Open forum infectious diseases · 2025
A Prospective Cohort Study on the Usage, Safety, and Efficacy of Delamanid in Patients With Pulmonary Multidrug-Resistant Tuberculosis in South Korea.
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Mok Jeongha, Seo Haesook, Cho Youngsoo, Lee Taehoon, Kim Sang-Ha, Park Hye Kyeong, Oh Jee Youn, Shim Tae Sun
Аннотация
BACKGROUND: Delamanid has demonstrated potential in the treatment of multidrug-resistant (MDR) or rifampicin-resistant tuberculosis (TB); however, real-world data on its effectiveness and safety remain limited.
METHODS: This prospective cohort study enrolled patients with pulmonary MDR-TB who were treated with a delamanid-containing longer regimen under programmatic conditions in South Korea between 2017 and 2021. Data on delamanid usage, safety, and efficacy were analyzed separately.
RESULTS: In total, 147 patients were included in the usage and safety analyses (mean age, 50.7 years; 60.5% male). Adherence to delamanid was high, with a median adherence of 100.0%; 98.6% (n = 145) of the patients received more than 80% of the prescribed dose. Delamanid-related adverse events (AEs) occurred in 44.2% (n = 65) of patients, with the most common AEs being nausea (10.9%), pruritus (6.8%), and QT interval prolongation (6.1%). Serious delamanid-related AEs were reported in 4.1% (n = 6) of the patients, and QTcF intervals exceeding 500 ms were observed in 6.8% (n = 10) during treatment. For the efficacy analysis, 105 and 122 patients were included in the treatment response (at the end of delamanid treatment) and treatment outcome (at the end of MDR-TB treatment) evaluations, respectively. Among those who were culture-positive at baseline, 92.0% achieved sputum culture conversion during delamanid treatment. The overall treatment success rate was 86.9%.
CONCLUSIONS: Delamanid demonstrated favorable safety and efficacy profiles for MDR-TB treatment under programmatic conditions, providing valuable and up-to-date evidence supporting its promising role in MDR-TB management.
METHODS: This prospective cohort study enrolled patients with pulmonary MDR-TB who were treated with a delamanid-containing longer regimen under programmatic conditions in South Korea between 2017 and 2021. Data on delamanid usage, safety, and efficacy were analyzed separately.
RESULTS: In total, 147 patients were included in the usage and safety analyses (mean age, 50.7 years; 60.5% male). Adherence to delamanid was high, with a median adherence of 100.0%; 98.6% (n = 145) of the patients received more than 80% of the prescribed dose. Delamanid-related adverse events (AEs) occurred in 44.2% (n = 65) of patients, with the most common AEs being nausea (10.9%), pruritus (6.8%), and QT interval prolongation (6.1%). Serious delamanid-related AEs were reported in 4.1% (n = 6) of the patients, and QTcF intervals exceeding 500 ms were observed in 6.8% (n = 10) during treatment. For the efficacy analysis, 105 and 122 patients were included in the treatment response (at the end of delamanid treatment) and treatment outcome (at the end of MDR-TB treatment) evaluations, respectively. Among those who were culture-positive at baseline, 92.0% achieved sputum culture conversion during delamanid treatment. The overall treatment success rate was 86.9%.
CONCLUSIONS: Delamanid demonstrated favorable safety and efficacy profiles for MDR-TB treatment under programmatic conditions, providing valuable and up-to-date evidence supporting its promising role in MDR-TB management.