Outcomes in patients with multidrug- or rifampin-resistant tuberculosis treated with bedaquiline and/or delamanid under the South Korean nationwide approval process

In South Korea, the National Tuberculosis Expert Review Committee (NTBERC) has authorized the use of bedaquiline and delamanid in patients with multidrug-resistant or rifampin-resistant tuberculosis (MDR/RR-TB) since September 1, 2016. We aimed to evaluate the treatment outcomes in patients who used these drugs under NTBERC approval prior to the introduction of short-course all-oral regimens. This nationwide cohort study included patients with pulmonary MDR/RR-TB whose NTBERC-approved treatment included bedaquiline and/or delamanid and was initiated between September 1, 2016, and December 31, 2022. Treatment outcomes were categorized according to 2013 WHO definitions, and the treatment success rate was defined as the proportion of patients in the “cured” and “treatment completed” categories. During the study period, 2,078 patients applied for NTBERC approval, and 1,985 (95.5%) were approved. Among 1,546 patients included patients (median age 54.0 years; 69.0% male), 63.3% had FQ-susceptible TB and 28.5% had FQ-resistant TB; FQ data were unavailable in 8.2%. The median total treatment duration was 19.3 months and was shorter in the FQ-susceptible group than in the FQ-resistant group (19.1 vs. 20.7 months, p < 0.0001). The median duration of bedaquiline and delamanid use was 5.6 months. Patients received a median of 5.0 drugs, and the number of drugs was lower in the FQ-susceptible group than in the FQ-resistant group (5.0 vs. 6.0, p < 0.0001). The overall treatment success rate was 80.0%, with no significant difference between FQ-susceptible and FQ-resistant groups (81.5% vs. 80.3%, p = 0.58). Younger age (<60 years) and higher BMI (≥18.5 kg/m2) were associated with higher odds of treatment success (adjusted odds ratio [aOR] 4.19, 95% confidence interval (CI) [3.16, 5.55]; aOR 2.42, 95% CI [1.77, 3.31]). In contrast, chronic renal failure, bilateral lung involvement, and AFB smear positivity at treatment initiation were associated with lower odds of success (aOR 0.56, 95% CI [0.32, 0.98]; aOR 0.60, 95% CI [0.45, 0.79]; aOR 0.74, 95% CI [0.56, 0.99]). Under South Korea’s nationwide approval process, longer individualized regimens containing bedaquiline and/or delamanid achieved acceptable treatment success rate in patients with MDR/RR-TB, including patients with FQ resistance. Not applicable. Retrospectively registered