Treatment Outcomes of Patients With Multidrug Resistant / Rifampicin Resistant Tuberculosis Under the Nationwide Approval Process for Bedaquiline or Delamanid Use

Abstract Rationale In South Korea, the National Tuberculosis Expert Review Committee (NTBERC) has authorized the use of newly developed anti-tuberculosis (TB) drug, bedaquiline and delamanid, for patients with multidrug-resistant or rifampin-resistant tuberculosis (MDR/RR-TB) since September 1, 2016. This study aimed to evaluate the treatment outcomes of MDR/RR-TB patients in whom bedaquiline or delamanid use was approved prior to the introduction of short-course all-oral regimens. Methods This nationwide cohort study included patients with pulmonary MDR/RR-TB who initiated treatment with bedaquiline or delamanid in South Korea between September 1, 2016, and December 31, 2022, following NTBERC approval. Treatment outcomes were categorized as cured, treatment completed, treatment failed, died, lost to follow-up, or not evaluated. Treatment success was defined as the sum of the “cured” and “treatment completed” categories. Outcomes were analyzed for the overall cohort and stratified by fluoroquinolone resistance status. Results During the study period, 2,097 patients with pulmonary MDR/RR-TB applied for the use of bedaquiline or delamanid, of whom 1,894 (90.3%) received NTBERC approval. The final analysis included 1,547 patients. The median age was 54.0 years (IQR: 41.0-67.0), and 1,067 patients (69.0%) were male. Among these, 1,103 (71.3%) were susceptible to fluoroquinolones, while 441 (28.5%) were resistant. The overall treatment success rate was 80.0%. There was no significant difference in success rates between the fluoroquinolone-susceptible and fluoroquinolone-resistant groups (79.9% vs. 80.3%, P = 0.859). Younger age (<60 years) (adjusted odds ratio (aOR): 4.12, 95% confidence interval (CI): 3.15-5.54) and higher BMI (≥18.5 kg/m²) (aOR: 2.42, 95% CI: 1.77-3.31) were associated with treatment success. Conclusions Individualized longer regimens incorporating bedaquiline or delamanid under the nationwide approval process achieved high treatment success rates in patients with MDR/RR-TB.