Comparison of QTc interval changes in drug-resistant tuberculosis patients on delamanid-containing regimens versus shorter treatment regimens.

BACKGROUND: Delamanid (DLM) is a relatively new drug for drug-resistant tuberculosis (DR-TB) that has been used in Indonesia since 2019 despite its limited safety data. DLM is known to inhibit hERG potassium channel with the potential to cause QT prolongation which eventually leads to Torsades de pointes (TdP). OBJECTIVE: This study aims to analyse the changes of QTc interval in DR-TB patients on DLM regimen compared to shorter treatment regimens (STR). METHODS: A retrospective cohort was implemented on secondary data obtained from two participating hospitals. The QTc interval and the changes in QTc interval from baseline (ΔQTc) were assessed every 4 weeks for 24 weeks. RESULTS: The maximum increased of QTc interval and ΔQTc interval were smaller in the DLM group with mean difference of 18,6 (95%CI 0.3 to 37.5) and 31.6 milliseconds (95%CI 14.1 to 49.1) respectively. The proportion of QTc interval prolongation in DLM group were smaller than STR group (RR=0.62; 95%CI 0.42 to 0.93). CONCLUSION: This study has shown that DLM regimens are less likely to increase QTc interval compared to STR. However, close monitoring of the risk of QT interval prolongation needs to be carried out upon the use of QT interval prolonging antituberculoid drugs.

Bedaquiline Effect on QT Interval of Drugs-Resistant Tuberculosis Patients: Real World Data.

BACKGROUND: Bedaquiline (BDQ) is effective as part of treatment regimen for drug-resistant tuberculosis (DR-TB), but the cardiac safety profile of BDQ is not fully elucidated. This study aimed to analyse the cardiac safety of BDQ by examining its effect on the QT interval of DR-TB patients. METHODS: This is a retrospective study cohort conducted in two DR-TB referral hospitals in Indonesia. The QT interval before and after therapy using BDQ was measured manually and corrected using the Fridericia formula (QTcF). The QT interval profile was analysed over time during BDQ treatment. RESULTS: A total of 105 subjects participated in the study. The maximum mean difference (standard deviation) of QTcF after treatment with the baseline (∆QTcF) is 34,06 (52,92) ms after three months of therapy. During BDQ treatment, clinically significant QTcF prolongations was observed in 37.1% subjects with neither arrhythmia nor any other adverse cardiac event occurred. The interval QT prolongation led to BDQ discontinuation in 15.2% subjects temporarily and in 6.7% subjects permanently. There were seven deaths (6.7%) during the treatment. CONCLUSION: During BDQ treatment, maximum QT prolongation was observed after three months of BDQ therapy. Therefore, more intensive cardiac monitoring is recommended during this period and afterwards.

Fat and vitamin E intake affect multidrug-resistant tuberculosis patients' quality of life: A cross-sectional study.

OBJECTIVE: To determine the association between fat and vitamin E intake with quality of life in patients with pulmonary MDR-TB. METHODS: This was a cross-sectional study conducted at Dr. M. Goenawan Partowidig do Hospital, Cisarua, Indonesia, from April to May 2019. Ninety-two patients were enrolled in this study. Fat intake was assessed using 24 hours food recall, vitamin E intake was assessed using a semi-quantitative food frequency questionnaire (FFQ), and quality of life was obtained by a short form 36 questionnaire (SF 36). Data were analyzed using Pearson and Spearman correlation test. RESULTS: Subjects' mean fat intake was 32.9 ± 11.1% of total calories per-day, which meant that most of the subjects consumed enough fat. Mean vitamin E intake was 4.6 ± 2.7 mg/day, which did not meet the recommended dietary allowance (RDA). The mean quality of life score was 47.22 ± 14.9. There was a significant association between fat intake and quality of life (r = 0.22; p = 0.032) and vitamin E intake with quality of life (r = 0.22, p = 0.035). CONCLUSIONS: There is a significant association between fat and vitamin E intake with quality of life among pulmonary MDR-TB patients. Further research is needed to evaluate the intervention by modifying food intake and giving vitamin E to MDR-TB patients.