Use of delamanid for M/XDR-TB treatment under programmatic conditions in Latvia

Introduction. Since 2014 Delamanid (Dlm) was introduced in M/XDR-TB treatment under programmatic conditions. The aim of this study was to analyse experience of Dlm use. Methods. For all MDR-TB cases treatment regimens (Tx) are designed by MDR-TB expert committee. Dlm is prescribed for patients with risk of failure of Tx due to resistance or severe intolerance of key 2 nd line drugs. We analysed clinical and demographic data for all patients who received Dlm during the period of July 2014 to February 2016. Data were collected from patient9s medical records. Results. In total 20 MDR TB patients received Dlm: 3 female and 17 male with median age 46 years, including 2 children (11 and 13 years old). Newly diagnosed-12 patients and 8 previously treated for TB. Resistance pattern for study group-ethambutol 95%, pyrazinamide 85%, kanamycin 60%, capreomycin 65%, amikacin 55%, levofloxacin 50%, moxifloxacin 25%, linezolid 0%, etionamide 50%, cycloserine 15%, PAS 50%. 14 patients have finished treatment with Dlm with median duration of 209 days, 6 are cured, one was lost to follow up. The duration of Dlm use was extended beyond 6 months for 50% of patients. For paediatric cases the duration of Dlm was 6 months with 12 months total duration of Tx. There were 4 adverse events that were possibly related to Dlm. Two patients had QTc interval higher than 450ms,but none increased above 500ms. Conclusions. With Dlm now it is possible to prescribe effective Tx even for complicated M/XDR-TB patients. Our experience shows that due to limited Tx options there is clear indication to extend Dlm use beyond 6 months. Although numbers are limited experience so far indicates that Dlm is safe drug for all patients, including children.