Late Breaking Abstract - Initiation of patient enrollment in treatment with BPaL in Ukraine: first intermediate results

BPaL implementation started in Ukraine in November 2020, with the National Institute for TB and Lung Diseases (TB Institute), under TB Reach “Pilot Study to Evaluate the Effectiveness and Safety of the BPaL Treatment Regimen in Ukraine” project implemented by Organization for Appropriate Technology in Health (OATH) together with KNCV Tuberculosis Foundation (KNCV) as an OR. A patient selection, monitoring system and treatment was conducted according to approved OR Protocol. The International Advisory Council (IAC) was established, comprising National TB Institute, OATH, KNCV, PATH, and Ukraine9s NTP to ensure efficient selection of patients with pre-XDR-TB or failure/intolerance of previous MDR-TB treatment. As of June 2021, 92 patients were screened and 80 patients were enrolled in the OR. Main reasons for exclusion were: previous treatment with Bdq or Lzd for more than 4 weeks, Lzd resistance, quinolone susceptibility; critically ill with concomitant diseases, no inform consent. There were 12 patients excluded after started treatment and continued BPaL – 68 patients. Totally 45 (66,2 %) patients with AEs were registered, with more than one AEs in 13 patients. 3-4 Grade AEs - in 15 patients. Main AEs registered are - myelosuppression in 26 and hepatotoxicity in 13 patients. Intermediate results of 32 patients who started treatment in November 2020 - January 2021: 5 – excluded; 10 – cured; 1 – died; 1 – LTFU; 15 – are continuing the BPaL with culture conversion in 1-2 months. <b>Conclusions:</b> Ukraine is the first country in the world started implementation of the BPaL under OR conditions with excellent preliminary results