A Prospective Cohort Study on the Usage, Safety, and Efficacy of Delamanid in Patients With Pulmonary Multidrug-Resistant Tuberculosis in South Korea

TL;DR

A study in South Korea found that delamanid is generally safe and effective for treating multidrug-resistant tuberculosis, with most patients adhering to the treatment and achieving positive outcomes.

Contribution

This study provides real-world evidence on delamanid's safety and efficacy in treating MDR-TB under programmatic conditions in South Korea.

Findings

High adherence to delamanid was observed, with 98.6% of patients receiving more than 80% of the prescribed dose.

Delamanid-related adverse events occurred in 44.2% of patients, with serious events in 4.1% and QT interval prolongation in 6.8%.

92.0% of culture-positive patients achieved sputum culture conversion, and the overall treatment success rate was 86.9%.

Abstract

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.

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.

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%.

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.

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