-TB) (DREAM) was a 5-year (2015 to 2019) phenotypic drug resistance surveillance study across 11 countries. DREAM assessed the susceptibility of 5,036 MDR-TB isolates of bedaquiline treatment-naive patients to bedaquiline and other antituberculosis drugs by the 7H9 broth microdilution (BMD) and 7H10/7H11 agar dilution (AD) MIC methods. Bedaquiline AD MIC quality control (QC) range for the H37Rv reference strain was unchanged, but the BMD MIC QC range (0.015 to 0.12 mg/ml) was adjusted compared with ranges from a multilaboratory, multicountry reproducibility study conforming to Clinical and Laboratory Standards Institute Tier-2 criteria. Epidemiological cutoff values of 0.12 mg/ml by BMD and 0.25 mg/ml by AD were consistent with previous bedaquiline breakpoints. An area of technical uncertainty or intermediate category was set at 0.25 mg/ml and 0.5 mg/ml for BMD and AD, respectively. When applied to the 5,036 MDR-TB isolates, bedaquiline-susceptible, -intermediate, and -resistant rates were 97.9%, 1.5%, and 0.6%, respectively, for BMD and 98.8%, 0.8%, and 0.4% for AD. Resistance rates were the following: 35.1% ofloxacin, 34.2% levofloxacin, 33.3% moxifloxacin, 1.5% linezolid, and 2% clofazimine. Phenotypic cross-resistance between bedaquiline and clofazimine was 0.4% in MDR-TB and 1% in pre-extensively drug-resistant (pre-XDR-TB)/XDR-TB populations. Coresistance to bedaquiline and linezolid and clofazimine and linezolid were 0.1% and 0.3%, respectively, in MDR-TB and 0.2% and 0.4%, respectively, in pre-XDR-TB/XDR-TB populations. Resistance rates to bedaquiline appear to be low in the bedaquiline-treatment-naive population. No treatment-limiting patterns for cross-resistance and coresistance have been identified with key TB drugs to date.
AB - Bedaquiline Drug Resistance Emergence Assessment in Multidrug-resistant tuberculosis (MDR-TB) (DREAM) was a 5-year (2015 to 2019) phenotypic drug resistance surveillance study across 11 countries. DREAM assessed the susceptibility of 5,036 MDR-TB isolates of bedaquiline treatment-naive patients to bedaquiline and other antituberculosis drugs by the 7H9 broth microdilution (BMD) and 7H10/7H11 agar dilution (AD) MIC methods. Bedaquiline AD MIC quality control (QC) range for the H37Rv reference strain was unchanged, but the BMD MIC QC range (0.015 to 0.12 mg/ml) was adjusted compared with ranges from a multilaboratory, multicountry reproducibility study conforming to Clinical and Laboratory Standards Institute Tier-2 criteria. Epidemiological cutoff values of 0.12 mg/ml by BMD and 0.25 mg/ml by AD were consistent with previous bedaquiline breakpoints. An area of technical uncertainty or intermediate category was set at 0.25 mg/ml and 0.5 mg/ml for BMD and AD, respectively. When applied to the 5,036 MDR-TB isolates, bedaquiline-susceptible, -intermediate, and -resistant rates were 97.9%, 1.5%, and 0.6%, respectively, for BMD and 98.8%, 0.8%, and 0.4% for AD. Resistance rates were the following: 35.1% ofloxacin, 34.2% levofloxacin, 33.3% moxifloxacin, 1.5% linezolid, and 2% clofazimine. Phenotypic cross-resistance between bedaquiline and clofazimine was 0.4% in MDR-TB and 1% in pre-extensively drug-resistant (pre-XDR-TB)/XDR-TB populations. Coresistance to bedaquiline and linezolid and clofazimine and linezolid were 0.1% and 0.3%, respectively, in MDR-TB and 0.2% and 0.4%, respectively, in pre-XDR-TB/XDR-TB populations. Resistance rates to bedaquiline appear to be low in the bedaquiline-treatment-naive population. No treatment-limiting patterns for cross-resistance and coresistance have been identified with key TB drugs to date.
KW - Bedaquiline
KW - Drug resistance
KW - Drug susceptibility testing
KW - Mycobacterium tuberculosis
KW - Tuberculosis
KW - Variants
UR - http://www.scopus.com/inward/record.url?scp=85123432299&partnerID=8YFLogxK
U2 - 10.1128/JCM.02919-20
DO - 10.1128/JCM.02919-20
M3 - Article
C2 - 34705538
AN - SCOPUS:85123432299
SN - 0095-1137
VL - 60
JO - Journal of Clinical Microbiology
JF - Journal of Clinical Microbiology
IS - 1
M1 - e02919-20
ER -
