Bedaquiline in the treatment of extensively drugresistant tuberculosis

Abstract

Introduction. Extensive drug resistance (XDR) M. Tuberculosis (MBT) is considered the main factor that reduces the effectiveness of the treatment of TB patients around the world, including Russia. A significant role in improving the effectiveness of chemotherapy (CT) in people with resistant TB belongs to the introduction of new anti-TB drugs, the first of which was bedaquiline (LP-002281).Objective. To assess the profile of an XDR-TB patient receiving bedaquiline and the efficacy of chemotherapy regimens including bedaquiline in patients with XDR pulmonary tuberculosis.Materials and methods. The study is retrospective, non-comparative, descriptive. The data of 88 patients who received bedaquiline in the XDR-TB treatment regimen in anti-tuberculosis institutions of the Saratov region in 2017–2018.Results. Patients with chronic TB prevailed – 50/88 [56.8%, 95% CI 46.3–67.4], every fourth patient had a history of surgery. The cessation of bacterial excretion, confirmed by bacterioscopy, was achieved in 51/67 [76.1%, 95% CI 65.7–86.5] patients; by cultural method – in 47/67 [70,1%, 95% CI 59.0–81.3]. Negative sputum smear in a significant proportion of patients 43/51 [84.3%, 95% CI 52.4–75.9] was observed after 12 weeks of therapy, negative cultures in 36/47 [76.6%, 95% CI 41.6–65.9] – after 16 weeks.Discussion. Compared to individual patient analyzes – 43% success rate in the treatment of XDR-TB, in our cohort of XDR-TB patients treated with bedaquiline, the success rate was 53.4%, which is consistent with data from a large study describing the safety in 2017, tolerability and efficacy of bedaquiline and could be higher in the absence of “discontinuations from treatment”.Conclusion. The regimens of treatment of patients with XDR-tuberculosis with the inclusion of bedaquiline are effective in terms of the termination of bacterial excretion, confirmed by bacterioscopy and culture in patients with a complex course of a specific process with previous ineffective therapy.

Efficacy of Tuberculosis Treatment in Patients with Drug-Resistant Tuberculosis with the Use of Bedaquiline: The Experience of the Russian Federation

“…The difference lies in the formation of treatment regimens taking into account the available anti-TB drugs, as well as the end of studies after 24–26 weeks of the intensive phase of therapy with bedaquiline. A few researchers were able to get data regarding the efficacy of therapy and long-term results of treatment after the end of the main course of treatment, including a comparison of the results obtained in patients with MDR TB and XDR TB [ 27 , 30 , 36 , 37 ].…”

“…When analyzing the data obtained, we noted the absence of a comprehensive description of comorbidities among patients in some studies. Unfortunately, long-term results of treatment patients with MDR and XDR were carried out only in five studies [ 25 , 26 , 30 , 35 , 36 , 37 ]. In other studies, data analysis was carried out until the end of the drug intake.…”

“… The efficacy of the TB treatment with the use of bedaquiline by the end of 24–26 weeks of therapy. Borisov et al [ 22 ], Morozova et al [ 23 ], Balasanyantzh [ 24 ], Lepshina et al [ 26 ], Konovalova et al [ 27 ], Kondakova et al [ 28 ], Tihonova et al [ 29 ], Borisov et al [ 30 ], Golubchikov et al [ 31 ], Danilova et al [ 32 ], Danilova et al [ 32 ], Stavickaya et al [ 33 ], Yablonskiy et al [ 35 ], Starshinova et al [ 36 ], Morozova et al [ 37 ]). …”