Results of treatment with bedaquiline containing regimens of MDR/XDR tuberculosis patients including those with concurrent HIV infection (the experience of Leningrad Region)

Abstract

The effectiveness of tuberculosis control is associated with efficacy of treatment of TB patients and above all patients with multiple and extensive drug resistance (MDR/XDR MTB). Patients with TB/HIV co-infection providethe significant impact on the situation.The objective of the studyis to assess outcomes of chemotherapy regimens containing bedaquiline in patients with MDR/XDR TB including those with concurrent HIV infection.Subjects and methods. The efficacy and safety of the regimes containing bedaquiline were assessed in the intensive phase of chemotherapy in 80 patients with MDR/XDR TB: Group1 consisted of 46 patients with negative HIV status (ICD10 code A15-A19); Group 2 – 34 HIV positive patients at the advanced stage with manifestations of a mycobacterial infection (ICD10 code B20.0).Results. Treatment outcomes in the groups were as follows: the effective treatment was statistically significantly more frequent in Group 1 versus Group 2 (80.4 and 52.9%, respectively, p = 0.0088). Treatment failure was registered in 3 patients from each group; treatment defaults were statistically significantly more frequent in Group 2 compared to Group 1: in 8/34 versus 2/46 (p = 0.011). 3 patients were transferred out in both Group 1 and Group 2 (3/46 and 3/34, p = 0.69). During treatment, only 1 patient from Group 2 developed an adverse event, most likely associated with the in-take of bedaquiline, a heart rhythm disorder (ventricular arrhythmia) and prolongation of QTcF > 450 ms.