Adverse events in patients with MDR TB, treated by three types of the chemotherapy regimens

<b>Background:</b> The new regimens for MDR TB, presented by WHO in 2018, August, are promising, but their feasibility, depended on safety, isn’t tested enough in real-life conditions. <b>Methods:</b> The retrospective/prospective study include 205 pts with pulmonary MDR TB (18-78 y.o., 64.4% male), divided in 3 groups: “classic” optimized basic regimen (OBR) – 80 pts, OBR and 1-2 of the “fifth group drugs” – 51 pts (OBR+) and the “modern regimen”, based on Bdq Lnz Mox/Lev Cycl with 1-2 other second-line drugs (MR – 74 pts). The groups were equal by gender, age and concomitant diseases (about 50% – COPD; gastrointestinal, liver and heart diseases – about 20% each). Patients on MR had longer history of TB (&gt;5 years in 32.4% vs 12,5% on OBR and 19,6% on OBR+) and the higher rate of previously outcome “treatment failure” (34.3% vs 8.8% and 21.6%, accordingly). <b>Results:</b> No differences between 3 regimens were obtained in number of pts both with all adverse events (AE) (OBR – 61.3%, OBR+ – 68.6%, MR – 67.6%, p=0.61) and seriously AE (III-IV): 17.5%, 19.6% and 16.2%, accordingly, p=0.89). The AE spectrum had the minimal variation: allergic reactions were more often (p&lt;0.001) in the OBR+ (47,1%) and MR (39.2%), then in OBR (25.0%), but the hepatotoxicity – in OBR (33.8%, p=0,03), then in OBR+ (21.6%) and MR (23.0%). Chemotherapy was totally interrupted due to the SAE (from 3 days up to 4 weeks) in 13.8% on OBR, 9.8% on BOR+ and 9.5% – MR (p=0.66). <b>Conclusion:</b> Inclusion of the new drugs in MDR TB treatment regimens didn’t increase the number of AE and SAE and didn’t substantially modify or extend the AE/SAE spectrum. So, the new regimen can be widely implemented in the all categories of patients.