title: Clinical benefit of delamanid (OPC-67683) in the treatment of multidrug-resistant tuberculosis patients in China.
abstract: The cure rates are much lower for multidrug-resistant (MDR) tuberculosis (TB) patients. Delamanid (OPC-67683) has been evaluated in phase-II MDR-TB clinical trials. Herein, we reviewed MDR-TB cases in which treatment regimens, with/without delamanid, were administered. Thirty-eight patients were enrolled; 26 received delamanid-containing regimens (treatment group) while 12 received placebo-containing regimens (control group) for 56 days. Data regarding clinical/radio-microbiological characteristics, drug tolerability, and treatment outcomes were collected. We found that all patients had isolates resistant to a median of 5 (range 2-7) drugs; 24 (92.3%) patients in treatment group and 11 (91.7%) in control group had cavities. Culture conversion was obtained in 32 pulmonary TB cases (median 74.5 days). At data censure, 30/38 patients successfully completed therapy with documented negative cultures for at least 18 months before the end of treatment. Two patients (5 consecutive negative cultures) are still on treatment. Six patients had poor outcome (3 failures/2 lost/1 death). In 13 patients, adverse events were observed that included mental disorder, QT interval prolongation, and increased blood cortisol whereas only 3 patients stopped delamanid treatment because of adverse events. It was, therefore, concluded that delamanid was well-tolerated, had low rates of discontinuation, and could be effective for treating MDR-TB.
authors.affiliation: Tuberculosis Diagnosis and Treatment Center, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.
authors.forename: Qing
authors.initials: Q
authors.lastname: Zhang
authors.forename: Yidian
authors.initials: Y
authors.lastname: Liu
authors.forename: Shenjie
authors.initials: S
authors.lastname: Tang
authors.forename: Wei
authors.initials: W
authors.lastname: Sha
authors.forename: Heping
authors.initials: H
authors.lastname: Xiao
mesh_terms: D000293:Adolescent; D000328:Adult; D000995:Antitubercular Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002681:China; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D001523:Mental Disorders / Q000209:etiology; D008875:Middle Aged; D009593:Nitroimidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D010080:Oxazoles / Q000009:adverse effects / Q000627:therapeutic use*; D015990:Placebo Effect; D007319:Sleep Initiation and Maintenance Disorders / Q000209:etiology; D016896:Treatment Outcome; D018088:Tuberculosis, Multidrug-Resistant / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D000995:Antitubercular Agents; D009593:Nitroimidazoles; C516022:OPC-67683; D010080:Oxazoles