Effectiveness and safety of regimen containing bedaquiline and delamanid in patients with drug-resistant tuberculosis.

Abstract

Background: Bedaquiline and delamanid have been included in the individualized treatment regimen (ITR) to treat patients with drug-resistant tuberculosis (DR-TB).

Objective: The objective of this study is to compare the effectiveness of sputum culture conversion and the safety of ITR containing bedaquiline and delamanid.

Methods: Data were collected retrospectively from medical records of DR-TB patients who received ITR between January 2020 and December 2021. Patients were divided into bedaquiline and bedaquiline-delamanid groups. Sputum culture was evaluated until 6 months of treatment. Measurement of QTc interval, renal and liver function test, and serum potassium were evaluated to assess safety during the study period. We used Chi-square to analyze a difference in cumulative culture conversion; meanwhile, Wilcoxon and Mann-Whitney tests were used to analyze differences in laboratory data for each and between the two groups, respectively.

Results: Fifty-one eligible DR-TB patients met the inclusion criteria, 41 in the bedaquiline and 10 in bedaquiline-delamanid group. 43/51 patients had a positive culture at baseline. After 6 months of treatment, 42/43 DR-TB patients (97.6%) had sputum culture conversion and no difference between the two groups (P ≥ 0.05). QTc interval within normal limit and no patient had a QTc >500 ms during the study period. Creatinine levels significantly differed between the two groups 6 months after treatment (P < 0.05).

Conclusion: DR-TB patients who received all oral ITR containing bedaquiline and or delamanid demonstrated favorable sputum conversion with a tolerable safety profile.